Aripiprazole Mylan Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Mylan Pharma 5 mg tablets EFG

Aripiprazole Mylan Pharma 10 mg tablets EFG

Aripiprazole Mylan Pharma 15 mg tablets EFG

Aripiprazole Mylan Pharma 30 mg tablets EFG

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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 Aripiprazol Mylan Pharma is and what it is used for

Aripiprazol Mylan Pharma 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 characterised by symptoms such as hearing, seeing, and feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazol Mylan Pharma is used to treat adults and adolescents aged 13 years and older who have a disorder characterised 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 Aripiprazol Mylan Pharma.

2. What you need to know before taking Aripiprazole Mylan Pharma

Do not take Aripiprazole Mylan Pharma

• 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 Aripiprazole Mylan Pharma

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 Mylan Pharma, 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 in the face;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke, 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, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you, 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 ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have some 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.

Other medicines and Aripiprazole Mylan Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Medicines that lower blood pressure: Aripiprazole Mylan Pharma 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 your blood pressure.

If you are taking Aripiprazole Mylan Pharma with any other medicine, it may mean that your doctor needs to change your dose of Aripiprazole Mylan Pharma or the dose of the other medicines. It is especially important that you 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 side effects or reduce the effect of Aripiprazole Mylan Pharma; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Mylan Pharma, 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 amitriptiline) 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 side effects; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Mylan Pharma, you must inform your doctor.

Taking Aripiprazole Mylan Pharma 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with Aripiprazole Mylan Pharma during the last trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

If you are taking Aripiprazole Mylan Pharma, your doctor will discuss with you whether you should breastfeed, considering the benefit to you of treatment and the benefit to your baby of breastfeeding. If you are being treated with Aripiprazole Mylan Pharma, 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 Mylan Pharma contains maltose

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

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Aripiprazole Mylan Pharma

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

This medicine should be initiated with the oral solution (liquid) at a low dose. The dose may gradually 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 Mylan Pharma is too strong or too weak, inform your doctor or pharmacist.

Try to take Aripiprazole Mylan Pharma 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 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 you have taken more Aripiprazole Mylan Pharma than your doctor has recommended (or if someone else has taken part of your 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 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 Mylan Pharma

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 Aripiprazole Mylan Pharma

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Mylan Pharma 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 adverse effects

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

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

• diabetes mellitus
• difficulty sleeping
• feeling of anxiety
• feeling of restlessness and inability to stay still, difficulty remaining seated
• akathisia (an uncomfortable sensation of inner restlessness and an overwhelming urge to keep moving)
• jerking, palpitations, or uncontrollable spasmodic movements
• tremors
• headache
• fatigue
• drowsiness
• dizziness
• tremor and blurred vision
• reduced frequency of bowel movements or difficulty defecating
• indigestion
• feeling of malaise
• increased saliva production
• vomiting
• feeling of tiredness

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

• increased or decreased levels of the hormone prolactin in blood
• excessively high blood sugar levels
• depression
• altered or increased sexual interest
• uncontrollable movements of the mouth, tongue, or limbs (tardive dyskinesia)
• muscle disorder causing twisting movements (dystonia)
• restless legs syndrome
• double vision
• ocular photosensitivity
• rapid heartbeat
• sudden drop in blood pressure upon standing, causing dizziness or fainting
• hiccups

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

• low white blood cell count
• low platelet count in blood
• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, and hives)
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma
• elevated blood sugar
• low sodium levels in blood
• loss of appetite (anorexia)
• weight loss
• suicidal thoughts, suicide attempt
• feeling of aggression
• agitation
• nervousness
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, 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 rigidity)
• speech disorder
• fixed eye position
• unexplained sudden death
• potentially life-threatening irregular heartbeat
• myocardial infarction
• slower heartbeat
• blood clots in the veins, especially 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 you notice any of these symptoms, seek immediate medical attention)
• high blood pressure
• fainting
• accidental inhalation of food with risk of pneumonia (lung infection)
• muscle spasms around the glottis
• inflammation of the pancreas
• difficulty swallowing
• diarrhea
• 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
• skin redness
• skin photosensitivity
• unusual hair loss or thinning
• 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 skin rash, followed later by generalized skin 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 if exposed during pregnancy
• prolonged and/or painful erection
• difficulty controlling core body temperature or overheating
• chest pain
• swollen hands, ankles, or feet
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin
• inability to resist the impulse, instinct, or temptation to perform an action that may 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 behavior concerning to you or others, for example, increased sexual appetite;
  • uncontrollable excessive shopping;
  • binge eating (eating 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 behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in frequency and type to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness—especially when standing up after lying down or sitting—which were common (more than 1 in 100 patients).

Reporting of adverse effects

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

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Aripiprazole Mylan Pharma

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

Aripiprazole Mylan Pharma appearance of the product and contents of the pack

Aripiprazole Mylan Pharma 5 mg tablets are blue, round, biconvex, 6.1 mm in diameter, engraved with "5" on one side.

Aripiprazole Mylan Pharma 10 mg tablets are pink, round, biconvex, 8.1 mm in diameter, engraved with "10" on one side.

Aripiprazole Mylan Pharma 15 mg tablets are yellow, round, biconvex, 10.1 mm in diameter, engraved with "15" on one side.

Aripiprazole Mylan Pharma 30 mg tablets are pink, oval, biconvex, 17.1 mm long and 8.1 mm wide, engraved with "30" on one side.

The tablets are supplied in perforated PA PVC-aluminum/aluminum/aluminum foil blisters packed in cardboard cartons containing 14, 28, 56, or 98 tablets, 28×1 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 more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}

Other sources of information

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