Aripiprazol ratiopharm 10 mg comprimidos efg

Patient Information Leaflet: Package Insert

Aripiprazol ratiopharm 10 mg Tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Aripiprazol ratiopharm

3. How to take Aripiprazol ratiopharm

4. Possible side effects

5. Storage of Aripiprazol ratiopharm

6. Contents of the pack and additional information

Aripiprazol ratiopharm 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 ratiopharm 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 ratiopharm.

Do not take Aripiprazol ratiopharm

• 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.

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

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.

Before starting treatment with aripiprazol, 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 drowsiness that interferes with your normal daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you or the person who cares for you or your family 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 in you and that you 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 cause falls. You should be cautious, especially if you are an elderly patient or have some weakness.

Children and adolescents

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

Taking Aripiprazol ratiopharm with other medicines

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

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

These medicines may increase the risk of side effects or reduce the effect of aripiprazol. If you observe any unusual symptoms when taking any of these medicines with aripiprazol, you should 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:

• 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 diseases;
• 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 medicines may increase the risk of side effects; if you observe any unusual symptoms when using any of these medicines with Aripiprazol ratiopharm, you should inform your doctor.

Taking Aripiprazol ratiopharmwith food, drinks, and alcohol

This medicine can be taken regardless of meals. You should 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 medicine.

The following symptoms may occur in newborn babies of mothers who have been 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, you should 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, you should 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 ratiopharm contains lactose and sodium

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

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

Follow exactly the administration instructions for 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 ratiopharm is for oral use.

Try to take the Aripiprazol ratiopharm tablet at the same time every day.

It does not matter if you take it with or without food.

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 ratiopharm without consulting your doctor first.

If you take more Aripiprazol ratiopharm 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 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.

If you forgot to take Aripiprazol ratiopharm

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 ratiopharm

Do not stop 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 (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 passing stools 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):

• 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,
• photosensitivity of the eyes,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, confusion or fainting,
• hypotension

The following side effects have been reported during the marketing ofaripiprazolbut 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, attempted suicide 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 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 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),
• inflammation of the pancreas
• 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,
• rigidity,
• 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 central 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 sex drive and concerning behavior for yourself or others, for example, increased sex drive;
  • uncontrollable excessive buying;
  • binge eating (eating 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 ofadults, except for drowsiness, involuntary spasms or contractions, restlessness, and fatigue, which were very frequent (affects 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 lying or sitting, which were frequent (affects 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 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 thismedicine.

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.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aripiprazol ratiopharm

The active ingredient is aripiprazole. Each tablet contains 10 mg of aripiprazole.
The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, sodium croscarmellose, red iron oxide (E-172).

Appearance of the product and contents of the package

Aripiprazol ratiopharm 10 mg tablets are oval-shaped, pink to light pink in color, engraved with “10” on one face and with a notch on the other face.

The tablet can be divided into equal doses.

It is presented in OPA-Aluminum-PVC/Aluminum blisters packaged in boxes containing 10, 14, 28, 30, 49, 56, or 98 tablets.

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

Only some package sizes may be marketed.

Holder of the marketing authorization

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,123 51

Greece

This medicine is authorized in the Member States with the following names:

Last review date of this leaflet: June 2024

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