ARIPIPRAZOLE Zentiva 5 mg Tablets

Introduction

Package Leaflet: Information for the User

Aripiprazol Zentiva 5 mg tablets EFG

Aripiprazol Zentiva 10 mg tablets EFG

Aripiprazol Zentiva 15 mg tablets EFG

Aripiprazol Zentiva 30 mg tablets EFG

aripiprazole

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Aripiprazol Zentiva and what is it used for
2. What you need to know before you take Aripiprazol Zentiva
3. How to take Aripiprazol Zentiva
4. Possible side effects
5. Storage of Aripiprazol Zentiva
6. Contents of the pack and other information

1. What is Aripiprazol Zentiva and what is it used for

Aripiprazol Zentiva contains the active substance aripiprazole and belongs 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 characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral monotony. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazol Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes severe irritability. In adults, it also prevents this condition in patients who have responded to treatment with Aripiprazol Zentiva.

2. What you need to know before you take Aripiprazol Zentiva

Do not take Aripiprazol 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 you start taking Aripiprazol Zentiva.

There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or feelings of harming yourself.

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

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) or a family history of diabetes
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• a history of gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing somnolence that interferes with your daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you suffer from dementia (loss of memory and other mental abilities), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or very fast or irregular heartbeat.

Tell your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause somnolence, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. You should be cautious, especially if you are an elderly patient or suffer from weakness.

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 Aripiprazol Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Medicines that lower blood pressure: Aripiprazol Zentiva may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you use any medicine to control blood pressure.

If you are taking Aripiprazol Zentiva with another medicine, it may mean that your doctor needs to change your dose of Aripiprazol Zentiva or the other medicine. It is especially important that you mention to your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as 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 Aripiprazol Zentiva; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Zentiva, you should tell your doctor.

Medicines that increase serotonin levels are commonly used in diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for diseases such as depression, generalized 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 antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive diseases;
• St. John's Wort (Hypericum perforatum) used in plant-based medicines for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Zentiva, you should tell your doctor.

Taking Aripiprazol Zentiva with food, drinks, and alcohol

This medicine can be taken independently of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with Aripiprazol Zentiva in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking Aripiprazol Zentiva, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with Aripiprazol Zentiva, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazol Zentiva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Aripiprazol Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Aripiprazol Zentiva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

This medicine should be started with the oral solution (liquid) at a low dose. The dose can be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

If you think the effect of Aripiprazol Zentiva is too strong or too weak, tell your doctor or pharmacist.

Try to take Aripiprazol Zentiva at the same time each day.It does not matter if you take it with or without food. Always take the tablets with water and swallow them whole.

Even if you feel better, do not change or interrupt the daily dose of Aripiprazol Zentiva without consulting your doctor first.

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

If you take more Aripiprazol Zentiva than you should

If you realize that you have taken more Aripiprazol Zentiva than your doctor recommended (or if someone else has taken some of your Aripiprazol Zentiva), contact your doctor immediately. If you cannot contact your doctor, go to the nearest hospital and take the package with you.

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

• rapid heartbeat, agitation/aggressiveness, language problems;
• unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle stiffness and somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If you forget to take Aripiprazol Zentiva

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to make up for the missed dose.

If you stop taking Aripiprazol Zentiva

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazol Zentiva tablets for the time your doctor has indicated.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

• diabetes mellitus,
• sleeping problems,
• anxiety,
• feeling of restlessness and inability to stay still, difficulty staying seated,
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly),
• uncontrolled twisting, contorting, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shivering and blurred vision,
• difficulty evacuating or decreased frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of fatigue.

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• increase or decrease in prolactin hormone levels in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• ocular photosensitivity,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, lightheadedness, or fainting,
• hypo.

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but their frequency is unknown (frequency cannot be estimated from available data):

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, and redness),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,
• high blood sugar,
• insufficient sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide, and suicide,
• aggression,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),
• speech disorder,
• fixation of the eyeballs in a position,
• sudden unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slower heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasms of the muscles around the glottis (a part of the larynx),
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• liver inflammation,
• yellowing of the skin and the white part of the eyes,
• abnormal liver values in blood tests,
• rash,
• skin photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudo-flu-like symptoms with a rash on the face and later with a generalized rash, high temperature, swollen lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased eosinophilia,
• abnormal muscle breakdown that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns due to exposure to the drug during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin A1c,
• inability to resist the impulse, instinct, or temptation to perform an action that may 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 disturbing behavior for you or others, for example, increased sexual appetite;

? uncontrolled excessive shopping;

? binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger);

? tendency to wander.

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other Adverse Effects in Children and Adolescents

Adolescents aged 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrolled contractions, restlessness, and fatigue, which were very frequent (affecting more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness, especially when standing up after sitting or lying down, which were frequent (affecting more than 1 in 100 patients).

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Zentiva

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

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol Zentiva

• 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, colloidal anhydrous silica, sodium croscarmellose, magnesium stearate.

Appearance of Aripiprazol Zentiva and Package Contents

The 5 mg Aripiprazol Zentiva tablets are round, uncoated, white or almost white, beveled edges, smooth, with "5" engraved on one side and flat on the other, with an approximate diameter of 6 mm.

The 10 mg Aripiprazol Zentiva tablets are round, uncoated, white or almost white, with "10" engraved on one side and a score line on the other, with an approximate diameter of 8 mm.

The 15 mg Aripiprazol Zentiva tablets are round, uncoated, white or almost white, beveled edges, smooth, with "15" engraved on one side and flat on the other, with an approximate diameter of 8.8 mm.

The 30 mg Aripiprazol Zentiva tablets are uncoated, capsule-shaped, white or almost white, with "30" engraved on one side and a score line on the other, with approximate dimensions of 15.5 x 8 mm.

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

Not all pack sizes may be marketed.

Marketing Authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu