Aripiprazole Mylan Pharma

Package leaflet: Information for the user

Aripiprazole Mylan Pharma 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets

aripiprazole
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

What this leaflet contains

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

1. What Aripiprazolo Mylan Pharma is and what it is used for

Aripiprazolo Mylan Pharma contains the active substance aripiprazole and belongs to a group of
medicines called antipsychotics.
It is used to treat adults and adolescents from the age of 15 who are affected by a disorder characterized by symptoms such as hearing, seeing, or perceiving things that are not present, suspiciousness, false beliefs, disorganized speech and behavior, and blunted emotions. People with this condition may also feel depressed, guilty, anxious, or tense.
Aripiprazolo Mylan Pharma is also used to treat adults and adolescents from the age of 13 affected by a condition characterized by symptoms such as feeling "overly excited", having excessive energy, needing much less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents the recurrence of this condition in adults who have responded to treatment with Aripiprazolo Mylan Pharma.

2. What you should know before taking Aripiprazole Mylan Pharma

Do not take Aripiprazole Mylan Pharma

• 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 taking Aripiprazole Mylan Pharma.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your
doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Mylan Pharma, inform your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• epilepsy (seizures), as your doctor may decide to monitor you more closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke, or transient ischaemic attack (TIA), or blood pressure abnormalities;
• history of blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of excessive gambling.

If you notice weight gain, develop unusual movements, experience drowsiness interfering with normal daily activities, have difficulty swallowing, or develop allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform the doctor if you have ever had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviour have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness accompanied by high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others.
These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, binge eating, excessive spending, abnormally increased sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. You should be especially cautious if you are elderly or debilitated.

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.

Other medicines and Aripiprazole Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Medicines that lower blood pressure: Aripiprazole Mylan Pharma may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Taking Aripiprazole Mylan Pharma together with certain medicines may require your doctor to adjust the dose of Aripiprazole Mylan Pharma or of the other medicines. It is particularly important to inform your doctor about the following medicines:

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

These medicines may increase the risk of side effects or reduce the effectiveness of Aripiprazole Mylan Pharma; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Mylan Pharma.
Medicines that increase serotonin levels are typically used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan, used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine and fluoxetine), used for depression, OCD, panic, and anxiety;
• other antidepressants (e.g., venlafaxine and tryptophan), used in major depressive disorder;
• tricyclics (e.g., clomipramine and amitriptyline), used for depressive illness;
• St. John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression;
• painkillers (e.g., tramadol and meperidine), used to relieve pain;
• triptans (e.g., sumatriptan and zolmitriptan), used to treat migraine.

These medicines may increase the risk of side effects; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Mylan Pharma.

Aripiprazole Mylan Pharma with food, drinks, and alcohol
This medicine may be taken regardless of food intake.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers used Aripiprazole Mylan Pharma tablets during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Mylan Pharma, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other.
If you are taking this medicine, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.

Aripiprazole Mylan Pharma contains maltose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Sodium content
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Aripiprazole Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may
prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be started at a low dose using the oral solution (liquid).
The dose may be gradually increased up to the recommended dose for adolescents of 10 mg
once daily. However, your doctor may prescribe a lower or higher dose, up to a
maximum of 30 mg once daily.
If you feel that the effect of Aripiprazole Mylan Pharma is too strong or too weak, consult your
doctor or pharmacist.
Try to take Aripiprazole Mylan Pharma at the same time every day. It does not matter whether you take it
with or without food. Always take the tablet with water, swallowing it whole.
Even if you feel better, do not change or stop the daily dose of Aripiprazole Mylan Pharma
without first consulting your doctor.
If you take more Aripiprazole Mylan Pharma than you should
If you realize that you have taken more Aripiprazole Mylan Pharma than your doctor has
recommended (or if someone else has taken Aripiprazole Mylan Pharma), 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 an overdose of aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness or sleepiness, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole Mylan Pharma
If you forget a dose, take it as soon as you remember, but do not take two doses on the same
day.
If you stop taking Aripiprazole Mylan Pharma
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazole Mylan Pharma for the full duration prescribed by your doctor.
If you have any questions about how to use this medicine, consult 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 mellitus
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty staying still,
• akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
• uncontrollable contractions, jerking movements or twisting,
• tremor,
• headache,
• tiredness,
• drowsiness,
• feeling lightheaded,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• feeling unwell,
• increased saliva production compared to usual,
• vomiting,
• feeling of fatigue.

