ARIPIPRAZOLE COMBIX 15 mg TABLETS

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

Do not take Aripiprazol Combix

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Combix 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 drowsiness that interferes with your daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

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 lead to falls. Caution should be exercised, especially if you are an elderly patient or suffer from weakness.

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 Aripiprazol Combix have been reported.

Talk to your doctor immediately if you experience numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

Children and adolescents

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

Taking Aripiprazol Combix with other medicines

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

Medicines that lower blood pressure: Aripiprazol Combix 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 Aripiprazol Combix with another medicine, you may need to change your dose of Aripiprazol Combix. 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 producing side effects; if you observe any unusual symptoms when using any of these medicines with Aripiprazol Combix, you should inform your doctor.

Taking Aripiprazol Combix with food, drinks, and alcohol

Aripiprazol Combix can be taken independently of meals.

Consumption of alcohol should be avoided while taking Aripiprazol Combix.

Pregnancy, breastfeeding, and fertility

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 Aripiprazol 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 Aripiprazol Combix, you should not breastfeed.

Driving and using machines

Aripiprazol may produce symptoms such as drowsiness, dizziness, or changes in vision, and reduce reaction capacity. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Aripiprazol Combix contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Aripiprazol Combix

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

Aripiprazol Combix should be started with the oral solution (liquid) at a low dose. Gradually, the dose may 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 Aripiprazol Combix is too strong or too weak, inform your doctor or pharmacist.

Try to take the Aripiprazol Combix tablet at the same time every 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 Aripiprazol Combix without consulting your doctor first.

If you take more Aripiprazol Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aripiprazol Combix

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 discomfort, 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 lying down or sitting, or feel that their heart is racing or have double vision.

Some people may feel depressed. Some patients may experience altered or increased sexual interest.

Increased levels of the hormone prolactin in the blood.

Hiccup.

Photosensitivity of the eyes.

The following side effects have been reported during the marketing of aripiprazol, 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 of 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, gambling addiction; suicidal thoughts, attempted suicide,
• Speech disorder, seizures, serotonin syndrome (a reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, 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,
• Redness of the skin and sensitivity to light, unusual hair loss or decreased hair growth, 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,
• Fixation of the eyeballs in a position.

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

Since the marketing of aripiprazol oral, the following side effects have been reported, but their frequency of occurrence is unknown: Aggression

Other side effects in children and adolescents

Adolescents aged 13 years 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 (affecting 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 lying down or sitting, which were common (affecting up to 1 in 10 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazol Combix

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 refers to the last day of the month shown.

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

6. Contents of the pack and other information

Composition of Aripiprazol Combix

• The active substance is aripiprazol. Each tablet contains 15 mg of aripiprazol.

• The other ingredients (excipients) are: mannitol (E421), crospovidone type A, aspartame (E951), calcium stearate, and peppermint flavor 501500TP0504 (natural flavors, corn maltodextrin, and modified corn starch).

Appearance of the product and pack contents

White or almost white, round, biconvex tablets with the inscription "ZE 14" on one side and smooth on the other.

OPA/Aluminum/PVC-Aluminum blisters. Packs containing 28 or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet: April 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/