Aripiprazole Zentiva - patient leaflet, side effects, dosage

- 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

• 1. What Aripiprazole Zentiva is and what it is used for

• 2. What you need to know before you take Aripiprazole Zentiva

• 3. How to take Aripiprazole Zentiva

• 4. Possible side effects

• 5. How to store Aripiprazole Zentiva

• 6. 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.

Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are an elderly patient or have some debility.

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. John’s 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 obsessive-compulsive disorder (OCD) andas 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
• Selective-serotonin-reuptake-inhibitors (SSRIs) (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 medicinal product.

Aripiprazole Zentiva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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,
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
• uncontrollable twitching, jerking or writhing movements,
• 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),
• restless legs,
• double vision,
• eye sensitivity to light,
• 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,

fixation of the eyeballs in one position,

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,

skin sensitivity to light,

baldness,

excessive sweating,

serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),

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.

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 × 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

Deutschland Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010	Nederland Zentiva, k.s. Tel: +31 202 253 638
Eesti Zentiva, k.s. Tel: +372 52 70308	Norge Zentiva, k.s. Tlf: +47 219 66 203
EMáSa Zentiva, k.s. Tql: +30 211 198 7510	Österreich Zentiva, k.s. Tel: +43 720 778 877
España Zentiva, k.s. Tel: +34 931 815 250	Polska Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00
France Zentiva France Tél: +33 (0) 800 089 219	Portugal Zentiva Portugal, Lda Tel: +351210601360
Hrvatska Zentiva d.o.o. Tel: +385 1 6641 830	Romania ZENTIVA S.A. Tel: +4 021.304.7597
Ireland Zentiva, k.s. Tel: +353 766 803 944	Slovenija Zentiva, k.s. Tel: +386 360 00 408
Ísland Zentiva, k.s. Sími: +354 539 0650	Slovenská republika Zentiva, a.s. Tel: +421 2 3918 3010
Italia Zentiva Italia S.r.l. Tel: +39–02–38598801	Suomi/Finland Zentiva, k.s. Puh/Tel: +358 942 598 648
Kúnpog Zentiva, k.s. Tql: +357 240 30 144	Sverige Zentiva, k.s. Tel: +46 840 838 822
Latvija Zentiva, k.s. Tel: +371 67893939	United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2408
This leaflet was last revised in

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