Package Leaflet: Information for the User

Aripiprazol Sandoz 5mg tablets

Aripiprazol Sandoz 10mg tablets

Aripiprazol Sandoz 15mg tablets

Aripiprazol Sandoz 20mg tablets

Aripiprazol Sandoz 30mg tablets

aripiprazol

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 give it to others even if they have similar symptoms to you, as it may harm them.

•If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

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

2.What you need to know before taking Aripiprazol Sandoz

3.How to take Aripiprazol Sandoz

4.Possible side effects

5.Storage of Aripiprazol Sandoz

6.Contents of the pack and additional information

Aripiprazol Sandoz contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years or more who suffer from a condition characterised by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioural state. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol Sandoz is used to treat adults and adolescents aged 13 years or more who suffer from a disorder characterised by symptoms such as feeling euphoric, having excessive energy, needing much less sleep 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 Sandoz.

Do not take Aripiprazol Sandoz

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Sandoz.

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

Before starting treatment with aripiprazol, 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

• Convulsions, 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

• A 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 have dementia (loss of memory and other mental abilities), you or your caregiver 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. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported.

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 that you cannot resist, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sexual appetite, or excessive concern about increased 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 lead to falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and adolescents

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

Taking Aripiprazol Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Medications that lower blood pressure: Aripiprazol Sandoz may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are taking Aripiprazol Sandoz with any other medication, it may mean that your doctor needs to change your dose of Aripiprazol Sandoz or the dose of other medications. It is especially important to mention to your doctor if you are taking:

•medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);

•antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);

•antifungal medications (such as ketoconazole, itraconazole);

•certain medications 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 medications may increase the risk of adverse effects or reduce the effect of aripiprazol; if you observe any unusual symptoms when taking any of these medications with aripiprazol, you should inform your doctor.

Medications that increase serotonin levels are generally used to treat conditions 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 conditions 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 disorders;

•St. John's Wort (Hypericum perforatum) used in herbal medications for mild depression;

•analgesics (such as tramadol and pethidine) used to relieve pain;

•triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications with aripiprazol, you should inform your doctor.

Taking Aripiprazol Sandoz with food, drinks, and alcohol

This medication can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

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

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

Driving and operating machinery

During treatment with this medication, 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 Sandoz contains lactose

If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15mg once a day.However, your doctor may prescribe lower and higher doses up to a maximum of 30mg once a day.

Use in children and adolescents

To initiate treatment with a low dose, an alternative formulation (oral liquid solution) may be used, which will be more suitable than Aripiprazol Sandoz. Gradually, the dose may be increased tothe recommended dose for adolescents of 10mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30mg once a day.

If you estimate that the action of Aripiprazol is too strong or too weak, inform your doctor or pharmacist.

Try to take the Aripiprazol tablet at the same time every day. It does not matter if you take it with or without food. Take the tablets with water and swallow them whole.

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

If you take more Aripiprazol Sandoz than you should

If you realize that you have taken more Aripiprazol Sandoz tablets than your doctor recommended (or if someone else has taken some of your Aripiprazol Sandoz tablets), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring 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 forgot to take Aripiprazol Sandoz

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol Sandoz

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

If you have any other questions 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 patients):

•diabetes mellitus;

•sleep problems;

•anxiety;

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

•akathisia (an uncomfortable feeling of internal restlessness and an overwhelming need to move constantly);

•involuntary movements of twisting, contorting, or spasmodic movements;

•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 patients):

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

•excessively high levels of sugar in the blood;

•depression;

•altered or increased sex drive;

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

•muscle disorder causing twisting movements (dystonia);

•restless legs;

•double vision;

• photosensitivity of the eyes

•rapid heartbeat;

•low blood pressure when standing, causing dizziness, confusion, or fainting;

•hypotension.

The following side effects have been reported during the post-marketing phase of aripiprazole oral, but the frequency of occurrence is unknown:

•low white blood cell count;

•low platelet count;

•allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, 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, attempts, 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 immediate medical attention);

•high blood pressure;

•fainting;

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

•spasms of the 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 the white part of the eyes;

•abnormal liver function test results;

•hives;

•skin photosensitivity;

•hair loss;

•excessive sweating;

•severe allergic reactions, such as the drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as pseudogripal symptoms with a rash on the face, and later with a generalized rash, high fever, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);

•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 medications during pregnancy;

•prolonged and/or painful erection;

•difficulty controlling central body temperature or overheating;

•chest pain;

•swollen hands, ankles, or feet;

•in blood tests: fluctuations in blood sugar levels, increased hemoglobin A1c levels.

•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;

-uncontrollable excessive 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 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 getting up from lying or sitting, which were frequent (affects up to 1 in 10 patients).

Reporting of side effects

If you experience any 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 directly through theAnnex Vincluded in theEuropean Medicines Agency's website. 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 blister pack, bottle, and box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Use within 3 months after the first opening of the bottle.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Aripiprazol Sandoz

Aripiprazol Sandoz 5 mg tablets

•The active ingredient is aripiprazol. Each tablet contains 5mg of aripiprazol.

•The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, aluminum lake of indigo carmine (E132).

Aripiprazol Sandoz 10 mg tablets

•The active ingredient is aripiprazol. Each tablet contains 10mg of aripiprazol.

•The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, iron oxide red (E172).

Aripiprazol Sandoz 15 mg tablets

•The active ingredient is aripiprazol. Each tablet contains 15mg of aripiprazol.

•The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, iron oxide yellow.

Aripiprazol Sandoz 20 mg tablets

•The active ingredient is aripiprazol. Each tablet contains 20mg of aripiprazol.

•The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.

Aripiprazol Sandoz 30 mg tablets

•The active ingredient is aripiprazol. Each tablet contains 30mg of aripiprazol.

•The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, iron oxide red (E172).

Appearance of Aripiprazol Sandoz and packaging

Aripiprazol Sandoz 5 mg tablets

Aripiprazol Sandoz 5mg tablets are round, blue, speckled tablets, with a diameter of approximately 6.0mm, engraved with “SZ” on one side and “444” on the other side.

Aripiprazol Sandoz 10 mg tablets

Aripiprazol Sandoz 10mg tablets are round, pink, speckled tablets, with a diameter of approximately 6.0mm, engraved with “SZ” on one side and “446” on the other side.

Aripiprazol Sandoz 15 mg tablets

Aripiprazol Sandoz 15mg tablets are round, yellow, speckled tablets, with a diameter of approximately 7.0mm, engraved with “SZ” on one side and “447” on the other side.

Aripiprazol Sandoz 20 mg tablets

Aripiprazol Sandoz 20mg tablets are round, white,with a diameter of approximately 7.8mm,engraved with “SZ” on one side and “448” on the other side.

Aripiprazol Sandoz 30 mg tablets

Aripiprazol Sandoz 30mg tablets are round, pink, speckled,with a diameter of approximately 9.0mm,engraved with “SZ” on one side and “449” on the other side.

The 5 mg, 10 mg, 15 mg, and 30 mg tablets are presented in the following forms:

Aluminum//aluminum blisters packaged in boxes containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets.

Unit dose blisters of aluminum//aluminum packaged in boxes containing 14x1, 28x1, 49x1, 56x1or 98x1tablets.

HDPE bottle containing a desiccant of silica gel and a polyester filler packaged in boxes of 100 tablets.

The 20 mg tablets are presented in blisters packaged in boxes containing 14, 28, 49, 56 or 98 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Responsible for Manufacturing

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Eslovenia

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

Târgu Mures 540472

Rumanía

Lek S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Polonia

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: 09/2022

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.