Olanzapine Glenmark Europe
olanzapine
Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine Glenmark Europe 20 mg orodispersible tablets
Olanzapine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Olanzapine Glenmark Europe is and what it is used for
What you need to know before you take Olanzapine Glenmark Europe
How to take Olanzapine Glenmark Europe
Possible side effects
How to store Olanzapine Glenmark Europe
Contents of the pack and other information
Olanzapine Glenmark Europe contains the active substance olanzapine. Olanzapine Glenmark Europe belongs to a group of medicines called antipsychotics.
Olanzapine Glenmark Europe is used to treat the following conditions:
Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this
disease may also feel depressed, anxious or tense.
Moderate to severe manic episodes,a condition with symptoms of excitement or euphoria
Olanzapine Glenmark Europe has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
(listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.
if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Talk to your doctor or pharmacist before you take Olanzapine Glenmark Europe
The use of Olanzapine Glenmark Europe in elderly patients with dememtia is not recommended as it may have serious side effects.
Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Glenmark Europe, tell your doctor.
Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.
Weight gain has been seen in patients taking Olanzapine Glenmark Europe. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark Europe. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark Europe and regularly during
treatment.
Tell your doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Stroke or “mini” stroke (temporary symptoms of stroke)
Parkinson’s disease
Prostate problems
A blocked intestine (Paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures
If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Olanzapine Glenmark Europe is not for patients who are under 18 years.
Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe is taken in combination with
antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking:
Medicines for Parkinson’s disease
Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) – it may be necessary to change your Olanzapine Glenmark Europe dose.
Do not drink any alcohol if you have been given Olanzapine Glenmark Europe as together with alcohol it may make you feel drowsy.
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark Europe can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Glenmark Europe in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
There is a risk of feeling drowsy when you are given Olanzapine Glenmark Europe. If this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine Glenmark Europe contains a source of phenylalanine. This may be harmful for people with phenylketonuria.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many Olanzapine Glenmark Europe orodispersible tablets to take and how long you should continue to take them. The daily dose of Olanzapine Glenmark Europe is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark Europe unless your doctor tells you to.
You should take your Olanzapine Glenmark Europe orodispersible tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapine Glenmark Europe orodispersible tablets are for oral use. Put the tablet in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed. You can also place the tablet in a full glass or cup of water or other suitable beverage (orange juice, apple juice, milk or coffee) and stir. Drink it straightaway.
Patients who have taken more Olanzapine Glenmark Europe than they should, have
experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your
pack of tablets.
Take your tablets as soon as you remember. Do not take two doses in one day.
Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine Glenmark Europe for as long as your doctor tells you.
If you suddenly stop taking Olanzapine Glenmark Europe, symptoms such as sweating, unable to
sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you have:
unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the
face or tongue;
blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people)
especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;
a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
Weight gain
Sleepiness
Increases in the levels of prolactin in the blood.
In the early stages 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 will usually pass on its own but if it does not, tell your doctor.
Changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes.
Increases in the level of sugars in the blood and urine.
Increases in levels of uric acid and creatine phosphokinase in the blood
Feeling more hungry.
Dizziness.
Restlessness.
Tremor.
Unusual movements (dyskinesias).
Constipation.
Dry mouth.
Rash.
Loss of strength.
Extreme tiredness.
Water retention leading to swelling of the hands, ankles or feet.
Fever
Joint pain
Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma
seizures, usually associated with a history of seizures (epilepsy)
muscle stiffness or spasms (including eye movements)
Restless legs syndrome
problems with speech
stuttering,
Slow heart rate.
Sensitivity to sunlight.
Bleeding from the nose.
Abdominal distension
Drooling
Memory loss or forgetfulness
Urinary incontinence, lack of ability to urinate.
Hair loss.
Absence or decrease in menstrual periods.
Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Lowering of normal body temperature.
Abnormal rhythms of the heart.
Sudden unexplained death.
Inflammation of the pancreas causing severe stomach pain, fever and sickness.
Liver disease appearing as yellowing of the skin and white parts of the eyes.
Muscle disease presenting as unexplained aches and pains.
Prolonged and/or painful erection.
Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson’s disease Olanzapine Glenmark Europe may worsen the symptoms
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 via the nation a l reportin g sy stem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of sight and reach and of children
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is olanzapine
Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or 20 mg olanzapine
The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate
Olanzapine Glenmark Europe 5mg:
yellow coloured circular flat bevelled edge orodispersible tablets with ‘B’ debossed on one side. Olanzapine Glenmark Europe 10 mg:
yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘D’ debossed on other side.
Olanzapine Glenmark Europe 15 mg:
yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘E’ debossed on other side.
Olanzapine Glenmark Europe 20 mg:
yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘F’ debossed on other side.
Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg and 20 mg are available in aluminium foil blisters of 28, 56, and 70 orodispersible tablets
Not all pack sizes may be marketed.
Glenmark Arzneimittel GmbH Industriestr. 31, D – 82194 Gröbenzell, Germany
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park, Croxley Green,
Hertfordshire, WD18 8YA, United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Pharmaceuticals B.V.
Tél/Tel: + 31 629 62 4818 / +31 40 245 3611
Glenmark Arzneimittel GmbH Tel: + 49 (8142) 44392 0
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Viso Farmacéutica S.L.U Tél/Tel: + 34 911 593 944
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199
Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Glenmark Pharmaceuticals Europe Limited Tél/Tel: + 44 (0) 800 4580 383
http ://www.ema.europ a .e u