SERTRALINE TEVA 100 MG

Israel - English - Ministry of Health

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Active ingredient:
SERTRALINE AS HYDROCHLORIDE
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N06AB06
Pharmaceutical form:
FILM COATED TABLETS
Composition:
SERTRALINE AS HYDROCHLORIDE 100 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
SERTRALINE
Therapeutic area:
SERTRALINE
Therapeutic indications:
For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertaline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.
Authorization number:
132 13 30900 01
Authorization date:
2014-11-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

16-08-2020

SERT TAB PL SH 140520

SERT TAB PL SH 140520

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

)PREPARATIONS( – 1986

The medicine is dispensed with

a doctor’s prescription only

SERTRALINE TEVA 50 mg

Film-coated Tablets

Each film-coated tablet contains:

Sertraline )as hydrochloride( 50 mg

SERTRALINE TEVA 100 mg

Film-coated Tablets

Each film-coated tablet contains:

Sertraline )as hydrochloride( 100 mg

A list of the inactive ingredients in the

preparation is detailed in section 6.

Read the leaflet carefully in its entirety

before using the medicine. This leaflet

contains concise information about the

medicine. If you have further questions, refer

to the doctor or pharmacist.

This medicine has been prescribed to treat

you. Do not pass it on to others. It may harm

them, even if it seems to you that their medical

condition is similar to yours.

This medicine is not intended for use in

children or adolescents under 18 years of age.

What should I know about the medicine?

Antidepressants and anti-anxiety medicines

increase the risk of suicidal behavior and

thoughts in children, adolescents and young

adults up to the age of 25.

When starting treatment with the medicine,

patients of all ages and their relatives

should monitor behavioral changes

such as: worsening of the depression,

suicidal thoughts, aggression and the like.

If changes such as these occur, refer to the

doctor immediately )see section 2(.

1. WHAT IS THE MEDICINE INTENDED

FOR?

The medicine is intended for the treatment of

symptoms of depression in patients with or

without a history of mania. After achieving

an adequate response, continued treatment

with the medicine is effective in preventing

recurrence of the primary depressive episode

or of additional recurrent depressive episodes.

Therapeutic group:

The medicine belongs to the SSRIs group,

selective serotonin reuptake inhibitors.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive )allergic( to the active

ingredient or to any of the additional

ingredients contained in the medicine

)detailed in section 6(.

You are taking, or have taken, medicines

from the monoamine oxidase inhibitor

group )such as: selegiline, moclobemide(

or monoamine oxidase inhibitor-like

medicines )such as linezolid(. Wait at least

one week after completing treatment with

sertraline before starting treatment with

monoamine oxidase inhibitors. Similarly,

wait at least two weeks after completing

treatment with monoamine oxidase

inhibitors before starting treatment with

sertraline.

You are concomitantly taking a medicine

called pimozide )a medicine intended for

mental disorders such as psychosis(.

Special warnings regarding use of the

medicine

Before treatment with Sertraline Teva, tell

the doctor if:

You suffer, or have suffered in the past, from

epilepsy or a history of seizures. Inform the

doctor immediately if a seizure occurs.

You have suffered in the past from manic

depressive disorder )bipolar disorder( or

schizophrenia. Inform the doctor immediately

if a manic episode occurs.

You have or have had thoughts of harming

yourself or suicidal thoughts )see below in

this section “Suicidal thoughts and worsening

of your depression or anxiety disorder”(.

You have serotonin syndrome. In rare cases,

this syndrome may occur when you are

taking certain medicines at the same time as

this preparation )for symptoms, see section 4

“Side Effects”(. Your doctor would have told

you if you have suffered from this syndrome

in the past.

You have low blood sodium levels, since

treatment with Sertraline Teva may cause

this. Inform the doctor if you are taking certain

medicines for treatment of hypertension, as

these medicines may alter blood sodium

levels. Be particularly careful in elderly

people; they are at higher risk.

You suffer from a liver disease. In this case,

the doctor may decide to reduce the dosage

of the medicine administered.

You suffer from diabetes. Taking this

preparation may affect your blood glucose

levels, and there may therefore be a need to

adjust the dosage of your medicines for the

treatment of diabetes.

You have suffered from bleeding disorders

or you are taking blood thinners )such as

acetylsalicylic acid )aspirin( or warfarin(

or medicines that may increase the risk of

bleeding.

You are being treated with electroconvulsive

therapy )ECT(.

You suffer from eye problems, such as certain

kinds of glaucoma )elevated eye pressure(.

You suffer from a heart rhythm irregularity,

following an electrocardiogram )ECG(,

known as prolonged QT interval.

You suffer from heart disease, low blood

potassium or magnesium levels, a family

history of a prolonged QT interval, slow heart

rate and concomitant use of medicines that

prolong the QT interval.

Akathisia/Restlessness:

Use of the medicine has been linked to a

troublesome restlessness and an urge to

move, when the patient is often unable to sit

or stand still )akathisia(. This effect occurs

mostly during the first few weeks of treatment.

Increasing the dosage may be harmful, so if

you develop such effects, you should inform

your doctor.

Withdrawal symptoms:

Side effects linked to stopping treatment are

common )withdrawal symptoms(, particularly

when treatment is stopped suddenly )see

sections 3 and 4(. The risk of the occurrence

of withdrawal symptoms depends on the

duration of treatment, the dosage and the

rate at which the dosage of the medicine is

reduced. Generally, the severity of these

symptoms is mild to moderate. However, these

symptoms can be serious in some patients.

These symptoms mostly occur in the first few

days after stopping treatment. In general, these

symptoms wear off on their own and gradually

disappear within two weeks. In some patients,

they may continue for longer )two-three months

or even longer(. When stopping treatment with

the medicine, it is recommended to reduce

the dosage gradually over several weeks or

months, and you should always consult the

doctor regarding the most appropriate way to

stop treatment.

Suicidal thoughts and worsening of your

depression or anxiety disorder:

If you are depressed and/or suffer from anxiety

disorders, you may sometimes have thoughts

of harming yourself or suicidal thoughts.

These effects are more likely to occur when

first starting to take antidepressants, as it takes

time before they begin to have an effect, usually

about two weeks, but sometimes even longer.

You may be more likely to think in such

a way:

If you have previously had suicidal

thoughts or thoughts about harming

yourself.

If you are a young adult. Data from

clinical trials have shown an increased risk

of suicidal behavior in adults under 25 years

of age with psychiatric conditions that were

treated with antidepressants.

If, at any time, you have thoughts of harming

yourself or suicidal thoughts, contact your

doctor or proceed to a hospital immediately.

You may find it useful to share with a relative or

close friend that you are depressed or suffering

from an anxiety disorder, and ask them to read

this leaflet. You may ask them to tell you if they

think your depression or anxiety disorder has

gotten worse, or if they are worried about

changes in your behavior.

Problems with sexual function:

Medicines such as Sertraline Teva )also called

SSRIs( could cause symptoms of problems

with sexual function )see section 4(. In some

cases, these symptoms continued even after

treatment was stopped.

Drug interactions:

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements,

tell the doctor or pharmacist.

Certain medicines affect the way Sertraline

Teva works, or Sertraline Teva itself can reduce

the effectiveness of other medicines taken at

the same time.

Do not use this medicine if you are being

treated with the following medicines:

Medicines

called

monoamine

oxidase

inhibitors, such as: moclobemide )to treat

depression( and selegiline )to treat Parkinson’s

disease(, linezolid )an antibiotic(, methylene

blue )to treat high levels of methemoglobin in

the blood(, medicines to treat mental disorders

such as psychosis )pimozide(.

Taking Sertraline Teva together with these

medicines may cause serious side effects.

Tell your doctor if you are taking the following

medicines:

Medicines containing amphetamines )used

to treat attention deficit hyperactivity disorder

)ADHD(, narcolepsy and obesity(.

Preparations containing the Hypericum herb

)St. John’s Wort( – the effect of the Hypericum

herb may last for one to two weeks.

Products containing the amino acid

tryptophan.

Preparations for treatment of severe pain

)such as tramadol(.

Medicines used for anesthesia or for

treatment of chronic pain )such as: fentanyl,

mivacurium and succinylcholine(.

Preparations for treatment of migraine )such

as sumatriptan(.

Blood thinning medicines )warfarin(.

Medicines for treatment of pain/arthritis

)nonsteroidal anti-inflammatory drugs

]NSAIDs[, such as: ibuprofen, acetylsalicylic

acid ]aspirin[(.

Sedatives )diazepam(.

Diuretics.

Medicines for treatment of epilepsy

)phenytoin, phenobarbital, carbamazepine(.

Medicines for treatment of diabetes

)tolbutamide(.

Medicines for treatment of excessive acidity,

peptic ulcer or heartburn )cimetidine,

omeprazole, lansoprazole, pantoprazole,

rabeprazole(.

Medicines for treatment of mania and

depression )lithium(.

Other medicines for treatment of depression

)such

amitriptyline,

nortriptyline,

nefazodone, fluoxetine, fluvoxamine(.

Medicines for treatment of schizophrenia

and other mental disorders )such as:

perphenazine,

levomepromazine

olanzapine(.

Medicines for treatment of hypertension,

chest pain, or to regulate the rate and rhythm

of the heart )such as: verapamil, diltiazem,

flecainide, propafenone(.

Medicines for treatment of bacterial infections

)such

rifampicin,

clarithromycin,

telithromycin, erythromycin(.

Medicines for treatment of fungal infections

)such as: ketoconazole, itraconazole,

posaconazole, voriconazole, fluconazole(.

Medicines for treatment of HIV/AIDS and

hepatitis C )protease inhibitors such as:

ritonavir, telaprevir(.

Medicines to prevent nausea and vomiting

after

operation

chemotherapy

)aprepitant(.

Medicines known to increase the risk for

changes in the heart’s electrical activity )such

as: antipsychotics and certain antibiotics(.

Use of the medicine and food:

The medicine can be taken with or without

food. Swallow the tablet with a little water.

Do not drink grapefruit juice during treatment

with the medicine, since this may cause an

increase in the level of the medicine in the

blood.

Use

of

the

medicine

and

alcohol

consumption:

Avoid consumption of alcohol during treatment

with the medicine.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you

are pregnant or planning a pregnancy, consult

with your doctor before using this medicine.

The safety of sertraline has not yet been fully

established in pregnant women. Sertraline

Teva will only be given during pregnancy if your

doctor considers that the benefit outweighs any

possible risk to the fetus.

Inform the doctor if you are taking sertraline

Teva during pregnancy. Taking it during

pregnancy, particularly in the last trimester,

may increase the risk of a serious condition

in newborns, called persistent pulmonary

hypertension of the newborn )PPHN(. This

condition makes the baby breathe faster and

appear bluish. These symptoms usually start to

appear during the first 24 hours after the baby

is born. If this happens to your baby, refer to

your doctor immediately.

Other symptoms from which the newborn

baby could suffer usually appear during the

first 24 hours after birth. The symptoms include:

breathing difficulty, blue discoloration of the

skin, skin that is too cold or too hot, blue lips,

vomiting or feeding problems, excessive

tiredness, sleeping difficulties, continuous

crying, stiff or lax muscles, tremor, agitation

or fits, increased reflexes, irritability, decrease

in blood sugar level.

