Aripiprazol teva 5 mg comprimidos efg

Package Insert: Information for the Patient

Aripiprazol Teva 5 mg 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 read 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 who 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.

1. What is Aripiprazol Teva and how is it used

2. What you need to know before starting to take Aripiprazol Teva

3. How to take Aripiprazol Teva

4. Possible adverse effects

5. Storage of Aripiprazol Teva

6. Contents of the package and additional information

Aripiprazol Teva contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 years or more who suffer from a condition characterised by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioural state. People in this state may also feel depressed, guilty, restless or tense.

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

Do not takeAripiprazol Teva

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

Warnings and precautions

Consult your doctor before starting to take aripiprazol.

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

Before starting treatment with Aripiprazol Teva, tell your doctor if you have:

• 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), family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure
• blood clots or family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• history of addiction to gambling

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

If you are an elderly person with dementia (memory loss 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.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way that you cannot resist, known as impulse control disorder, which may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping the dose.

Aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Be cautious, especially if you are an elderly person or have weakness.

Children and adolescents

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

Taking Aripiprazol Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications that lower blood pressure: Aripiprazol may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are taking aripiprazol with any other medication, it may mean that your doctor needs to change your dose of aripiprazol or the other medications. It is especially important to mention to your doctor if you are taking:

• medications 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 medications 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, primidone)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medications may increase the risk of adverse effects or reduce the effect of aripiprazol. If you observe any unusual symptoms when taking any of these medications with aripiprazol, inform your doctor.

Medications that increase serotonin levels are generally used to treat conditions that include 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 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 disorders;
• St. John's Wort (Hypericum perforatum) used in herbal remedies for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications with Aripiprazol Teva, inform your doctor.

Taking Aripiprazol Teva with food, drinks, and alcohol

This medication can be taken regardless of meals. Avoid consuming alcohol.

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 medication.

The following symptoms may occur in newborn babies of mothers treated with aripiprazol in the last trimester 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.

Inform your doctor immediately if you are breastfeeding.

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

Driving and operating machinery

During treatment with this medication, 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 Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication as 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 this medication is too strong or weak, inform your doctor or pharmacist.

Aripiprazol Teva is for oral use.

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

5 mg

Take the tablets always with water and swallow them whole.

10 mg/15 mg

Take the tablets always with water. The tablet can be divided into equal doses.

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

If you take more Aripiprazol Teva than you should

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.

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

• rapid heartbeats, 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 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.

If you forgot to take Aripiprazol Teva

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 Teva

Do not stop treatment just becauseyou feel better. It is essential that you continue taking Aripiprazol Teva 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 (may affect up to 1 in 10 patients):

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

Less frequent side 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 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 heart rate,
• drop in blood pressure upon standing, causing dizziness, confusion or fainting,

• hypotension

The following side effects have been reported during the marketing of aripiprazol but the frequency of occurrence is unknown (the frequency cannot be estimated with the available data):

• 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, attempt and suicide,
• suicidal thoughts, attempt and suicide,
• aggression,
• agitation,
• anxiety,
• malignant neuroleptic syndrome (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 a feeling of intense 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,
• slower 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 notice any of these symptoms, seek immediate medical attention),
• 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 inflammation
• 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 values 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, with a rash on the face, followed by a widespread rash, high temperature, swollen lymph nodes, elevated liver enzyme levels in blood tests, and increased eosinophil count,
• abnormal muscle degradation 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 painful erection,
• difficulty controlling central body temperature or overheating,
• chest pain,
• swollen hands, ankles or feet,
• in blood tests: fluctuations in 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 severe personal or family consequences;
  • altered or increased sex drive and concerning behavior for yourself or others, for example, increased sex drive;
  • uncontrollable excessive buying;
  • binge eating (ingesting 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; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been reported a higher number of fatal cases while taking aripiprazol. 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 spasms or 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 movements of the limbs, and dizziness, especially when getting up after lying down or sitting, which were frequent (may affect up to 1 in 10 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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.

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.

This medication does notrequire special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask the pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Active Ingredient Composition of AripiprazolTeva

The active ingredient is aripiprazol. Each tablet contains 5 mg of aripiprazol.

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

Appearance of the Product and Contents of the Package

Aripiprazol Teva 5 mg tablets are light yellow, round, flat, beveled-edge tablets, engraved with “5” on one face and smooth on the other face.

They are packaged in OPA-Aluminum-PVC/Aluminum blisters and are available in boxes containing 7, 7 x 1, 14, 14 x 1, 15, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1, or 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U

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

28108 Alcobendas. Madrid.

Spain

Responsible for Manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren.

Germany

or

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem.

Netherlands

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 the Member States with the Following Names:

This leaflet was approved in: June 2024

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