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

• increase or decrease in blood levels of the hormone prolactin,
• excessively high blood sugar levels,
• depression,
• change or increase in sexual interest,
• uncontrollable movements of the mouth, tongue and lips (tardive dyskinesia),
• muscular disorders causing twisting movements (dystonia),
• restlessness in the legs,
• double vision,
• light sensitivity in the eyes,
• fast heartbeat,
• drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting,
• hiccups.

The following side effects have been reported since the start of marketing of oral aripiprazole, but the frequency with which they occurred is not known:

• low levels of white blood cells in the blood,
• low levels of platelets in the blood,
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low level of sodium in the blood,
• high blood sugar levels,
• insufficient level of sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• sudden unexplained death,
• potentially life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat,
• blood clots (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 breathing difficulties (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of muscles around the vocal cords,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• cases of abnormal liver function test results,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a skin rash on the face which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and increase in a type of white blood cells (eosinophilia),
• abnormal muscle breakdown which may cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty in controlling internal body temperature or conditions of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased glycated haemoglobin.
• inability to resist the impulse, urge or temptation to carry out an action that could be harmful to you or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual drive,
  • excessive and uncontrollable shopping,
  • uncontrolled 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 off. 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, more deaths have been reported during treatment with aripiprazole.
In addition, cases of stroke or transient ischaemic attack have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and older have experienced side effects similar in frequency and type to those in adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and tiredness, which were very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable limb movements and dizziness, especially when rising from a lying or sitting position, which were common (more than 1 in 100 patients).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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. How to store Aripiprazole Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer carton after "Exp." or "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aripiprazole Mylan Pharma contains

• The active substance is aripiprazole. Each 5, 10, 15, 30 mg tablet contains 5, 10, 15, 30 mg of aripiprazole, respectively.
• The other components of the 5 mg tablets are: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, Indigotin (E132), and magnesium stearate.
• The other components of the 10 mg and 30 mg tablets are: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, iron oxide red (E172), and magnesium stearate.
• The other components of the 15 mg tablets are: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, iron oxide yellow (E172), and magnesium stearate.

Description of the appearance of Aripiprazole Mylan Pharma and contents of the pack
Aripiprazole Mylan Pharma 5 mg tablets are blue to light blue, mottled, round, biconvex tablets, 6.1 mm in diameter, with "5" engraved on one side.
Aripiprazole Mylan Pharma 10 mg tablets are pink, round, biconvex tablets, 8.1 mm in diameter, with "10" engraved on one side.
Aripiprazole Mylan Pharma 15 mg tablets are yellow, round, biconvex tablets, 10.1 mm in diameter, with "15" engraved on one side.
Aripiprazole Mylan Pharma 30 mg tablets are pink, round, biconvex tablets, 17.1 mm in length and 8.1 mm in width, with "30" engraved on one side.
Aripiprazole Mylan Pharma 5 mg, 10 mg, 15 mg and 30 mg tablets are available in blisters packed in cartons containing 14, 28, 56 or 98 tablets and 28 x 1 tablets (unit dose).
Aripiprazole Mylan Pharma 5 mg, 10 mg and 15 mg tablets are also available in bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Pharmathen International S.A.,
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi 69300,
Greece
or
Pharmathen S.A.,
6, Dervenakion,
Pallini 15351,
Attiki,
Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: 358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

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