Olanzapine Mylan Pharma

Package leaflet: Information for the user

Olanzapina Mylan Pharma 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine
Generic medicine
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 they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this package leaflet:

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

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

Olanzapina Mylan Pharma contains the active substance olanzapine and belongs to a group of medicines called antipsychotics.
Olanzapina Mylan Pharma is used to treat schizophrenia, a condition characterized by symptoms such as hearing, seeing, or sensing things that are not real, having false beliefs, unusual suspicions, and social withdrawal. People with this illness may also feel depressed, anxious, or tense.
Olanzapina Mylan Pharma is used to treat moderate to severe manic episodes, a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, speaking very rapidly with quickly changing thoughts, and sometimes severe irritability. Olanzapine also acts as a mood stabilizer to prevent the recurrence of debilitating mood swings (depression) associated with this condition.

2. What you should know before taking Olanzapine Mylan Pharma

Do not take Olanzapine Mylan Pharma:

• if you are allergic to olanzapine or to any of the other excipients (listed in section 6). An allergic reaction may present as skin rash, itching, swelling of the face, lips, tongue, throat, difficulty breathing or shortness of breath. If you have experienced this before, inform your doctor.
• if you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapine Mylan Pharma

• if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.
• if you are an elderly patient with dementia, as you may experience serious side effects.
• if you have diabetes.
• if you suffer from heart disease.
• if you have been told you have electrolyte imbalances in the blood (particularly low levels of potassium and magnesium).
• if you were born with a prolonged QT interval (seen on ECG, an electrical recording of the heart).
• if you have liver or kidney problems.
• if you have Parkinson's disease.
• if you have a history of epileptic seizures or convulsions (epilepsy).
• if you have an enlarged prostate.
• if you have intestinal blockage (paralytic ileus).
• if you have a low white blood cell count in the blood (which may be caused by certain medications, radiotherapy, chemotherapy, or a bone marrow disorder).
• if you have been told you have elevated levels of certain white blood cells or a bone marrow disorder in which excessive blood cell production occurs, called myeloproliferative disease.
• stroke or "mini" strokes (transient stroke symptoms).
• if you are a smoker (as dosage adjustment of olanzapine may be necessary).

During treatment
If you experience a combination of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and mental confusion or drowsiness, contact your doctor, as they may decide to discontinue Olanzapine Mylan Pharma.
If you notice uncontrolled movements of the face or tongue, contact your doctor, as they may consider reducing the dose or stopping Olanzapine Mylan Pharma.
Weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or managing your diet.
Elevated levels of sugar and fats (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor may request blood tests to monitor sugar and certain fat levels in your blood before starting this medicine.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents
Olanzapine Mylan Pharma is not recommended for patients under 18 years of age.

Other medicines and Olanzapine Mylan Pharma
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking any of the following:

• medicines for Parkinson's disease.
• antidepressants or medicines for anxiety or to help sleep (tranquilizers), as these may make you feel drowsy.
• carbamazepine (used as an antiepileptic or mood stabilizer).
• fluvoxamine (an antidepressant).
• ciprofloxacin (an antibiotic).
• medicines that may affect heart rhythm, such as antiarrhythmics (e.g., amiodarone, sotalol, quinidine, disopyramide), antibiotics belonging to the macrolide group, tricyclic antidepressants.
• activated charcoal (a chemical used to absorb other medicines), which should be taken at least 2 hours before or after olanzapine, as it may interfere with olanzapine absorption.

Taking Olanzapine Mylan Pharma with alcohol
You should not drink alcohol while taking Olanzapine Mylan Pharma, as combining the medicine with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You should not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.
The following symptoms may occur in newborns of mothers who used olanzapine during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.

Driving and using machines
Olanzapine Mylan Pharma may cause drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Content of aspartame
Olanzapine Mylan Pharma 5 mg orodispersible tablets contain 1.975 mg of aspartame per tablet.
Olanzapine Mylan Pharma 10 mg orodispersible tablets contain 3.950 mg of aspartame per tablet.
Olanzapine Mylan Pharma 15 mg orodispersible tablets contain 5.950 mg of aspartame per tablet.
Olanzapine Mylan Pharma 20 mg orodispersible tablets contain 7.900 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly metabolize it.

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

3. HOW TO TAKE OLANZAPINE MYLAN PHARMA

Always take OLANZAPINE MYLAN PHARMA exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how much OLANZAPINE MYLAN PHARMA orodispersible tablets to take and for
how long you should continue taking them. The daily dose of OLANZAPINE MYLAN PHARMA ranges from 5 to
20 mg. Consult your doctor if your symptoms return, but do not stop taking OLANZAPINE MYLAN PHARMA unless
your doctor tells you to do so.
You should take OLANZAPINE MYLAN PHARMA orodispersible tablets once daily, as advised by your doctor.
Try to take the tablets at the same time each day; it does not matter whether you take them with or without food.
OLANZAPINE MYLAN PHARMA orodispersible tablets are for oral use.
OLANZAPINE MYLAN PHARMA orodispersible tablets break easily, so handle them with care. Do not handle the tablets with wet hands, as they may break.

1. For perforated blisters, hold the blister at the edges and gently separate one blister cavity from the rest of the strip by pulling along the perforated line around the cavity.
2. Gently peel off the backing. For non-perforated blisters, take care not to detach the backing of adjacent tablets.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be easily swallowed. Alternatively, you may dissolve the tablet in a glass of water, orange juice, apple juice, milk, or coffee and stir. With some beverages, the mixture may change color and become cloudy. Drink immediately.

If you take more OLANZAPINE MYLAN PHARMA than you should
Contact your doctor or go to the hospital immediately. Show the doctors the medicine packaging.
Patients who have taken an overdose of OLANZAPINE MYLAN PHARMA have experienced the following symptoms:
increased heart rate, agitation/aggression, difficulty speaking, 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 stiffness, and mental dullness or drowsiness, slowed breathing, inhalation of fluids into the trachea and lungs (aspiration), increased or decreased blood pressure, and abnormal heart rhythm.
If you forget to take OLANZAPINE MYLAN PHARMA
Take the missed tablet as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking OLANZAPINE MYLAN PHARMA
Do not stop treatment with OLANZAPINE MYLAN PHARMA just because you feel better. It is important to continue taking OLANZAPINE MYLAN PHARMA for as long as your doctor instructs.
If you stop treatment with OLANZAPINE MYLAN PHARMA suddenly, you may experience symptoms such as sweating, difficulty sleeping, agitation (tremor), anxiety, or feelings of discomfort (nausea) and malaise (vomiting). Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapina Mylan Pharma can cause side effects, although not everybody gets them.
If you notice any of the following side effects, contact your doctor immediately:
Common (may affect up to 1 in 10 patients):

• an increase in infections causing sore throat, mouth ulcers or fever; these may be signs of a reduced number of white blood cells that help fight infection (leucopenia, neutropenia)

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

• allergic reactions such as rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing
• formation of blood clots in the veins, especially in the legs (signs include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing
• diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones in blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, breathing difficulties, slow heartbeat, unusual muscle pain or feeling of weakness, fatigue or discomfort) or coma
• abnormal heart rhythm
• epileptic seizures (fits), usually associated with a history of epileptic seizures
• uncontrolled movements of the mouth, tongue, cheeks or jaw, which may spread to arms and legs (tardive dyskinesia)
• difficulty urinating or emptying the bladder

Rare (may affect up to 1 in 1,000 people):

• yellowing of the whites of the eyes or skin, dark urine, pale-coloured bowel movements, itching, drowsiness or tiredness, fever, nausea, weakness and abdominal pain (these may be signs of liver problems)
• combination of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure and feeling numb or drowsy (neuroleptic malignant syndrome)
• unusual or dangerously fast heartbeat (ventricular tachycardia/fibrillation)
• inflammation of the pancreas causing severe stomach pain spreading to the back
• lowering of normal body temperature causing chills, cold or pale skin
• destruction of muscle fibres causing muscle pain, weakness or floppiness accompanied by dark urine (rhabdomyolysis)
• prolonged and/or painful erection

Not known (frequency cannot be estimated from the available data)

• flu-like symptoms with rash initially on the face spreading subsequently, high temperature, swollen lymph nodes, increased levels of liver enzymes found in blood tests and increase in a type of white blood cells in the blood (eosinophilia). These may be signs of drug reaction with eosinophilia and systemic symptoms (DRESS).

Other possible side effects include
Very common (may affect more than 1 in 10 people):

• weight gain
• drowsiness
• increased levels of prolactin which may be detected in blood tests
• in the early stages of treatment, some people may feel dizzy or faint (with reduced heart rate), especially when getting up from a lying or sitting position. These symptoms usually disappear on their own, but if they do not, inform your doctor.

Common (may affect up to 1 in 10 patients):

• increased levels of certain blood cells, circulating fats, and at the beginning of treatment, a temporary increase in liver enzymes which may be detected in blood tests
• increased levels of sugar in blood and urine which may be detected in blood or urine tests
• increases in levels of uric acid, alkaline phosphatase and creatine phosphokinase which may be detected in blood tests
• increased feeling of hunger
• dizziness
• restlessness or difficulty sitting still
• tremor, rigid posture, slow movements and shuffling gait (parkinsonism)
• unusual movements (dyskinesia)
• constipation
• dry mouth
• skin rashes
• unusual weakness
• extreme tiredness
• fluid retention leading to swelling of the hands, ankles or feet
• fever
• joint pain
• sexual dysfunction such as decreased libido in males and females or inability to maintain an erection in men

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

• uncontrollable muscle stiffness or spasms involving the head (including eye movements), neck and body
• restless legs syndrome
• speech problems
• stuttering
• reduced heart rate
• increased sensitivity of the skin to sunlight
• nosebleeds
• feeling of bloating (abdominal distension)
• memory loss or forgetfulness
• inability to control urine, problems starting to urinate or maintaining the flow
• hair loss
• absence or reduction of menstrual periods
• changes in the breasts of males and females
• abnormal production of breast milk in females
• increased levels of bilirubin in the blood which may be detected in blood tests

Rare (may affect up to 1 in 1,000 people):

• withdrawal symptoms such as sweating, difficulty sleeping, agitation, anxiety, feeling or state of malaise
• bleeding or bruising that lasts longer than usual or unexpected (thrombocytopenia)

Not known (frequency cannot be estimated from the available data):

• withdrawal symptoms in newborns such as skin colour changes, diarrhoea, excessive crying or feeding problems, poor feeding, growth retardation, sneezing

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, inability to control urination, falls, extreme tiredness, visual hallucinations (seeing things that are not there), increased body temperature, skin redness and walking difficulties. Some fatal cases have been reported in this particular group of patients.
Olanzapina Mylan Pharma may worsen symptoms in patients with Parkinson's disease and cause hallucinations (seeing, hearing or feeling things that are not there).
Reporting of side effects
If you experience any side effects, 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 at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapina Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use Olanzapina Mylan Pharma after the expiry date stated on the carton and blister.
Store in the original packaging to protect from light and 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. Other information

What Olanzapina Mylan Pharma contains
Each orodispersible tablet contains 5 mg of olanzapine as the active substance.
Each orodispersible tablet contains 10 mg of olanzapine as the active substance.
Each orodispersible tablet contains 15 mg of olanzapine as the active substance.
Each orodispersible tablet contains 20 mg of olanzapine as the active substance.
The other ingredients are: mannitol, microcrystalline cellulose, guar gum, crospovidone, magnesium stearate, anhydrous colloidal silica, aspartame (E951) (see section 2 "Olanzapina Mylan Pharma contains aspartame") and sodium lauryl sulfate.

Description of the appearance of Olanzapina Mylan Pharma and contents of the pack
Olanzapina Mylan Pharma 5 mg is available as tablets that are pale yellow to yellow in colour, completely mottled, round, flat-faced, with bevelled edges, engraved with "M" on one side and "OE1" on the other.
Olanzapina Mylan Pharma 10 mg is available as tablets that are pale yellow to yellow in colour, completely mottled, round, flat-faced, with bevelled edges, engraved with "M" on one side and "OE2" on the other.
Olanzapina Mylan Pharma 15 mg is available as tablets that are pale yellow to yellow in colour, completely mottled, round, flat-faced, with bevelled edges, engraved with "M" on one side and "OE3" on the other.
Olanzapina Mylan Pharma 20 mg is available as tablets that are pale yellow to yellow in colour, completely mottled, round, flat-faced, with bevelled edges, engraved with "M" on one side and "OE4" on the other.
Olanzapina Mylan Pharma orodispersible tablets are available in packs containing 28, 35, 56, 70 and 98 tablets and in perforated unit dose blisters containing (28, 35, 56, 70 and 98) x 1 tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900, Komárom, Mylan útca 1, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
IT: OLANZAPINA MYLAN PHARMA 5mg, 10 mg, 15 mg, & 20 mg