Package Leaflet: Information for the User

Aripiprazol Stada 5 mg Tablets EFG

Aripiprazol Stada 10 mg Tablets EFG

Aripiprazol Stada 15 mg Tablets EFG

Aripiprazol Stada 30 mg Tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Aripiprazol Stada

3.How to take Aripiprazol Stada

4.Possible side effects

5.Storage of Aripiprazol Stada

6.Contents of the pack and additional information

Aripiprazol Stada contains the active substance aripiprazol and belongs to a group of medicines called 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 Stada 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 Stada.

Do not take Aripiprazol Stada

•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 Stada.

There have been cases of patients who experience thoughts and behaviors of self-harm during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Stada, tell your doctor 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, as your doctor may want to monitor you more closely

•irregular and involuntary muscle movements, especially in the face

•cardiovascular diseases (heart and circulation 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 the formation of blood clots

•history of addiction to gambling

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

If you are an elderly patient and have dementia (loss of memory and other mental abilities), you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you have thoughts or feelings of harming yourself. There have been cases of patients who experience thoughts and behaviors of self-harm during treatment with aripiprazol.

Tell 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.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way in you and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. You should be cautious, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. The safety and effectiveness of this medicine in these patients are unknown.

Other medicines and Aripiprazol Stada

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

Medicines that lower blood pressure:

Aripiprazol may increase the effect of medicines used to lower blood pressure.

Make sure to inform your doctor if you are using any medicine to control blood pressure.

If you are taking Aripiprazol Stada with any other medicine, it may mean that your doctor needs to change your dose of Aripiprazol Stada or the dose of the other medicines. It is especially important to mention to 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 to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);

•some medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as, for example, indinavir, ritonavir);

•anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);

•some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazol Stada; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Stada, you should inform your doctor.

Medicines that increase serotonin levels are generally used to treat diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

•triptans, tramadol, and tryptophan used to treat diseases such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain;

•selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat 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 diseases;

•St. John's Wort (Hypericum perforatum) used in herbal remedies for 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 observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Stada, you should inform your doctor.

Taking Aripiprazol Stada with food, drinks, and alcohol

This medicine can be taken regardless of meals. You should avoid consuming alcohol while taking Aripiprazol Stada.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There may be the following symptoms in newborn babies, of mothers who have been treated with Aripiprazol Stada in the last trimester of pregnancy (last three months of your pregnancy): tremor, 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.

If you are taking Aripiprazol Stada, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit for you of your treatment and the benefit for your baby of breastfeeding. If you are being treated with Aripiprazol 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 operating machinery

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

Aripiprazol Stada contains lactose and sodium

If your doctor has told 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; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 Stada should be started with an oral solution (liquid) at a low dose. If an oral solution is needed, your doctor will prescribe another aripiprazol product. 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 Stada is too strong or weak, inform your doctor or pharmacist.

Administration method

Try to take Aripiprazol Stada at the same time every day.It does not matter if you take it with or without food.

Take the tablet with water and swallow it whole.

Even if you feel better, do not alter or interrupt the daily dose of Aripiprazol Stada without consulting your doctor first.

If you take more Aripiprazol Stada than you should

If you realize that you have taken more Aripiprazol Stada tablets than your doctor recommended (or if someone else has taken some of your Aripiprazol Stada tablets), consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested or go to the nearest hospital bringing the packaging with you.

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

• rapid heartbeats, agitation/aggression, language 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, slower breathing, choking, 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 Aripiprazol Stada

If you forget a dose, take the missed dose as soon as you remember, but do not take two doses in one day. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol Stada

Do not stop treatment just because you feel better. It is essential that you continue taking Aripiprazol Stada for the time your doctor has indicated.

If you have any other doubts 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 people):

•diabetes mellitus;

•sleep problems;

•anxiety;

•restlessness and inability to stay still, difficulty staying seated;

• akathisia (an uncomfortable feeling of inner restlessness and a pressing need to move constantly);

•involuntary movements, twisting, contorting or spasmodic movements, restless legs;

•tremors;

•headaches;

•fatigue;

•drowsiness;

•dizziness;

•shaking and blurred vision;

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

•indigestion;

•nausea;

•increased saliva production;

•vomiting;

•feeling of fatigue.

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

•increased or decreased levels of prolactin hormone in the blood;

•high blood sugar;

•depression;

•altered or increased sex drive;

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

•muscle disorder causing twisting movements (dystonia);

• restless legs;

•double vision;

• light sensitivity;

•rapid heartbeat;

•low blood pressure when standing, causing dizziness, fainting or loss of consciousness;

•hypotension.

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

•low white blood cell count;

•low platelet count;

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

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

•high blood sugar,

•insufficient sodium levels in the blood;

•loss of appetite (anorexia);

•weight loss;

•weight gain;

•suicidal thoughts, attempt and suicide;

•aggression;

•agitation;

•nervousness;

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

•seizures;

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

•speech disorder;

•fixation of the eyeballs in a position;

•sudden and unexplained death;

•potentially fatal irregular heartbeat;

•heart attack;

•slow heart rate;

•blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately);

•high blood pressure;

•fainting;

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

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

•pancreatitis;

•difficulty swallowing;

•diarrhea;

•abdominal discomfort;

•stomach upset;

•liver failure;

•inflammation of the liver;

•yellowing of the skin and the white part of the eyes;

•abnormal liver function test results;

•hives;

•light sensitivity;

•hair loss;

•excessive sweating;

• severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with symptoms similar to the flu, with a rash on the face, followed by a widespread rash, high temperature, swollen lymph nodes, elevated liver enzymes seen in blood tests, and increased eosinophils.;

•abnormal muscle degradation that can cause kidney problems;

•muscle pain;

•rigidity;

•involuntary loss of urine (incontinence);

•difficulty urinating;

•symptoms of withdrawal in newborns due to exposure to the drug during pregnancy;

•prolonged and painful erection;

•difficulty controlling central body temperature or overheating;

•chest pain;

•swollen hands, ankles or feet;

•abnormal blood sugar levels, hemoglobin A1c fluctuations in blood tests.

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

- strong impulse to gamble excessively despite serious personal or family consequences;

- altered or increased sex drive and concerning behavior for yourself or others, such as increased sex drive;

- compulsive buying;

- binge eating (eating 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; he will explain how to manage or reduce the symptoms.

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

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, involuntary spasms or 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 movements of the limbs, and dizziness, especially when getting up from lying or sitting, which were common (affects up to 1 in 10 patients).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for Pharmacovigilance 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.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit 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. In this way, you will help protect the environment.

Composition of Aripiprazole Stada

The active ingredient is aripiprazole.

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

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

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

Aripiprazole 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 flavor (aroma substances, natural aroma substances, lactose, magnesium carbonate hydroxide), magnesium stearate (Ph.Eur.), aluminium lake carmine blue (E132) (only in the 5 mg dose), red iron oxide (E172) (only in the 10 mg and 30 mg doses) and yellow iron oxide (E172) (only in the 15 mg dose).

Appearance of the product and contents of the package

Aripiprazole Stada 5 mg tablets EFGare round, flat, pale blue tablets with scattered spots and 6 mm in diameter.

Aripiprazole Stada 10 mg tablets EFGare round, flat, pale pink tablets with scattered spots and 8 mm in diameter.

Aripiprazole Stada 15 mg tablets EFGare round, flat, pale yellow tablets with scattered spots and 10 mm in diameter.

Aripiprazole Stada 30 mg tablets EFGare round, flat, pale pink tablets with scattered spots and 13 mm in diameter.

Aripiprazole Stadais available in the following formats:

Aripiprazole Stada 5 mg tablets EFG

It is presented in blisterspacked in a cardboard box containing 14, 28, 30, 49, 50, 56 or 98 tablets or 14x1, 28x1, 30x1, 49x1, 50x1, 56x1 or 98x1 tablets.

Aripiprazole Stada 10 mg tablets EFG

It is presented in blisterspacked 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.

Aripiprazole Stada 15 mg tablets EFG

It is presented in blisterspacked 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.

Aripiprazole Stada 30 mg tablets EFG

It is presented in blisterspacked 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 some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 - Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer responsible

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

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 with 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

BelgiumAripiprazole EG 10 mg tabletten

Aripiprazole EG 15 mg tabletten

Aripiprazole EG 30 mg tabletten

CroatiaAripiprazol STADA 10 mg tablete

Aripiprazol STADA 15 mg tablete

Aripiprazol STADA 30 mg tablete

Denmark:Aripiprazol STADA

SloveniaAripiprazol STADA 10 mg tablete

Aripiprazol STADA 15 mg tablete

SlovakiaAripiprazol STADA 15mg 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

NetherlandsAripiprazol CF 5 mg tabletten

HungaryAripiprazol STADA 15 mg tabletta

Aripiprazol STADA 30 mg tabletta

LuxembourgAripiprazole EG 10 mg comprimés

Aripiprazole EG 15 mg comprimés

Aripiprazole EG 30 mg comprimés

PortugalAripiprazol Ciclum

RomaniaAripiprazol STADA 10 mg comprimate

Aripiprazol STADA 15 mg comprimate

Sweden:Aripiprazol STADA

Last review date of this leaflet:November 2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/