ARIPIPRAZOLE TECNIGEN 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aripiprazole TecniGen 10 mg tablets EFG

Read the package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Aripiprazole TecniGen and what is it used for
2. What you need to know before taking Aripiprazole TecniGen
3. How to take Aripiprazole TecniGen
4. Possible side effects
5. Storage of Aripiprazole TecniGen
6. Package contents and additional information

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

Aripiprazole TecniGen contains the active substance aripiprazole and belongs to a group of medications called antipsychotics. It is used to treat adults and adolescents aged 15 years or 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 TecniGen is used to treat adults and adolescents aged 13 years or 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 taking Aripiprazole TecniGen

Do not take Aripiprazole TecniGen:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication 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
• 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 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. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazole have been reported.

Talk to 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.

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

Use of Aripiprazole TecniGen with other medications:

Inform your doctor or pharmacist if you are using or have recently used another medication, including those purchased without a prescription.

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

If you are using this medication with another medication, you may need to change your dose of aripiprazole. It is especially important to mention to your doctor the following:

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

Medications that increase serotonin levels: triptans, tramadol, tryptophan, ISRS (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine and amitriptyline), pethidine, St. John's Wort, and venlafaxine. These medications increase the risk of adverse effects; if you observe any unusual symptoms when using any of these medications with aripiprazole, you should inform your doctor.

Taking Aripiprazole TecniGen with food, drinks, and alcohol

Aripiprazole can be taken independently 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 medication.

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.

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 machines until you know how this medication affects you.

Aripiprazole TecniGen contains lactose

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

3. How to take Aripiprazole TecniGen

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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 or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

You should start taking this medication with the oral solution (liquid) at a low dose. Gradually, the dose can be 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 effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to take the aripiprazole tablets at the same time every day. It does not matter if you take them with or without food.

Always take the tablets with water and swallow them whole.

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

If you take more Aripiprazole TecniGen than you should

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 medication and the amount ingested.

If you forget to take Aripiprazole TecniGen

If you forget a dose, take the forgotten dose as soon as you remember, but do not take two doses in one day.

If you interrupt treatment with Aripiprazole TecniGen

Do not interrupt your treatment when you feel better. It is important that you continue taking aripiprazole for the time your doctor has indicated.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Common side effects (may affect up to 1 in 10 people):

• Diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• torsion, contortion, or spastic movements, restless legs;
• tremors;
• headache;
• fatigue;
• somnolence;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

Uncommon side effects (may affect up to 1 in 100 people):

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

The following side effects have been reported during the post-marketing phase of aripiprazole oral, 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 blood and urine), or coma;
• high blood sugar,
• insufficient sodium levels in blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• gambling addiction;
• aggression;
• agitation;
• nervousness;
• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
• seizures;
• serotonin syndrome (a reaction that can cause feelings of intense happiness, somnolence, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• 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 move through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, go to your doctor immediately);
• 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;
• 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 analyzes;
• rash;
• photosensitivity;
• hair loss;
• excessive sweating;
• 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 drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuation of blood sugar levels, increase in hemoglobin glycosylated.
• fixation of the eyeballs in a position;

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 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 somnolence, spasms or contractions, restlessness, and fatigue, which were very frequent (may affect more than 1 in 10 people) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness, especially when standing up after sitting or lying down, which were frequent (may affect up to 1 in 10 people).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es.

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

5. Storage of Aripiprazole TecniGen

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

Do not use this medication after the expiration date shown on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Aripiprazole TecniGen

• The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, and red iron oxide (E172)

Appearance of the product and package contents

Aripiprazole TecniGen 10 mg tablets EFG are elliptical, convex, and pink 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 last revision of this package leaflet: August 2016.

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