Aripiprazol tevagen 15 mg comprimidos bucodispersables efg

Package Insert: Information for the User

AripiprazolTevagen15mg buccodispersible tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Aripiprazolbelongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents of 15 years or more 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 monotony of emotional and behavioral behavior. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol is used to treat adults and adolescents of 13 years or more who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking 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 Aripiprazol.

Do not take Aripiprazol Tevagen

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Tevagen.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported. Inform 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 excessive thirst, increased urine production, 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 disease and circulation), a 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 addiction to gambling

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

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

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

Tell your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast 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 in you and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive intake or spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, a drop in blood pressure when standing, 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 have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years old. The safety and effectiveness of this medicine in these patients are unknown.

Other medicines and Aripiprazol Tevagen

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

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

If you are taking this medicine with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of other medicines. It is especially important to 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 aripiprazol. If you observe any unusual symptoms when taking any of these medicines with aripiprazol, inform your doctor.

Medicines that increase serotonin levels are generally used to treat 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 to treat 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;
• herbal remedies (such as St. John's Wort) 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 adverse effects; if you observe any unusual symptoms when using any of these medicines with aripiprazol, inform your doctor.

Taking Aripiprazol 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 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 aripiprazol in the last three months of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

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

Driving and operating machinery

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

Aripiprazol Tevagen contains sodium

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

Aripiprazol Tevagen contains aspartame

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

Aspartame is a source of phenylalanine thatmay be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly..

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents.Aripiprazol should be initiated with the oral solution (liquid) at a low dose. Gradually the dose may be increased tothe 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 estimate that the action of aripiprazol is too strong or weak, inform your doctor or pharmacist.

Try to take the aripiprazol buccodispersible tablet at the same time every day. It does not matter if you take it with or without food.

Do not open the blister pack until you are about to take it. To take a tablet, open the package and remove the aluminum from the blister pack, leaving the tablet visible. Do not press the tablet through the aluminum as this could damage it. Once the blister pack is opened, with dry hands, take the tablet and place the buccodispersible tablet completely on the tongue. The disintegration of the tablet occurs quickly with saliva. The buccodispersible 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 alter or interrupt the daily dose of aripiprazol without consulting your doctor first.

If you take moreAripiprazol Tevagenthan you should

If you realize that you have taken more aripiprazol than your doctor recommended (or if someone else has taken part of your aripiprazol), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the packaging with you.

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

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

Contact your doctor or 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 Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested.

If you forgot to takeAripiprazol Tevagen

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

If you interrupt treatment with Aripiprazol Tevagen

Do not interrupt your treatment just because you feel better. It is essential that you continue taking aripiprazol for the time your doctor has indicated.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects (can affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• feeling restless and unable to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly);
• involuntary movements of twisting, contorting, or spasmodic movements;
• tremors;
• headaches;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty passing stools or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling tired.

Less frequent side effects (can 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;
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
• eye sensitivity to light;
• rapid heartbeat;
• low blood pressure when standing, causing dizziness, fainting, or lightheadedness;

• hypotension

The following side 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);
• appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine), or coma;
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss
• weight gain;
• suicidal thoughts, attempts, and suicide;
• suicidal thoughts, attempts, and suicide;
• aggression;
• agitation;
• anxiety;
• neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting);
• seizures;
• serotonin syndrome (a reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden and unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slow heart rate;
• 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 experience any of these symptoms, seek medical attention immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food, which can lead to 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;
• inflammation of the liver;
• yellowing of the skin and white part of the eyes;
• abnormal liver enzyme levels in blood tests;
• hives;
• sensitivity to light;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with symptoms similar to the flu, followed by a rash on the face and then a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme levels in blood tests, and increased eosinophil counts;
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal in newborns due to exposure to the drug during pregnancy;
• prolonged and painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• abnormal blood sugar levels, hemoglobin A1c levels;
• inability to resist the impulse, instinct, or temptation to perform an action that can be harmful to yourself or others, which may include:
• • excessive and uncontrollable urge to gamble despite severe personal or family consequences;
  • altered or increased sex drive and concerning behavior for yourself or others, such as increased sex drive;
  • uncontrollable excessive buying;
  • 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, there have been reported cases of fatal outcomes while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experienced side effects similar in frequency and type to those of adults, except for drowsiness, involuntary movements, restlessness, and fatigue, which were very frequent (can 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 getting up from a lying or sitting position, which were frequent (can affect more than 1 in 100 patients).

Reporting of side effects

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

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

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofAripiprazol Tevagen

• The active ingredient is aripiprazol. Each buccal dispersible tablet contains15 mg of aripiprazol.
• The other components aremicrocrystalline cellulose type 102, silicified microcrystalline cellulose, anhydrous colloidal silica, yellow iron oxide (E-172), caramel, crospovidone type B, xylitol (E-967), aspartame (E-951), potassium acesulfame, tartaric acid, pineapple flavor, magnesium stearate.

Appearance of the product and content of the container

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

It is presented in OPA-Aluminio-PVC/Aluminio blister packs, packaged in boxes containing 28 tablets.

Marketing authorization holder

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B, 1st Floor,

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

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

Last review date of this leaflet:June 2024

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

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