Zyprexa 7.5 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ZYPREXA 2.5 mg film-coated tablets
ZYPREXA 5 mg film-coated tablets
ZYPREXA 7.5 mg film-coated tablets
ZYPREXA 10 mg film-coated tablets
ZYPREXA 15 mg film-coated tablets
ZYPREXA 20 mg film-coated tablets
olanzapine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What ZYPREXA is and what it is used for
- What you need to know before taking ZYPREXA
- How to take ZYPREXA
- Possible side effects
- How to store ZYPREXA
- Contents of the pack and other information
1. What ZYPREXA is and what it is used for
ZYPREXA contains the active substance olanzapine. ZYPREXA belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this condition may also feel depressed, anxious, or tense.
- Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.
ZYPREXA has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.
2. What you need to know before taking ZYPREXA
Do not take ZYPREXA
- If you are allergic to olanzapine or to any of the other ingredients of this medicine
- (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
- If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take ZYPREXA.
- The use of ZYPREXA is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
- Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking ZYPREXA, inform your doctor.
- Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this happens to you, contact your doctor immediately.
- Weight gain has been observed in patients taking ZYPREXA. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a dietitian.
- Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking ZYPREXA. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking ZYPREXA and regularly during treatment.
- If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type 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 (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 think you may have loss of body salts due to prolonged severe diarrhea or vomiting, or due to the use of diuretic medicines (water tablets)
If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient reduction in blood flow to the brain.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Children and adolescents
Patients under 18 years of age must not take ZYPREXA.
Other medicines and ZYPREXA
Only use other medicines together with ZYPREXA if authorized by your doctor. You may experience drowsiness if ZYPREXA is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, tell your doctor if you are taking:
- Medication for Parkinson's disease.
- Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of ZYPREXA may need to be adjusted.
Alcohol and ZYPREXA
Do not drink alcohol while taking ZYPREXA, as it may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You must not take this medicine while breastfeeding, as small amounts of ZYPREXA may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken ZYPREXA during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking ZYPREXA. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
ZYPREXA contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take ZYPREXA
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
Your doctor will tell you how many ZYPREXA tablets to take and for how long. The daily dose of ZYPREXA ranges from 5 mg to 20 mg. Speak with your doctor if your symptoms return, but do not stop taking ZYPREXA unless your doctor tells you to.
You should take your ZYPREXA tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. ZYPREXA coated tablets are for oral use. Swallow the ZYPREXA tablets whole with water.
If you take more ZYPREXA than you should
Patients who have taken more ZYPREXA than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the nearest hospital if you experience any of the symptoms listed above. Show the doctor the medicine package.
If you forget to take ZYPREXA
Take your tablets as soon as you remember. Do not take a double dose to make up for the missed dose.
If you stop taking ZYPREXA
Do not stop treatment just because you feel better. It is very important that you continue taking ZYPREXA for as long as your doctor advises.
If you stop taking ZYPREXA suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you gradually reduce the dose before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you have:
- unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue;
- blood clots in the veins (an uncommon adverse effect which 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 the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
- a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).
Very common adverse effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.
Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. mouth and throat swelling, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast in both men and women such as abnormal milk production or abnormal breast growth.
Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever and feeling unwell; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection.
Very rare adverse effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.
ZYPREXA may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ZYPREXA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
ZYPREXA should be stored in the original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of ZYPREXA
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The active substance is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg,
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15 mg or 20 mg of active substance. The exact amount is shown on your ZYPREXA packaging.
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The other components are
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Tablet core: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate,
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Tablet coating: hypromellose, titanium dioxide (E171) and carnauba wax.
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Additionally, the different strengths of ZYPREXA also contain the following components:
CONCENTRATION | OTHER COMPONENTS |
ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets | (tablet coating) shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour (E132), anhydrous ethanol, isopropyl alcohol, butyl alcohol, ammonium hydroxide |
ZYPREXA 15 mg tablets | (tablet coating) triacetin and indigo carmine colour (E132) |
ZYPREXA 20 mg tablets | (tablet coating) macrogol and synthetic red iron oxide (E172) |
Appearance of the product and contents of the pack
ZYPREXA 2.5 mg coated tablets are white and have "LILLY" and a numerical identification code "4112" printed on them.
ZYPREXA 5 mg coated tablets are white and have "LILLY" and a numerical identification code "4115" printed on them.
ZYPREXA 7.5 mg coated tablets are white and have "LILLY" and a numerical identification code "4116" printed on them.
ZYPREXA 10 mg coated tablets are white and have "LILLY" and a numerical identification code "4117" printed on them.
ZYPREXA 15 mg coated tablets are blue in colour.
ZYPREXA 20 mg coated tablets are pink in colour.
ZYPREXA is available in packs of 28, 35, 56, 70 or 98 tablets. Only certain pack sizes may be marketed.
Marketing Authorisation Holder:
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.
Manufacturer responsible for batch release:
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Fidelio Healthcare Limburg GmbH, Mundipharmastraße 2, 65549 Limburg an der Lahn, Germany.
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.
Date of the most recent revision of this package leaflet:
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.