Aripiprazole Tarbis 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Tarbis 10 mg 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 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What the leaflet contains:

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

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

Aripiprazole 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 years and older who have a disorder characterized by symptoms such as hearing, seeing, and 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.

2. What you need to know before starting Aripiprazole Tarbis

Do not take Aripiprazole Tarbis

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

Warnings and precautions

Talk to your doctor 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
• A history of gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you are an elderly patient with dementia (memory loss and other mental decline), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Contact your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazole.

Speak with your doctor immediately if you notice muscle stiffness or numbness with high fever, sweating, altered mental status, 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 is advised, especially if you are an elderly patient or have any degree of 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 Aripiprazole Tarbis with other medicines

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

Medicines that lower blood pressure: aripiprazole may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicines to control blood pressure.

If you are taking aripiprazole together with any other medicine, you may need to adjust your aripiprazole dose. 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), pethidine, St. John's Wort, and venlafaxine. These medicines increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole Tarbis with food, drinks, and alcohol

Aripiprazole Tarbis can be taken regardless of meals.

Alcohol consumption should be avoided while taking this medication.

Pregnancy, breastfeeding, and fertility

Do not take aripiprazole if you are pregnant unless 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 whose mothers have been treated with aripiprazole during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.

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 Aripiprazole Tarbis affects you.

Aripiprazole Tarbis 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 Aripiprazole Tarbis

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

Aripiprazole treatment should be initiated 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 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 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 your daily dose of aripiprazole without first consulting your doctor.

If you take more Aripiprazole Tarbis than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aripiprazole Tarbis

If you miss a dose, take it as soon as you remember. However, do not take a double dose to make up for the missed dose.

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 experiences them.

Frequent adverse effects (may affect up to 1 in 10 patients): spasms or uncontrollable contractions, headache, fatigue, nausea, vomiting, stomach discomfort, constipation, increased saliva production, dizziness, sleep disturbances, agitation, anxiety, somnolence, tremor, and blurred vision.

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

Some people may feel depressed.

Increased blood levels of the hormone prolactin.

Hiccups.

Ocular photosensitivity.

The following adverse effects have been reported during post-marketing use of aripiprazole, but their frequency is unknown (frequency cannot be estimated from the available data):

Changes in levels of certain blood cells; unusual heartbeat, unexplained sudden death, heart attack; allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness); elevated blood sugar levels, onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low sodium levels in blood; weight gain, weight loss, anorexia; restlessness, agitation, anxiety, gambling addiction; suicidal thoughts, suicide attempt, and completed suicide; speech disorder, seizures, serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling intoxicated, fever, sweating, or muscle stiffness), a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate; fainting, elevated blood pressure, blood clots in veins—especially in the legs (symptoms include leg swelling, pain, and redness)—which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you experience any of these symptoms, contact your doctor immediately); spasms of muscles around the glottis, accidental inhalation of food with risk of pneumonia, difficulty swallowing; pancreatitis; liver failure, liver inflammation, yellowing of the skin and whites of the eyes (jaundice), abnormal liver function tests, abdominal and stomach discomfort, diarrhea; skin redness and light sensitivity, unusual hair loss or thinning, excessive sweating; muscle stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; prolonged and/or painful erection; difficulty regulating core body temperature or overheating, chest pain, and swollen hands, ankles, or feet; aggression; fixed gaze (oculogyria).

In elderly patients with dementia, an increased 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 and older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable 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 limb movements, and dizziness—especially when standing up after lying down or sitting—which were common (may affect more than 1 in 100 patients).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Tarbis

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

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

6. Contents of the pack and other information

Composition of Aripiprazole Tarbis

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

Appearance of the product and contents of the pack

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

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

Only certain 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 medicinal product 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 most recent review of this leaflet: June 2020

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