2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets
Olanzapine
WHAT OLANZAPINE GLENMARK IS AND WHAT IT IS USED FOR
Olanzapine Glenmark contains the active substance olanzapine. Olanzapine Glenmark belongs to the group of 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 Glenmark prevents the recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
2. WHAT YOU NEED TO KNOW BEFORE TAKING OLANZAPINE GLENMARK
Do not take Olanzapine Glenmark
- if you are allergic (hypersensitive) to olanzapine 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 Glenmark.
- The use of Olanzapine Glenmark 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 been reported in patients taking Olanzapine Glenmark. 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 Glenmark. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Glenmark 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.
It is important that you 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
- seizures
- if 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 Glenmark is not for use in patients under 18 years of age.
Other medicines and Olanzapine Glenmark
Only take other medicines during Olanzapine Glenmark 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 stabilization), fluvoxamine (for depression) or ciprofloxacin ( antibiotics ) – it may be necessary to adjust your Olanzapine Glenmark dose .
Olanzapine Glenmark with alcohol
Do not drink alcohol during treatment with Olanzapine Glenmark, 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 or pharmacist for advice before taking this medicine. You should not take this medicine if you are breastfeeding, as small amounts of Olanzapine Glenmark may pass into breast milk.
In newborns whose mothers have taken Olanzapine Glenmark during the last trimester (the 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 contact your doctor.
Driving and using machines
There is a risk that you may feel drowsy when using Olanzapine Glenmark. If this happens, do not drive or use any tools or machines and consult your doctor.
Olanzapine Glenmark contains Aspartame
Olanzapine Glenmark tablets contain a source of phenylalanine. May be harmful in patients with phenylketonuria.
HOW TO TAKE OLANZAPINE GLENMARK
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 Glenmark 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 Glenmark once a day. Try to take Olanzapine Glenmark 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 Glenmark than you should
Patients who have taken too much Olanzapine Glenmark have the following symptoms: rapid heart rate, agitation/aggression, difficulty speaking, involuntary movement disorders (especially in the face or tongue), and loss of consciousness. Other symptoms may include shooting confusion, seizures ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness and 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 Glenmark
Take your tablets as soon as you remember. Do not take two doses on the same day.
If you stop taking Olanzapine Glenmark
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 Glenmark, 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 can affect up to 1 in 10 users) especially in the face or tongue
- blood clots in the veins (a less common side effect that can affect up to 1 in 100 people) 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
- somnolence
- 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 levels of blood cells , blood fats and at the beginning of treatment, temporarily increased number of liver enzymes
- increased blood sugar and urine levels
- elevated levels of uric acid and creatinine phosphokinase in the blood
- increased appetite
- dizziness
- restlessness
- tremors
- movement difficulties ( dyskinesia )
- constipation
- dry mouth
- rash
- impotence
- extreme fatigue
- fluid retention leading to swelling of the hands, ankles or feet
- fever, joint pain
- sexual problems such as decreased sexual 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
- stamming
- slow heartbeat
- sun sensitivity
- nosebleed
- stretched abdomen
- dreglande
- memory loss or forgetfulness
- urinary incontinence; difficulty urinating
- hair loss
- missed or shortened menstruation
- and breast changes in men and women such as abnormal production of breast milk or abnormal enlargement.
Rare side effects (may affect up to 1 in 1,000 people) include
- lowering of the normal body temperature
- abnormal heart rhythm
- sudden, unexplained death
- inflammation of the pancreas that led to severe stomach pain, fever and malaise
- liver disease that manifests itself 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 erection .
Very rare side effects (may affect up to 1 in 10,000 patients) include:
- Severe allergic reactions such as drug reaction 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 Glenmark may worsen the symptoms.
HOW TO STORE OLANZAPINE GLENMARK
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
The medicine 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 PACKAGING AND OTHER INFORMATION
Content declaration
Content declaration
– The active substance is olanzapine.
Each Olanzapine Glenmark tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg,
15 mg or 20 mg olanzapine.
The other ingredients are mannitol (E421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate.
What the medicine looks like and contents of the pack
Olanzapine Glenmark is marketed as:
Olanzapine Glenmark 2.5 mg:
Yellow, round tablets with a flat rounded edge marked with ‘A’ on one side.
Olanzapine Glenmark 5 mg:
Yellow, round tablets with a flat rounded edge marked with ‘B’ on one side.
Olanzapine Glenmark 7.5 mg:
Yellow, round tablets with a flat rounded edge marked with ‘C’ on one side.
Olanzapine Glenmark 10 mg:
Yellow, round tablets with a flat rounded edge marked with ‘OL’ on one side and ‘D’ on the other side.
Olanzapine Glenmark 15 mg:
Yellow, round tablets with a flat rounded edge marked with ‘OL’ on one side and ‘E’ on the other side.
Olanzapine Glenmark 20 mg:
Yellow, round tablets with a flat rounded edge marked with ‘OL’ on one side and ‘F’ on the other side.
Olanzapine Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg are available in aluminum blister packs of 28, 56, 70, and 98 tablets.
Olanzapine Glenmark 20 mg is available in aluminum blister packs of 28, 35, 56, 70, and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, D – 82194
Gröbenzell, Germany
Manufacturer
Glenmark Pharmaceuticals sro
City Tower, Hvězdova 1716 / 2b, 140 78 Prague 4
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green,
Hertfordshire, WD18 8YA,
UK