Aripiprazol Glenmark

Leaflet accompanying the packaging: information for the user

Arypiprazol Glenmark, 15 mg, tablets

Aripiprazolum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Arypiprazol Glenmark and what is it used for
• 2. Important information before taking Arypiprazol Glenmark
• 3. How to take Arypiprazol Glenmark
• 4. Possible side effects
• 5. How to store Arypiprazol Glenmark
• 6. Contents of the packaging and other information

1. What is Arypiprazol Glenmark and what is it used for

Arypiprazol Glenmark contains the active substance aripiprazole, which belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 and older with a condition whose symptoms include: seeing, hearing, and feeling things that are not real, suspiciousness, delusions, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, guilty, anxious, or tense. Arypiprazol Glenmark is used to treat adults and adolescents aged 13 and older with a condition whose symptoms include: severe excitement, overflowing energy, less need for sleep than usual, very fast speech, racing thoughts, and sometimes very severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Arypiprazol Glenmark.

2. Important information before taking Arypiprazol Glenmark

When not to take Arypiprazol Glenmark:

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

Warnings and precautions

Before starting treatment with Arypiprazol Glenmark, you should discuss it with your doctor. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings related to self-harm. Before starting treatment with Arypiprazol Glenmark, you should tell your doctor if you have:

• high blood sugar levels (typical symptoms include: excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as close monitoring by your doctor may be necessary;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and blood vessel diseases), a family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as the use of antipsychotic medicines is associated with their formation;
• a history of gambling addiction.

If you notice an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any swallowing difficulties, or symptoms of an allergic reaction, you should inform your doctor. If an elderly patient with dementia has a history of stroke or "mini" stroke, they, their caregiver, or relative should inform the doctor. You should immediately inform your doctor if you experience thoughts or desires related to self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience muscle stiffness or muscle stiffness with high fever, excessive sweating, mental disorders, or very rapid or irregular heartbeat. If you or your family member/caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, urge, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as: compulsive gambling, excessive eating or excessive spending, excessive sexual drive, or increased frequency and intensity of sexual thoughts or feelings. Your doctor may consider changing the dose or discontinuing the medicine. Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be cautious, especially in elderly or weakened patients.

Children and adolescents

This medicine should not be used in children and adolescents under 13 years of age. It is not known whether the use of the medicine is safe and effective in these patients.

Arypiprazol Glenmark and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Blood pressure-lowering medicines: Arypiprazol Glenmark may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should tell your doctor. During treatment with Arypiprazol Glenmark, your doctor may consider changing the dose of Arypiprazol Glenmark or other medicines you are taking. It is especially important to inform your doctor about the use of:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressant medicines or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medicines (such as ketoconazole, itraconazole);
• certain medicines used to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g., indinavir, ritonavir);
• antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or reduce the effect of Arypiprazol Glenmark. If you experience any unusual symptoms while taking these medicines with Arypiprazol Glenmark, you should tell your doctor. Medicines that increase serotonin levels are usually used to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, tryptophan, used to treat 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 to treat depression, OCD, panic, and anxiety;
• other antidepressant medicines (such as venlafaxine and tryptophan), used to treat severe depression;
• tricyclic medicines (such as clomipramine, amitriptyline), used to treat depression;
• St. John's Wort (Hypericum perforatum) used as a herbal remedy for mild depression;
• painkillers (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

Taking these medicines may increase the risk of side effects; if you experience any unusual symptoms while taking any of these medicines with Arypiprazol Glenmark, you should tell your doctor.

Arypiprazol Glenmark with food, drink, and alcohol

The medicine can be taken with or without food. You should not drink alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor for advice before taking this medicine. In newborns whose mothers took Arypiprazol Glenmark during the last trimester of pregnancy (the last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your baby experiences any of these symptoms, you should contact your doctor. If you are taking Arypiprazol Glenmark, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best methods for feeding your baby if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances (see section 4) may occur. You should take this into account when performing activities that require full attention, such as driving or operating machinery.

Arypiprazol Glenmark contains lactose

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Arypiprazol Glenmark

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. The recommended dose for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day. To achieve a dose of 5 mg or 10 mg, you should, after consulting your doctor, use a different medicine available on the market containing the active substance aripiprazole.

Use in children and adolescents

Treatment with this medicine can be started with a low dose of aripiprazole in the form of an oral solution (in liquid form). The dose can be gradually increased to a recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day. If you think that the effect of this medicine is too strong or too weak, you should tell your doctor or pharmacist. Arypiprazol Glenmark should be taken every day at the same time.The medicine can be taken with or without food. The tablet should be swallowed whole, with a glass of water. Even if you feel better, you should not change the dose or stop taking Arypiprazol Glenmark without first discussing it with your doctor.

