2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
olanzapine
What Olanzapine Mylan is and what it is used for
Olanzapine Mylan contains the active substance olanzapine. Olanzapine Mylan belongs to the group of drugs neuroleptics and is used to treat the following conditions:
- Schizophrenia, a disease with symptoms such as hearing, seeing or feeling something that does not exist, delusions, unusual suspicion and withdrawal. People with these conditions may also feel depressed, anxious or tense.
- Moderate to severe manic episodes, a condition with symptoms such as arousal and euphoria .
Olanzapine Mylan prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
What you need to know before you take Olanzapine Mylan
Do not take Olanzapine Mylan
- if you are allergic (hypersensitive) to olanzapine, peanuts or soy or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching , swollen face, swollen lips or difficulty breathing. If this happens, consult your doctor.
- if you have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).
Warnings and cautions
Talk to your doctor or pharmacist before taking Olanzapine Mylan.
- The use of Olanzapine Mylan in elderly patients with dementia is not recommended as it may cause serious side effects .
- Drugs of this type can cause abnormal movements of the face or tongue. Contact your doctor if this happens.
- This type of medicine can also cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness. These side effects are extremely rare, but if they do occur, contact your doctor immediately.
- Weight gain has occurred in patients taking Olanzapine Mylan. You and your doctor should check your weight regularly. Consider referral to a dietitian or help with a diet list if necessary.
- High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have been reported in patients taking Olanzapine Mylan. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Mylan and then at regular intervals during treatment.
- Tell your doctor if you or anyone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
You must tell your doctor if you suffer from any of the following diseases:
- stroke or mild form of stroke (temporary symptoms of stroke )
- Parkinson’s disease
- prostate problem
- intestinal upset (paralytic ileus )
- liver or kidney disease
- blood disease
- heart disease
- diabetes
- seizuresif you know you may be salt deficient due to prolonged severe diarrhea and vomiting or using diuretics ( diuretics )
For dementia patients, the doctor should be informed if the patient has had a stroke or a milder form of stroke.
If you are over 65, your blood pressure should be checked regularly by your doctor.
Children and young people
Olanzapine Mylan is not for use in patients under 18 years of age.
Other medicines and Olanzapine Mylan
Only take other medicines during Olanzapine Mylan treatment if your doctor advises you to do so. Along with the following medicines, drowsiness may occur medicines for depression and anxiety and sleeping pills (sedatives).
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- medicines for Parkinson’s disease
- carbamazepine (for epilepsy and mood stabilizers), fluvoxamine (for depression) or ciprofloxacin ( antibiotics ) – it may be necessary to adjust your dose of Olanzapine Mylan.
Olanzapine Mylan with alcohol
Do not drink alcohol during treatment with Olanzapine Mylan, as it may cause drowsiness with alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. You should not take this medicine if you are breastfeeding, as small amounts of Olanzapine Mylan may pass into breast milk.
In newborns whose mothers have taken olanzapine during the last trimester (last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, agitation, difficulty breathing, and difficulty eating. If your child gets any of these symptoms, you may need to consult a doctor.
Driving and using machines
There is a risk that you may feel drowsy when using Olanzapine Mylan. If this happens, do not drive or use any tools or machines and consult your doctor.
Olanzapine Mylan contains lactose and soy lecithin
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablet coating contains soy lecithin. If you are allergic to peanuts or soy, do not take these tablets.
How to take Olanzapine Mylan
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one and the duration of treatment is determined by your doctor. Dose one of Olanzapine Mylan is 5 – 20 mg per day. Contact your doctor if symptoms return but do not stop taking the medicine unless your doctor tells you to.
You should take Olanzapine Mylan once a day. Try to take Olanzapine Mylan at the same time each day either at mealtime or between meals. The tablets should be taken by mouth and swallowed whole with water.
If you take more Olanzapine Mylan than you should
Patients who have taken too much Olanzapine Mylan have the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, involuntary movement disorders (especially in the face or tongue), and loss of consciousness. Other symptoms may include acute confusion, seizures ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness, drowsiness or drowsiness, slow breathing, difficulty breathing, high or low blood pressure, abnormal heart rhythm. Contact your doctor or hospital immediately if you experience any of the listed symptoms. Take the remaining tablets with you.
If you forget to take Olanzapine Mylan
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Olanzapine Mylan
It is important that you follow your doctor’s instructions and do not stop taking the medicine because you feel better.
If you suddenly stop taking Olanzapine Mylan, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting. Your doctor may recommend that you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you get:
- involuntary movement disorders (a common side effect that may affect up to 1 in 10 people), especially in the face or tongue;
- blood clots in the veins (a less common side effect that can occur in up to 1 in 100 users), especially in the legs (symptoms are swelling, pain and redness on the legs). The blood clots can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
- a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or drowsiness (the frequency of this side effect can not be calculated from the available data).
