Aripiprazole Tevagen 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Tevagen 15 mg orodispersible tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aripiprazole Tevagen is and what it is used for

Aripiprazole 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 characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized 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 Aripiprazole.

2. What you need to know before taking Aripiprazole Tevagen

Do not take Aripiprazole Tevagen

• 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 Tevagen.

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

Before starting treatment with this medicine, tell your doctor if you have:

• High blood sugar levels (characterised by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes
• Seizures, as your doctor may wish to monitor you more closely
• Irregular and involuntary muscle movements, especially of the face
• Cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or "mini" strokes, or 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 have 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.

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

Speak to your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

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 known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased 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 motor function and balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have any degree of physical 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.

Other medicines and Aripiprazole Tevagen

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

Taking this medicine together with other medicines may mean that your doctor needs to adjust the dose of aripiprazole or of 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);
• Medicines to treat fungal infections (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);
• 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 to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• 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), a herbal remedy used 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 increase the risk of adverse effects; if you notice any unusual symptoms when using any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole Tevagen with food, drinks, and alcohol

This medicine can be taken regardless 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 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 difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

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. If you are being treated with aripiprazole, 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.

Aripiprazole Tevagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

Aripiprazole Tevagen contains aspartame

This medicine contains 4.5 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Aripiprazole Tevagen

Follow exactly the instructions for using this medicine 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 think that the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to take the aripiprazole orodispersible tablet at the same time each day. It does not matter whether you take it with or without food.

Do not open the blister pack until you are ready to take the tablet. To take a tablet, open the packaging and peel back the aluminium foil from the blister so that the tablet becomes visible. Do not push the tablet through the foil, as this may damage it. Once the blister is opened, with dry hands, take the tablet and place the entire orodispersible tablet on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid. Alternatively, the tablet may be dissolved in water and the resulting suspension drunk.

Even if you feel better, do not change or stop your daily dose of aripiprazole without first consulting your doctor.

If you take more Aripiprazole Tevagen than you should

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

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, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

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

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.

If you forget to take Aripiprazole Tevagen

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

If you stop taking Aripiprazole Tevagen

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for as long as your doctor has instructed.

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 will experience them.

Common 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;
• drowsiness;
• 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 the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• a muscular 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 phase of oral aripiprazole, but their frequency is unknown:

• low levels of white blood cells;
• low levels of platelets;
• 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;
• fixation of the eyeballs in one position;
• 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 of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, contact your doctor immediately);
• elevated 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);
• 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;
• 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 appears as flu-like symptoms with a rash on the face, followed by a 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 due to exposure to medication during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling core body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: increased or fluctuating 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:
  • 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.

In elderly patients with dementia, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, 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 drowsiness, spasms or uncontrollable 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 when standing up after lying down or sitting—which were common (may affect more than 1 in 100 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 Tevagen

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the 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 Aripiprazole Tevagen

• The active substance is aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
• The other components are microcrystalline cellulose type 102, silicified microcrystalline cellulose, anhydrous colloidal silica, yellow iron oxide (E-172), carmellose, crospovidone type B, xylitol (E-967), aspartame (E-951), acesulfame potassium, tartaric acid, pineapple flavour, magnesium stearate.

Appearance of the product and contents of the pack

Aripiprazole Tevagen 15 mg is presented as light yellow, round, flat tablets with bevelled edges, marked with "15" on one side and plain on the other.

It is supplied in OPA-Aluminum-PVC/Aluminum blisters packed in cardboard boxes containing 28 tablets.

Marketing Authorisation Holder

Teva Pharma, S.L.U
C/ Anabel Segura 11, Edificio Albatros B, 1st Floor,
28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren,
Germany

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd)
Prilaz baruna Filipovica 25, Zagreb
10000 Zagreb
Croatia

Teva Operations Poland Sp. z o.o.
Ul. Mogilska 80
31-546 Krakow
Poland

TEVA Gyógyszergyár Zrt.
Pallagi út 13
H-4042 Debrecen
Hungary

Actavis Ltd.
BLB015-016
Bulebel Industrial Estate
Zejtun ZTN3000
Malta

Date of the most recent revision of this leaflet: June 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es /

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79779/P_79779.html