Aripiprazole Zentiva

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  • Aripiprazole Zentiva
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Staðsetning

  • Fáanlegt í:
  • Aripiprazole Zentiva
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Psycholeptics,
  • Lækningarsvæði:
  • Schizophrenia, Bipolar Disorder
  • Ábendingar:
  • Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
  • Vörulýsing:
  • Revision: 5

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/003899
  • Leyfisdagur:
  • 24-06-2015
  • EMEA númer:
  • EMEA/H/C/003899
  • Síðasta uppfærsla:
  • 30-03-2019

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/276403/2015

EMEA/H/C/003899

EPAR summary for the public

Aripiprazole Zentiva

aripiprazole

This is a summary of the European public assessment report (EPAR) for Aripiprazole Zentiva. It

explains how the Agency assessed the medicine to recommend its authorisation in the EU and its

conditions of use. It is not intended to provide practical advice on how to use Aripiprazole Zentiva.

For practical information about using Aripiprazole Zentiva, patients should read the package leaflet or

contact their doctor or pharmacist.

What is Aripiprazole Zentiva and what is it used for?

Aripiprazole Zentiva is used in patients with the following mental illnesses:

schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and

speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions

(false beliefs). Aripiprazole Zentiva is used in patients aged 15 years or over;

bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally

high mood), alternating with periods of normal mood. They may also have episodes of depression.

Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent

new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Zentiva

is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13

years or over.

Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine’. This means

that Aripiprazole Zentiva is similar to a ‘reference medicine’ already authorised in the European Union

(EU) called Abilify. For more information on generic medicines, see the question-and-answer document

here

Aripiprazole Zentiva

EMA/276403/2015

Page 2/3

How is Aripiprazole Zentiva used?

Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets

that dissolve in the mouth; 10, 15 and 30 mg). It can only be obtained with a prescription.

For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed

by a ‘maintenance’ dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting

dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased

to the recommended dose of 10 mg once a day.

For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by

mouth once a day, either on its own or in combination with other medicines. To prevent manic

episodes in adults, the same dose should be continued.

For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day

(using an aripiprazole product available in liquid form), which is gradually increased to the

recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.

The dose should be adjusted in patients who are taking other medicines that affect the way

Aripiprazole Zentiva is broken down in the body. For further information, see the Summary of Product

Characteristics (also part of the EPAR).

The orodispersible tablets can be used in patients who have difficulty swallowing tablets.

How does Aripiprazole Zentiva work?

The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine. Its exact

mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve

cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’,

chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly

by being a ‘partial agonist’ for the receptors for the neurotransmitters dopamine and 5-

hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5-

hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since

dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole

helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing

them from returning.

How has Aripiprazole Zentiva been studied?

Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to

determine that it is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent

when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aripiprazole Zentiva?

Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its

benefits and risks are taken as being the same as the reference medicine’s.

Why is Aripiprazole Zentiva approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance

with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be

Aripiprazole Zentiva

EMA/276403/2015

Page 3/3

bioequivalent to Abilify. Therefore, the CHMP’s view was that, as for Abilify, the benefit outweighs the

identified risk. The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of

Aripiprazole Zentiva?

A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as

possible. Based on this plan, safety information has been included in the summary of product

characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions

to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be

supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in

patients between 13 and 17 years.

Other information about Aripiprazole Zentiva

The European Commission granted a marketing authorisation valid throughout the European Union for

Aripiprazole Zentiva on 25 June 2015.

The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the

Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment

reports. For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also

part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 06-2015.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Aripiprazole Zentiva 5 mg tablets

Aripiprazole Zentiva 10 mg tablets

Aripiprazole Zentiva 15 mg tablets

Aripiprazole Zentiva 30 mg tablets

aripiprazole

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 Aripiprazole Zentiva is and what it is used for

What you need to know before you take Aripiprazole Zentiva

How to take Aripiprazole Zentiva

Possible side effects

How to store Aripiprazole Zentiva

Contents of the pack and other information

1.

What Aripiprazole Zentiva is and what it is used for

Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines

called antipsychotics.

It is used to treat adults and adolescents aged 15 years and older who suffer from a disease

characterised by symptoms such as hearing, seeing or sensing things which are not there,

suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People

with this condition may also feel depressed, guilty, anxious or tense.

Aripiprazole Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from

a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much

less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

In adults it also prevents this condition from returning in patients who have responded to the treatment

with Aripiprazole Zentiva.

2.

What you need to know before you take Aripiprazole Zentiva

Do not take Aripiprazole Zentiva

if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed

in section 6).

Warnings and precautions

Talk to your doctor before taking Aripiprazole Zentiva.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor

immediately if you are having any thoughts or feelings about hurting yourself.

Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from

high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts

of urine, increase in appetite and feeling weak) or family history of diabetes

fits (seizures) since your doctor may want to monitor you more closely

involuntary, irregular muscle movements, especially in the face

cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular

disease, stroke or “mini” stroke, abnormal blood pressure

blood clots, or family history of blood clots, as antipsychotics have been associated with

formation of blood clots

past experience with excessive gambling.

If you notice you are gaining weight, develop unusual movements, experience somnolence that

interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell

your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities),

you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever,

sweating, altered mental status, or very rapid or irregular heart beat.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings

to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation

to carry out certain activities that could harm yourself or others. These are called impulse control

disorders and can include behaviours such as addictive gambling, excessive eating or spending,

an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.

Your doctor may need to adjust or stop your dose.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe

and effective in these patients.

Other medicines and Aripiprazole Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: Aripiprazole Zentiva may increase the effect of medicines used

to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood

pressure under control.

Taking Aripiprazole Zentiva with some medicines may mean the doctor will need to change your dose

of Aripiprazole Zentiva or the other medicines. It is especially important to mention the following

to your doctor:

Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)

Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,

paroxetine, venlafaxine, St. Johnʼs Wort)

Antifungal medicines (such as ketoconazole, itraconazole)

Certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors

e.g. indinavir, ritonavir)

Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)

Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva;

if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva,

you should see your doctor.

Medicines that increase the level of serotonin are typically used in conditions including depression,

generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well

as migraine and pain:

Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain

SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety

Other anti-depressants (such as venlafaxine and tryptophan) used in major depression

Tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness

St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression

Pain killers (such as tramadol and pethidine) used for pain relief

Triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any

of these medicines together with Aripiprazole Zentiva, you should see your doctor.

Aripiprazole Zentiva with food, drink and alcohol

This medicine can be taken regardless of meals.

Alcohol should be avoided.

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 for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole

Zentiva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or

weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops

any of these symptoms you may need to contact your doctor.

If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast

feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding.

You should not do both. Talk to your doctor about the best way to feed your baby if you are taking

this medicine.

Driving and using machines

Dizziness and vision problems may occur during treatment with this medicine (see section 4). This

should be considered in cases where full alertness is required, e.g. when driving a car or handling

machines.

Aripiprazole Zentiva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.

3.

How to take Aripiprazole Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower

or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

This medicinal product may be started at a low dose with the oral solution (liquid) form. The dose

may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However

your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of Aripiprazole Zentiva is too strong or too weak, talk

to your doctor or pharmacist.

Try to take Aripiprazole Zentiva at the same time each day.

It does not matter whether you take it

with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better

, do not alter or discontinue the daily dose of Aripiprazole Zentiva without

first consulting your doctor.

Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for breaking the tablet.

If you take more Aripiprazole Zentiva than you should

If you realise you have taken more Aripiprazole Zentiva than your doctor has recommended

(or if someone else has taken some of your Aripiprazole Zentiva), contact your doctor right away.

If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

Rapid heartbeat, agitation/aggressiveness, problems with speech.

Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,

Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood

pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take Aripiprazole Zentiva

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one

day.

If you stop taking Aripiprazole Zentiva

Do not stop your treatment just because you feel better. It is important that you carry on taking

Aripiprazole Zentiva for as long as your doctor has told you to.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

trembling,

headache,

tiredness,

sleepiness,

light-headedness,

shaking and blurred vision,

decreased number of or difficulty making bowel movements,

indigestion,

feeling sick,

more saliva in mouth than normal,

vomiting,

feeling tired.

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

increased blood levels of the hormone prolactin,

too much sugar in the blood,

depression,

altered or increased sexual interest,

uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),

muscle disorder causing twisting movements (dystonia),

double vision,

fast heart beat,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the

frequency for them to occur is

not known

low levels of white blood cells,

low levels of blood platelets,

allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),

onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,

high blood sugar,

not enough sodium in the blood,

loss of appetite (anorexia),

weight loss,

weight gain,

thoughts of suicide, suicide attempt and suicide;

feeling aggressive,

agitation,

nervousness,

combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and

sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),

seizure,

serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),

speech disorder,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in

the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty

in breathing (if you notice any of these symptoms, seek medical advice immediately),

high blood pressure,

fainting,

accidental inhalation of food with risk of pneumonia (lung infection),

spasm of the muscles around the voice box,

inflammation of the pancreas,

difficulty swallowing,

diarrhoea,

abdominal discomfort,

stomach discomfort,

liver failure,

inflammation of the liver,

yellowing of the skin and white part of eyes,

reports of abnormal liver tests values;

skin rash,

sensitivity to light,

baldness,

excessive sweating,

abnormal muscle breakdown which can lead to kidney problems,

muscle pain,

stiffness,

involuntary loss of urine (incontinence),

difficulty in passing urine;

withdrawal symptoms in newborn babies in case of exposure during pregnancy,

prolonged and/or painful erection,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.

inability to resist the impulse, drive or temptation to perform an action that could be harmful

to you or others, which may include:

strong impulse to gamble excessively despite serious personal or family consequences

altered or increased sexual interest and behaviour of significant concern to you or to

others, for example, an increased sexual drive

uncontrollable excessive shopping

binge eating (eating large amounts of food in a short time period) or compulsive eating

(eating more food than normal and more than is needed to satisfy your hunger)

a tendency to wander away.

