Aripiprazole Teva-Ratiopharm 15 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aripiprazole Teva-ratiopharm 15 mg tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4. >

Contents of the leaflet

1. What Aripiprazole Teva-ratiopharm is and what it is used for
2. What you need to know before taking Aripiprazole Teva-ratiopharm
3. How to take Aripiprazole Teva-ratiopharm
4. Possible side effects
5. How to store Aripiprazole Teva-ratiopharm
6. Contents of the pack and other information

1. What Aripiprazol Teva-ratiopharm is and what it is used for

Aripiprazol Teva-ratiopharm 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 have an illness characterised by symptoms such as hearing, seeing, and sensing things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. People in this condition may also feel depressed, guilty, uneasy, or tense.

Aripiprazol Teva-ratiopharm is used to treat adults and adolescents aged 13 years and older who have a disorder characterised by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with Aripiprazol Teva-ratiopharm.

2. What you need to know before taking Aripiprazole Teva-ratiopharm

Do not take Aripiprazole Teva-ratiopharm

• if you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting aripiprazole.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole have been reported. Inform your doctor immediately if you have thoughts or feelings about harming yourself.

Before starting treatment with Aripiprazole Teva-ratiopharm, tell your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) 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 problems), 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 blood clot formation
• a history of gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you are an elderly person with 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.

Inform 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 could harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are an elderly patient or have any weakness.

Children and adolescents

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

Taking Aripiprazole Teva-ratiopharm with other medicines

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

Medicines that lower blood pressure: Aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control your blood pressure.

If you are taking aripiprazole with any other medicine, it may mean that your doctor needs to adjust your dose of aripiprazole or the dose of the other medicines. It is especially important to tell your doctor if you are taking:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's wort)
• Antifungals (such as ketoconazole, itraconazole)
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors like indinavir, ritonavir)
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital, primidone)
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of aripiprazole. If you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Medicines that increase serotonin levels are generally used in conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), 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 disorders;
• St. John's wort (Hypericum perforatum) used in herbal 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 while taking any of these medicines together with Aripiprazole Teva-ratiopharm, you must inform your doctor.

Taking Aripiprazole Teva-ratiopharm with food, drinks, and alcohol

This medicine can be taken regardless of meals. Consumption of alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

Make sure to inform your doctor immediately if you are breastfeeding.

If you are taking aripiprazole, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. 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

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.

Aripiprazole Teva-ratiopharm contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg (1 mmol) of sodium per tablet, which means it is considered essentially "sodium-free".

3. How to take Aripiprazole Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

Aripiprazole should be initiated with the oral solution (liquid) at a low dose. Gradually, the dose may be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once daily.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Aripiprazole Teva-ratiopharm is for oral use.

Try to take the Aripiprazole Teva-ratiopharm tablet at the same time each day. It does not matter whether you take it with or without food.

5 mg

Always take the tablets with water and swallow them whole.

10 mg/15 mg

Always take the tablets with water. The tablet may be divided into equal doses.

Even if you feel better, do not change or stop the daily dose of Aripiprazole Teva-ratiopharm without first consulting your doctor.

If you take more Aripiprazole Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.

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

• rapid heartbeat, agitation/aggression, speech 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 rigidity and drowsiness, slower breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

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

If you forget to take Aripiprazole Teva-ratiopharm

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

If you stop taking Aripiprazole Teva-ratiopharm

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Teva-ratiopharm for the length of time prescribed by your doctor.

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 everyone experiences them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• diabetes mellitus,
• sleep disturbances,
• anxiety,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving),
• uncontrollable twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• somnolence,
• dizziness,
• shakiness and blurred vision,
• difficulty passing stools or reduced frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of tiredness

Uncommon adverse effects (may affect up to 1 in 100 patients):

• increased or decreased levels of prolactin hormone in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sex drive,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• a muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye photosensitivity,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting,
• hiccups

The following adverse effects have been reported during the post-marketing use of aripiprazole, but their frequency is unknown (cannot be estimated from the 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,
• low levels of sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt, and suicide,
• suicidal thoughts, suicide attempt, and suicide,
• aggression,
• agitation,
• nervousness,
• neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, decreased level of consciousness, sudden changes in blood pressure and heart rate, and fainting),
• seizures,
• serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),
• speech disorder,
• fixed eye position (oculogyric crisis),
• unexplained sudden death,
• potentially life-threatening irregular heartbeat,
• heart attack,
• slower heartbeat,
• 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 breathing (if you experience any of these symptoms, contact your doctor immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasms of muscles around the glottis (a part of the larynx),
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function test results,
• rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia),
• abnormal breakdown of muscle tissue that may lead to kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns exposed to medication during pregnancy,
• prolonged and/or painful erection,
• difficulty regulating core body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin,
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:
  • a strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sex drive;
  • uncontrollable excessive shopping;
  • binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating 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, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in type and frequency to those in adults, except for somnolence, uncontrollable spasms or contractions, restlessness, and fatigue, which were very common (may affect 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 upon standing from a lying or sitting position—which were common (may affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazol Teva-ratiopharm

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.

The other components are monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, sodium croscarmellose, yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Aripiprazol Teva-ratiopharm 15 mg tablets are light yellow, round, flat, with bevelled edges, engraved with "15" on one side and a score line on the other side.

The tablet can be divided into equal doses.

It is presented in OPA-Aluminum-PVC/Aluminum blisters packed in cartons containing 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid.

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren.

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd)

Prilaz baruna Filipovica 25, Zagreb

10000 Zagreb

Croatia

or

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80

31-546 Krakow

Poland

or

Actavis Ltd,

BLB 015-016, Bulebel Industrial Estate,

Zejtun, ZTN3000

Malta

or

Pharmapath S.A.

28is Oktovriou 1 Agia Varvara, 12351

Greece

This medicinal product is authorized in Member States under the following names:

Date of the most recent review of this leaflet: December 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79691/P_79691.html

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