OLANZAPINA 5 mg Ородисперсная Таблетка

Содержание инструкции

1. Olanzapina Mylan Pharma 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets
   1. What Olanzapina Mylan Pharma is and what it is used for
   2. What you need to know before taking Olanzapina Mylan Pharma
   3. HOW TO TAKE OLANZAPINA MYLAN PHARMA
   4. Possible side effects
   5. How to store Olanzapina Mylan Pharma
   6. Further Information

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

Olanzapina

Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What Olanzapina Mylan Pharma is and what it is used for.
• 2. What you need to know 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 ingredient olanzapine and belongs to a group of medicines
called antipsychotics.
Olanzapina Mylan Pharma is used to treat schizophrenia, a disease with symptoms such as hearing,
seeing, feeling things that do not exist, having false ideas, unusual suspicions and social withdrawal. People with
this disease 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 “up”, having an excessive amount of energy, needing much less
sleep than usual, talking very quickly with rapidly changing ideas and sometimes severe
irritability. Olanzapine also acts as a mood stabilizer to prevent the further occurrence
of the disabling highs and lows (depression) of mood associated with this condition.

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

Do not take Olanzapina Mylan Pharma:

• if you are allergic to olanzapine or any of the other ingredients (listed in section 6). An allergic reaction can be recognised by skin rash, itching, swelling of the face, lips, tongue, throat, difficulty breathing or shortness of breath. If this has happened to you before, tell your doctor
• if you have 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 Olanzapina Mylan Pharma

• if you or someone in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots
• if you are an elderly person 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 your 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 problems with your liver or kidneys
• if you have Parkinson’s disease
• if you have a history of seizures or convulsions (epilepsy)
• if you have an enlarged prostate
• if you have a blockage of the intestine (paralytic ileus)
• if you have a low count of white blood cells in your blood (which can be caused by some medicines, radiotherapy, chemotherapy or a bone marrow disease)
• if you have been told you have increased levels of some white blood cells or a bone marrow disease in which an excessive level of blood cells is called myeloproliferative disease
• stroke or “mini” strokes (temporary symptoms of stroke)
• if you are a smoker (because a dosage adjustment of olanzapine may be necessary).

During treatment
If you notice a combination of very high fever, rapid breathing, excessive sweating, change
of mood, muscle stiffness, high blood pressure and dizziness or drowsiness, see your
doctor as your doctor may decide to stop Olanzapina Mylan Pharma.
If you notice uncontrolled movements of the face or tongue, see your doctor as your doctor
may consider reducing the dose or stopping Olanzapina Mylan Pharma.
Weight gain has been observed in patients taking olanzapine. You and your doctor must
regularly monitor your weight. If necessary, consider consulting a dietitian or help with
a diet.
High levels of sugars and fats (triglycerides and cholesterol) have been observed in patients who
were taking olanzapine. Your doctor may request blood tests to check the levels of
sugar and some fats in the blood before starting to take this medicine.
As a routine precaution, if you are over 65 years of age, your blood pressure should be checked by
your doctor.

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

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

• medicines for Parkinson’s Disease.
• antidepressants or medicines for anxiety or to help you sleep (tranquillisers) because you may feel sleepy
• carbamazepine (used as an anti-epileptic or mood stabiliser)
• fluvoxamine (an antidepressant)
• ciprofloxacin (an antibiotic)
• medicines that can alter your heart rhythm, such as antiarrhythmics (such as amiodarone, sotalol, quinidine, disopyramide), antibiotics (belonging to the macrolide group), tricyclic antidepressants
• activated charcoal (a chemical used to absorb other medicines), this should be taken at least 2 hours before or after taking olanzapine because it can interfere with the absorption of olanzapine.

Taking Olanzapina Mylan Pharma with alcohol
You should not drink alcohol if you have been prescribed Olanzapina Mylan Pharma, because taking the medicine with
alcohol can cause you to feel sleepy.

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

Driving and using machines
If you take Olanzapina Mylan Pharma there is a risk of drowsiness or dizziness. If this happens you should not
drive or use tools or machines. Tell your doctor.

Aspartame content
Olanzapina Mylan Pharma 5 mg orodispersible tablets contains 1.975 mg of aspartame per
tablet.
Olanzapina Mylan Pharma 10 mg orodispersible tablets contains 3.950 mg of aspartame per
tablet.
Olanzapina Mylan Pharma 15 mg orodispersible tablets contains 5.950 mg of aspartame per
tablet.
Olanzapina Mylan Pharma 20 mg orodispersible tablets contains 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 that causes a build-up of phenylalanine because the body cannot process it
correctly.

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

3. HOW TO TAKE OLANZAPINA MYLAN PHARMA

Always take Olanzapina Mylan Pharma exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
Your doctor will tell you how much Olanzapina Mylan Pharma orodispersible tablets you need to take and for
how long you need to continue taking it. The daily dose of Olanzapina Mylan Pharma is between 5 and
20 mg. Consult your doctor if your symptoms reappear, but do not stop taking Olanzapina Mylan
Pharma unless your doctor tells you to.
You should take Olanzapina Mylan Pharma orodispersible tablets once a day, following your
doctor’s instructions. Try to always take the tablets at the same time of day; it does not matter
whether you take them on a full or empty stomach. The orodispersible tablets of Olanzapina Mylan Pharma are for
oral use.
Olanzapina Mylan Pharma orodispersible tablets break easily, so you must handle them
with care. Do not handle the tablets with wet hands as they may break.

• 1. For perforated blisters, hold the blister by the edges and separate one pocket from the rest of the strip by gently pulling along the perforated line around the pocket.
• 2. Gently peel off the backing. For non-perforated blisters, be careful not to detach the backing of adjacent tablets.
• 3. Gently remove the tablet
• 4. Place the tablet in your mouth. It will dissolve directly in your mouth, so you can easily swallow it. It is also possible to dissolve the tablet in a glass of water, orange juice, apple juice, milk or coffee and stir. With some drinks, the mixture may change color and also become opaque. Drink immediately.

If you take more Olanzapina Mylan Pharmathan you should
Contact your doctor or go directly to the hospital. Show the doctors the packaging of the tablets.
Patients who have taken more Olanzapina Mylan Pharma than they should have presented the following signs:
increased heart rate, agitation/aggression, difficulty speaking, unusual movements
(especially of the face or tongue) and reduced level of consciousness. Other signs may be: confusion
acute, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity and
dizziness or drowsiness, slowed breathing, inhalation of liquids into the
trachea and lungs (aspiration), increased or decreased blood pressure, abnormal heart rhythm.

If you forget to take Olanzapina Mylan Pharma
Take the tablet as soon as you remember. Do not take a double dose to make up for
forgetting the dose.

If you stop taking Olanzapina Mylan Pharma
Do not stop taking Olanzapina Mylan Pharma just because you feel better. It is important
that you continue to take Olanzapina Mylan Pharma until your doctor tells you to.
If you suddenly stop taking Olanzapina Mylan Pharma, symptoms may appear
such as sweating, difficulty sleeping, agitation (tremor), anxiety or feeling unwell
(nausea) and feeling sick (vomiting). Your doctor may suggest that you gradually reduce the dose before
stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapina Mylan Pharma can cause side effects, although not everyone will experience them.

