Aripiprazole Combix 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Combix 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are
• adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Aripiprazole Combix belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 years and older who have an illness characterized by symptoms such as hearing, seeing, or feeling 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.

Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Aripiprazole Combix

Do not take Aripiprazole Combix

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

Warnings and precautions

Talk to your doctor before starting to take Aripiprazole Combix 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" strokes, abnormal blood pressure.
• Blood clots or a 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, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which could lead to falls. Caution is advised, especially if you are an elderly patient or have any degree of physical weakness.

If you have dementia (memory loss and other cognitive impairments), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with Aripiprazole Combix have been reported.

Speak to your doctor immediately if you notice numbness or muscle stiffness accompanied by high fever, sweating, altered mental state, or a very rapid or irregular heartbeat.

Children and adolescents

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

Taking Aripiprazole Combix 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 Combix may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medication to control blood pressure.

If you are taking Aripiprazole Combix together with other medicines, you may need to adjust your Aripiprazole Combix 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 when taking any of these medicines together with Aripiprazole Combix, you must inform your doctor.

Taking Aripiprazole Combix with food, drinks, and alcohol

Aripiprazole Combix can be taken regardless of meals.

Alcohol consumption should be avoided while taking Aripiprazole Combix.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

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

If you are taking Aripiprazole Combix, you must not breastfeed.

Driving and using machines

Aripiprazole may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Aripiprazole Combix contains aspartame

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

3. How to take Aripiprazol Combix

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. 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

Aripiprazol Combix should be initiated with the oral solution (liquid) at a low dose. The dose may gradually be 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 feel that 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 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 the daily dose of Aripiprazol Combix without first consulting your doctor.

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 at: 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 missed dose as soon as you remember it, but do not take a double dose to make up for the forgotten 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 will experience 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, drowsiness, 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 or experience double vision.

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

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,
• Irregular heartbeat,
• Unexplained sudden 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 blood sodium levels,
• Weight gain, weight loss, anorexia,
• Restlessness, agitation, anxiety, gambling addiction; suicidal thoughts, suicide attempt,
• Speech disorder, seizures, serotonin syndrome (a reaction that may cause intense feelings of well-being, 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 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,
• Inflammation of the pancreas,
• Liver failure, liver inflammation, yellowing of the skin and whites of the eyes, abnormal liver test results, abdominal and stomach discomfort, diarrhea,
• Skin redness and light sensitivity, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness,
• Involuntary loss of urine, difficulty urinating,
• Prolonged and/or painful erection,
• Difficulty controlling core body temperature or overheating, chest pain, and swollen hands, ankles, or feet,
• Fixed eye position.

In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Since the marketing of oral aripiprazole, the following adverse effect has been reported, but its frequency is unknown: Aggression.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in type and frequency to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affects 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 (affects up to 1 in 10 patients).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Combix

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole Combix

• The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other components (excipients) are: mannitol (E421), crospovidone type A, aspartame (E951) and calcium stearate.

Appearance of the product and contents of the pack

White or almost white, oval, biconvex tablets, with the imprint "5" engraved on one side and smooth on the other.

Blister packs made of OPA/Aluminium/PVC-Aluminium. 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 the most recent revision of this leaflet: April 2020

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