Aripiprazole Tecnigen 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole TecniGen 5 mg tablets EFG

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Aripiprazole TecniGen is and what it is used for
2. What you need to know before taking Aripiprazole TecniGen
3. How to take Aripiprazole TecniGen
4. Possible side effects
5. How to store Aripiprazole TecniGen

Pack contents and other information

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

Aripiprazol TecniGen contains the active substance aripiprazole and 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 sensing 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.

Aripiprazol TecniGen 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 the recurrence of this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Aripiprazol TecniGen

Do not take Aripiprazol TecniGen:

• if you are allergic to the active substance or to any of the components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes
• seizures
• irregular and involuntary muscle movements, especially in the face
• cardiovascular diseases, 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 blood clot formation
• history of gambling addiction.

If you notice that you are gaining weight, develop unusual movements, experience 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 behavior during treatment with aripiprazole have been reported.

Speak to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have some degree of weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known whether this medicine is safe and effective in these patients. Consult your doctor or pharmacist before taking this medicine.

Taking Aripiprazol TecniGen with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

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 blood pressure.

If you are taking this medicine together with any other medicine, you may need to adjust your dose of aripiprazole. It is especially important to tell your doctor about the following:

• Medicines to correct heart rhythm
• Antidepressants or herbal remedies used to treat depression and anxiety
• Antifungals
• Certain medicines used to treat HIV infection
• Anticonvulsants used to treat epilepsy

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), meperidine, St. John's wort, and venlafaxine. These medicines increase the risk of adverse effects; if you notice any unusual symptoms when taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazol TecniGen with food, drinks, and alcohol

Aripiprazole can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

Make sure to inform your doctor immediately if you are breastfeeding.

If you are taking aripiprazole, you should not breastfeed.

Driving and using machines

Do not drive or operate tools or machinery until you know how this medicine affects you.

Aripiprazol TecniGen contains lactose

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

3. How to take Aripiprazol TecniGen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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

Treatment with this medicine should be started with the oral solution (liquid) at a low dose. The dose may then be gradually 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, tell your doctor or pharmacist.

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

Always take the tablets with water and swallow them whole.

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

If you take more Aripiprazol TecniGen than you should

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 Aripiprazol TecniGen

If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.

If you stop taking Aripiprazol TecniGen

Do not stop your treatment when 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 people):

• Diabetes mellitus;
• sleep disturbances;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty remaining seated;
• uncontrolled twisting, writhing, or spasmodic movements, restless legs;
• tremor;
• headache;
• fatigue;
• somnolence;
• 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 people):

• increased levels of the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscular disorder causing twisting movements (dystonia);
• double vision;
• rapid heartbeat;
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
• hiccups;
• ocular photosensitivity.

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

• low white blood cell count;
• low platelet count;
• 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;
• high blood sugar;
• low sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, suicide attempt, and suicide;
• gambling addiction;
• aggression;
• agitation;
• nervousness;
• a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
• 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;
• 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 in the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if you notice any of these symptoms, contact your doctor immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• spasms of 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;
• light sensitivity;
• baldness;
• excessive sweating;
• abnormal breakdown of muscles that may lead to kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns following exposure to medications during pregnancy;
• prolonged and/or painful erection;
• difficulty regulating core body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin;
• fixation of the eyeballs in one position.

In elderly patients with dementia, a higher number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years or older experienced adverse effects similar in type and frequency to those in adults, except for somnolence, uncontrolled spasms or contractions, restlessness, and fatigue, which were very common (may affect more than 1 in 10 people), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness—especially upon standing up from lying or sitting positions—which were common (may affect up to 1 in 10 people).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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. Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole TecniGen

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines or their packaging, consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole TecniGen

• The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other components are: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and indigo carmine (E132).

Appearance of the product and contents of the pack

Aripiprazole TecniGen 5 mg tablets EFG are blue, elliptical, convex tablets.

They are presented in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra - Portugal

Date of the most recent revision of this leaflet: August 2016.

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