Aripiprazole Aurovitas

Patient Information Leaflet: Information for the Patient

Aripiprazole Aurovitas,15 mg, orally disintegrating tablets
Aripiprazolum
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Aripiprazole Aurovitas, orally disintegrating tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics. They are used to treat adults and adolescents aged 15 years and older with schizophrenia, a mental illness that causes the patient to experience delusions, hallucinations, and disorganized thoughts and behaviors. Patients with these symptoms may also experience depression, anxiety, or guilt.

2. Important information before taking Aripiprazole Aurovitas

When not to take Aripiprazole Aurovitas

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

Warnings and precautions

Before taking Aripiprazole Aurovitas, tell your doctor:

• if you have a history of heart problems or stroke;
• if you have diabetes or a family history of diabetes;
• if you have seizures (epilepsy);
• if you have involuntary movements of the face or body;
• if you have a history of blood clots or deep vein thrombosis;
• if you have a history of gambling problems.

Tell your doctor if you experience any of the following:

• weight gain;
• unusual movements;
• drowsiness that interferes with daily activities;
• difficulty swallowing;
• allergic reactions.

Children and adolescents

Aripiprazole Aurovitas should not be used in children and adolescents under 13 years of age.The safety and efficacy of aripiprazole in children and adolescents under 13 years of age have not been established.

Aripiprazole Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.

• medicines that lower blood pressure;
• medicines used to treat depression, anxiety, or other mental health conditions;
• medicines used to treat fungal infections;
• medicines used to treat HIV;
• medicines used to treat epilepsy;
• antibiotics used to treat tuberculosis.

Aripiprazole Aurovitas with food, drink, and alcohol

Aripiprazole Aurovitas can be taken with or without food.

Do not drink alcohol while taking Aripiprazole Aurovitas.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or planning to become pregnant, tell your doctor before taking Aripiprazole Aurovitas.

Driving and using machines

Aripiprazole Aurovitas may cause dizziness and blurred vision.Be careful when driving or operating machinery.

Aripiprazole Aurovitas contains aspartame

Aripiprazole Aurovitas contains 3.1 mg of aspartame per orally disintegrating tablet.Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder.

Aripiprazole Aurovitas contains lactose and glucose

If you have been told you have an intolerance to some sugars, tell your doctor before taking Aripiprazole Aurovitas.

3. How to take Aripiprazole Aurovitas

Always take Aripiprazole Aurovitas exactly as your doctor or pharmacist has told you.If you are unsure, ask your doctor or pharmacist.

The recommended dose of Aripiprazole Aurovitas for adults is 15 mg once a day.Your doctor may prescribe a lower or higher dose, but it should not exceed 30 mg per day.

How to take Aripiprazole Aurovitas

Take Aripiprazole Aurovitas once a day at the same time.You can take it with or without food.

Open the blister pack just before taking the medicine.Take the orally disintegrating tablet out of the blister pack with dry hands. Place it on your tongue and let it dissolve. You can take it with or without water.

If you take more Aripiprazole Aurovitas than you should

If you have taken more Aripiprazole Aurovitas than you should, contact your doctor or the nearest hospital immediately.

If you forget to take Aripiprazole Aurovitas

If you forget to take a dose, take it as soon as you remember.Do not take a double dose to make up for a forgotten dose.

If you stop taking Aripiprazole Aurovitas

Do not stop taking Aripiprazole Aurovitas unless your doctor tells you to.It is important to continue taking the medicine as prescribed by your doctor.

4. Possible side effects

Like all medicines, Aripiprazole Aurovitas can cause side effects, although not everybody gets them.

• Common side effects (may affect up to 1 in 10 people):
• diabetes
• sleep disturbances
• anxiety
• restlessness
• involuntary movements
• tremors
• headache
• fatigue
• drowsiness
• dizziness
• blurred vision
• constipation
• nausea
• vomiting
• excessive salivation

Uncommon side effects (may affect up to 1 in 100 people):

• increased prolactin levels
• high blood sugar levels
• depression
• changes in sexual function
• involuntary movements of the face, tongue, or body
• muscle stiffness
• double vision
• increased sensitivity to light
• rapid heartbeat
• low blood pressure
• hiccups

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects were similar to those in adults, except for:

• very common (affecting more than 1 in 10 people):drowsiness, involuntary movements, restlessness, fatigue
• common (affecting up to 1 in 10 people):upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, tremors, involuntary movements, dizziness

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist.You can also report side effects directly to the national reporting system.

5. How to store Aripiprazole Aurovitas

Keep Aripiprazole Aurovitas out of the sight and reach of children.

Do not use Aripiprazole Aurovitas after the expiry date stated on the blister pack and carton.

Store Aripiprazole Aurovitas in its original packaging to protect it from moisture.

6. Contents of the pack and other information

What Aripiprazole Aurovitas contains

• The active substance is aripiprazole.Each orally disintegrating tablet contains 15 mg of aripiprazole.
• The other ingredients are:lactose monohydrate, magnesium stearate, silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, yellow iron oxide (E172), vanilla flavor powder (contains glucose), aspartame (E951), acesulfame potassium (E950), tartaric acid.

What Aripiprazole Aurovitas looks like and contents of the pack

Aripiprazole Aurovitas is a yellow, round, orally disintegrating tablet with the marking "AD15" on one side.It is available in blister packs of 10, 14, 28, 30, 49, 50, 98, or 100 tablets.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

Manufacturer

Synthon Hispania, S.L.

Synthon s.r.o.

Betapharm Arzneimittel GmbH

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

Czech Republic:Aripiprazol Apotex

Netherlands:Aripiprazol Genthon 10 mg/ 15 mg orodispergeerbare tabletten

Germany:Aripiprazol beta 10 mg/ 15 mg Schmelztabletten

Poland:Aripiprazole Aurovitas

Date of last revision of the leaflet: