Package Leaflet: Information for the User

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

aripiprazol

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

2.What you need to know before you start taking Aripiprazol Mylan Pharma

3.How to take Aripiprazol Mylan Pharma

4.Possible side effects

5.Storage of Aripiprazol Mylan Pharma

6.Contents of the pack and additional information

Aripiprazol Mylan Pharma contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents of 15 years or more who suffer from a disease characterized by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioral behavior. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol Mylan Pharma is used to treat adults and adolescents of 13 years or more who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking very quickly with flight of ideas and sometimes, severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with Aripiprazol Mylan Pharma.

Do not take Aripiprazol Mylan Pharma

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Mylan Pharma

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Mylan Pharma, tell your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a history of addiction to gambling.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles 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 in you and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. Its safety and effectiveness in these patients are unknown.

Other medicines and Aripiprazol Mylan Pharma

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

Medicines that lower blood pressure: Aripiprazol Mylan Pharma may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are using any medicine to control blood pressure.

If you are taking Aripiprazol Mylan Pharma with any other medicine, it may mean that your doctor needs to change your dose of Aripiprazol Mylan Pharma or the dose of the other medicines. It is especially important to mention to your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based 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, for example, 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 adverse effects or reduce the effect of Aripiprazol Mylan Pharma; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Mylan Pharma, you should inform your doctor.

Medicines that increase serotonin levels are generally used to treat diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat diseases such as depression, generalized anxiety 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 antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive diseases;
• St. John's Wort (Hypericum perforatum) used in plant-based 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 adverse effects; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Mylan Pharma, you should inform your doctor.

Taking Aripiprazol 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies, from mothers who have been treated with Aripiprazol Mylan Pharma in the last three months of pregnancy (last three months of your pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

If you are taking Aripiprazol Mylan Pharma, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated with Aripiprazol Mylan Pharma, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Aripiprazol 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; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe lower and higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

This medication should be started with the oral solution (liquid) at a low dose. The dose can gradually be increased tothe recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

If you estimate that the action of Aripiprazol Mylan Pharma is too strong or too weak, inform your doctor or pharmacist.

Try to take Aripiprazol Mylan Pharma at the same time every day. It does not matter if you take it with or without food. Take the tablets with water and swallow them whole.

Even if you feel better, do not alter or interrupt the daily dose of Aripiprazol Mylan Pharma without consulting your doctor first.

If you take more Aripiprazol Mylan Pharma than you should

If you realize that you have taken more Aripiprazol Mylan Pharma than your doctor recommended (or if someone else has taken part of your Aripiprazol Mylan Pharma), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the packaging with you.

Patients who have taken too much aripiprazol have experienced the following symptoms:

•rapid heartbeats, agitation/aggressiveness, language 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, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you forgot to take Aripiprazol Mylan Pharma

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol Mylan Pharma

Do not stop treatment just because you feel better. It is essential that you continue taking Aripiprazol Mylan Pharma for the time your doctor has indicated.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• diabetes mellitus
• difficulty sleeping
• sensation of anxiety
• sensation of restlessness and inability to remain still, difficulty staying seated
• akathisia (an uncomfortable feeling of internal restlessness and an imperative need to move constantly)
• tremors, palpitations, or uncontrollable spasmodic movements
• shakiness
• headache
• fatigue
• drowsiness
• dizziness
• shakiness and blurred vision
• decreased bowel frequency or difficulty passing stools
• heaviness in the stomach
• sensation of discomfort
• excessive saliva production
• vomiting
• sensation of fatigue

Less frequent side effects(may affect up to 1 in 100 patients):

• increase or decrease in prolactin hormone levels in the blood
• excessively high blood sugar levels
• depression
• alteration or increase in sexual interest
• uncontrollable movements of the mouth, tongue, or limbs (tardive dyskinesia)
• muscle disorder causing twisting movements (dystonia)
• restless legs syndrome
• double vision
• photosensitivity of the eyes
• rapid heartbeat
• brusque drop in blood pressure upon standing, causing dizziness or fainting
• hypotension

The following side effects have been reported during the post-marketing phase of oral aripiprazole, but thefrequencyof occurrence isunknown:

• low white blood cell count
• low platelet count in the blood
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and urticaria)
• appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine), or coma
• high blood sugar levels
• insufficient sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• thoughts of suicide, attempted suicide
• sensation of aggression
• agitation
• nervousness
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome)
• seizures
• serotonin syndrome (a reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity)
• speech disorder
• fixation of the eyeballs in a position
• sudden and unexplained death
• potentially fatal irregular heartbeat
• myocardial infarction
• slower heart rate
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention)
• high blood pressure
• fainting
• accidental inhalation of food with a risk of pneumonia (lung infection)
• spasms of the muscles around the glottis
• pancreatitis
• difficulty swallowing
• diarrhea
• abdominal discomfort
• stomach discomfort
• liver failure
• inflammation of the liver
• yellowing of the skin and white part of the eyes
• abnormal liver analysis results
• skin redness
• cutaneous photosensitivity
• unusual hair loss or thinning
• excessive sweating
• severe allergic reactions, such as the drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as pseudogripal symptoms with facial rash, and later with generalized rash, high fever, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and increased eosinophil count
• abnormal muscle tears that can cause kidney problems
• muscle pain
• rigidity
• involuntary loss of urine (incontinence)
• difficulty urinating
• symptoms of withdrawal in newborns in case of exposure during pregnancy
• prolonged and/or painful erection
• difficulty controlling central body temperature or overheating
• chest pain
• swollen hands, ankles, or feet
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin A1c
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:
• • strong impulse to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and concerning behavior for yourself or others, for example, increased sexual appetite;
  • uncontrollable excessive buying;
  • binge eating (ingestion of large amounts of food in a short period) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger);
  • tendency to wander.

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been reported a higher number of fatal cases while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experienced side effects similar in frequency and type to those of adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very frequent (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 getting up after lying down or sitting, which were frequent (more than 1 in 100 patients).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Aripiprazol Mylan Pharma

• The active ingredient is aripiprazol. Each 5, 10, 15, 30 mg tablet contains 5, 10, 15, 30 mg of aripiprazol respectively.
• The other components for 5 mg are crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, indigo carmine (E132) and magnesium stearate.
• The other components for 10, 30 mg are crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, red iron oxide (E172) and magnesium stearate.
• The other components for 15 mg are crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, yellow iron oxide (E172) and magnesium stearate.

Aripiprazol Mylan Pharma appearance of the product and contents of the package

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

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

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

Aripiprazol Mylan Pharma 30 mg tablets are pink, oval, biconvex, 17.1 mm in length, 8.1 mm in width, engraved with “30” on one side.

They are supplied in aluminized aluminum/PVC-aluminized perforated blister packs PA in cartons containing 14, 28, 56 or 98, 28×1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Responsible Person

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/AAAA}

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.