Sertraline 50mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Sertraline hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
N06AB06
INN (International Name):
Sertraline hydrochloride
Dosage:
50mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04030300

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may

harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Sertraline Tablets are and what they are used for

What you need to know before you take Sertraline Tablets

How to take Sertraline Tablets

Possible side effects

How to store Sertraline Tablets

Contents of the pack and other information

1. What Sertraline Tablets are and what they are used for

This medicine is one of a group of antidepressant or anti-obsessional drugs called

the Selective Serotonin Reuptake Inhibitors (SSRIs).

Sertraline is used to treat depression and prevention of recurrence of depression, Panic

disorder, Obsessive Compulsive Disorder (OCD), Social anxiety disorder or Post

Traumatic Stress Disorder (PTSD). It is also used to treat OCD in children and

adolescents aged 6 – 17 years old.

Your doctor has decided that this medicine is suitable for treating your illness.

Depression is a clinical illness. If you have been feeling sad, tearful, unable to sleep

properly or to enjoy life as you used to, Sertraline Tablets may help you to feel better.

It may also help treat the anxiety which may accompany your depression. If you are

not sure why you are on these tablets, ask your doctor.

OCD and Panic disorders are illnesses linked to anxiety. If you have been constantly

troubled by persistent ideas (obsessions) that make you carry out repetitive rituals

(compulsions) Sertraline Tablets may help you. If you are not sure why you are on

these tablets, ask your doctor.

PTSD is a condition that can occur after a very emotionally traumatic experience, and

has some symptoms that are similar to depression and anxiety. If you suffer from

PTSD, Sertraline Tablets may help you.

Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised

by feelings of intense anxiety or distress in social situations (for example: talking to

strangers, speaking in front of groups of people, eating or drinking in front of others

or worrying that you might behave in an embarrassing manner).

The tablets are not sleeping tablets or tranquillisers.

2.

What you need to know before you take sertraline tablets

Do not take Sertraline tablets:

If you are allergic (hypersensitive) to sertraline or any of the other ingredients in

these tablets (see 6. Further Information for a list of ingredients

If you are taking, or have you taken in the last two weeks, any medicines called

monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide or

methylene blue) or MAOI like drugs (such as linezolid). If you stop treatment with

sertraline, you must wait until at least one week before you start treatment with a

MAOI.

If you are taking Pimozide used to treat schizophrenia

Warnings and precautions

Talk to your doctor or pharmacist before taking Sertraline: if you

have diabetes; your blood glucose levels may be altered due to Sertraline and

your diabetes medicines may need to be adjusted.

Serotonin syndrome or Neuroleptic Malignant Syndrome. In rare cases these

syndromes may occur when you are taking certain medicines at the same time as

sertraline.

have low sodium level in your blood measured by a blood test with the doctor.

suffered from bleeding disorders or have been taking medicines which thin the

blood (e.g acetylsalicylic acid aspirin or warfarin) as may increase the risk of

bleeding.

Liver disease as your doctor may decide you should have a lower dose.

are elderly as you may be more at risk of having low sodium level in your

blood.

have kidney failure or kidney dysfunction.

have ever had an epileptic fits

are being or have been treated with electroconvulsive therapy (ECT)

have a history of mania/hypomania

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may

harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Sertraline Tablets are and what they are used for

What you need to know before you take Sertraline Tablets

How to take Sertraline Tablets

Possible side effects

How to store Sertraline Tablets

Contents of the pack and other information

1. What Sertraline Tablets are and what they are used for

This medicine is one of a group of antidepressant or anti-obsessional drugs called

the Selective Serotonin Reuptake Inhibitors (SSRIs).

Sertraline is used to treat depression and prevention of recurrence of depression, Panic

disorder, Obsessive Compulsive Disorder (OCD), Social anxiety disorder or Post

Traumatic Stress Disorder (PTSD). It is also used to treat OCD in children and

adolescents aged 6 – 17 years old.

Your doctor has decided that this medicine is suitable for treating your illness.

Depression is a clinical illness. If you have been feeling sad, tearful, unable to sleep

properly or to enjoy life as you used to, Sertraline Tablets may help you to feel better.

It may also help treat the anxiety which may accompany your depression. If you are

not sure why you are on these tablets, ask your doctor.

OCD and Panic disorders are illnesses linked to anxiety. If you have been constantly

troubled by persistent ideas (obsessions) that make you carry out repetitive rituals

(compulsions) Sertraline Tablets may help you. If you are not sure why you are on

these tablets, ask your doctor.

PTSD is a condition that can occur after a very emotionally traumatic experience, and

has some symptoms that are similar to depression and anxiety. If you suffer from

PTSD, Sertraline Tablets may help you.

Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised

by feelings of intense anxiety or distress in social situations (for example: talking to

strangers, speaking in front of groups of people, eating or drinking in front of others

or worrying that you might behave in an embarrassing manner).

The tablets are not sleeping tablets or tranquillisers.

2.

What you need to know before you take sertraline tablets

Do not take Sertraline tablets:

If you are allergic (hypersensitive) to sertraline or any of the other ingredients in

these tablets (see 6. Further Information for a list of ingredients

If you are taking, or have you taken in the last two weeks, any medicines called

monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide or

methylene blue) or MAOI like drugs (such as linezolid). If you stop treatment with

sertraline, you must wait until at least one week before you start treatment with a

MAOI.

If you are taking Pimozide used to treat schizophrenia

Warnings and precautions

Talk to your doctor or pharmacist before taking Sertraline: if you

have diabetes; your blood glucose levels may be altered due to Sertraline and

your diabetes medicines may need to be adjusted.

Serotonin syndrome or Neuroleptic Malignant Syndrome. In rare cases these

syndromes may occur when you are taking certain medicines at the same time as

sertraline.

have low sodium level in your blood measured by a blood test with the doctor.

suffered from bleeding disorders or have been taking medicines which thin the

blood (e.g acetylsalicylic acid aspirin or warfarin) as may increase the risk of

bleeding.

Liver disease as your doctor may decide you should have a lower dose.

are elderly as you may be more at risk of having low sodium level in your

blood.

have kidney failure or kidney dysfunction.

have ever had an epileptic fits

are being or have been treated with electroconvulsive therapy (ECT)

have a history of mania/hypomania

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline 50 mg and 100 mg Tablets (Film coated)

(sertraline hydrochloride)

2

have or previously had thoughts of suicide or wanting to harm yourself (See

below: Thoughts of suicide, suicidal attempts and worsening of your depression

or anxiety disorder)

are a child or adolescent under 18 years old. Sertraline should only be used to treat

children and adolescents aged 6-17 years old, suffering from obsessive compulsive

disorder (OCD). If you are being treated for this disorder, your doctor will want to

monitor you closely (see below Use in children and adolescents).

If you have eye problems, such as certain kinds of glaucoma (increased pressure

in the eye).

Sertraline may cause symptoms of sexual dysfunction (see section 4). In some

cases, these symptoms have continued after stopping treatment.