If you notice any of the following side effects, contact your doctor immediately:
Common (may affect up to 1 in 10 people):

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

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

• allergic reactions such as rash, itching, swelling of the face, lips, mouth or throat that can 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 can 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 the blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heartbeat, unusual muscle pain or feeling weak, tired or unwell) or coma.
• abnormal heart rhythm
• seizures (convulsions), usually associated with a history of seizures
• uncontrollable movements of the mouth, tongue, cheeks or jaw, which can spread to the 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 stools, itching, drowsiness or fatigue, fever, nausea, weakness and abdominal pain (these may be signs of liver problems)
• combination of very high fever, rapid breathing, excessive sweating, change in mood, muscle rigidity, 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, which spreads to the back
• lowering of the normal body temperature causing chills, cold or pale skin
• destruction of muscle fibers causing muscle pain, weakness or tenderness accompanied by dark urine (rhabdomyolysis)
• prolonged and/or painful erection

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

• flu-like symptoms with a rash initially on the face that then spreads, high temperature, swollen lymph nodes, increased levels of liver enzymes detected by blood tests and an increase in a type of white blood cells in the blood (eosinophilia). These may be signs of a 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 can be detected by 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 this is not the case, tell your doctor.

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

• increased levels of certain blood cells, circulating fats and at the beginning of treatment, a temporary increase in liver enzymes that can be detected by blood tests.
• increased levels of sugars in the blood and urine which can be detected by blood or urine tests.
• increases in levels of uric acid, alkaline phosphatase and creatine phosphokinase which can be detected by blood tests.
• feeling of increased appetite.
• dizziness.
• restlessness or difficulty staying still.
• tremor, rigid posture, slow movements and shuffling gait (parkinsonism).
• unusual movements (dyskinesia).
• constipation.
• dry mouth.
• skin rashes.
• Unusual weakness
• extreme fatigue.
• 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 people):

• uncontrollable muscle stiffness or spasms involving the head (including eye movements), neck and body
• restless legs syndrome
• problems with speech
• stammering
• slowed heart rate
• increased sensitivity of the skin to sunlight
• nosebleeds
• feeling of fullness (abdominal distension)
• loss of memory or forgetfulness
• inability to control urination, problems starting to urinate or maintaining the flow
• hair loss
• absence or decrease of menstrual periods
• changes in breast tissue in males and females
• abnormal production of breast milk in females
• increased levels of bilirubin in the blood which can be detected by blood tests.

Rare (may affect up to 1 in 1000 people):

• signs of withdrawal such as sweating, difficulty falling asleep, agitation, anxiety, feeling or being unwell
• bleeding or bruising that lasts longer than normal or unexpected (thrombocytopenia)

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

• signs of withdrawal in newborns such as skin discoloration, diarrhea, excessive feeding or crying, poor feeding, slowed growth, sneezing

During treatment with olanzapine, elderly patients with dementia may suffer from stroke,
pneumonia, inability to control urination, falls, extreme fatigue, visual hallucinations (seeing things
that do not exist), increased body temperature, skin flushing and problems with
walking. 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 do not exist).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through 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 packaging and blister.
Store in the original package to protect from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Further Information

What Olanzapina Mylan Pharma contains
Each orodispersible tablet contains 5 mg of olanzapine as the active ingredient.
Each orodispersible tablet contains 10 mg of olanzapine as the active ingredient.
Each orodispersible tablet contains 15 mg of olanzapine as the active ingredient.
Each orodispersible tablet contains 20 mg of olanzapine as the active ingredient
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 light yellow to yellow colored, completely mottled, round,
flat-faced tablets with bevelled edges, with "M" engraved on one side and "OE1"
on the other.
Olanzapina Mylan Pharma 10 mg is available as light yellow to yellow colored, completely mottled, round,
flat-faced tablets with bevelled edges, with "M" engraved on one side and "OE2"
on the other.
Olanzapina Mylan Pharma 15 mg is available as light yellow to yellow colored, completely mottled, round,
flat-faced tablets with bevelled edges, with "M" engraved on one side and "OE3"
on the other.
Olanzapina Mylan Pharma 20 mg is available as light yellow to yellow colored, completely mottled, round,
flat-faced tablets with bevelled edges, with "M" engraved 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 single-dose blisters containing (28, 35, 56, 70 and 98) x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
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 Member States of the European Economic Area with the
following denominations:
IT: OLANZAPINA MYLAN PHARMA 5mg, 10 mg, 15 mg, & 20 mg