Tell your doctor if you experience any of these behaviours; he/she will discuss ways

of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.

In addition, cases of stroke or “mini” stroke have been reported.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type

to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness,

and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry

mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled

movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position,

were common (may affect up to 1 in 10 people).

Reporting of side effects

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

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Aripiprazole Zentiva

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

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your 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 Aripiprazole Zentiva contains

The active substance is aripiprazole. Each tablet contains 5 mg/10 mg/15 mg/30 mg of aripiprazole.

The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone,

hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.

What Aripiprazole Zentiva looks like and contents of the pack

Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5’

debossed on one side and plain on the other side with diameter approx. 6 mm.

Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10’ debossed

on one side and snap tab breakline on the other side with diameter approx. 8 mm.

Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with

‘15’ debossed on one side and plain on the other side with diameter approx. 8.8 mm.

Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30’

debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.

Pack size: 14, 28, 49, 56, or 98 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

S.C. Zentiva S.A.

50 Theodor Pallady Blvd.

Bucharest 032266

Romania

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Aripiprazole Zentiva 10 mg orodispersible tablets

Aripiprazole Zentiva 15 mg orodispersible tablets

Aripiprazole Zentiva 30 mg orodispersible tablets

aripiprazole

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 Aripiprazole Zentiva is and what they are used for

What you need to know before you take Aripiprazole Zentiva

How to take Aripiprazole Zentiva

Possible side effects

How to store Aripiprazole Zentiva

Contents of the pack and other information

1.

What Aripiprazole Zentiva is and what it is used for

Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines

called antipsychotics.

It is used to treat adults and adolescents aged 15 years and older who suffer from a disease

characterised by symptoms such as hearing, seeing or sensing things which are not there,

suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People

with this condition may also feel depressed, guilty, anxious or tense.

Aripiprazole Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from

a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much

less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

In adults it also prevents this condition from returning in patients who have responded to the treatment

with Aripiprazole Zentiva.

2.

What you need to know before you take Aripiprazole Zentiva

Do not take Aripiprazole Zentiva

if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed

in section 6).

Warnings and precautions

Talk to your doctor before taking Aripiprazole Zentiva.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor

immediately if you are having any thoughts or feelings about hurting yourself.

Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from

high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts

of urine, increase in appetite and feeling weak) or family history of diabetes

fits (seizures) since your doctor may want to monitor you more closely

involuntary, irregular muscle movements, especially in the face

cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular

disease, stroke or “mini” stroke, abnormal blood pressure

blood clots, or family history of blood clots, as antipsychotics have been associated with

formation of blood clots

past experience with excessive gambling

If you notice you are gaining weight, develop unusual movements, experience somnolence that

interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell

your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you

or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever,

sweating, altered mental status, or very rapid or irregular heart beat.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings

to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation

to carry out certain activities that could harm yourself or others. These are called impulse control

disorders and can include behaviours such as addictive gambling, excessive eating or spending,

an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.

Your doctor may need to adjust or stop your dose.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe

and effective in these patients.

Other medicines and Aripiprazole Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: Aripiprazole Zentiva may increase the effect of medicines used

to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood

pressure under control.

Taking Aripiprazole Zentiva with some medicines may mean the doctor will need to change your dose

of Aripiprazole Zentiva or the other medicines. It is especially important to mention the following

to your doctor:

Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)

Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,

paroxetine, venlafaxine, St. Johnʼs Wort)

Antifungal medicines (such as ketoconazole, itraconazole)

Certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors

e.g. indinavir, ritonavir)

Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)

Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva;

if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva

tablets, you should see your doctor.

Medicines that increase the level of serotonin are typically used in conditions including depression,

generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well

as migraine and pain:

Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain

SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety

Other anti-depressants (such as venlafaxine and tryptophan) used in major depression

Tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness

St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression

Pain killers (such as tramadol and pethidine) used for pain relief

Triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any

of these medicines together with Aripiprazole Zentiva, you should see your doctor.

Aripiprazole Zentiva with food, drink and alcohol

This medicine can be taken regardless of meals.

Alcohol should be avoided.

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 for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole

Zentiva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or

weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops

any of these symptoms you may need to contact your doctor.

