ARIPIPRAZOL TARBIS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aripiprazol Tarbis10mg tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Aripiprazol Tarbis is and what it is used for
2. What you need to know before you take Aripiprazol Tarbis
3. How to take Aripiprazol Tarbis
4. Possible side effects
5. Storage of Aripiprazol Tarbis
6. Contents of the pack and other information

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

Aripiprazol Tarbis contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 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.

2. What you need to know before you take Aripiprazol Tarbis

Do not take Aripiprazol Tarbis

• If you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take this medicine 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 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 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 daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or the person who cares for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Inform your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behaviors 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 very fast or irregular heartbeat.

Aripiprazole 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. You should be cautious, especially if you are an elderly patient or suffer from weakness.

Children and adolescents

Aripiprazole is not used in children and adolescents under 13 years of age. Consult your doctor or pharmacist before taking this medicine.

Taking Aripiprazol Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 use any medicine to control blood pressure.

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

? Medicines to correct heart rhythm

? Antidepressants or herbal remedies used to treat depression and anxiety

? Antifungals

? Certain medicines to treat HIV infection

? Anticonvulsants used to treat epilepsy

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

Taking Aripiprazol Tarbis with food, drinks, and alcohol

Aripiprazol Tarbis can be taken independently of meals.

Consumption of alcohol should be avoided while taking this medicine.

Pregnancy, breastfeeding, and fertility

Do not take aripiprazole if you are pregnantunless you have discussed it with your doctor.

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 aripiprazole 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.

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 Aripiprazol Tarbis affects you.

Aripiprazol Tarbis contains lactose

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

3. How to take Aripiprazol Tarbis

Follow exactly the administration instructions of this medicine 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 or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

Aripiprazole should be started with the oral solution (liquid) at a low dose. The dose can be gradually 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 that the action of this medicine is too strong or too weak, inform your doctor or pharmacist.

Try to take the aripiprazole tablet at the same time each day. It does not matter if 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 interrupt the daily dose of aripiprazole without consulting your doctor first.

If you take moreAripiprazol Tarbisthan 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 medicine and the amount ingested.

If you forget to takeAripiprazol Tarbis

If you forget a dose, take the forgotten dose as soon as you remember, but do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people): spasms or uncontrolled contractions, headache, fatigue, nausea, vomiting, stomach upset, constipation, increased saliva production, dizziness, sleep disturbances, agitation, anxiety, drowsiness, tremors, and blurred vision.

Uncommon side effects (may affect up to 1 in 100 people): some people may feel dizzy, especially when standing up after being lying down or sitting, or feel that their heart is racing.

Some people may feel depressed.

Increased blood levels of the hormone prolactin.

Hiccup.

Eye photosensitivity

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

Changes in the levels of some blood cells; unusual heartbeat, sudden unexplained death, heart attack; allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and redness); high blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low sodium levels in the blood; weight gain, weight loss, anorexia; nervousness, agitation, anxiety, addiction to gambling; suicidal thoughts, attempted suicide, and completed suicide; speech disorder, seizures, serotonin syndrome (a reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), combination of fever, muscle stiffness, rapid breathing, sweating, altered mental state, and sudden changes in blood pressure and heart rate; fainting, high blood pressure, 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); muscle spasms around the glottis, accidental inhalation of food with risk of pneumonia, difficulty swallowing; pancreatitis; liver failure, liver inflammation, yellowing of the skin and the white part of the eyes, abnormal liver values, abdominal and stomach discomfort, diarrhea; skin redness and sensitivity to light, unusual hair loss, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; prolonged and/or painful erection; difficulty controlling body temperature or overheating, chest pain, and swollen hands, ankles, or feet; aggression; 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 and older experienced side effects similar in frequency and type to those of adults, except for drowsiness, spasms or uncontrolled contractions, restlessness, and fatigue, which were very common (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 standing up after being lying down or sitting, which were common (may affect more than 1 in 100 patients).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazol Tarbis

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazol Tarbis

• The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, red iron oxide (E-172).

Appearance of the product and contents of the pack

Aripiprazol Tarbis 10 mg tablets are round, biconvex, and pale pink in color.

Each pack contains 28 and 30 tablets, packaged in aluminum-aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

• Uriach y Compañía, S.A.

Av. Camí Reial, 51-57

08184 - Palau-solità i Plegamans (Barcelona)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Malta: Aripiprazol Uriach 10 mg tablets

Spain: Aripiprazol Tarbis 10 mg tablets

Date of the last revision of this leaflet: June 2020

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