If you notice that your baby has any of these

symptoms following the birth, or you are

concerned about your baby’s condition,

contact the doctor.

There is proof that Sertraline is secreted into

breast milk. Do not use Sertraline Teva if you

are breastfeeding, unless the doctor considers

that the benefit of the medicine outweighs any

possible risk to your baby.

Studies performed in animals have determined

that certain medicines such as Sertraline Teva

may impair sperm quality. Theoretically, this

may impair fertility, but impairment of human

fertility has not been observed as yet.

Driving and operating machinery:

Use of this medicine may impair your ability

to drive or operate machinery. Therefore,

do not drive a vehicle or operate dangerous

machinery until you know how the medicine

affects your ability to perform these activities.

Important information about some of the

ingredients in this medicine:

This medicine contains less than 23 mg of

sodium per tablet, and is therefore considered

to be sodium free.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the

doctor’s instructions. Check with the doctor

or pharmacist if you are uncertain about

the dosage and treatment regimen for the

preparation. The dosage and treatment

regimen will be determined by the doctor only.

The usual dose is generally: Take the medicine

once a day in the morning or the evening.

Your doctor will instruct you for how long to

take this medicine. This depends on the nature

of your illness and how well you respond to

treatment.

The improvement in symptoms may occur only

after a few weeks. In general, the treatment for

depression should be continued for 6 months

after improvement occurs.

If you suffer from liver or kidney problems,

inform your doctor and follow his treatment

instructions.

Do not exceed the recommended dose!

The medicine can be taken with or without

food.

Sertraline Teva 50 mg: The tablets can be

halved at the score line.

There is no information regarding chewing and

crushing.

Sertraline Teva 100 mg: The tablets can be

halved at the score line.

There is no information regarding chewing and

crushing.

If you accidentally take a higher dosage

If you took an overdose, or if a child has

accidentally swallowed the medicine, refer

immediately to a doctor or proceed to a hospital

emergency room, and bring the package of the

medicine with you.

Signs of an overdose may include: drowsiness,

nausea and vomiting, rapid heart rate,

agitation, tremor, dizziness, and in rare cases

loss of consciousness.

If you forget to take the medicine

If you forgot to take this medicine at the

required time, skip the forgotten dose and take

the next dose at the scheduled time. Never take

a double dose instead of the forgotten dose!

Adhere to the treatment regimen as

recommended by the doctor.

If you stop taking the medicine

Even if there is an improvement in your health,

do not stop treatment with the medicine without

consulting a doctor. The doctor will instruct you

on how to stop the treatment gradually over

several weeks, before you finally stop taking

the medicine. Abrupt discontinuation of the

medicine may be accompanied by effects such

as: dizziness, numbness, sleep disturbances,

anxiety or agitation, headaches, nausea and

vomiting, tremor. If you experience any of

these side effects or other side effects upon

discontinuation of the treatment, please inform

the doctor.

Do not take medicines in the dark! Check

the label and the dose each time you take

a medicine. Wear glasses if you need them.

If you have further questions regarding

use of the medicine, consult the doctor

or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Sertraline Teva

may cause side effects in some users. Do

not be alarmed when reading the list of side

effects. You may not suffer from any of them.

Nausea is the most common side effect.

Side effects are dose-dependent and usually

disappear or lessen with continued treatment.

Tell the doctor immediately:

If you experience any of the following

symptoms after taking this medicine; these

symptoms could be serious.

If you develop a severe skin rash that causes

blistering )erythema multiforme( )this can

also affect the mouth and tongue(. These

may be signs of Stevens-Johnson Syndrome

or Toxic Epidermal Necrolysis. Your doctor

will stop your treatment in these cases.

Allergic reaction or allergy, which may include

symptoms such as: an itchy skin rash,

breathing difficulties, wheezing, swollen

eyelids, face or lips.

If you experience restlessness, confusion,

diarrhea, high fever, high 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 this medicine. In this case, the doctor

may stop your treatment.

If your skin and eyes turn yellow, which may

indicate liver damage.

If you experience symptoms of depression

with thoughts of self-harm, or suicidal

thoughts.

If you start to feel restless, and in conditions

where you are not able to sit or stand still after

you started to take this medicine. You should

tell the doctor if you start to feel restless.

If you have a fit )seizure(.

If you had a manic episode )see section

2 “Special warnings regarding use of the

medicine”(.

The following side effects have been

observed in clinical studies in adults, and

during use of the medicine after it was

marketed.

Very common side effects

Effects that occur in more than one user

in ten:

Insomnia, dizziness, sleepiness, headache,

diarrhea, nausea, dry mouth, ejaculation

failure, fatigue.

Common side effects

Effects that appear in 1-10 in 100 users:

Catching a cold, sore throat, runny nose.

Decreased appetite, increased appetite.

Anxiety, depression, agitation, decreased

sexual interest, nervousness, feeling

strange, nightmare, teeth grinding.

Tremor, muscular movement disorders

)such as: moving a lot, tense muscles,

difficulty walking, muscle stiffness, spasms

and involuntary muscle movements(*,

numbness and tingling, muscle tension, lack

of attention, altered taste.

Visual disturbances.

Ringing in the ears.

Palpitations.

Hot flushes.

Yawning.

Indigestion, constipation, abdominal pain,

vomiting, flatulence.

Increased sweating, rash.

Back pain, joint pain, muscle pain.

Menstrual irregularities, erection problems.

Malaise, chest pain, weakness, fever.

Weight gain.

Injury.

Uncommon side effects

Effects that appear in 1-10 in 1,000 users:

Inflammation of the intestine, ear infection.

Tumor.

Hypersensitivity, seasonal allergy.

Decreased thyroid hormone levels.

Suicidal thoughts, suicidal behavior*,

psychotic disorder, abnormal thoughts,

apathy, hallucinations, aggression, euphoric

sensation, paranoia.

Forgetfulness, decreased sensation,

involuntary muscle contractions, fainting,

moving a lot, migraine, convulsion, dizziness

while standing up, impaired coordination,

speech disorder.

Dilated pupils.

Ear pain.

Fast heartbeat, heart problems.

Bleeding )such as stomach bleeding(*,

hypertension, flushing, blood in the urine.

Shortness of breath, nose bleed, breathing

difficulties, wheezing.

Tarry stools, tooth disorders, inflammation

of the esophagus, tongue problems,

hemorrhoids, increased salivation, difficulty

swallowing, burping, tongue disorder.

Swollen eyes, hives, hair loss, itching, purple

spots on the skin, skin problem accompanied

by blisters, dry skin, facial swelling, cold

sweat.

Osteoarthritis, muscle twitching, muscle

cramps*, muscular weakness.

Increase in frequency of urination, difficulty

urinating, inability to urinate, urinary

incontinence, increase in urination, nighttime

urination.

Sexual dysfunction in men and women,

significant vaginal bleeding, vaginal

bleeding.

Swelling of legs, chills, difficulty walking,

thirst.

Increase in liver enzyme levels, weight loss.

Cases of suicidal thoughts and behavior

have been reported during treatment with

Sertraline or soon after discontinuation of

Sertraline treatment )see section 2(.

Rare side effects

Effects that appear in 1-10 in 10,000 users:

Diverticulitis, swollen lymph glands,

decreased number of platelets*, decreased

number of white blood cells*.

Acute allergic reaction, endocrine problems*.

High cholesterol, problems controlling blood

sugar level )diabetes(, low blood sugar

levels, increase in blood sugar levels*, low

blood sodium level*.

Physical symptoms due to stress or

emotions, terrifying abnormal dreams*,

dependence on medicines, sleep walking,

premature ejaculation.

Coma, abnormal movements, difficulty

moving, increased sensation, sudden, acute

headache )may be a sign of a serious condition

involving reversible constriction of cerebral

blood vessels(*, sensory disturbance.

Seeing spots, glaucoma, double vision,

sensitivity of the eye to light, blood in the eye,

unequal sized pupils*, visual disturbance*,

tear problem.

Heart attack, dizziness, fainting or chest

discomfort which could be signs of

changes in the electrical activity )seen on

electrocardiogram( or irregular rhythm of the

heart*, slow heartbeat.

Impaired blood circulation in the limbs.

Fast breathing, progressive scarring of lung

tissue )interstitial lung disease(*, closing up

of the throat, difficulty talking, slow breathing,

hiccups.

Mouth ulcers, pancreatitis*, blood in stools,

tongue ulcers, sore mouth.

Problems with liver function, serious liver

dysfunction*, yellowing of the skin and eyes

)jaundice(*.

Skin reaction to sun*, skin edema*, change

in hair structure, strange body odor, hair

follicle rash, breakdown of muscle tissue*,

bone disorder.

Difficulty when beginning to urinate,

decreased urination.

Breast discharge, vaginal dryness, genital

discharge, pain and redness of penis

and foreskin area, breast enlargement*,

prolonged erection.

Hernia, decreased tolerance to medicines.

Increase in blood cholesterol levels,

abnormal laboratory tests*, changes in

sperm quality, problems with clotting*.

Widening of blood vessels.

Side effects of unknown frequency

)effects whose frequency has not yet been

determined(:

Jaw lock*.

Bedwetting*.

Partial vision loss.

Side effects reported during use of the

medicine, after marketing began, are

marked by *.

Symptoms that may occur in the case of

discontinuation of treatment:

If you suddenly stop taking the medicine, you

may develop side effects such as: dizziness,

numbness, sleep disturbances, agitation or

anxiety, headaches, nausea, vomiting and

tremor )see section 3(.

An increased risk of bone fractures has been

observed in patients who took medicines of

this type.

If a side effect occurs, if one of the side

effects worsens or if you suffer from a side

effect not mentioned in the leaflet, consult

with the doctor.

Side effects can be reported to the Ministry

of Health by clicking on the link “Report Side

Effects of Drug Treatment” found on the Ministry

of Health homepage )www.health.gov.il(

that directs you to the online form for reporting

side effects, or by entering the link:

https://sideeffects.health.gov.il

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine, and any

other medicine, should be kept in a safe

place out of the reach and sight of children

and/or infants in order to avoid poisoning.

Do not induce vomiting unless explicitly

instructed to do so by a doctor.

Do not use the medicine after the expiry date

)exp. date( that appears on the package.

The expiry date refers to the last day of that

month.

Storage conditions: Store the medicine

in a dry place, below 25°C.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Sertraline Teva 50 mg:

Microcrystalline cellulose, dibasic calcium

phosphate dihydrate, croscarmellose sodium,

povidone, hypromellose, titanium dioxide

)E171(, magnesium stearate, macrogol,

polysorbate, indigo carmine )E132(.

Sertraline Teva 100 mg:

Microcrystalline cellulose, dibasic calcium

phosphate dihydrate, croscarmellose sodium,

povidone, polyvinyl alcohol-part hydrolyzed,

magnesium stearate, titanium dioxide )E171(,

macrogol, talc, iron oxide yellow )E172(, iron

oxide black )E172(.

What the medicine looks like and contents

of the package:

Sertraline Teva 50 mg: Light blue, film-coated

elliptical shaped tablet, scored on one side and

debossed with “9” and “3” on each side of the

score-line. Debossed with “7176” on the other

side of the tablet.

Quantity in the package: 28 or 30 tablets.

Sertraline Teva 100 mg: Light yellow, film-coated

elliptical shaped tablet, scored on one side and

debossed with “9” and “3” on each side of the

score-line. Debossed with “7177” on the other

side of the tablet.

Quantity in the package: 28 or 30 tablets.

Not all package sizes may be marketed.

Name of License Holder and its Address:

Teva Pharmaceutical Industries Ltd., P.O.B.

3190, Petah-Tikva, 49131.

Name of Manufacturer and its Address:

Teva Pharmaceutical Industries Ltd., P.O.B.

3190, Petah-Tikva, 49131.

The leaflet was revised in March 2020.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Sertraline Teva 50 mg:

132.12.30899

Sertraline Teva 100 mg: 132.13.30900

ربكأ

ً

ايئاود

ً

ارادقم أطخلاب تلوانت اذإ نم أطخلاب لفط علب اذإ وأ

اطرفم

ايئاود

ارادقم تلوانت اذإ ،ىفشتسملا يف ئراوطلا ةفرغل وأ بيبطلا ىلإ

لااح هجوت ،ءاودلا .ءاودلا ةبلع كعم رضحأو نايثغ ،ساعن :لمشت نأ نكمي يئاودلا رادقملا طرف تاملاع تاقوأ يفو راود ،نافجر ،ءوده ةلق ،بلقلا مظن عرست ،ؤيقتو .يعولا نادقف ةردان ءاودلا لوانت تيسن اذإ تيوفت بجي ،بولطملا تقولا يف ءاودلا اذه لوانت تيسن اذإ يف مداقلا يئاودلا رادقملا لوانتو يسنملا يئاودلا رادقملا .ةصصخملا ةعاسلا يئاودلا رادقملا نع

اضوع

افعاضم

ايئاود

ارادقم لوانت زوجي لا !لاوحلأا نم لاح يأ يف يسنملا .بيبطلا ةيصوت بسحب جلاعلا ىلع ةبظاوملا بجي ءاودلا لوانت نع تفقوت اذإ ،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا نع فقوتلا زوجي لا نع بيبطلا كدشري .ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح لبق ،عيباسأ ةدع ةدمل يجيردت لكشب جلاعلا نع فقوتلا ةيفيك

ايئاهن ءاودلا لامعتسإ نع فقوتلا ،راود :لثم ضارعأب قفارتي دق ءاودلا نع ئجافملا فقوتلا نإ نايثغ ،عادص ،ءوده ةلق وأ قلق ،مونلا يف تابارطضإ ،ردخ

نم يناعت تنك اذإ ،بيبطلا غلابإ ءاجرلا .نافجر ،تاؤيقتو ىرخأ ةيبناج ضارعأ نم وأ ،ةيبناجلا ضارعلأا كلت ىدحإ .جلاعلا نع فقوتلا دنع عباط صيخشت بجي ! ةمتعلا يف ةيودلأا لوانت زوجي لا اهيف لوانتت

ةرم لك

يف يئاودلا رادقملا نم دكأتلاو ءاودلا . كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض . ءاود ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا رشتسا ةيبناجلا ضارعلأا )4

اضارعأ ببسي دق عڤيت نيلارترس لامعتسإ نإ ،ءاود لكب امك ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا ضعب دنع ةيبناج .اهنم

ايأ يناعت لاأ زئاجلا نم .ةيبناجلا ةيبناجلا ضارعلأا .

اعويش رثكلأا يبناجلا ضرعلا وه نايثغلا نإ يف لقت وأ لوزت ام بلغلأا ىلعو يئاودلا رادقملاب قلعتت

وطملا جلاعلا :لاحلا يف بيبطلا غلب اذه لامعتسإ دعب ةيلاتلا ضارعلأا ىدحإ نم يناعت تنك اذإ .ةريطخ نوكت دق ضارعلأا هذه ،ءاودلا روهظل يدؤي يذلا ديدش يدلج حفط كيدل روطت اذإ ىلع

اضيأ رثؤي دق

،)لاكشلأا ةددعتم ىمامح( تلاصيوح سنڤيتس ةمزلاتمل

اضارعأ نوكت نأ نكمي هذه .)ناسللاو مفلا وأ ،)Stevens-Johnson Syndrome( نوسنوج ـ .)Toxic Epidermal Necrolysis( يمسلا ةرشبلا رخن .تلااحلا هذه يف كب صاخلا جلاعلا فاقيإب كبيبط موقي

اضارعأ لمشت نأ نكمي يتلا ،ةيساسح وأ يسسحت لعف در خافتنإ ،ريفص ،سفنتلا يف تابوعص ،كاح يدلج حفط :لثم .نيتفشلا يف وأ هجولا يف ،نينفجلا يف ،ةعفترم ةنوخس ،لاهسإ ،كابترإ ،ءوده ةلق نم يناعت تنك اذإ ضارعأ هذه .عيرس ضبنو دئاز قرعت ،مدلا طغض عافترإ تلااح يف ةمزلاتملا هذه رهظت دق .نينوتوريسلا ةمزلاتم .ءاودلا اذه عم تقولا سفنب ةنيعم ةيودأ لامعتسإ دنع ةردان .كجلاع فقوي نأ ةلاحلا هذه يف بيبطلا نأش نم هنأش نم يذلا رملأا ،كينيع يفو كدلج يف رارفصإ ثدح اذإ .دبكلا ررضت ىلع لدي نأ ىذلأا قاحللإ راكفأ عم بائتكلإا ضارعأ نم يناعت تنك اذإ .ةيراحتنإ راكفأ وأ يتاذلا رداق ريغ اهيف نوكت تلااحو ةحار ةلقب روعشلاب أدبت تنك اذإ

اذه لامعتسإ ءدب دعب ةكرح نودب فوقولا وأ سولجلا ىلع .ةحارلا مدعب روعشلاب تأدب اذإ بيبطلا غلابإ كيلع .ءاودلا .)جلاتخإ( ةبون نم كتاناعم لاح يف 2 ةرقفلا رظنأ( سوهل )ثدح( ضراع كيدل لصح اذإ .)»ءاودلا لامعتسإب قلعتت ةصاخ تاريذحت« ةيريرسلا ثاحبلأا يف ةيلاتلا ةيبناجلا ضارعلأا تظحول .هقيوست دعب ءاودلا لامعتسإ للاخو نيغلابلا ىدل ضارعأ )very common(

ً

ادج ةعئاش ةيبناج ضارعأ :ةرشع نم دحاو لمعتسم نم رثكأ ىدل رهظت لشف ،مفلا يف فافج ،نايثغ ،لاهسإ ،عادص ،ساعن ،راود ،قرأ .قاهرإ ،يونملا لئاسلا فذق يف ىدل رهظت ضارعأ )common( ةعئاش ةيبناج ضارعأ :100 نيب نم نيلمعتسم 1-10 .حشر ،ةرجنحلا يف ملأ ،ماكز .ماعطلل ةيهشلا ةدايز ،ماعطلل ةيهشلا ضافخنإ ،ةيبصع ،ةيسنجلا ةبغرلا صقانت ،ءوده ةلق ،بائتكإ ،قلق .نانسلأا لكآت ،سيباوك ،بيرغ روعش ،ةكرحلا ةرثك :لثم( ةكرحلا تلاضع يف تابارطضإ ،نافجر ،تلاضعلا بلصت ،يشملا يف ةبوعص ،تلاضعلا يف رتوت لمنت ،*)تلاضعلا ةكرح يف ةيدارإ لا تاكرحو تاصلقت .قاذملا يف تاريغت ،ءاغصلإا مدع ،تلاضعلا رتوت ،زخوو .ةيؤرلا يف تابارطضإ .نينذلأا يف نينط .بلق تابرض .رحلا نم تابه .بؤاثت .تازاغ ،تاؤيقت ،نطبلا يف ملأ ،كاسمإ ،ةيمضه تابارطضإ .حفط ،دئاز قرعت .تلاضعلا يف ملأ ،لصافملا يف ملأ ،رهظلا يف ملاآ .يركذلا بيضقلا باصتنإ يف لكاشم ،ثمطلا ماظتنإ مدع .ةنوخس ،فعض ،ردصلا يف ملأ ،ةكعوب روعشلا .نزولا ديازت .ةباصإ )uncommon( ةعئاش ريغ ةيبناج ضارعأ :1,000 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ .نذلأا يف ثولت ،ءاعملأا يف باهتلإ .مرو .ةيمسوم ةيساسح ،ةيساسح طرف .ةيقردلا ةدغلا تانومروه ةبسن ضافخنإ راكفأ ،يناهذ بارطضإ ،*يراحتنإ كولس ،ةيراحتنإ راكفأ ناهذ ،ةوشنب روعشلا ،ةيناودع ،نايذه ،ةلاابم لا ،ةذاش .يئلايخ ،ةيدارإ لا ةيلضع تاصلقت ،ساسحلإا يف صقانت ،نايسن ،فوقولا دنع راود ،جلاتخإ ،ةقيقش ،ةكرحلا ةدايز ،ءامغإ .قطنلا يف للخ ،قيسنتلا ررضت .نيتقدحلا عسوت .نينذلأا يف ملأ .ةيبلق لكاشم ،بلقلا ضبن عرست ،دروت ،مدلا طغض عافترإ ،*)ةدعملا يف فزن لثم( ةفزنأ .لوبلا يف مد .ريفص ،سفنتلا يف تابوعص ،فاعر ،سفنتلا يف قيض ،ءيرملا يف باهتلإ ،نانسلأا يف تابارطضإ ،تفزلا هبشي زارب يف ةبوعص ،باعللا زارفإ ديازت ،ريساوب ،ناسللا يف لكاشم .ناسللا يف بارطضإ ،تاؤشجت ،علبلا ةيجسفنب طقن ،ةكح ،رعشلا طقاست ،ىرش ،نينيعلا خافتنإ فافج ،تلاصيوحب قفارتت يتلا دلجلا يف ةلكشم ،دلجلا ىلع .دراب قرعت ،هجولا يف خافتنإ ،دلجلا تاصلقت ،ةيلضع تاجنشت ،يرومضلا لصافملا باهتلإ .يلضع فعض ،*ةيلضع سلس ،لوبتلا مدع ،لوبتلا ةبوعص ،لوبتلا ةريتو يف ةدايز .يليل لوبت ،لوبتلا ديازت ،لوبلا ،ءاسنلاو لاجرلا ىدل يسنجلا يفيظولا ءادلأا يف بارطضإ .يلبهم فزن ،لبهملا نم ظوحلم فزن .شطع ،يشملا يف ةبوعص ،ةريرعشق ،نيلجرلا يف خافتنإ .نزولا صقانت ،دبكلا تاميزنإ بسن يف عافترإ يراحتنإ كولسو ةيراحتنإ راكفأ روهظل تلااح نع غل

ُ

ب

نع فقوتلا نم

ً

ابيرق وأ نيلارترس ـب جلاعلا ةرتف للاخ .)2 ةرقفلا رظنأ( نيلارترس ـب جلاعلا 1-10 ىدل رهظت ضارعأ )rare( ةردان ةيبناج ضارعأ :10,000 نيب نم نيلمعتسم ،ةيوافميللا ددغلا خافتنإ ،)Diverticulitis( جترلا باهتلإ ددع يف ضافخنإ ،*ةيومدلا تاحيفصلا ددع يف ضافخنإ .*ءاضيبلا مدلا ايلاخ .*ةيوامصلا ددغلا يف لكاشم ،داح يسسحت لعف در نزاوت ىلع ةرطيسلا يف تابارطضإ ،لورتسلوكلا عافترإ ،مدلا يف ركسلا ةبسن ضافخنإ ،)يركس( مدلا يف ركسلا مويدوصلا ةبسن ضافخنإ ،*مدلا يف ركسلا بسن يف عافترإ .*مدلا يف ةعزفم ملاحأ ،لاعفنلإا وأ رتوتلا ءارج ةيدسج ضارعأ ركبملا فذقلا ،مونلا للاخ يشملا ،ةيودلأاب قلعتلا ،*ةذاشو .ينملل عادص ،سيساحلأا طرف ،ةكرحلا ةبوعص ،ةذاش تاكرح ،تابس كرش

ت يتلا ةريطخ ةلاحل ةملاع نوكي دق( يئاجفو ،داح تابارطضإ ،*)غامدلا يف ةيومدلا ةيعولأل سوكع قيضت .سحلا يف ،ءوضلل نيعلا ةيساسح ،ةيؤرلا جاودزإ ،اموكولچ ،طقن ةيؤر يف بارطضإ ،*نيتقدحلا مجح يف فلاتخإ ،نيعلا يف مد .عومدلا يف ةلكشم ،*ةيؤرلا نوكت دق يتلا ردصلا يف جاعزنإ وأ ءامغإ ،راود ،ةيبلق ةبون هتظحلام نكمي يذلا( يئابرهكلا طاشنلا يف ريغتل تاملاع ،*بلقلا مظن ماظتنإ مدع وأ )بلقلل يئابرهكلا طيطختلا يف .ءيطب ضبن .فارطلأا يف مدلا نايرج يف للخ يوئر ضرم( ةئرلا جيسنل مدقتم بدنت ،عيرس سفنت سفنت ،قطنلا يف ةبوعص ،ةرجنحلا يف قيضت ،*)يللاخ .ةقوزاح ،ءيطب ،زاربلا يف مد ،*سايركنبلا يف باهتلإ ،مفلا يف تاحرقت

.مفلا يف ملأ ،ناسللا يف تاحرقت ،*دبكلا فئاظو يف ريطخ للخ ،دبكلا فئاظو يف لكاشم .*)ناقري( نينيعلاو دلجلا رارفصإ ،رعشلا ةينب يف ريغت ،*دلجلا ةمذو ،*سمشلل يدلج لعف در جيسن ككفت ،رعشلا تابيرج يف حفط ،مسجلل ةبيرغ ةحئار .ماظعلا يف بارطضإ ،*لضعلا .لوبتلا صقانت ،لوبتلا ءدب يف ةبوعص ءاضعلأا نم تازارفإ ،لبهملا يف فافج ،نييدثلا نم زارفإ ،ةفلقلاو يركذلا بيضقلا ةقطنم يف رارمحإو ملأ ،ةيلسانتلا .يركذلا بيضقلل لصاوتم باصتنإ ،*نييدثلا مخضت .ةيودلأا لمحت ةلق ،قتف صوحفلا ةملاس مدع ،مدلا يف لورتسلوكلا بسن يف عافترإ .*رثختلا يف لكاشم ،فاطنلا ةدوج يف تاريغت ،*ةيربخملا .ةيومد ةيعوأ عسوت اهعويش ضارعأ( فورعم ريغ اهعويش ةيبناج ضارعأ :)دعب ددحي مل .*كفلا زازك .*يليللا لوبتلا .ةيؤرلل يئزج نادقف ءاودلا لامعتسإ للاخ اهنع غل

ُ

ب يتلا ةيبناجلا ضارعلأا .* ـب ةم

ّ

لعم هقيوست ةيادب دعب :جلاعلا نع فقوتلا لاح يف رهظت دق يتلا ضارعلأا زئاجلا نمف ،ئجافم لكشب ءاودلا لوانت نع كفقوت لاح يف تابارطضإ ،ردخ ،راود :لثم ةيبناج ضارعأ كيدل روطتت نأ رظنأ( نافجرو ؤيقت ،نايثغ ،عادص ،قلق وأ ةيبصع ،مونلا يف .)3 ةرقفلا ىدل ماظعلا يف روسك ثودح ةروطخ يف ةدايز تظحول .عونلا اذه نم ةيودأ اولمعتسإ نيذلا ىضرملا ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ ،ةرشنلا هذه يف ركذي مل يبناج ضرع نم يناعت امدنع وأ .بيبطلا ةراشتسإ كيلع ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا ىلع طغضلا ةحصلا ةرازو عقومل ةيسيئرلا ةحفصلا ىلع دوجوملا »يئاود غيلبتلل رشابملا جذومنلل كهجوي يذلا )www.health.gov.il( :طبارلا حفصت قيرط نع وأ ،ةيبناج ضارعأ نع

https://sideeffects.health.gov.il

؟ءاودلا نيزخت ةيفيك )5 يف رخآ ءاود لكو ءاودلا اذه ظفح بجي ! ممستلا بنجت لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم ببست لا . ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و . بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا خيرات ريشي .ةبلعلا رهظ ىلع رهظي يذلا )exp. date( .رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ءاضقنإ ،فاج ناكم يف ءاودلا نيزخت بجي :نيزختلا فورظ .ةيوئم ةجرد 25 نود ةرارح ةجردب ةيفاضإ تامولعم )6

اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي :غلم 50 عڤيت نيلارترس

Microcrystalline cellulose, dibasic calcium

phosphate dihydrate, croscarmellose

sodium, povidone, hypromellose, titanium

dioxide )E171(, magnesium stearate,

macrogol, polysorbate, indigo carmine

)E132(.

:غلم 100 عڤيت نيلارترس

Microcrystalline cellulose, dibasic calcium

phosphate dihydrate, croscarmellose

sodium, povidone, polyvinyl alcohol-part

hydrolyzed, magnesium stearate, titanium

dioxide )E171(, macrogol, talc, iron oxide

yellow )E172(, iron oxide black )E172(.

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك نولب ،لكشلا يوضيب يلطم صرق :غلم 50 عڤيت نيلارترس رطشلل طخ دجوي صرقلا نم دحاو بناج يف .يوامس قرزأ يف .رطشلا طخ يبناج ىلع ةعوبطم »3« ـو »9« ماقرلأاو

7176« مقرلا عوبطم صرقلل يناثلا بناجلا

اصرق 30 وأ 28 :ةبلعلا يف صارقلأا ةيمك هنول ،لكشلا يوضيب يلطم صرق :غلم 100 عڤيت نيلارترس رطشلل طخ دجوي صرقلا نم دحاو بناج يف .حتاف رفصأ يف .رطشلا طخ يبناج ىلع ةعوبطم »3« ـو »9« ماقرلأاو .»7177« مقرلا عوبطم صرقلل يناثلا بناجلا

اصرق 30 وأ 28 :ةبلعلا يف صارقلأا ةيمك .بلعلا ماجحأ ةفاك قوست لاأ زئاجلا نم :هناونعو زايتملإا بحاص ، . ض.م ةيبطلا تارضحتسملاو ةيودلأل عڤيت .49131 ، اڤكت ـ حتيﭘ ، 3190 . ب.ص :هناونعو جتنملا مسإ ، . ض.م ةيبطلا تارضحتسملاو ةيودلأل عڤيت .49131 ،اڤكت ـ حتيﭘ ،3190 . ب.ص .2020 راذآ يف اهدادعإ مت ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر :ةحصلا

132 12 30899

:غلم 50 عڤيت نيلارترس

132 13 30900

:غلم 100 عڤيت نيلارترس ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف ،كلذ نم مغرلا ىلع .ركذملا ةمتت

ץרמ

2020

ה/דבכנ ת/חקור ,ה/ אפור

העידומ עבט תרבח לע

םינוכדעה

םיאבה

ןולעב ןכרצל

:םירישכתה לש

עבט ןילרטרס

תופוצמ תוילבט ,ג"מ

Sertraline Teva 50mg, Film coated tablets

עבט ןילרטרס

תופוצמ תוילבט ,ג"מ

Sertraline Teva 100mg, Film coated tablets

Contains:

Sertraline Teva 50 mg contains Sertraline (as hydrochloride) 50 mg

Sertraline Teva 100 mg contains Sertraline (as hydrochloride) 100 mg

ןכרצל ןולעב םינוכדע

-------------------------------------------------------------------------------------------------------

:םושירה תדועתב הרשואש יפכ היוותה

For the treatment of symptoms of depression in patients with or without a history of

mania.

Following

satisfactory

response,

continuation

with

sertaline

therapy

effective in preventingrelapse of the initial episode of depression or recurrence of

further depressive episodes.

תופסות) דבלב םיירקיעה םינוכדעה םילולכ ןלהלש טוריפב ,ןכדוע ןכרצל ןולעהש עידוהל וננוצרב תונמוסמ םודאב

:(קוחמ טסקטכ עדימ תורסהו

הפורתב שומישה ינפל

:םא הפורתב שמתשהל ןיא

הפורתה הליכמ רשא םיפסונה םיביכרמהמ דחא לכל וא ליעפה רמוחל (יגרלא) שיגר התא םיטרופמ) ףיעסב

זאדיסקוא ןימאונומ יבכעמ תחפשממ תופורת תלטנ וא לטונ התא

,ןילי'גלס :ןוגכ) ןיתמהל שי .(דילוזניל ןוגכ) זאדיסקוא ןימאונומ יבכעמ תויומד תופורת וא (דימבולקומ

תוחפל

עובש

םייעובש

ןימאונומ יבכעמב לופיטה תלחתהו ןילרטרסב לופיטה םויס רחאל ע ,ןכ ומכ .זאדיסקוא ןימאונומ יבכעמב לופיטה םויס רחאל םייעובש תוחפל ןיתמהל ךיל .ןילרטרסב לופיטה תלחתהו זאדיסקוא

ןוגכ תוישפנ תוערפהל תדעוימה הפורת) דיזומיפ םשב הפורת תינמז וב לטונ התא .(הזוכיספ

הפורתב שומישל תועגונה תודחוימ תורהזא

:םא אפורל רפס ,עבט ןילרטרסב לופיטה ינפל

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רגאמב םוסרפל חלשנ ןכרצל ןולעה תואירבה דרשמ לש טנרטניאה רתאבש תופורתה

http://www.health.gov.il

.עבט תרבחל הינפ י"ע ספדומ ולבקל ןתינו ,

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