Restlessness/Akathisia:

The use of sertraline has been linked to akathisia (a distressing restlessness and need

to move, often unable to sit or stand still). This is most likely to occur during the first

few weeks of treatment. Increasing the dose may be harmful to patients who develop

such symptoms.

Withdrawal Reactions:

Withdrawal reactions when treatment is stopped are common, particularly if the treatment

is stopped suddenly (see section 4, possible side effects). The risk of withdrawal

symptoms depends on the length of treatment, dosage, and the rate at which the dose

is reduced. Generally, such symptoms are mild to moderate. However, they can be

serious in some patients. They normally occur within the first few days after stopping

treatment. In general, such symptoms disappear on their own and wear off within 2

weeks. In some patients they may last longer (2-3 months). When stopping treatment

with sertraline it is recommended to reduce the dose gradually over a period of several

weeks or months, depending on the patient's needs.

Thoughts of suicide, suicidal attempts and worsening of your depression or anxiety

disorder:

If you are depressed and/or have anxiety disorders you can sometimes have thoughts

of harming or killing yourself. These may be increased when first starting anti-

depressants, since these medicines all take time to work, usually about two weeks but

sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or harming yourself.

If you are a young adult. Information from clinical trials has shown an increased

risk of suicidal behaviour in adults aged less than 25 years with psychiatric

conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor

or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have

an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you

if they think your depression or anxiety is getting worse, or if they are worried about

changes in your behaviour.

Children and adolescents:

Sertraline should not usually be used in children and adolescents less than 18 years

old, except for patients with Obsessive Compulsive Disorder aged 6-17 years old.

Patients under 18 have an increased risk of undesirable effects, such as suicide attempt,

suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and

anger) when they are treated with this class of medicines. Nevertheless, it is possible

that your doctor decides to prescribe Sertraline to a patient under 18 if it is in the

patient's interest. If your doctor has prescribed sertraline to a patient less than 18 years

old and you want to discuss this, please contact him/her. Furthermore, if any of the

symptoms listed above appear or worsen when a patient under 18 is taking sertraline,

you should inform your doctor. Also, the long-term safety of Sertraline in regard to

growth, maturation and cognitive and behavioural development in this age group has

not yet been demonstrated.

Other medicines and setraline tablets:

Please tell your doctor or pharmacist if you are taking or have recently taken any other

medicines including medicines obtained without a prescription. Some medicines can

affect the way sertraline works, or sertraline can reduce the effectiveness of other

medicines taken at the same time

Taking sertraline together with the following medicines may cause serious side

effects:

Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemid to

treat depression) and selegiline (to treat Parkinson's disease) and the antibiotic

linezolid. Do not use setraline together with these medicines

Medicines to treat mental disorders such as psychosis (pimozide). Do not use

sertraline together with pimozide

Tell your doctor BEFORE starting your medicine if you are taking any of the

following:

Herbal medicine containing St. John’s Wort (Hypericum perforatum). The

effects of St. John’s Wort may last for 1-2 weeks.

Products containing the amino acid tryptophan.

Medicines to treat severe pain (e.g tramadol).

Medicines used in anaesthesia or to treat chronic pain (fentanyl).

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3

Medicines to treat migraines (e.g sumatriptan.)

Blood thinning medicine (warfarin).

Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug (NSAID)

such as ibuprofen, acetylsalicylic acid (aspirin)

Sedatives (diazepam).

Diuretics (also called ‘water’ tablets).

Medicines to treat epilepsy (phenytoin, Phenobarbital, carbamazepine)

Medicines to treat diabetes (tolbutamide)

Medicines to treat excessive stomach acid,ulcers and heartburn (cimetidine,

omeprazole, lanzoprazole, pantoprazole, rabeprazole)

Medicines to treat mania and depression (lithium)

Other medicines to treat depression (such as amitriptyline, nortriptyline,

nefazodone, fluoxetine, fluvoxamine)

Medicines to treat schizophrenia and other mental disorders (such as perphenazine,

levomepromazine and olanzapine).

Medicines to treat high blood pressure, chest pain or regulate the rate and rhythm

of the heart (such as verapamil, diltiazem, flecainide, propafenone).

Medicines used to treat bacterial infections (such as rifampicin, clarithromycin,

telithromycin, erythromycin).

Medicines used to treat fungal infections (such as ketoconazole, itraconazole,

posaconazole, voriconazole, fluconazole).

Medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors such as

ritonavir, telaprevir).

Medicines used to prevent nausea and vomiting after an operation or chemotherapy

(aprepitant).

Sertraline Tablets with food, drink and alcohol

It is not recommended to take Sertraline tablets with alcohol. Sertraline can be

taken with or without food.

Sertraline should not be taken in combination with grapefruit juice, as this may

increase the level of sertraline in your body.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of sertraline has not fully been established in pregnant women. Sertraline

will only be given to pregnant women if the doctor considers that the benefit for the

mother exceeds any possible risk to the foetus. Women of childbearing potential

should employ an adequate method of contraception if taking sertraline

There is evidence that sertraline is excreted in human breast milk. Sertraline should

only be used in women during lactation, if the doctor considers that the benefit for

the mother exceeds any possible risk to the baby.

Make sure your midwife and/or doctor know you are on sertraline. When taken during

pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline

may increase the risk of a serious condition in babies, called persistent pulmonary

hypertension of the new born (PPHN), making the baby breathe faster and appear

bluish. These symptoms usually begin during the first 24 hours after the baby is born. If

this happens to your baby you should contact your midwife and/or doctor immediately.

Your newborn baby might also have other conditions, which usually begin during the

first 24 hours after birth. Symptoms include:

trouble with breathing,

a bluish skin or being to hot or cold,

blue lips,

vomiting or not feeding properly,

being very tired, not able to sleep or crying a lot,

stiff or floppy muscles,

tremors, jitters or fits,

increased reflex reactions,

irritability,

low blood sugar.

If your baby has any of these symptoms when it is born, or you are concerned about

your baby’s health, contact your doctor or midwife who will be able to advise you.

Some medicines like sertraline may reduce the quality of sperm in animal studies.

Theoretically, this could affect fertility, but the impact on human fertility has not

been observed as yet.

Driving and using machines

Psychotropic drugs such as sertraline may influence your ability to drive or use

machines. You should therefore not drive or operate machinery, until you know how

this medication affects your ability to perform these activities.

3. HOW TO TAKE

Always take sertraline exactly as your doctor has told you. Sertraline tablets may be

taken with or without food. Sertraline tablets are for oral administration only. Take

your medication once daily either in the morning or evening. You should check with

your doctor or pharmacist if you are not sure.

The usual dose is:

Adults: Depression and Obssessive Compulsive Disorder

For depression and OCD, the usual effective dose is 50mg/day.

The daily dose may be

4

increased in 50mg increments and at intervals of at least one week over a period of

weeks. The maximum recommended dose is 200mg/day.

Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder:

For panic disorder, social anxiety disorder and post traumatic stress disorder, treatment

should be started at 25mg/day and increased to 50mg/day after a week.

The daily dose then may be increased in 50mg increments over a period of weeks.

The maximum recommended dose is 200mg/day

Children and adolescents:

Sertraline must only be used to treat children and adolescents suffering from OCD aged

6-17 years old.

Obsessive Compulsive Disorder:

Children aged 6-12: the recommended starting dose is 25mg daily. After one week,

your doctor may increase this to 50mg daily. The maximum dose is 200mg daily.

Adolescents aged 13 to 17:

The recommended starting dose is 50mg daily. The maximum dose is 200mg daily.

If you have liver or kidney problems, please tell your doctor and follow the doctor’s

instructions.

The doctor will advise you on how long to take this medication for. This will depend

on the nature of your illness and how well you are responding to the treatment. It may

take several weeks before your symptoms begin to improve.

If you take more Sertraline Tablets than you should

If you take too many tablets or someone else takes your tablets, consult your nearest

casualty department or doctor for advice. Always take the labelled medicine package

with you, whether there is any medication left or not. Symptoms of overdose may

include drowsiness, nausea and vomiting, rapid heart rate, shaking, agitation, dizziness

and in rare cases unconsciousness.

If you forget to take Sertraline Tablets

Do not worry. If you forget to take a tablet, do not take that tablet. Just take the next

tablet at the right time. It is possible to suffer withdrawal effects if you miss a dose

but this is very rare. If this happens to you, please contact your doctor.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Sertraline Tablets

Do not stop taking sertraline unless your doctor tells you to. Your doctor will want to

gradually reduce your dose of sertraline over several weeks, before you finally stop

taking this medicine. If you suddenly stop taking this medicine you may experience side

effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches,

feeling sick, being sick and shaking. If you experience any of these side effects, or any

other side effects whilst stopping taking sertraline, please speak to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or

pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines Sertraline Tablets can cause side effects, although not everybody

gets them. Nausea is the most common side effect. The side effects depend on the dose

and are often transient with continued treatment.

Tell your doctor immediately:

If you experience any of the following symptoms after taking this medicine, these

symptoms can be serious.

If you develop a severe skin rash that causes blistering (erythema multiforme),

(this can affect the mouth and tongue). These may be signs of a condition known

as Stevens Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor

will stop your treatment in these cases.

Allergic reaction or allergy, which may include symptoms such as an itchy skin

rash, breathing problems, wheezing, swollen eyelids, face or lips.

If you experience agitation, confusion, diarrhoea, high temperature and blood

pressure, excessive sweating and rapid heartbeat. These are symptoms of

Serotonin Syndrome. In rare cases this syndrome may occur when you are taking

certain medicines at the same time as sertraline. Your doctor may wish to stop

your treatment.

If you develop yellow skin and eyes which may mean liver damage.

If you experience depressive symptoms with ideas of harming or killing yourself

(suicidal thoughts).

If you start to get feelings of restlessness and are not able to sit or stand still after

you start to take Sertraline. You should tell your doctor if you start to feel restless.

If you have a fit (seizure).

If you have a manic episode (see section 2 “Warnings and precautions”)

The following side effects were seen in clinical trials in adults.

Very common side effects (may affect more than 1 in 10 people):

Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth,

ejaculation failure, fatigue.

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Common side effects (may affect up to 1 in 10 people):

Sore throat, anorexia, increased appetite, decreased appetite, depression, feeling strange,

nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding,

numbness and tingling, shaking, muscle tense, abnormal taste, lack of attention, visual

disturbance, ringing in ears, palpitations, hot flush, yawning, abdominal pain, vomiting,

constipation, upset stomach, gas, rash, increased sweating, muscle pain, sexual dysfunction,

erectile dysfunction, chest pain, joint pain, malaise.

Uncommon side effects (may affect up to 1 in 100 people):

Chest cold, runny nose, hypersensitivity, hallucination, low thyroid hormones,

hallucination, feeling too happy, lack of caring, thinking abnormal, aggression,

convulsion, involuntary muscle contractions, abnormal co-ordination, moving a lot,

amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine,

fainting, enlarged pupils, ear pain, fast heartbeat, high blood pressure, flushing, breathing

difficulty, possible wheezing, shortness of breath, nose bleed, oesophageal problem,

difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, eye

swelling, purple spots on skin, face oedema, hair loss, cold sweat, dry skin, hives,

itching, osteoarthritis, muscular weakness, back pain, muscle twitching, night time

urination, unable to urinate, increase in urination, increase in frequency of urination,

problem urinating, urinary incontinence, vaginal haemorrhage, female sexual dysfunction,

menstrual irregularities, chills, fever, weakness, thirst, increase in liver enzyme levels,

weight decreased, weight increased.

Rare (may affect up to 1 in 1,000 people):

Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar,

physical symptoms due to stress or emotions, drug dependence, psychotic disorder, paranoia,

suicidal thoughts, sleep walking, premature ejaculation, serious allergic reaction which

causes difficulty in breathing or dizziness, coma, abnormal movements, difficulty moving,

increased sensation, sensory disturbance,glaucoma, tear problem, spots in front of eyes,

double vision, light hurts eye, blood in the eye, unequal sized pupil, vision abnormal,

problems controlling blood sugar levels (diabetes), heart attack, slow heart beat, heart

problem, poor circulation of arms and legs, closing up of throat, breathing fast, breathing

slow, difficulty talking, hiccups, blood in stool, sore mouth, tongue ulceration, tooth

disorder, tongue problem, mouth ulceration, problems with liver function, skin problem

with blisters, hair rash, hair texture abnormal, skin odour abnormal, bone disorder, decreased

urination, urinary hesitation, excessive vaginal bleeding, dry vaginal area, red painful penis

and foreskin, genital discharge, prolonged erection, breast discharge, hernia, injection site

scarring, drug tolerance decreased, difficulty walking, semen abnormal, increase in blood

cholesterol levels, injury, relaxation of blood vessels procedure, cases of suicidal ideation

and suicidal behaviours have been reported during sertraline therapy or early after treatment

discontinuation.

Not known: frequency cannot be estimated from the available data

After marketing sertraline, the following side effects have been reported:

Decrease in white blood cells, decrease in clotting cells, endocrine problem, low blood

salt, increase in blood sugar levels, terrifying abnormal dreams, suicidal behaviour, muscular

movement problems (such as moving a lot, tense muscles and difficulty walking and

stiffness, spasms and involuntary movements of the muscles), sudden severe headache

(which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction

Syndrome(RCVS)), vision abnormal, partial loss of vision, bleeding problems (such as

nose bleed, stomach bleeding, or blood in urine), progressive scarring of lung tissue

(Interstitial Lung Disease), pancreatitis, serious liver function problems, yellow jaundice,

skin oedema, skin reaction to sun, muscle cramps, breast enlargement, unable to control

urination, abnormal laboratory tests, problems with clotting, and severe allergic reaction.

An increased risk of bone fractures has been observed in patients taking this type of

medicine.

Symptoms that can occur when treatment is discontinued

If you suddenly stop taking this medicine you may experience side effects such as

dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick,

being sick and shaking (see section 3. “If you stop taking Sertraline”).

Undesirable effects which occurred most commonly in children were:

Inclinical trials with children and adolescents, the side effects were generally similar

to adults (see above). The most common side effects in children and adolescents were

headache, insomnia, diarrhoea and feeling sick.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes

any possible side effects not listed in this leaflet. You can also report side effects

directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By

reporting side affects you can help provide more information on the safety of this

medicine.

How quickly will the treatment start to work?

You may need to take Sertraline Tablets for up to 2-4 weeks before you notice them

starting to work and some people feel worse before they feel better. Your doctor will

want to monitor your progress closely during this period. You must keep taking

Sertraline Tablets to help you get better.

6

See your doctor before your tablets run out.

Even if you begin to feel better, keep taking your tablets. You may need to keep

taking them to stay well and it could be harmful if you stop taking your tablets

suddenly.

What if you do not feel better?

Tell your doctor if:

You have taken a course of tablets and you still feel unwell.

You feel worse.

You have suicidal thoughts or want to harm yourself. Sertraline may increase the

risk of these thoughts especially when you first start taking it. Please let your

family and/or friends know about this risk. You must seek help and advice if you

start to feel worse or want to self harm.

5.

HOW TO STORE SERTRALINE TABLETS

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the box. The expiry date refers

to the last day of that month.

Do not throw away medicines via wastewater or household waste. Ask you

pharmacist how to throw away medicines you no longer use. These measures

will help protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Sertraline Tablets contain:

The active substance is sertraline hydrochloride

The other ingredients are: calcium hydrogen phosphate, hydroxypropylcellulose,

Hypromellose, magnesium stearate, microcrystalline cellulose, Macrogol, polysorbate-80,

sodium starch glycollate and titanium dioxide (E171).

What Sertraline Tablets look like and contents of the pack

Sertraline 50mg Tablets are white, oblong, biconvex, film-coated tablets with score

line on one face.

Sertraline 100mg Tablets are white, oblong, biconvex, film-coated tablets. The tablets

come in blisters of 28 tablets in a cardboard carton.

Sertraline 50 mg Tablets - PL 21880/0097

Sertraline 100 mg Tablets - PL 21880/0098

This leaflet was last updated in July 2019

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail : info@medreich.co.uk

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Sertraline 50 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Sertraline hydrochloride equivalent to 50 mg sertraline.

For excipients, see 6.1.

3.

Pharmaceutical Form

Film coated tablets.

50 mg white, oblong, biconvex, film-coated tablet with score line on one face.

4.1

Therapeutic indications

Sertraline is indicated for the treatment of:

Major depressive episodes. Prevention of recurrence of major depressive

episodes.

Panic disorder, with or without agoraphobia.

Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-

17 years.

Social anxiety disorder.

Post traumatic stress disorder (PTSD)

4.2

Posology and method of administration

Sertraline 50 mg and 100 mg Tablets should be given as a single daily dose

either in the morning or evening. Sertraline Tablets can be administered with

or without food.

Sertraline tablets are for oral administration only

Adults:

Initial Treatment

Depression and OCD

Sertraline treatment should be started at a dose of 50 mg/day.

Panic Disorder, PTSD, and Social Anxiety Disorder

Therapy should be initiated at 25 mg/day. After one week, the dose should be

increased to 50 mg once daily. This dosage regimen has been shown to reduce

the frequency of early treatment emergent side effects characteristic of panic

disorder.

Titration

Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD

Patients not responding to a 50 mg dose may benefit from dose increases.

Dose changes should be made in steps of 50 mg at intervals of at least one

week, up to a maximum of 200 mg/day. Changes in dose should not be made

more frequently than once per week given the 24-hour elimination half life of

sertraline.

The onset of therapeutic effect may be seen within 7 days. However, longer

periods are usually necessary to demonstrate therapeutic response, especially

in OCD.

Maintenance

Dosage during long-term therapy should be kept at the lowest effective level,

with subsequent adjustment depending on therapeutic response.

Depression

Longer-term treatment may also be appropriate for prevention of recurrence of

major depressive episodes (MDE). In most of the cases, the recommended

dose in prevention of recurrence of MDE is the same as the one used during

current episode. Patients with depression should be treated for a sufficient

period of time of at least 6 months to ensure they are free from symptoms.

Panic disorder and OCD

Continued treatment in panic disorder and OCD should be evaluated regularly,

as relapse prevention has not been shown for these disorders.

Paediatric patients:

Children and adolescents with obsessive compulsive disorder

Age 13-17 years: Initially 50 mg once daily.

Age 6-12 years: Initially 25 mg once daily. The dosage may be increased to 50

mg once daily after one week.

Subsequent doses may be increased in case of less than desired response in 50

mg increments over a period of some weeks, as needed. The maximum dosage

is 200 mg daily. However, the generally lower bodyweights of children

compared to those of adults should be taken into consideration when

increasing the dose from 50 mg. Dose changes should not occur at intervals of

less than one week.

Efficacy is not shown in paediatric major depressive disorder.

No data is available for children under 6 years of age (see also section 4.4)

Use in the elderly:

Elderly should be dosed carefully, as elderly may be more at risk for

hyponatraemia (see section 4.4).

Use in hepatic insufficiency:

The use of sertraline in patients with hepatic disease should be approached

with caution. A lower or less frequent dose should be used in patients with

hepatic impairment (see section 4.4). Sertraline should not be used in cases of

severe hepatic impairment as no clinical data are available (see section 4.4).

Use in renal insufficiency:

No dosage adjustment is necessary in patients with renal insufficiency (see

section 4.4).

Withdrawal symptoms seen on discontinuation of sertraline:

Abrupt discontinuation should be avoided. When stopping treatment with

sertraline the dose should be gradually reduced over a period of at least one to

two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4

and 4.8). If intolerable symptoms occur following a decrease in the dose or

upon discontinuation of treatment, then resuming the previously prescribed

dose may be considered. Subsequently, the physician may continue decreasing

the dose, but at a more gradual rate.

4.3

Contraindications

Hypersensitivity to the active substance or any of the excipients.

Concomitant

treatment

with

irreversible

monoamine

oxidase

inhibitors

(MAOIs)

is contraindicated due to the risk of serotonin syndrome with

symptoms such as agitation, tremor and hyperthermia. Sertraline must not be

initiated

least

days

after

discontinuation

treatment

with

irreversible MAOI. Sertraline must be discontinued for at least 7 days before

starting treatment with an irreversible MAOI

(see section 4.5).

Concomitant use in patients taking pimozide is contra-indicated (see section

4.5 - Interaction with Other Medicaments and Other Forms of Interaction).

4.4

Special warnings and special precautions for use

Monoamine oxidase inhibitors See 'Contra-indications'.

Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS):

The development of potentially life-threatening syndromes like serotonin

syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported

with SSRIs, including treatment with sertraline. The risk of SS or NMS with

SSRIs is increased with concomitant use of serotonergic drugs (including

serotonergic antidepressant, triptans), with drugs which impair metabolism of

serotonin (including MAOIs e.g. methylene blue), antipsychotics and other

dopamine antagonists and with opiate drugs. Patients should be monitored for

the emergence of signs and symptoms of SS or NMS syndrome (see section

4.3 –Contraindications).

Switching from Selective Serotonin Reuptake Inhibitors (SSRIs),

antidepressants or antiobsessional drugs:

There is limited controlled experience regarding the optimal timing of

switching from SSRIs, antidepressants or anti-obsessional drugs to sertraline.

Care and prudent medical judgment should be exercised when switching,

particularly from long-acting agents such as fluoxetine.

Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT

agonists:

Co-administration of sertraline with other drugs which enhance the effects of

serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT

agonists, or the herbal medicine, St John's Wort (hypericum perforatum),

should be undertaken with caution and avoided whenever possible due to the

potential for a pharmacodynamic interaction.

Activation of hypomania or mania:

Manic/hypomanic symptoms have been reported to emerge in a small

proportion of patients treated with marketed antidepressant and anti-

obsessional drugs, including sertraline. Therefore sertraline should be used

with caution in patients with a history of mania/hypomania. Close surveillance

by the physician isrequired. Sertraline should be discontinued in any patient

entering a manic phase.

Schizophrenia:

Psychotic symptoms might become aggravated in schizophrenic patients.

Seizures

Seizures may occur with sertraline therapy: sertraline should be avoided in

patients with unstable epilepsy and patients with controlled epilepsy should be

carefully monitored. Sertraline should be discontinued in any patient who

develops seizures.

Suicide/Suicidal

thoughts/Suicide

attempts

or

clinical

worsening

Depression is associated with an increased risk of suicidal thoughts, self harm

suicide

(suicide-related

events).

This

risk

persists

until

significant

remission occurs. As improvement may not occur during the first few weeks

more

treatment,

patients

should

closely

monitored

until

such

improvement occurs. It is general clinical experience that the risk of suicide

may increase in the early stages of recovery.

Other psychiatric conditions for which sertraline is prescribed can also be

associated with an increased risk of suicide-related events. In addition, these

conditions may be co-morbid with major depressive disorder. The same

precautions observed when treating patients with major depressive disorder

should therefore be observed when treating patients with other psychiatric

disorders.

Patients

with

history

suicide-related

events,

those

exhibiting

significant degree of suicidal ideation prior to commencement of treatment are

known to be at greater risk of suicidal thoughts or suicide attempts, and should

receive

careful

monitoring

during

treatment.

meta-analysis

placebo-controlled clinical trials of antidepressant drugs in adult patients with

psychiatric disorders showed an increased risk of suicidal behaviour with

antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should

accompany drug therapy especially in early treatment and following dose

changes. Patients (and caregivers of patients) should be alerted about the need

to monitor for any clinical worsening, suicidal behaviour or thoughts and

unusual changes in behaviour and to seek medical advice immediately if these

symptoms present.

Use in Children and adolescents under 18 years old

Sertraline should not be used in the treatment of children and adolescents

under the age of 18 years, except for patients with obsessive compulsive

disorder aged 6-17 years old. Suicide-related behaviours (suicide attempt and

suicidal thoughts), and hostility (predominantly aggression, oppositional

behaviour and anger) were more frequently observed in clinical trials among

children and adolescents treated with antidepressants compared to those

treated with placebo. If, based on clinical need, a decision to treat is

nevertheless taken; the patient should be carefully monitored for appearance of

suicidal symptoms. In addition, long-term safety data in children and

adolescents concerning growth, maturation and cognitive and behavioural

development are lacking. Physicians must monitor paediatric patients on long

term treatment for abnormalities in these body systems.

Abnormal bleeding/Haemorrhage

There have been reports of cutaneous bleeding abnormalities such as

ecchymoses and purpura and other hemorrhagic events such as gastrointestinal

or gynaecological bleeding, including fatal haemorrhages with SSRIs.

Caution is advised in patients taking SSRIs, particularly in concomitant use

with drugs known to affect platelet function (e.g. anticoagulants atypical

antipsychotics and phenothiazines, most tricyclic antidepressants,

acetylsalicylic acid/aspirin and non-steroidal anti-inflammatory drugs

(NSAIDs)) as well as in patients with a history of bleeding disorders (see

section 4.5).

Hyponatraemia:

Hyponatraemia may occur as a result of treatment with SSRIs or SNRIs

including sertraline. In many cases, hyponatraemia appears to be the result of a

syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases of

serum sodium levels lower than 110 mmol/l have been reported.

Elderly patients may be at greater risk of developing hyponatraemia with

SSRIs and SNRIs. Also patients taking diuretics or who are otherwise volume-

depleted may be at greater risk (see Use in elderly). Discontinuation of

sertraline should be considered in patients with symptomatic hyponatraemia

and appropriate medical intervention should be instituted. Signs and symptoms

of hyponatraemia include headache, difficulty concentrating, memory

impairment, confusion, weakness and unsteadiness which may lead to falls.

Signs and symptoms associated with more severe and/or acute cases have

included hallucination, syncope, seizure, coma, respiratory arrest, and death.

Sexual dysfunction:

Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine

reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see

section 4.8). There have been reports of long-lasting sexual dysfunction where

the symptoms have continued despite discontinuation of SSRIs/SNRI.

Withdrawal symptoms seen on discontinuation of sertraline treatment:

Withdrawal symptoms when treatment is discontinued are common,

particularly if discontinuation is abrupt (see section 4.8). In clinical trials,

among patients treated with sertraline, the incidence of reported withdrawal

reactions was 23% in those discontinuing sertraline compared to 12% in those

who continued to receive sertraline treatment.

The risk of withdrawal symptoms may be dependent on several factors

including the duration and dose of therapy and the rate of dose reduction.

Dizziness, sensory disturbances (including paraesthesia), sleep disturbances

(including insomnia and intense dreams), agitation or anxiety, nausea and/or

vomiting, tremor and headache are the most commonly reported reactions.

Generally these symptoms are mild to moderate; however, in some patients

they may be severe in intensity. They usually occur within the first few days of

discontinuing treatment, but there have been very rare reports of such

symptoms in patients who have inadvertently missed a dose. Generally these

symptoms are self-limiting and usually resolve within 2 weeks, though in

some individuals they may be prolonged (2-3 months or more). It is therefore

advised that sertraline should be gradually tapered when discontinuing

treatment over a period of several weeks or months, according to the patient's

needs (see section 4.2).

Akathisia/psychomotor restlessness:

The use of sertraline has been associated with the development of akathisia,

characterised by a subjectively unpleasant or distressing restlessness and need

to move often accompanied by an inability to sit or stand still. This is most

likely to occur within the first few weeks of treatment. In patients who develop

these symptoms, increasing the dose may be detrimental.

Hepatic impairment:

Sertraline is extensively metabolised by the liver. A multiple dose

pharmacokinetic study in subjects with mild, stable cirrhosis demonstrated a

prolonged elimination half-life and approximately three-fold greater AUC and

in comparison with normal subjects. There were no significant

differences in plasma protein binding observed between the two groups. The

use of sertraline in patients with hepatic disease should be approached with

caution. A lower or less frequent dose should be used in patients with hepatic

impairment. Sertraline should not be used in patients with severe hepatic

impairment (see section 4.2).

Renal impairment:

Sertraline is extensively metabolised, and excretion of unchanged drug in

urine is a minor route of elimination. In studies of patients with mild to

moderate renal impairment (creatinine clearance 30-60 ml/min) or moderate to

severe renal impairment (creatinine clearance 10-29 ml/min), multiple-dose

pharmacokinetic parameters (AUC

0-24

or Cmax) were not significantly

different compared with controls. Sertraline dosing does not have to be

adjusted based on the degree of renal impairment.

Use in the elderly

Over 700 elderly patients (>65 yrs) have participated in clinical studies with

Sertraline. The pattern and incidence of adverse reactions in the elderly was

similar to that in younger patients. SSRIs or SNRIs including sertraline have

however been associated with cases of clinically significant hyponatraemia in

elderly patients, who may be at greater risk for this adverse event (see

Hyponatraemia in section 4.4).

Diabetes

In patients with diabetes, treatment with an SSRI may alter glycaemic control,

possibly due to improvement of depressive symptoms. Glycaemic control

should be carefully monitored in patients receiving sertraline and the dosage of

insulin and/or concomitant oral hypoglycaemic medicinal products may be

needed to be adjusted.

Electroconvulsive therapy (ECT) There are no studies establishing the risks or

benefits of the combined use of ECT and sertraline.

Grapefruit juice

The administration of sertraline with grapefruit juice is not recommended (see

section 4.5).

Interference with urine screening tests

False-positive urine immunoassay screening tests for benzodiazepines have

been reported in patients taking sertraline. This is due to lack of specificity of

the screening tests. False-positive test results may be expected for several days

following discontinuation of sertraline therapy. Confirmatory tests, such as gas

chromatography/mass spectrometry, will distinguish sertraline from

benzodiazepines.

Angle-Closure Glaucoma

SSRIs including sertraline may have an effect on pupil size resulting in

mydriasis. This mydriatic effect has the potential to narrow the eye angle

resulting in increased intraocular pressure and angle-closure glaucoma,

especially in patients pre-disposed. Sertraline should therefore be used with

caution in patients with angle-closure glaucoma or history of glaucoma.

4.5

Interaction with other medicinal products and other forms of interaction

Contraindications

Monoamine oxidase inhibitors

Irreversible MAOIs (e.g.selegiline):

Sertraline must not be used in combination with irreversibleMAOIs such as

selegiline. Sertraline must not be initiated for at least 14 days after

discontinuation of treatment with an irreversible MAOI. Sertraline must be

discontinued for at least 7 days before starting treatment with an irreversible

MAOI (see section 4.3).

Reversible, selective MAO-A inhibitor (moclobemide):

Due to the risk of serotonin syndrome, the combination of sertraline with a

reversible and selective MAOI, such as moclobemide, should not be

given.Following treatment with a reversible MAO inhibitor, a shorter

withdrawal period than 14 days may be used before initiation of sertraline

treatment. It is recommended that sertraline should be discontinued for at least

7 days before starting treatment with a reversible MAOI (see section 4.3).

Reversible, non-selective MAOI (linezolid):

The antibiotic linezolid is a weak reversible and non-selective MAOI and

should not be given to patients treated with sertraline (see section 4.3).

Severe adverse reactions have been reported in patients who have recently

been discontinued from an MAOI (e.g. methylene (blue) and started on

sertraline, or have recently had sertraline therapy discontinued prior to

initiation of an MAOI. These reactions have included tremor, myoclonus,

diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with

features resembling neuroleptic malignant syndrome, seizures, and death.

Pimozide:

Increased pimozide levels of approximately 35% have been demonstrated in a

study of a single low dose pimozide (2 mg). These increased levels were not

associated with any changes in EKG. While the mechanism of this interaction

is unknown, due to the narrow therapeutic index of pimozide, concomitant

administration of sertraline and pimozide is contraindicated (see section 4.3).

Co-administration with sertraline is not recommended

CNS depressants and alcohol

The co-administration of sertraline 200mg daily did not potentiate the effects

of alcohol, carbamazepine, haloperidol, or phenytoin on cognitive and

psychomotor performance in healthy subjects; however, the concomitant use

of sertraline and alcohol is not recommended.

Other serotonergic drugs

(see section 4.4)

Caution is also advised with fentanyl (used in general anaesthesia or in the

treatment of chronic pain), and with other opiate drugs.

Special precautions

Lithium

In placebo-controlled trials in normal volunteers, the co-administration of

sertraline and lithium did not significantly alter lithium pharmacokinetics but

did result in an increase in tremor relative to placebo, indicating a possible

pharmacodynamic interaction. When co-administering sertraline with lithium,

patients should be appropriately monitored.

Phenytoin:

A placebo-controlled trial in normal volunteers suggests that chronic

administration of sertraline 200 mg/day does not produce clinically important

inhibition of phenytoin metabolism. Nonetheless, as some case reports have

emerged of high phenytoin exposure in patients using sertraline, it is

recommended that plasma phenytoin concentrations be monitored following

initiation of sertraline therapy, with appropriate adjustments to the phenytoin

dose. In addition, co-administration of phenytoin may cause a reduction of

sertraline plasma levels. It cannot be excluded that other CYP3A4 inducers,

e.g. phenobarbital, carbamazepine, St John´s Wort, rifampicin may cause a

reduction of sertraline plasma levels

Triptans:

There have been rare post-marketing reports describing patients with

weakness, hyperreflexia, incoordination, confusion, anxiety and agitation

following the use of sertraline and sumatriptan. Symptoms of serotonergic

syndrome may also occur with other products of the same class (triptans). If

concomitant treatment with sertraline and triptans is clinically warranted,

appropriate observation of the patient is advised (see section 4.4).

Warfarin:

Co-administration of sertraline (200 mg daily) with warfarin resulted in a

small but statistically significant increase in prothrombin time, which may in

some rare cases unbalance the INR value.

Accordingly, prothrombin time should be carefully monitored when sertraline

therapy is initiated or stopped.

Other drug interactions, digoxin, atenolol, cimetidine:

Co-administration with cimetidine caused a substantial decrease in sertraline

clearance. The clinical significance of these changes is unknown.

Sertraline had no effect on the beta-adrenergic blocking ability of atenolol.

No interaction with sertraline (200 mg daily) was observed with digoxin.

Drugs affecting platelet function:

The risk of bleeding may be increased when medicines acting on platelet

function (e.g. NSAIDs, acetylsalicylic acid and ticlopidine) or other medicines

that might increase bleeding risk are concomitantly administered with SSRIs,

including sertraline (see section 4.4).

Drugs Metabolized by Cytochrome P450:

Sertraline may act as a mild-moderate inhibitor of CYP 2D6. Chronic dosing

with sertraline 50 mg daily showed moderate elevation (mean 23%-37%) of

steady-state desipramine plasma levels (a marker of CYP 2D6 isozyme

activity). Clinical relevant interactions may occur with other CYP 2D6

substrates with a narrow therapeutic index like class 1C antiarrhythmics such

as propafenone and flecainide, TCAs and typical antipsychotics, especially at

higher sertraline dose levels.

Sertraline does not act as an inhibitor of CYP 3A4, CYP 2C9, CYP 2C19, and

CYP 1A2 to a clinically significant degree. This has been confirmed by in-vivo

interaction studies with CYP3A4 substrates (endogenous cortisol,

carbamazepine, terfenadine, alprazolam), CYP2C19 substrate diazepam, and

CYP2C9 substrates tolbutamide, glibenclamide and phenytoin. In vitro studies

indicate that sertraline has little or no potential to inhibit CYP 1A2.

Intake of three glasses of grapefruit juice daily increased the sertraline plasma

levels by approximately 100% in a cross-over study in eight Japanese healthy

subjects. Interaction with other CYP3A4 inhibitors has not been established.

Therefore, the intake of grapefruit juice should be avoided during treatment

with sertraline (see section 4.4).

Based on the interaction study with grapefruit juice, it cannot be excluded that

the concomitant administration of sertraline and potent CYP3A4 inhibitors,

e.g. protease inhibitors, ketoconazole, itraconazole, posaconazole,

voriconazole, clarithromycin, telithromycin and nefazodone, would result in

even larger increases in exposure of sertraline. This also concerns moderate

CYP3A4 inhibitors, e.g. aprepitant, erythromycin, fluconazole, verapamil and

diltiazem. The intake of potent CYP3A4 inhibitors should be avoided during

treatment with sertraline.

Sertraline plasma levels are enhanced by about 50% in poor metabolizers of

CYP2C19 compared to rapid metabolizers (see section 5.2). Interaction with

strong inhibitors of CYP2C19 e.g. omeprazole, lansoprazole, pantoprazole,

rabeprazole, fluoxetine, fluvoxamine cannot be excluded.

St John's Wort

Concomitant use of the herbal remedy St John's wort (Hypericum perforatum)

in patients receiving SSRIs should be avoided since there is a possibility of

serotonergic potentiation

4.6

Fertility, Pregnancy and Lactation

Pregnancy

There are no well controlled studies in pregnant women. However, a

substantial amount of data did not reveal evidence of induction of congenital

malformations by sertraline. Animal studies showed evidence for effects on

reproduction probably due to maternal toxicity caused by the

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 1 -

Public Assessment Report

SERTRALINE 50 MG TABLETS

SERTRALINE 100 MG TABLETS

(SERTRALINE HYDROCHLORIDE)

PL 20658/0001-2

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 2 -

SERTRALINE TABLETS

(sertraline hydrochloride) PL 20658/0001-2

UKPAR

TABLE OF CONTENTS

Lay Summary

Page 3

Scientific discussion

Page 4

Steps taken for assessment

Page 17

Steps taken after authorisation – summary

Page 18

Summary of Product Characteristics

Page 19

Product Information Leaflet

Page 40

Labelling

Page 41

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 3 -

SERTRALINE 50 AND 100 MG TABLETS

(SERTRALINE HYDROCHLORIDE)

PL 20658/0001-2

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Torrent

Pharma GmbH Marketing Authorisation (licence) for the medicinal products Sertraline 50

mg and 100 mg Tablets (PL 20658/0001-2). Sertraline tablets are indicated for treatment of

symptoms of depressive illness, including the accompanying symptoms of anxiety.

This is a prescription only medicine [POM].

The clinical data presented to the MHRA, before licensing, demonstrated that sertraline

tablets are bioequivalent to the reference product, Lustral Tablets, first approved in the

United Kingdom on 19

November 1990 (PLs 00057/0308 and 0309).

Based on the information provided, sertraline tablets from Torrent Pharma are

interchangeable with Lustral Tablets.

No new or unexpected safety concerns arose from this application and it was decided that

the benefits of using sertraline tablets outweigh the risks; hence a Marketing Authorisation

has been granted.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 4 -

SERTRALINE 50 AND 100 MG TABLETS

(SERTRALINE HYDROCHLORIDE)

PL 20658/0001-2

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 5

Pharmaceutical assessment

Page 6

Preclinical assessment

Page 13

Clinical assessment

Page 14

Overall conclusions and risk benefit assessment

Page 16

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 5 -

INTRODUCTION

Based on the review of the data on quality, safety and efficacy the UK granted marketing

authorisations for the medicinal products sertraline tablets (PL 20658/0001-2) to Torrent

Pharma GmbH on 23

March 2006. The product is a prescription only medicine.

The application was submitted as an abridged application according to Article 10.1

[formerly Article 10.1(a)(iii)] of Directive 2001/83/EC as amended, claiming essential

similarity to Lustral Tablets (Pfizer) first approved in The United Kingdom on

November 1990.

The product contains the active ingredient sertraline hydrochloride. Sertraline is a potent

and specific inhibitor of neuronal serotonin (5-HT) uptake in vitro and in vivo, but is

without affinity for muscarinic, serotonergic, dopaminergic, adrenergic, histaminergic,

GABA or benzodiazepine receptors.

Sertraline exhibits dose proportional pharmacokinetics over a range of 50 to 200 mg. After

oral administration of sertraline in man, peak blood levels occur within 4.5 to 8.4 hours.

Daily doses of sertraline achieve steady-state after one week. Sertraline has a plasma half-

life of approximately 26 hours with a mean half-life for young and elderly adults ranging

from 22 to 36 hours. Sertraline is approximately 98% bound to plasma proteins. The

principal metabolite, N-desmethylsertraline, is inactive in in-vivo models of depression and

has a half-life of approximately 62 to 104 hours. Sertraline and N-desmethylsertraline are

both extensively metabolised in man and the resultant metabolites excreted in faeces and

urine in equal amounts. Only a small amount (less than 0.2%) of unchanged sertraline is

excreted in the urine.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 6 -

PHARMACEUTICAL ASSESSMENT

LICENCE NO:

PL 20658/0001-2

PROPRIETARY NAME:

Sertraline 50mg and 100mg Tablets

ACTIVE(S):

Sertraline

COMPANY NAME:

Torrent Pharmaceuticals Limited

E.C. ARTICLE:

Article 10.1

[formerly Article 10.1(a)(iii) of Directive 2001/83/EC]

LEGAL STATUS:

1.

INTRODUCTION

1.1

Legal Basis

These national abridged, complex and standard applications for oral immediate release

tablets containing 50 and 100mg of sertraline are submitted under Article 10.1 [formerly

Article 10.1(a)(iii)], claiming essential similarity to Lustral Tablets, which were first

authorised in the UK on 19

November 1990 (PLs 00057/0308 and 0309). In support of

these applications, Torrent has provided a bioequivalence study performed by Vulm a.s of

Slovakia using Zoloft (brand name in Germany, Austria and Denmark) 100 mg tablets,

manufactured by Pfizer, Germany as the reference product. Hence, the 10 year rule is

complied with.

1.2

Use

The active, Sertraline hydrochloride, is a naphthaleneamine derivative, is a selective

serotonin re-uptake inhibitor with actions and uses similar to those of fluoxetine. It is

administered by mouth and in the treatment of depression, the usual initial dose is 50 mg

daily, increased, if necessary, in increments of 50 mg at intervals of at least a week to a

maximum of 200 mg daily.

2.

MARKETING AUTHORISATION APPLICATION FORM

2.1

Name(s)

The proposed names of the products are Sertraline 50 mg and 100 mg Tablets. The

products have been named in line with current requirements.

2.2

Strength, pharmaceutical form, route of administration, container and pack

sizes

The products contain Sertraline hydrochloride equivalent to 50mg and 100mg of Sertraline

respectively. The tablets are packed into a white opaque blister of PVC film coated with

PVdc and aluminium foil coated with heat sealable lacquer of vinyl monochlorohexane

(VMCH). The proposed shelf-life (24 months) and storage conditions (This medicinal

product does not require any special storage conditions) are consistent with the details

registered for the cross-reference products.

2.3

Legal status

These products will be subject to a medical prescription.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 7 -

2.4

Marketing authorisation holder/Contact Persons/Company

The proposed Marketing Authorisation holder is Torrent Pharma GmbH, Gregor-Umhof-

Strasse 11, 76694 Forst, Germany.

The Qualified Person responsible for pharmacovigilance is stated and their CV is included.

2.5

TSE

The applicant has provided a declaration that no materials of animal origin are used in

manufacture of the finished product. Supporting statements to the same effect have been

provided from suppliers of the following excipients: Magnesium stearate, propylene glycol

and polysorbate 80. This is acceptable.

DRUG SUBSTANCE

The manufacturer and the site of manufacture is Torrent Pharmaceuticals Limited (TPL),

Ahmdebad Mehsana Highway post office – Indrad, Taluka Kadi, District: Mehana – 382

721, Gujarat, India.

The finished product manufacturer has also provided a drug substance specification.

Certificates of Analysis (CoAs) for batches of the drug substance tested on receipt have

been provided.

Analytical

Procedures

Analytical procedures are described.

Validation of Analytical Procedures

Satisfactory validation data are provided for the analytical procedures.

Batch Analysis

Results of industrial scale batches of sertraline are within specification.

Reference standards

Satisfactory primary and working reference standards are identified.

Stability

Batches stored under ICH real time conditions show compliance with set limits during the

approved retest period.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

- 8 -

DOSAGE FORM

Composition

The composition is satisfactory and tabulated below.

Name of constituents

Function

Reference to

Standards

Active constituent

Sertraline Hydrochloride

Active

Ph. Eur

Other constituents

Microcrystalline Cellulose

Ph. Eur

Sodium Starch Glycollate

(Type A)

Ph. Eur

Calcium Hydrogen

Phosphate Dihydrate

Ph. Eur

Hydroxypropyl Cellulose

Ph. Eur

Polysorbate

Ph. Eur

Magnesium Stearate

Ph. Eur

Hypromellose 6 CPS

Coat

Ph. Eur

Propylene Glycol

Coat

Ph. Eur

Titanium Dioxide

Coat

Ph. Eur

PHARMACEUTICAL DEVELOPMENT

Excipients

The formulation is film-coated tablets, comprising of excipients that comply with Ph. Eur.

The function and concentration of the excipients used is standard and accepted.

The applicant has stated that each batch of excipients is fully tested according to the

proposed specifications upon receipt. Raw materials are not tested prior to use in the

finished product provided the raw material is still within its retest period. This is

acceptable.

Pharmacokinetic studies

Satisfactory CoAs are provided for the biobatches.

Container Closure System

Sertraline tablets are packed in blisters of white opaque PVC film (coated with 90 GSM

PVDC film on one side) sealed with printed aluminium lidding foil with VMCH heat seal

lacquer.

Each blister strip contains 10 tablets. The blister strips are packed in printed cartons

containing a total of 30 tablets (3 strips of 10).

Data are provided for the primary packaging to show compliance with EU food safety

requirements

Microbiological Attributes

The microbiological attributes are controlled in the finished product specification to

Ph. Eur. 5.1.4 category 3A and accepted.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

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Compatibility

Stated ‘not relevant’ but can be inferred from the product stability data, and accepted.

MANUFACTURE

GMP Statement and Manufacturing Chain

The manufacturing site for the product is Torrent Pharmaceuticals Limited, Mehsana 382

721, Gujarat, India. Responsibilities at this site also include assembly and packaging. A

satisfactory copy of the German manufacturing licence/GMP report is provided. The site of

batch release is Biokanol Pharma GmbH, Kehler Strasse 7, Rastatt D-76437, Germany, for

which a satisfactory of the Marketing Authorisation is provided.

Description of the Manufacturing Process

A satisfactory formula and description of manufacture are provided.

There are no re-processing required for manufacture.

Critical phases of the manufacturing process have been satisfactorily identified and

appropriate in-process controls are in place.

The analytical methods and limits are the same as those used in finished product testing and

comply with current guidelines and accepted. The tablets are blister packed with

satisfactory in-process controls.

In-process batch data for validation batches are satisfactory. The validation results

demonstrate homogeneity of blends and consistent manufacture.

The validation protocol provided is considered adequate for the purpose.

Control of Excipients

The list of excipients, complying with Ph. Eur. requirements, is given under “Composition

of the medicinal product” above.

Satisfactory Certificates of Analysis have been provided for each excipient and are

accepted. The compendial methodology is used in testing.

Specifications

A satisfactory finished product specification is provided.

Analytical Procedures

Satisfactory validation data are provided.

Batch data

Satisfactory data are provided for batches manufactured at the proposed site and are

considered representative of the product to be marketed. Dissolution data including

standard deviations and profiles are reported.

MHRA PAR – Sertraline Tablets PL 20658/0001-2

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Characterisation of Impurities

This is satisfactory.

Reference Samples

Reference samples are identified.

Container Closure System

Satisfactory details of supplier specification, product construction, standards and

compliance statements are provided. In-house specification giving details of tests

performed on receipt are provided.

Standard Storage Conditions

Based on stability data at real time and accelerated conditions. The data support the product

shelf-life of 24 months with no special storage conditions.

The samples provided for stability studies are representative of the product to be marketed

in the proposed pack.

The programme is ongoing. The stability programme is satisfactory as the applicant has

agreed to place the first three commercial/production batches on stability.

Bioanalytical Methods and Validation

Satisfactory methodology and validation data are provided.

Quality Overall Summary

This is satisfactory.

Essential Similarity

The following data support essential similarity:

Acceptable choice of test and reference products

Acceptable bioequivalence between test and reference product

Comparative dissolution profiles are provided for test and reference product

The impurity profile of the test product is comparable with that of the reference

product and considered satisfactory

The active substance comply with relevant principles in ICH guidelines

PRODUCT PARTICULARS

Product Brand Name

This is considered satisfactory.

Summary of Product Characteristics

Satisfactory SPC provided.

Patient Information Leaflet

Satisfactory coloured mock-ups are provided

.

The applicant has until 1

July 2008 to

amend the order in which the information appears in the leaflet and provide user testing

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