Olanzapine Glenmark
Italy
Table of Contents
- Patient Information Leaflet: Information for the User
- Olanzapina Glenmark 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
- 1. What Olanzapina Glenmark is and what it is used for
- 2. What you need to know before taking Olanzapine Glenmark
- 3. How to take Olanzapine Glenmark
- 4. Possible side effects
- 5. How to store Olanzapine Glenmark
- 6. Package contents and other information
Patient Information Leaflet: Information for the User
Olanzapina Glenmark 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
olanzapine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
1 What Olanzapina Glenmark is and what it is used for
2 What you need to know before taking Olanzapina Glenmark
3 How to take Olanzapina Glenmark
4 Possible side effects
5 How to store Olanzapina Glenmark
6 Contents of the pack and other information
1. What Olanzapina Glenmark is and what it is used for
Olanzapina Glenmark contains the active substance olanzapine. Olanzapina Glenmark belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
- schizophrenia, a disorder with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
- moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria.
Olanzapina Glenmark has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapine.
2. What you need to know before taking Olanzapine Glenmark
Do not take Olanzapine Glenmark
- if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, swelling of the face, swelling of the lips, or shortness of breath. If you have experienced any of these, inform your doctor.
- if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).
Warnings and precautions
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.
- Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after you have been given Olanzapine Glenmark, inform your doctor.
- Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately.
- Weight gain has been observed in patients taking Olanzapine Glenmark. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or adopting a dietary management program.
- High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Glenmark. Your doctor should perform blood tests to monitor sugar levels and certain blood fat levels before you start taking Olanzapine Glenmark and regularly during treatment.
- Inform your doctor if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
If you have any of the following conditions, inform your doctor as soon as possible:
- Stroke or transient ischemic attack (TIA) (temporary stroke-like symptoms)
- Parkinson’s disease
- Prostate problems
- Intestinal blockage (paralytic ileus)
- Liver or kidney disease
- Blood disorders
- Heart disease
- Diabetes
- Seizures
- If you know you may experience excessive loss of salt due to severe and prolonged diarrhea and vomiting (due to illness) or due to the use of diuretics (water tablets)
If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Olanzapine Glenmark is not indicated for patients under 18 years of age.
Other medicines and Olanzapine Glenmark
During treatment with Olanzapine Glenmark, take other medicines only after obtaining approval from your doctor. You may feel drowsy if Olanzapine Glenmark is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:
- medicines for Parkinson’s disease.
- carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Olanzapine Glenmark may need to be adjusted.
Olanzapine Glenmark and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Glenmark, as taking Olanzapine Glenmark together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of Olanzapine Glenmark may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapine Glenmark during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Driving and using machines
When taking Olanzapine Glenmark, you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapine Glenmark contains aspartame
Olanzapine Glenmark contains aspartame, which is a source of phenylalanine. This may be harmful to people with phenylketonuria.
3. How to take Olanzapine Glenmark
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Glenmark tablets to take and for how long you should continue taking them. The daily dose of Olanzapine Glenmark ranges from 5 mg to 20 mg.
If your symptoms return, discuss this with your doctor, but do not stop taking Olanzapine Glenmark unless your doctor tells you to do so.
You should take Olanzapine Glenmark tablets once daily, as directed 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 Glenmark coated tablets are for oral use. Swallow the Olanzapine Glenmark tablets whole with water.
If you take more Olanzapine Glenmark than you should
Patients who have taken more Olanzapine Glenmark than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and reduced level of consciousness.
Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or somnolence, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or go to hospital immediately if any of these symptoms occur. Show your doctor the package of tablets.
If you forget to take Olanzapine Glenmark
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking Olanzapine Glenmark
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapine Glenmark for as long as your doctor considers necessary.
If you suddenly stop taking Olanzapine Glenmark, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and 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, this medicine can cause side effects, although not everyone experiences them.
Immediately inform your doctor if you experience:
- unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
- blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If you experience any of these symptoms, seek medical advice immediately;
- a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect cannot be estimated from the available data).
Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; increased levels of prolactin in the blood. In the initial stages of treatment, some people may experience dizziness or fainting (with a slowed heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the initial stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; 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; and sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in the blood and urine) or coma; epileptic seizures, usually occurring in individuals with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome). DRESS initially presents with flu-like symptoms, a facial rash that later becomes widespread, high body temperature, swollen lymph nodes, increased liver enzyme levels observed in blood tests, and an increase in a type of white blood cells (eosinophilia).
In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, elevated body temperature, skin redness, and gait disturbances may occur. Fatal cases have been reported in this specific patient group.
In patients with Parkinson's disease, Olanzapine Glenmark may worsen symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Olanzapine Glenmark
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word Exp. The expiry date refers to the last day of the month indicated.
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Olanzapina Glenmark contains
- The active substance is olanzapine.
- Each Olanzapina Glenmark tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
- The excipients are: mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate.
Description of the appearance of Olanzapina Glenmark and contents of the pack
Olanzapina Glenmark 2.5 mg is available as:
Yellow, round tablets with bevelled edges, marked with the letter “A” on one side.
Olanzapina Glenmark 5 mg:
Yellow, round tablets with bevelled edges, marked with the letter “B” on one side.
Olanzapina Glenmark 7.5 mg:
Yellow, round tablets with bevelled edges, marked with the letter “C” on one side.
Olanzapina Glenmark 10 mg:
Yellow, round tablets with bevelled edges, marked with “OL” on one side and the letter “D” on the other side.
Olanzapina Glenmark 15 mg:
Yellow, round tablets with bevelled edges, marked with “OL” on one side and the letter “E” on the other side.
Olanzapina Glenmark 20 mg:
Yellow, round tablets with bevelled edges, marked with “OL” on one side and the letter “F” on the other side.
Olanzapina Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg is available in aluminum blisters containing 28, 56, 70, and 98 tablets.
Olanzapina Glenmark 20 mg is available in aluminum blisters containing 28, 35, 56, 70, and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, D – 82194,
Gröbenzell, Germany
Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Praha 4,
Czech Republic
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
България Luxembourg/Luxemburg
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
Česká republika Magyarország
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
Danmark Malta
Glenmark Pharmaceuticals Nordic AB Glenmark Arzneimittel GmbH, Germany
Tel: +46 (0)40 35 48 10 Tel: +49 (8142) 44392 0
Deutschland Nederland
Glenmark Arzneimittel GmbH Glenmark Pharmaceuticals B.V.
Tel: +49 (8142) 44392 0 Tel: +31 800 33 555 33
Eesti Norge
Glenmark Arzneimittel GmbH, Germany Glenmark Pharmaceuticals Nordic AB
Tel: +49 (8142) 44392 0 Tel: +46 (0)40 35 48 10
Ελλάδα Österreich
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
España Polska
Viso Farmacéutica S.L.U Glenmark Arzneimittel GmbH, Germany
Tel: +34 911 593 944 Tel: +49 (8142) 44392 0
France Portugal
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
Hrvatska România
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
Ireland Slovenija
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
Ísland Slovenská republika
Glenmark Pharmaceuticals Nordic AB Glenmark Arzneimittel GmbH, Germany
Tel: +46 (0)40 35 48 10 Tel: +49 (8142) 44392 0
Italia Suomi/Finland
Glenmark Arzneimittel GmbH, Germany Glenmark Pharmaceuticals Nordic AB
Tel: +49 (8142) 44392 0 Tel: +46 (0)40 35 48 10
Κύπρος Sverige
Glenmark Arzneimittel GmbH, Germany Glenmark Pharmaceuticals Nordic AB
Tel: +49 (8142) 44392 0 Tel: +46 (0)40 35 48 10
Latvija United Kingdom (Northern Ireland)
Glenmark Arzneimittel GmbH, Germany Glenmark Arzneimittel GmbH, Germany
Tel: +49 (8142) 44392 0 Tel: +49 (8142) 44392 0
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu