Aripiprazole Stada 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Stada 5 mg tablets EFG

Aripiprazole Stada 10 mg tablets EFG

Aripiprazole Stada 15 mg tablets EFG

Aripiprazole Stada 30 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Stada is and what it is used for
2. What you need to know before taking Aripiprazole Stada
3. How to take Aripiprazole Stada
4. Possible side effects
5. How to store Aripiprazole Stada
6. Contents of the pack and other information

1. What Aripiprazol Stada is and what it is used for

Aripiprazol Stada 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 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.

Aripiprazol Stada 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 Aripiprazol Stada.

2. What you need to know before taking Aripiprazole Stada

Do NOT take Aripiprazole Stada

• 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 Stada.

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

Before starting treatment with Aripiprazole Stada, tell your doctor if you have:

• high blood sugar levels (characterised by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes
• seizures, as your doctor may wish to monitor you more closely
• irregular and involuntary muscle movements, especially in the face
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or "mini" stroke, or 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, 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 (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.

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

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

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which could lead to falls. Caution should be taken, especially if you are elderly or have some degree of weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.

Other medicines and Aripiprazole Stada

Tell 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 increase 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 Stada together with any other medicine, your doctor may need to adjust the dose of Aripiprazole Stada or the other medicines. It is especially important to tell your doctor if you are taking:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• Antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's wort);
• Medicines for fungal infections (antifungals) (such as ketoconazole, itraconazole);
• Certain medicines for HIV infection (such as efavirenz, nevirapine, and protease inhibitors like indinavir, ritonavir);
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Stada; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Stada, you must inform your doctor.

Medicines that increase serotonin levels are generally used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalised anxiety disorder, OCD, and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive disorders;
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Stada, you must inform your doctor.

Taking Aripiprazole Stada with food, drinks, and alcohol

This medicine can be taken regardless of meals. Alcohol consumption should be avoided while taking Aripiprazole Stada.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with Aripiprazole Stada during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

If you are taking Aripiprazole Stada, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with Aripiprazole Stada, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines

Dizziness and vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazole Stada contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Aripiprazole Stada

Follow exactly the instructions for using 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

Aripiprazole Stada should be initiated with an oral solution (liquid) at a low dose. If an oral solution is needed, your doctor will prescribe another aripiprazole product. Gradually, the dose may 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 Aripiprazole Stada is too strong or too weak, inform your doctor or pharmacist.

Method of administration

Try to take Aripiprazole Stada at the same time each day. It does not matter whether you take it with or without food.

Always take the tablet with water and swallow it whole.

Even if you feel better, do not change or stop the daily dose of Aripiprazole Stada without first consulting your doctor.

If you take more Aripiprazole Stada than you should

If you realize you have taken more tablets of Aripiprazole Stada than your doctor has recommended (or if someone else has taken some of your Aripiprazole Stada tablets), contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91.562.04.20 stating the medicine and the amount taken, or go to the nearest hospital, taking the packaging with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems;
• unusual movements (especially of the face or tongue), and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Aripiprazole Stada

If you miss a dose, take the missed dose as soon as you remember, but do not take two doses on the same day. Do not take a double dose to make up for a missed dose.

If you stop taking Aripiprazole Stada

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Stada for as long as your doctor has instructed.

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.

Common adverse effects (may affect up to 1 in 10 people):

• diabetes mellitus;

• sleep problems;

• anxiety;

• feeling restless and unable to stay still, difficulty remaining seated;

  • akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving constantly);

• uncontrollable twisting, writhing, or spasmodic movements, restless legs;

• tremor;

• headache;

• fatigue;

• drowsiness;

• dizziness;

• shakiness and blurred vision;

• difficulty passing stools or reduced frequency of bowel movements (constipation);

• indigestion;

• nausea;

• increased saliva production;

• vomiting;

• feeling of tiredness.

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

• increase or decrease in blood levels of prolactin hormone;

• too much sugar in the blood;

• depression;

• altered or increased sex drive;

• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);

• muscular disorder causing twisting movements (dystonia);

  • restless legs;

• double vision;

  • eye sensitivity to light;

• rapid heartbeat;

• drop in blood pressure upon standing that causes dizziness, lightheadedness, or fainting;

• hiccups.

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

• low levels of white blood cells;

• low levels of platelets;

• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness);

• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;

• high blood sugar;

• low levels of sodium in the blood;

• loss of appetite (anorexia);

• weight loss;

• weight gain;

• suicidal thoughts, suicide attempt, and suicide;

• aggression;

• agitation;

• nervousness;

• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);

• seizures;

• serotonin syndrome (a reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);

• speech disorder;

• fixation of the eyeballs in one position;

• unexplained sudden death;

• potentially life-threatening irregular heartbeat;

• heart attack;

• slower heartbeat;

• blood clots in the 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, seek immediate medical attention);

• high blood pressure;

• fainting;

• accidental inhalation of food with risk of pneumonia (lung infection);

• spasms of muscles around the glottis (a part of the larynx);

• inflammation of the pancreas;

• difficulty swallowing;

• diarrhea;

• abdominal discomfort;

• stomach upset;

• liver failure;

• inflammation of the liver;

• yellowing of the skin and whites of the eyes;

• abnormal liver function test results;

• rash;

• skin sensitivity to light;

• baldness;

• excessive sweating;

  • severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by a widespread rash, high fever, enlarged lymph nodes, elevated liver enzymes seen in blood tests, and an increase in a type of white blood cells (eosinophilia).

• abnormal breakdown of muscle tissue that may lead to kidney problems;

• muscle pain;

• stiffness;

• involuntary loss of urine (incontinence);

• difficulty urinating;

• withdrawal symptoms in newborns due to exposure to medication during pregnancy;

• prolonged and/or painful erection;

• difficulty controlling core body temperature or overheating;

• chest pain;

• swollen hands, ankles, or feet;

• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin.

• inability to resist the impulse, urge, or temptation to perform an action that may be harmful to you or others, which may include:

  • strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behavior concerning to you or others, for example, increased sex drive;
  • uncontrollable excessive shopping;
  • binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);
  • tendency to wander.

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, increased numbers 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 drowsiness, uncontrollable spasms or 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 limb movements, and dizziness—especially when standing up after lying down or sitting—which were common (affecting up to 1 in 10 patients).

Reporting of adverse effects

If you experience any 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 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 Stada

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. 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 Point in your pharmacy. If you are unsure, please 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 Aripiprazol Stada

The active substance is aripiprazole.

Aripiprazol Stada 5 mg tablets EFG: each tablet contains 5 mg of aripiprazole.

Aripiprazol Stada 10 mg tablets EFG: each tablet contains 10 mg of aripiprazole.

Aripiprazol Stada 15 mg tablets EFG: each tablet contains 15 mg of aripiprazole.

Aripiprazol Stada 30 mg tablets EFG: each tablet contains 30 mg of aripiprazole.

The other components (excipients) are: mannitol, maltodextrin, microcrystalline cellulose, crospovidone Type B (Ph.Eur.), sodium hydrogen carbonate, tartaric acid, anhydrous colloidal silica, sodium saccharin (E954), vanilla cream flavour (flavouring agents, natural flavouring substances, lactose, magnesium carbonate hydroxide), magnesium stearate (Ph.Eur.), indigo carmine aluminium lake (E132) (only in the 5 mg dose), iron oxide red (E172) (only in the 10 mg and 30 mg doses), and iron oxide yellow (E172) (only in the 15 mg dose).

Appearance of the product and contents of the pack

Aripiprazol Stada 5 mg tablets EFG are round, flat, pale blue tablets with scattered specks, 6 mm in diameter.

Aripiprazol Stada 10 mg tablets EFG are round, flat, light pink tablets with scattered specks, 8 mm in diameter.

Aripiprazol Stada 15 mg tablets EFG are round, flat, pale yellow tablets with scattered specks, 10 mm in diameter.

Aripiprazol Stada 30 mg tablets EFG are round, flat, light pink tablets with scattered specks, 13 mm in diameter.

Aripiprazol Stada is available in the following pack sizes:

Aripiprazol Stada 5 mg tablets EFG
Presented in blisters packed in a cardboard box containing 14, 28, 30, 49, 50, 56 or 98 tablets or 14x1, 28x1, 30x1, 49x1, 50x1, 56x1 or 98x1 tablets.

Aripiprazol Stada 10 mg tablets EFG
Presented in blisters packed in a cardboard box containing 7, 14, 28, 30, 49, 50, 56, 60, 84, 90, 98 or 100 tablets or 7x1, 14x1, 28x1, 30x1, 49x1, 50x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 tablets, or in HDPE bottles with polypropylene caps with integrated desiccant containing 100 tablets.

Aripiprazol Stada 15 mg tablets EFG
Presented in blisters packed in a cardboard box containing 7, 14, 28, 30, 49, 50, 56, 60, 84, 90, 98 or 100 tablets or 7x1, 14x1, 28x1, 30x1, 49x1, 50x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 tablets, or in HDPE bottles with polypropylene caps with integrated desiccant containing 100 tablets.

Aripiprazol Stada 30 mg tablets EFG
Presented in blisters packed in a cardboard box containing 7, 14, 28, 30, 49, 56, 60, 84, 90 or 98 tablets or 7x1, 14x1, 28x1, 30x1, 49x1, 56x1, 60x1, 84x1, 90x1 or 98x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 - Sant Just Desvern
(Barcelona)
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany

or

Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

or

STADA Arzneimittel GmbH
Muthgasse 36
1190 Wien
Austria

or

STADA M&D SRL
Str. Trascaului nr. 10
Municipiul Turda
Judet Cluj 401135
Romania

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

Austria: Aripiprazol STADA 5 mg Tabletten
Aripiprazol STADA 10 mg Tabletten
Aripiprazol STADA 15 mg Tabletten
Aripiprazol STADA 30 mg Tabletten

Germany: Aripiprazol STADA 5 mg Tabletten
Aripiprazol STADA 10 mg Tabletten
Aripiprazol STADA 15 mg Tabletten
Aripiprazol STADA 30 mg Tabletten

Belgium: Aripiprazole EG 10 mg tabletten
Aripiprazole EG 15 mg tabletten
Aripiprazole EG 30 mg tabletten

Croatia: Aripiprazol STADA 10 mg tablete
Aripiprazol STADA 15 mg tablete
Aripiprazol STADA 30 mg tablete

Denmark: Aripiprazol STADA

Slovenia: Aripiprazol STADA 10 mg tablete
Aripiprazol STADA 15 mg tablete

Slovakia: Aripiprazol STADA 15 mg tablety

Spain: Aripiprazol Stada 5 mg comprimidos EFG
Aripiprazol STADA 10 mg comprimidos EFG
Aripiprazol STADA 15 mg comprimidos EFG
Aripiprazol STADA 30 mg comprimidos EFG

Finland: Aripiprazol STADA

France: Aripiprazole EG 5 mg comprimé
Aripiprazole EG 10 mg comprimé
Aripiprazole EG 15 mg comprimé

Netherlands: Aripiprazol CF 5 mg tabletten

Hungary: Aripiprazol STADA 15 mg tabletta
Aripiprazol STADA 30 mg tabletta

Luxembourg: Aripiprazole EG 10 mg comprimés
Aripiprazole EG 15 mg comprimés
Aripiprazole EG 30 mg comprimés

Portugal: Aripiprazol Ciclum

Romania: Aripiprazol STADA 10 mg comprimate
Aripiprazol STADA 15 mg comprimate

Sweden: Aripiprazol STADA

Date of the most recent revision of this leaflet: April 2026

Detailed 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/)