ARIPIPRAZOLE SANDOZ 5 mg TABLETS

Introduction

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

aripiprazole

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Aripiprazol Sandoz and what is it used for
2. What you need to know before you take Aripiprazol Sandoz
3. How to take Aripiprazol Sandoz
4. Possible side effects
5. Storage of Aripiprazol Sandoz
6. Contents of the pack and further information

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

Aripiprazol Sandoz 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 suffer from a disease characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral monotony. People in this state may also feel depressed, guilty, restless, or tense.

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

2. What you need to know before you take Aripiprazol Sandoz tablets

Do not take Aripiprazol Sandoz

• 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 Sandoz

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 aripiprazole, 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
• a 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 suffer from dementia (loss of memory and other mental abilities), you or the person who cares for you or a family member should inform your doctor if you have ever had a stroke or a "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 experience numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a 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 for you and that you 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.

Taking Aripiprazol Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Medicines that lower blood pressure: Aripiprazol Sandoz 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 Sandoz with another medicine, it may mean that your doctor needs to change your dose of Aripiprazol Sandoz 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 medicines 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 aripiprazole; if you notice any unusual symptoms when taking any of these medicines at the same time as aripiprazole, 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 aripiprazole, you should tell your doctor.

Taking Aripiprazol Sandoz with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

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

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole in the last trimester of pregnancy (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 aripiprazole, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated with aripiprazole, 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 maximum attention is required, for example, when driving or operating machinery.

Aripiprazol Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Aripiprazol Sandoz

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose for adults is 15mg 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

To initiate treatment with a low dose, an alternative formulation (oral liquid solution) may be used, which will be more suitable than Aripiprazol Sandoz. The dose can be gradually increased to the recommended dose for adolescents of 10mg 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 is too strong or too weak, tell your doctor or pharmacist.

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

Even if you feel better, do not change 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 contact your doctor, go to the nearest hospital and take the package with you.

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

• rapid heartbeat, 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 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 Sandoz

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

If you stop taking Aripiprazol Sandoz

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

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 all people suffer from them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• 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;
• tremor;
• headache;
• fatigue;
• drowsiness;
• 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 patients):

• increase or decrease in prolactin hormone levels in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscular disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
  • ocular photosensitivity

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

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, 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);
• 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, drowsiness, 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;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudo-flu-like symptoms with a rash on the face and, later, with a generalized rash, high temperature, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased eosinophilia;
• abnormal muscle breakdown 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: fluctuation of blood sugar levels, increased hemoglobin glycosylated.
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:
  • strong impulse to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and disturbing behavior for you or others, for example, increased sexual appetite;
  • uncontrollable excessive shopping;
  • binge eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than necessary 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 aged 13 and older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrollable contractions, restlessness, and fatigue, which were very frequent (affecting 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 (affecting 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 leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Sandoz

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

Do not use this medicine after the expiration date that appears on the blister pack, bottle, and carton after EXP. 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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol Sandoz

Aripiprazol Sandoz 5 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, aluminum lake of carmine (E132).

Aripiprazol Sandoz 10 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, iron oxide red (E172).

Aripiprazol Sandoz 15 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, yellow iron oxide.

Aripiprazol Sandoz 20 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 20 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

Aripiprazol Sandoz 30 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 30 mg of aripiprazole.
• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, iron oxide red (E172).

Appearance of Aripiprazol Sandoz and Package Contents

Aripiprazol Sandoz 5 mg tablets

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

Aripiprazol Sandoz 10 mg tablets

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

Aripiprazol Sandoz 15 mg tablets

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

Aripiprazol Sandoz 20 mg tablets

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

Aripiprazol Sandoz 30 mg tablets

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

The 5 mg, 10 mg, 15 mg, and 30 mg tablets are available in:

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

Unit-dose aluminum/aluminum blisters packaged in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1, or 98 x 1 tablets.

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

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

Str. Livezeni nr. 7A

Târgu Mures 540472

Romania

Lek S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet: 09/2022

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.