If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast

feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding.

You should not do both. Talk to your doctor about the best way to feed your baby if you are taking

this medicine.

Driving and using machines

Dizziness and vision problems may occur during treatment with this medicine (see section 4). This

should be considered in cases where full alertness is required, e.g., when driving a car or handling

machines.

Aripiprazole Zentiva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.

3.

How to take Aripiprazole Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower

or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

This medicinal product may be started at a low dose with the oral solution (liquid) form. The dose

may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However

your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of Aripiprazole Zentiva is too strong or too weak, talk

to your doctor or pharmacist.

Try to take Aripiprazole Zentiva at the same time each day.

It does not matter whether you take it

with or without food.

Do not open the blister until ready to administer. Immediately upon opening the blister, using dry

hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration

occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid. Alternatively,

disperse the tablet in water and drink the resulting suspension.

Even if you feel better

, do not alter or discontinue the daily dose of Aripiprazole Zentiva without

first consulting your doctor.

Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking

the tablet.

If you take more Aripiprazole Zentiva than you should

If you realise you have taken more Aripiprazole Zentiva than your doctor has recommended (or if

someone else has taken some of your Aripiprazole Zentiva), contact your doctor right away. If you

cannot reach your doctor, go to the nearest hospital and take the pack with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

Rapid heartbeat, agitation/aggressiveness, problems with speech.

Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,

Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood

pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take Aripiprazole Zentiva

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one

day.

If you stop taking Aripiprazole Zentiva

Do not stop your treatment just because you feel better. It is important that you carry on taking

Aripiprazole Zentiva orodispersible tablets for as long as your doctor has told you to.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

trembling,

headache,

tiredness,

sleepiness,

light-headedness,

shaking and blurred vision,

decreased number of or difficulty making bowel movements,

indigestion,

feeling sick,

more saliva in mouth than normal,

vomiting,

feeling tired.

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

increased blood levels of the hormone prolactin,

too much sugar in the blood,

depression,

altered or increased sexual interest,

uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),

muscle disorder causing twisting movements (dystonia),

double vision,

fast heart beat,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but

the frequency for them to occur is

not known

low levels of white blood cells;

low levels of blood platelets,

allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),

onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,

high blood sugar,

not enough sodium in the blood,

loss of appetite (anorexia),

weight loss,

weight gain,

thoughts of suicide, suicide attempt and suicide;

feeling aggressive,

agitation,

nervousness,

combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and

sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),

seizure,

serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),

speech disorder,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness

in the leg), which may travel through blood vessels to the lungs causing chest pain and

difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),

high blood pressure,

fainting,

accidental inhalation of food with risk of pneumonia (lung infection),

spasm of the muscles around the voice box,

inflammation of the pancreas,

difficulty swallowing,

diarrhoea,

abdominal discomfort,

stomach discomfort,

liver failure,

inflammation of the liver,

yellowing of the skin and white part of eyes,

reports of abnormal liver test values,

skin rash,

sensitivity to light,

baldness,

excessive sweating,

abnormal muscle breakdown which can lead to kidney problems,

muscle pain,

stiffness,

involuntary loss of urine (incontinence),

difficulty in passing urine,

withdrawal symptoms in newborn babies in case of exposure during pregnancy,

prolonged and/or painful erection,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.

inability to resist the impulse, drive or temptation to perform an action that could be harmful

to you or others, which may include:

strong impulse to gamble excessively despite serious personal or family consequences

altered or increased sexual interest and behaviour of significant concern to you

or to others, for example, an increased sexual drive

uncontrollable excessive shopping

binge eating (eating large amounts of food in a short time period) or compulsive eating

(eating more food than normal and more than is needed to satisfy your hunger)

a tendency to wander away.

Tell your doctor if you experience any of these behaviours; he/she will discuss ways

of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.

In addition, cases of stroke or “mini” stroke have been reported.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type

to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness,

and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry

mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled

movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position,

were common (may affect up to 1 in 10 people).

Reporting of side effects

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

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Aripiprazole Zentiva

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

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your 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 Aripiprazole Zentiva contains

The active substance is aripiprazole. Each orodispersible tablet contains 10 mg/15 mg/30 mg

of aripiprazole.

The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone,

hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium,

mango flavour, magnesium stearate.

What Aripiprazole Zentiva looks like and contents of the pack

Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10’

on one side and snap break line on other side with diameter approx. 7 mm.

Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets

debossed ‘15’ on one side and plain on the other side with diameter approx. 8 mm.

Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30’

on one side and snap break line on the other side with diameter approx. 10.2 mm.

Pack size: 14, 28 or 49 orodispersible tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

S.C. Zentiva S.A.

50 Theodor Pallady Blvd.

Bucharest 032266

Romania

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.