ARIPIPRAZOLE TEVAGEN 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

AripiprazoleTevagen15mg orodispersible tablets EFG

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.

Contents of the pack

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

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

Aripiprazolebelongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 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.

Aripiprazole is used to treat adults and adolescents aged 13 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 situation in patients who have responded to treatment with Aripiprazole.

2. What you need to know before you take Aripiprazole Tevagen

Do not take Aripiprazole Tevagen

• 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 starting to take Aripiprazole Tevagen.

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 starting treatment with this medicine, 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
• Irrregular and involuntary muscle movements, especially in the face
• Cardiovascular diseases (heart and circulation disease), 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
• 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 experience 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 cravings 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. Caution should be exercised, 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 Aripiprazole Tevagen

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: aripiprazole 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 this medicine with another medicine, it may mean that your doctor needs to change your dose of aripiprazole 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 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 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 adverse effects or reduce the effect of aripiprazole. If you observe any uncommon symptoms when taking any of these medicines at the same time as aripiprazole, you should inform 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:

• 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 illnesses;
• 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 increase the risk of producing adverse effects; if you observe any uncommon symptoms when using any of these medicines with aripiprazole, you should inform your doctor.

Taking Aripiprazole Tevagen 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole 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 aripiprazole, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit to you of your treatment and the benefit to your baby of breastfeeding. 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., it is 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 that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Aripiprazole Tevagen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult 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.Aripiprazole 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 action of aripiprazole is too strong or too weak, tell your doctor or pharmacist.

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

Do not open the blister until you are ready to take it. To take a tablet, open the package and remove the aluminum from the blister, leaving the tablet in sight. Do not push the tablet through the aluminum because this could damage it. Once the blister is open, with dry hands, take the tablet and place the entire aripiprazole orodispersible tablet on the tongue. The tablet disintegrates rapidly with saliva. The orodispersible tablet can be taken with or without liquid. Another option is to dissolve the tablet in water and drink the resulting suspension.

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

If you take more Aripiprazole Tevagen than you should

If you realize that you have taken more aripiprazole than your doctor recommended (or if someone else has taken part of your aripiprazole), 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.

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

If you forget to take Aripiprazole Tevagen

If you forget a dose, take the forgotten dose as soon as you remember, but do not take a double dose to make up for the forgotten 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 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);
• torsion, contortion, or spasmodic uncontrollable movements;
• tremor;
• headache;
• fatigue;
• sleepiness;
• 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 blood,

• excessively high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing torsion movements (dystonia),
• restless legs,
• double vision,
• ocular photosensitivity,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, fainting, or loss of consciousness,

• hypo

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and redness),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,
• insufficient sodium levels in blood,
• loss of appetite (anorexia),
• weight loss
• weight gain,
• suicidal thoughts, attempted suicide, and suicide,
• suicidal thoughts, attempted suicide, and suicide,
• aggression,
• agitation,
• nervousness,
• malignant neuroleptic syndrome (a combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of intense happiness, sleepiness, 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 blood vessels 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),
• muscle spasms 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 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 and then with a widespread rash, high temperature, swollen lymph nodes, increased liver enzyme levels 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 medication 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 yourself or others, which may include:
• • strong impulse to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and concerning behavior for you or others, for example, increased sexual appetite;
  • uncontrollable 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.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Tevagen

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAripiprazol Tevagen

• The active ingredient is aripiprazole. Each buccal dispersible 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, type B crospovidone, xylitol (E-967), aspartame (E-951), acesulfame potassium, tartaric acid, pineapple flavor, magnesium stearate.

Appearance of the Product and Package Contents

Aripiprazol Tevagen 15 mg is presented in the form of light yellow, round, and flat tablets with a beveled edge, engraved with "15" on one face and smooth on the other face.

It is presented in OPA-Aluminum-PVC/Aluminum blisters packaged in boxes containing 28 tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª Planta,

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren.

Germany

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem.

Netherlands

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

Date of the Last Revision of this Prospectus:June 2024

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

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