Package Insert: Information for the User

Aripiprazol TecniGen 5 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult with your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only and should not be given 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, pharmacist, or nurse even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

AripiprazolTecniGen contains the active substance aripiprazol andbelongs 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 TecniGen 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 AripiprazolTecniGen:

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

Warnings and precautions

Consult your doctor or pharmacist before starting this medication if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, 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 addiction to gambling

If you notice that you are gaining weight, developing unusual movements, experiencing sleepiness 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.

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 aripiprazol 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.

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

Children and adolescents

Do not use this medication in children and adolescents under 13 years of age. The safety and efficacy of this medication in these patients are unknown. Consult your doctor or pharmacist before taking this medication.

Use ofAripiprazol TecniGenwith other medications

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

Blood pressure medications: 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 using this medication with any other medication, you may need to change your aripiprazol dose. It is especially important to mention the following to your doctor:

• 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, amitriptyline), petidina, St. John's Wort, and venlafaxine. These medications increase the risk of producing adverse effects; if you observe any unusual symptoms when using any of these medications with aripiprazol, you should inform your doctor.

TakingAripiprazol TecniGenwith food, drinks, and alcohol

Aripiprazol 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 medication.

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

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

Do not breastfeed if you are taking aripiprazol.

Driving and operating machinery

Do not drive or operate tools or machines until you know how this medication affects you.

Aripiprazol TecniGen contains lactose

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

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

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 estimate that the action of aripiprazol is too strong or weak, inform your doctor or pharmacist.

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

Take the tablets with water and swallow them whole.

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

If you take more Aripiprazol TecniGen 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.

If you forget to take Aripiprazol TecniGen

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

If you interrupt treatment with Aripiprazol TecniGen

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

If you have any other questions 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 people):

• Diabetes mellitus;
• Difficulty sleeping;
• Anxiety;
• Feeling of restlessness and inability to stay still, difficulty staying seated;
• Uncontrolled twisting, contorting, or spasmodic movements, restless legs;
• 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 people):

• Increased levels of prolactin hormone 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);
• Dual vision;
• Accelerated heart rate;
• Drop in blood pressure upon standing, causing dizziness, confusion, or fainting;
• Hypo.
• Ocular photosensitivity

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,
• High blood sugar;
• Inadequate sodium levels in the blood;
• Loss of appetite (anorexia);
• Weight loss
• Weight gain
• Thoughts of suicide, attempted suicide, and suicide
• Game addiction;
• Aggression;
• Agitation;
• Anxiety;
• 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 can cause intense feelings of happiness, drowsiness, clumsiness, restlessness,feeling drunk, fever,sweating, or muscle rigidity);
• Speech disorder;
• Sudden 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), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, seek immediate medical attention);
• High blood pressure;
• Fainting;
• Accidental inhalation of food with a 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;
• Inflammation of the liver;
• Yellowing of the skin and white part of the eyes;
• Abnormal liver analysis;
• Hives;
• Light sensitivity;
• Baldness;
• Excessive sweating;
• 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 medications during pregnancy;
• Prolonged and/or 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.
• Fixation of the eyeballs in a position;

In elderly patients with dementia, there have been reported a higher number of fatal cases 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, uncontrolled 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 getting up from lying down or sitting, which were frequent (may affect up to 1 in 10 people).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Vigilance of Medicines for Human Use. Website: www.notificaRAM.es.

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

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

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

No special storage conditions are required.

Medications 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 ofAripiprazol TecniGen

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

Appearance of the product and content of the container

Aripiprazol TecniGen 5 mg tablets EFG are elliptical, convex and blue tablets.

They are presented in blister-type containers with 28 tablets.

Holder of the marketing authorization and responsible for the manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) Spain

Responsible for the manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra - Portugal

Last review date of this leaflet:August 2016.

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