Take more than the recommended dose of Arypiprazol Glenmark

If you have taken more than the recommended dose of Arypiprazol Glenmark (or if someone else has taken some of the Arypiprazol Glenmark medicine that was not intended for them), you should immediately contact your doctor. If it is not possible to contact your doctor, you should go to the nearest hospital, taking the packaging of the medicine with you. In patients who have taken too much aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation/aggression, speech problems;
• unusual body movements (especially of the face or tongue) and decreased consciousness.

Other symptoms include:

• severe confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, mental disorders, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heart rhythm.

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Miss a dose of Arypiprazol Glenmark

If you miss a dose, you should take the missed dose as soon as you remember. You should not take two doses in one day.

Stop taking Arypiprazol Glenmark

You should not stop treatment if you feel better. It is very important to take Arypiprazol Glenmark exactly as your doctor has told you and for the period prescribed by your doctor. If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• anxiety,
• restlessness and difficulty sitting still,
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of "emptiness in the head",
• image tremor and blurred vision,
• decreased number of bowel movements or difficulty with bowel movements (constipation),
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of fatigue.

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

• increased or decreased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changed or increased interest in sex,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• increased sensitivity of the eyes to light,
• rapid heartbeat,
• decreased blood pressure when changing position to standing, causing dizziness, feeling of emptiness in the head, or fainting,
• hiccups.

The following side effects have been reported after the introduction of aripiprazole in oral form to the market, but their frequency is not known:

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching of the skin, rash),
• onset of diabetes or worsening of its symptoms, ketoacidosis (presence of ketone bodies in the blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide, and suicide,
• feeling of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, mental disorders, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a condition that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, drunkenness, fever, sweating),
• speech disorders,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, you must immediately see a doctor),
• high blood pressure,
• fainting,
• accidental choking on food with a risk of pneumonia,
• spasm of the muscles around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• discomfort in the abdominal cavity,
• discomfort in the stomach,
• liver function disorders,
• hepatitis,
• yellowing of the skin and whites of the eyes,
• abnormal liver test results,
• skin rash,
• increased sensitivity of the skin to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, and then a rash appears on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia),
• abnormal breakdown of muscle leading to kidney function disorders,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty urinating,
• withdrawal syndrome in newborns in case of exposure to the medicine during pregnancy,
• prolonged and (or) painful erection,
• disorders of basic body temperature regulation or overheating,
• chest pain,
• swelling of the hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin levels,
• inability to resist the impulse, urge, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending,
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• urge to wander. If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.

In elderly patients with dementia taking aripiprazole, deaths have been reported more frequently. Additionally, strokes or "mini" strokes have been reported.

Additional side effects in children and adolescents

In adolescents aged 13 and older, the same side effects have been reported with a similar frequency as in adults, except for drowsiness, uncontrolled trembling or jerking movements, restlessness, and fatigue, which have been reported very frequently (more than 1 in 10 patients), as well as upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle trembling, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which have been reported frequently (more than 1 in 100 patients).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Arypiprazol Glenmark

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. or on the blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Arypiprazol Glenmark contains

• The active substance of the medicine is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are: sodium carboxymethylcellulose (type A), microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, yellow iron oxide (E172).

What Arypiprazol Glenmark looks like and contents of the pack

Arypiprazol Glenmark, 15 mg, is a round, biconvex, yellow tablet with the inscription "ARZ" and the number "15" on one side. The tablets are packaged in perforated, divisible into single doses blisters in a cardboard box. Available pack sizes:14 or 28 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert Str. 23, 40764 Langenfeld, Germany

Manufacturer/Importer

Synthon Hispania SL, C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain, Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78 Prague 4, Czech Republic

To obtain more detailed information on the medicine, you should contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o., ul. Osmańska 14, 02-823 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Aripiprazol Glenmark 5 mg Tabletten, Aripiprazol Glenmark 10 mg Tabletten, Aripiprazol Glenmark 15 mg Tabletten, Aripiprazol Glenmark 20 mg Tabletten, Aripiprazol Glenmark 30 mg Tabletten, Poland: Arypiprazol Glenmark, Czech Republic: Aripiprazol Glenmark 10 mg tablets, Aripiprazol Glenmark 15 mg tablets, Aripiprazol Glenmark 20 mg tablets, Date of last revision of the leaflet:11/2022