ARIPIPRAZOL STADA 30 mg TABLETS

2. What you need to know before you take Aripiprazol Stada

Do not take Aripiprazol Stada

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

Warnings and precautions

Talk to your doctor before starting to take Aripiprazol Stada.

There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Stada, tell your doctor if you suffer from

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) 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 a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• history of gambling addiction

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

If you are an elderly patient and suffer from 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.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or very fast or irregular heartbeat.

Tell your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way 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 gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause somnolence, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are an elderly patient or suffer from weakness.

Children and adolescents

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

Other medicines and Aripiprazol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines that lower blood pressure:

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

Make sure to tell your doctor if you use any medicine to control blood pressure.

If you are taking Aripiprazol Stada with another medicine, it may mean that your doctor needs to change your dose of Aripiprazol Stada or the other medicine. It is especially important that you 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);
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as 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 Aripiprazol Stada; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Stada, you should tell your doctor.

Medicines that increase serotonin levels are commonly used in 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 for diseases such as depression, generalized anxiety disorder, obsessive-compulsive 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 diseases;
• 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 when taking any of these medicines at the same time as Aripiprazol Stada, you should tell your doctor.

Taking Aripiprazol Stada with food, drinks, and alcohol

This medicine can be taken with or without food. You should avoid drinking alcohol while taking Aripiprazol Stada.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with Aripiprazol Stada in the last trimester (last three months of pregnancy): tremors, stiffness and/or muscle weakness, somnolence, 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, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. 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 using machines

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 some sugars, consult with them 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 Aripiprazol Stada

Follow exactly the administration instructions of this medicine given 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 or 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 aripiprazole product for you. The dose can be gradually increased to the 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 think the effect of Aripiprazol Stada is too strong or too weak, tell your doctor or pharmacist.

Method of administration

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

Always 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 tablets of Aripiprazol Stada than your doctor recommended (or if someone else has taken some of your Aripiprazol Stada tablets), consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone: 91.562.04.20 indicating the medicine and the amount ingested, or go to the nearest hospital with the package.

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

• rapid heartbeat, agitation/aggressiveness, 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 stiffness and somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or the 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 forgotten 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 the forgotten dose.

If you stop taking Aripiprazol Stada

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

If you have any further questions on 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 all people suffer from them.

Frequent Adverse Effects (may affect up to 1 in 10 people):

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
  • akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly);

• twisting, contorting, or spasmodic uncontrollable movements, restless legs;
• tremor;
• headache;
• fatigue;
• sleepiness;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

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 sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscular disorder that causes twisting movements (dystonia);
  • restless legs;

• double vision;
  • ocular sensitivity to light;

• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, drowsiness, or fainting;
• hypo.

The following adverse 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 levels of white blood cells;
• low levels of platelets;
• allergic reaction (e.g., swelling in 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,
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, 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 can cause feelings of intense happiness, sleepiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream 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;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver values in blood tests;
• rash;
• topical sensitivity to light;
• hair loss;
• excessive sweating;
  • severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms with a rash on the face and then with a widespread rash, high temperature, swollen lymph nodes, elevated liver enzymes in blood tests, and increased eosinophils (a type of white blood cell);

• abnormal degradation of muscles that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin.
• 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 sexual interest and worrying behavior for yourself or others, for example, increased sexual appetite;
  • uncontrollable excessive shopping;
  • binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other Adverse Effects in Children and Adolescents

Adolescents 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for sleepiness, spasms, or uncontrollable 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 standing up after sitting or lying down, which were frequent (affects up to 1 in 10 patients).

Reporting Adverse Effects

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

5. Conservation of Aripiprazol Stada

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is 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 should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol Stada

The active ingredient is aripiprazole.

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

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

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

Aripiprazol Stada 30 mg EFG tablets: 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 (flavoring substances, natural flavoring substances, lactose, magnesium carbonate), magnesium stearate (Ph.Eur.), aluminum lake carmine indigo (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 Package Contents

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

Aripiprazol Stada 10 mg EFG tablets are round, flat, pale pink tablets with scattered spots and 8 mm in diameter.

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

Aripiprazol Stada 30 mg EFG tablets are round, flat, pale pink tablets with scattered spots and 13 mm in diameter.

Aripiprazol Stada is available in the following formats:

Aripiprazol Stada 5 mg EFG tablets

They are presented in blister packs packaged 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 EFG tablets

They are presented in blister packs packaged 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.

Aripiprazol Stada 15 mg EFG tablets

They are presented in blister packs packaged 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.

Aripiprazol Stada 30 mg EFG tablets

They are presented in blister packs packaged 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.

Not all 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

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 medicine 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

Belgium: Aripiprazole EG 10 mg tablets

Aripiprazole EG 15 mg tablets

Aripiprazole EG 30 mg tablets

Croatia: Aripiprazol STADA 10 mg tablets

Aripiprazol STADA 15 mg tablets

Aripiprazol STADA 30 mg tablets

Denmark: Aripiprazol STADA

Slovenia: Aripiprazol STADA 10 mg tablets

Aripiprazol STADA 15 mg tablets

Slovakia: Aripiprazol STADA 15 mg tablets

Spain: Aripiprazol Stada 5 mg EFG tablets

Aripiprazol STADA 10 mg EFG tablets

Aripiprazol STADA 15 mg EFG tablets

Aripiprazol STADA 30 mg EFG tablets

Finland: Aripiprazol STADA

France: Aripiprazole EG 5 mg tablet

Aripiprazole EG 10 mg tablet

Aripiprazole EG 15 mg tablet

Netherlands: Aripiprazol CF 5 mg tablets

Hungary: Aripiprazol STADA 15 mg tablet

Aripiprazol STADA 30 mg tablet

Luxembourg: Aripiprazole EG 10 mg tablets

Aripiprazole EG 15 mg tablets

Aripiprazole EG 30 mg tablets

Portugal: Aripiprazol Ciclum

Romania: Aripiprazol STADA 10 mg tablets

Aripiprazol STADA 15 mg tablets

Sweden: Aripiprazol STADA

Date of the last revision of this prospectus:November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/