Aripiprazole Sandoz 15 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Sandoz 5mg tablets

Aripiprazole Sandoz 10mg tablets

Aripiprazole Sandoz 15mg tablets

Aripiprazole Sandoz 20mg tablets

Aripiprazole Sandoz 30mg tablets

aripiprazole

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aripiprazole Sandoz tablets are and what they are used for

Aripiprazole 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 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.

Aripiprazole Sandoz 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 Aripiprazole Sandoz.

2. What you need to know before taking Aripiprazole Sandoz tablets

Do not take Aripiprazole Sandoz

• 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 Sandoz.

Cases of patients experiencing suicidal thoughts and behaviours 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, tell your doctor if you have:

• high blood sugar levels (characterized 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 of the face;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke (transient ischaemic attack), 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, having difficulty swallowing, or showing allergic symptoms, please inform your doctor.

If you have 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 experience 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 are unable to 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 your ability to move and maintain balance, which could lead to falls. Caution is advised, especially if you are an elderly patient or have any degree of physical 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.

Taking Aripiprazole Sandoz with other medicines

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

Medicines that lower blood pressure: Aripiprazole Sandoz may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control blood pressure.

If you are taking Aripiprazole Sandoz with any other medicine, it may mean that your doctor needs to adjust your dose of Aripiprazole Sandoz or of 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 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 adverse effects or reduce the effect of aripiprazole. If you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

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

• triptans, tramadol, and tryptophan used for conditions 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 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 adverse effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole Sandoz with food, drinks, and alcohol

This medicine can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 whose mothers have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

If you are taking aripiprazole, 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, 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 Sandoz contains lactose

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

3. How to take Aripiprazole Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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

To initiate treatment with a lower dose, an alternative formulation (liquid oral solution) may be used, which is more suitable than Aripiprazole Sandoz. 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 is too strong or too weak, inform your doctor or pharmacist.

Try to take the Aripiprazole tablet at the same time each day. It does not matter whether 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 stop your daily dose of Aripiprazole without first consulting your doctor.

If you take more Aripiprazole Sandoz than you should

If you realize that you have taken more Aripiprazole Sandoz tablets than your doctor has prescribed (or if someone else has taken some of your Aripiprazole Sandoz tablets), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take 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 symptoms listed above.

If you forget to take Aripiprazole Sandoz

If you miss 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 Aripiprazole Sandoz

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Sandoz tablets 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• feeling restless and unable to stay still, difficulty remaining seated;
• akathisia (an uncomfortable inner restlessness and an urgent need to keep moving);
• uncontrollable twisting, writhing, or spasmodic movements;
• tremor;
• headache;
• tiredness;
• drowsiness;
• dizziness;
• shakiness and blurred vision;
• difficulty passing stools or reduced frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased production of saliva;
• vomiting;
• feeling of fatigue.

Uncommon side effects (may affect up to 1 in 100 patients):

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

• excessively high blood sugar levels;

• depression;

• altered or increased sex drive;

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

• a muscle disorder causing twisting movements (dystonia);

• restless legs;

• double vision;

  • ocular photosensitivity

• rapid heartbeat;

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

• hiccups.

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

• 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;
• a 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 well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixed eye position (oculogyria);
• unexplained sudden death;
• potentially life-threatening irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, contact your doctor immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• muscle spasms around the glottis (a part of the larynx);
• inflammation of the pancreas;
• difficulty swallowing;
• diarrhoea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and whites of the eyes (jaundice);
• abnormal liver function test results;
• rash;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed by generalized rash, high fever, swollen lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• abnormal muscle breakdown that may lead to kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to medicines during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling core body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuation in blood sugar levels, increased glycated haemoglobin;
• inability to resist the impulse, urge, or temptation to perform an action that could be harmful to yourself or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behaviour that is concerning to you or others, for example, increased libido;
  • 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 behaviours; they 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. In addition, cases of stroke or "mini" strokes have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects similar in frequency and type to those in adults, except for drowsiness, muscle spasms or uncontrollable contractions, restlessness, and tiredness, 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 upon standing up from lying or sitting down—which were common (affects up to 1 in 10 patients).

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Sandoz

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

Do not use this medicine after the expiry date stated on the blister, on the bottle, and on the carton following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Use within 3 months after first opening of the bottle.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Aripiprazole Sandoz

Aripiprazole Sandoz 5 mg tablets

• The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other components are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E132).

Aripiprazole Sandoz 10 mg tablets

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

Aripiprazole Sandoz 15 mg tablets

• The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other components are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, yellow iron oxide.

Aripiprazole Sandoz 20 mg tablets

• The active substance is aripiprazole. Each tablet contains 20 mg of aripiprazole.
• The other components are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

Aripiprazole Sandoz 30 mg tablets

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

Appearance of Aripiprazole Sandoz and contents of the pack

Aripiprazole Sandoz 5 mg tablets

Aripiprazole Sandoz 5 mg tablets are round, mottled blue tablets with an approximate diameter of 6.0 mm, marked with “SZ” on one side and “444” on the other.

Aripiprazole Sandoz 10 mg tablets

Aripiprazole Sandoz 10 mg tablets are round, mottled pink tablets with an approximate diameter of 6.0 mm, marked with “SZ” on one side and “446” on the other.

Aripiprazole Sandoz 15 mg tablets

Aripiprazole Sandoz 15 mg tablets are round, mottled yellow tablets with an approximate diameter of 7.0 mm, marked with “SZ” on one side and “447” on the other.

Aripiprazole Sandoz 20 mg tablets

Aripiprazole Sandoz 20 mg tablets are round, white tablets with an approximate diameter of 7.8 mm, marked with “SZ” on one side and “448” on the other.

Aripiprazole Sandoz 30 mg tablets

Aripiprazole Sandoz 30 mg tablets are round, mottled pink tablets with an approximate diameter of 9.0 mm, marked with “SZ” on one side and “449” on the other.

The 5 mg, 10 mg, 15 mg and 30 mg tablets are available in the following pack types:

Aluminium/aluminium blisters packed in cartons containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets.

Unit dose aluminium/aluminium blisters packed 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, packed in cartons of 100 tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of last review of this leaflet: 09/2022

Other sources of information

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