Package Insert: Information for the User

Aripiprazol Combix 15 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

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

Aripiprazol Combixbelongs to a group of medications known as antipsychotics.

It is used to treat adults and adolescents 15 years of age or older who suffer from a condition 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 state. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazol is used to treat adults and adolescents 13 years of age or older 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 Aripiprazol Combix

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Combix 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.
• A history of addiction to gambling.

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

Aripiprazol may cause drowsiness, a drop in blood pressure when standing, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. You should exercise caution, especially if you are an elderly patient or have weakness.

If you have dementia (loss of memory and other mental abilities), you or your caregiver 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 self-harm. Cases of patients experiencing suicidal thoughts and behavior during treatment with Aripiprazol Combix 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.

Children and adolescents

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

Taking Aripiprazol Combix with other medications

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

Blood pressure-lowering medications: Aripiprazol Combix 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 Aripiprazol Combix with any other medication, you may need to change your Aripiprazol Combix 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 Combix, you should inform your doctor.

Taking Aripiprazol Combix with food, drinks, and alcohol

Aripiprazol Combix can be taken regardless of meals.

It is recommended to avoid consuming alcohol 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 medication.

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, contact your doctor.

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

Do not breastfeed while taking Aripiprazol Combix.

Driving and operating machinery

Aripiprazol may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Aripiprazol Combix contains aspartame

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

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

Aripiprazol Combix should be started with the oral solution (liquid) at a low dose. The dose can gradually be increased tothe 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 Combix is too strong or too weak, inform your doctor or pharmacist.

Try to take theAripiprazol Combixtablet 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 Combix without consulting your doctor first.

If you take moreAripiprazol Combixthan you should

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

If you forgot to takeAripiprazol Combix

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

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 patients): muscle spasms or uncontrolled contractions, headaches, fatigue, nausea, vomiting, stomach discomfort, constipation, increased saliva production, dizziness, sleep disturbances, agitation, anxiety, drowsiness, tremors, and blurred vision.

Less frequent side effects (may affect up to 1 in 100 patients): some people may feel dizzy, especially when getting up from lying down or sitting, or feel their heart racing or double vision.

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

Increased blood levels of the hormone prolactin.

Hypophonia.

Ocular photosensitivity.

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

• Changes in levels of some blood cells,

• Irregular heartbeat,
• Sudden unexplained death,
• Myocardial infarction,
• Allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, hives, and redness),
• High blood sugar, appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium levels in the blood,
• Weight gain, weight loss, anorexia,
• Nervousness, agitation, anxiety, gambling addiction; suicidal thoughts, suicide attempt,
• Speech disorder, convulsions, serotonin syndrome (a reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate,
• Loss of consciousness, high blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can be transported through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention),

• Spasms of the muscles around the glottis, accidental inhalation of food with a risk of pneumonia, difficulty swallowing,

• Pancreatitis,
• Hepatic failure, liver inflammation, yellowing of the skin and white part of the eyes, abnormal liver function test results, abdominal and stomach discomfort, diarrhea,
• Redness of the skin and sensitivity to light, unusual or decreased hair loss, excessive sweating; stiffness or muscle cramps, muscle pain, weakness,
• Involuntary loss of urine, difficulty urinating,
• Prolonged and/or painful erection,
• Difficulty controlling central body temperature or overheating, chest pain, and swollen hands, ankles, or feet,
• Fixation of the eyeballs in a position.

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

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

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, muscle spasms or uncontrolled contractions, restlessness, and fatigue, which were very frequent (affects 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 getting up from lying down or sitting, which were frequent (affects up to 1 in 10 patients).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist. Even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after

CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 Combix

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

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

Appearance of the product and contents of the packaging

White or off-white, round, biconvex tablets with the inscription “ZE 14” engraved on one face and smooth on the other.

OPA/Aluminum/PVC-Aluminum blisters. Containers containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/Badajoz, 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: April 2020

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