Very common side effects (may affect more than 1 in 10 people): include weight gain, drowsiness, and increased levels of prolactin in the blood. At the beginning of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This often disappears by itself. If not, contact your doctor.
Common side effects (may affect up to 1 in 10 people): include changes in blood cell levels, blood fats and at the start of treatment, temporary increase in liver enzymes; increased blood sugar and urine levels; elevated levels of uric acid and creatinine phosphokinase in the blood; increased appetite, dizziness, restlessness, tremors, difficulty moving (dyskinesia); constipation, dry mouth, rash, weakness, extreme fatigue, fluid retention leading to swelling of the hands, ankles or feet, fever, joint pain and sexual problems such as decreased sex drive in men and women or erection problems in men.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (eg swelling of the mouth and throat, itching, rash); diabetes or exacerbation of diabetes, sometimes associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, generally with known susceptibility to seizures ( epilepsy ); muscle stiffness or spasms (including eye movements); ant crawls and feeling of restlessness in the legs at rest (restless legs); speech difficulties; stuttering, slow heartbeat, sun sensitivity, nosebleeds, distended abdomen, drooling, memory loss or forgetfulness, urinary incontinence, difficulty urinating, hair loss, missed or shortened menstruation and breast changes in men and women such as abnormal breast milk production or abnormal enlargement.
Rare side effects (may affect up to 1 in 1,000 people) include lowering of normal body temperature, abnormal heart rhythm, sudden, unexplained death, inflammation of the pancreas causing severe stomach pain, fever and malaise, liver disease manifesting in yellowing of the skin and whites of the eyes, muscle disease that manifests itself in unexplained aches and pains and prolonged and/or painful erections.
Very rare side effects include severe allergic reactions such as drug reactions with eosinophilia and systemic symptoms (DRESS). DRESS initially appears with flu-like symptoms with rash on the face and then by more widespread rash, fever, enlarged lymph nodes, elevated levels of liver enzymes seen in blood tests, and elevated levels of a type of white blood cell ( eosinophils ).
When taking olanzapine, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, increased body temperature, reddening of the skin, and difficulty walking. Some deaths have been reported in this specific patient group.
For patients with Parkinson’s disease, Olanzapine Mylan may worsen the symptoms.
How to store Olanzapine Mylan
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 carton or label after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Jars: Used within 90 days after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaged other information
Content declaration
- The active substance is olanzapine. Each tablet of Olanzapine Mylan contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is stated on your Olanzapine Mylan packaging.
- The other ingredients are (tablet core) lactose monohydrate (see section 2 ‘Olanzapine Mylan contains lactose’), maize starch, pregelatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E173in) (E173in), see section 2 (Olanzapine Mylan contains soy lecithin), xanthan gum (E415).
What the medicine looks like and contents of the pack
Olanzapine Mylan 2.5 mg are round, white film-coated tablets with bulging sides, labeled “OZ” over “2.5” on one side and “G” on the other.
Olanzapine Mylan 5 mg are round, white film-coated tablets with bulging sides, marked “OZ” with “5” on one side and “G” on the other side.
Olanzapine Mylan 7.5 mg are round, white film-coated tablets with bulging sides, labeled “OZ” over “7.5” on one side and “G” on the other.
Olanzapine Mylan 10 mg are round, white film-coated tablets with bulging sides, marked “OZ” with “10” on one side and “G” on the other side.
Olanzapine Mylan 15 mg are oval, white film-coated tablets with bulging sides, labeled “OZ” over “15” on one side and “G” on the other.
Olanzapine Mylan 20 mg are oval, white film-coated tablets with bulging sides, labeled “OZ” over “20” on one side and “G” on the other.
Blister:
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are supplied in packs of 10, 28, 30, 35, 56, 70 (2 x 35 multipacks) and 70 film-coated tablets.
Olanzapine Mylan 10 mg is supplied in packs of 7, 10, 28, 30, 35, 56, 70 (2 x 35) (multipack) and 70 film-coated tablets.
Perforated endosblister:
Olanzapine Mylan 2.5 mg, 15 mg, and 20 mg are supplied in packs of 28 x 1 film-coated tablets.
Olanzapine Mylan 5 mg and 10 mg are supplied in packs of 28 x 1 and 98 x 1 film-coated tablet.
Olanzapine Mylan 7.5 mg is supplied in packs of 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets.
Jars:
Olanzapine Mylan 2.5 mg and 5 mg are supplied in packs of 250 and 500 film-coated tablets.
Olanzapine Mylan 7.5 mg, 15 mg, and 20 mg are supplied in packs of 100 film-coated tablets.
Olanzapine Mylan 10 mg is supplied in packs of 100 and 500 film-coated tablets.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary.