Aripiprazole glenmark

Package leaflet: Information for the user

Arypiprazol Glenmark, 15 mg, tablets
Aripiprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Arypiprazol Glenmark is and what it is 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 years and older with a disorder whose symptoms include seeing, hearing or experiencing things that do not exist in reality, suspiciousness, beliefs that are not based in reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also feel sadness, guilt, anxiety or tension.

Arypiprazol Glenmark is also used to treat adults and adolescents aged 13 years and older with a disorder whose symptoms include intense excitement, increased energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also helps prevent recurrence of these symptoms in patients who responded to treatment with Arypiprazol Glenmark.

2. Important information before using Arypiprazol Glenmark

When not to use Arypiprazol Glenmark:

• if the patient is 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, discuss this with the doctor.
During treatment with aripiprazole, suicidal thoughts and behaviours have been reported.
The patient should immediately inform the doctor if experiencing thoughts or feelings related to harming oneself.

Before starting treatment with Arypiprazol Glenmark, inform the doctor if the patient has:

• high blood sugar levels (typical symptoms include excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (epilepsy), as close monitoring by the doctor may be necessary;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and circulation disorders), a family history of cardiovascular disease, stroke, or "mini" stroke (transient ischaemic attack), or abnormal blood pressure;
• a history of blood clots or a family history of blood clots, as antipsychotic medicines may increase the risk of clot formation;
• a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily activities, any swallowing difficulties, or allergic symptoms, they should inform the doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, caregiver, or relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Immediately inform the doctor if the patient develops thoughts or urges related to self-harm. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform the doctor if the patient develops muscle stiffness or muscle stiffness accompanied by high fever, excessive sweating, altered mental status, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel an urge or desire to behave in an unusual way and is unable to resist impulses, urges, or temptations to engage in activities that could harm themselves or others, this should be reported to the doctor.
These phenomena are known as impulse control disorders and may manifest as compulsive gambling, binge eating, compulsive spending, increased sex drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider adjusting the dose or discontinuing the medicine.
Arypiprazol may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which may lead to falls.
Caution is advised, 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 medicine is safe and effective in these patients.

Arypiprazol Glenmark and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

Medicines that lower blood pressure: Arypiprazol Glenmark may enhance the effect of blood pressure-lowering medicines. If the patient is taking such medicines, they should inform the doctor.
When Arypiprazol Glenmark is used with other medicines, the doctor may need to adjust the dose of Arypiprazol Glenmark or other medicines the patient is taking. It is especially important to inform the doctor about the use of:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressants 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 effectiveness of Arypiprazol Glenmark. If the patient experiences any unusual symptoms while taking these medicines together with Arypiprazol Glenmark, they should inform the doctor.

Medicines that increase serotonin levels, usually used in conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, tryptophan, used in the treatment of conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), used in the treatment of depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan), used in the treatment of severe depression;
• tricyclic antidepressants (such as clomipramine, amitriptyline), used in the treatment of 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 the patient experiences any unusual symptoms while taking any of these medicines together with Arypiprazol Glenmark, they should inform the doctor.

Arypiprazol Glenmark with food, drink, and alcohol
This medicine can be taken regardless of meals.
Do not drink alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult the doctor before using this medicine.
Newborns whose mothers have taken Arypiprazol Glenmark during the third trimester of pregnancy (last 3 months) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms occur in the newborn, contact the doctor.
If the patient is taking Arypiprazol Glenmark, the doctor will discuss whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. Do not take this medicine and breastfeed at the same time. Discuss the best feeding options with the doctor if the patient is taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account when performing tasks requiring full attention, such as driving or operating machinery.

Arypiprazol Glenmark contains lactose
If the doctor has informed the patient that they have an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Arypiprazol Glenmark

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, which must not exceed 30 mg once daily.
To achieve a dose of 5 mg or 10 mg, another arypiprazole-containing medicine available on the market should be used, after consulting with a doctor.
Use in children and adolescents
Treatment with this medicine may be initiated with a low dose of arypiprazole in the form of an oral solution (liquid formulation). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the treating doctor may prescribe a lower or higher dose, which must not exceed 30 mg once daily.
If the patient feels that the effect of this medicine is too strong or too weak, the doctor or pharmacist should be informed.
Arypiprazol Glenmark should be taken every day at the same time. The medicine may be taken with food or between meals. The tablet should be swallowed whole with water.
Even if the patient feels an improvement in their condition, the dose must not be changed or treatment discontinued without prior consultation with the doctor.
Taking more Arypiprazol Glenmark than prescribed
If a dose of Arypiprazol Glenmark higher than that prescribed by the doctor has been taken (or if someone else has taken a quantity of Arypiprazol Glenmark not intended for them), contact a doctor immediately. If contact with a doctor is not possible, go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken an excessive dose of arypiprazole, the following symptoms have occurred:

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

Other symptoms include:

• acute confusion, seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, excessive sweating;
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm.

If any of the above symptoms occur, contact a doctor or hospital immediately.
Missing a dose of Arypiprazol Glenmark
If a dose is missed, the patient should take the missed dose as soon as they remember. Do not take two doses on the same day.
Stopping treatment with Arypiprazol Glenmark
Do not stop treatment even if the patient feels better. It is very important to take Arypiprazol Glenmark exactly as directed by the doctor and for the duration prescribed by the doctor.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in less than 1 in 10 patients):

• diabetes,
• sleep disturbances,
• anxiety,
• motor restlessness and difficulty sitting still,
• akathisia (a feeling of inner restlessness and a compulsion to keep moving),
• uncontrollable trembling, jerking movements, or writhing movements,
• tremor,
• headache,
• fatigue,
• somnolence (drowsiness),
• feeling of "emptiness in the head",
• blurred vision or fluctuating vision,
• reduced number of bowel movements or difficulty defecating (constipation),
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• increased or decreased blood levels of the hormone prolactin,
• high blood sugar levels,
• depression,
• altered or increased interest in sexual activity,
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• light sensitivity (photophobia),
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, feeling of "emptiness in the head", or fainting,
• hiccups.

The following adverse reactions have been reported after arypiprazole oral formulation was introduced to the market, but their frequency is unknown:

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, skin itching, rash),
• onset of diabetes or worsening of its symptoms, ketoacidosis (presence of ketone bodies in blood and urine) or diabetic coma,
• high blood sugar levels,
• low blood sodium levels,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts, and suicides,
• feelings of aggression,
• agitation,
• nervousness,
• concurrent occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, sudden changes in blood pressure, changes in heart rate, and fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a condition that may cause extreme euphoria, drowsiness, lack of coordination, motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• oculogyria (fixed eye deviation),
• sudden unexplained death,
• life-threatening irregular heartbeat,
• myocardial infarction (heart attack),
• slow heartbeat, blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must seek immediate medical attention),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of pneumonia,
• laryngospasm (spasm of muscles around the vocal cords),
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver function disorders,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function test results,
• skin rash,
• photosensitivity (increased skin sensitivity to light),
• alopecia (hair loss),
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially resembles flu-like symptoms with a facial rash, followed by a rash spreading to other body parts, high fever, swollen lymph nodes, elevated liver enzymes (visible in blood tests), and increased levels of a specific type of white blood cells (eosinophilia),
• abnormal muscle breakdown leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty urinating,
• withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• prolonged and/or painful erection (priapism),
• disturbances in regulation of core body temperature or overheating,
• chest pain,
• swelling of hands, ankles, or feet,
• in blood tests: increased or fluctuating blood glucose levels, increased glycated hemoglobin levels,
• inability to resist an impulse, drive, or temptation to engage in behavior that may harm the patient or others, including behaviors such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased interest in sexual activity and behaviors significantly distressing to the patient or others, e.g. increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
  • urge to wander (pica-like behavior). If such behaviors occur, patients should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with arypiprazole, deaths have been reported more frequently. Additionally, strokes or "mini-strokes" (transient ischemic attacks) have been reported.

Additional adverse reactions in children and adolescents

In adolescents aged 13 years and older, the same adverse reactions have been reported at similar frequencies as in adults, except for somnolence, involuntary tremors or trembling during movement, motor restlessness, and fatigue, which occurred very commonly (in more than 1 in 10 patients), and upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle tremor, involuntary limb movements, and dizziness—particularly when standing up from a lying or sitting position—which occurred commonly (in more than 1 in 100 patients).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Arypiprazol Glenmark

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry
(Exp) or on the blister after the abbreviation: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Arypiprazol Glenmark contains

• The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are: sodium carboxymethyl starch (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 are round, biconvex, yellow tablets marked with "ARZ" and the number "15" on one side. The tablets are packed in perforated, unit-dose blisters within a cardboard carton.
Pack sizes available: 14 or 28 tablets
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Osmańska 14
02-823 Warsaw
Poland
This medicinal product is authorised for marketing 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 tablety
Aripiprazol Glenmark 15 mg tablety
Aripiprazol Glenmark 20 mg tablety