Aripiprazole Mylan Pharma 15 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aripiprazol Mylan Pharma 5 mg tablets EFG

Aripiprazol Mylan Pharma 10 mg tablets EFG

Aripiprazol Mylan Pharma 15 mg tablets EFG

Aripiprazol Mylan Pharma 30 mg tablets EFG

aripiprazole

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Aripiprazol Mylan Pharma is and what it is used for
2. What you need to know before taking Aripiprazol Mylan Pharma
3. How to take Aripiprazol Mylan Pharma
4. Possible adverse effects
5. How to store Aripiprazol 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 a disorder characterized by symptoms such as hearing, seeing, or feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People with 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 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 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 behaviour 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 (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, 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 a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Speak to your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental state, or a very fast 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 that you cannot 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 taken, 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 another 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 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 like 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), and social phobia, as well as 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 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 with or without food. Alcohol consumption should be avoided.

Pregnancy, breast-feeding and fertility

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

If you are taking Aripiprazole Mylan Pharma, your doctor will discuss with you whether you should breast-feed, considering the benefit of treatment for you and the benefit of breast-feeding for your baby. If you are being treated with Aripiprazole Mylan Pharma, you should not breast-feed. 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 told you that you have an intolerance to certain sugars, consult with him 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 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

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 think 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 your 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 prescribed (or if someone else has taken some of your Aripiprazole Mylan Pharma), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the container 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 decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness, slower 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 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 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 will experience them.

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

• diabetes mellitus
• difficulty sleeping
• feeling of anxiety
• 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 uncontrolled spastic movements
• tremors
• headache
• fatigue
• drowsiness
• dizziness
• tremor and blurred vision
• reduced frequency of bowel movements or difficulty defecating
• indigestion
• feeling of malaise
• increased production of saliva
• vomiting
• sensation of tiredness

Uncommon adverse 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
• disturbance or increased interest in sexual activity
• uncontrolled movements of the mouth, tongue, or limbs (tardive dyskinesia)
• muscular 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 levels of white blood cells
• low levels of platelets in the 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
• high blood sugar
• low levels of sodium in the blood
• loss of appetite (anorexia)
• weight loss
• suicidal thoughts, suicide attempt
• feeling of aggressiveness
• 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 stiffness)
• speech disorder
• fixation of the eyeballs in one position
• unexplained sudden death
• potentially life-threatening irregular heartbeat
• myocardial infarction
• slower heartbeat
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of 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)
• spasms of the muscles 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
• abnormal liver function test results
• skin redness
• cutaneous 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, and later progresses to generalized skin rash, high fever, enlarged 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 following exposure 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 yourself 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, e.g., increased sexual appetite;
  • 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 behaviors; 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 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, uncontrolled spasms or 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 movements of the limbs, 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 they are possible adverse effects not listed in this leaflet. You can 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging 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 tablet: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, indigo carmine (E132), and magnesium stearate.
• Other ingredients for the 10 mg and 30 mg tablets: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, iron oxide red (E172), and magnesium stearate.
• Other ingredients for the 15 mg tablet: 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 boxes containing 14, 28, 56, or 98 tablets, or 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 medicinal product, 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 website of the European Medicines Agency http://www.ema.europa.eu.