Zyprexa Velotab 15 mg orodispersible tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ZYPREXA VELOTAB 5 mg orodispersible tablets
ZYPREXA VELOTAB 10 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg orodispersible tablets
olanzapine
Read the entire leaflet carefully before you start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What ZYPREXA VELOTAB is and what it is used for
- What you need to know before taking ZYPREXA VELOTAB
- How to take ZYPREXA VELOTAB
- Possible side effects
- How to store ZYPREXA VELOTAB
- Contents of the pack and other information
1. What ZYPREXA VELOTAB is and what it is used for
ZYPREXA VELOTAB contains the active substance olanzapine. ZYPREXA VELOTAB belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following disorders:
- Schizophrenia, a condition whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
- Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.
ZYPREXA VELOTAB has been shown to prevent 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 VELOTAB
Do not take ZYPREXA VELOTAB
- If you are allergic to olanzapine or any of the other ingredients of this medicine
- (listed in section 6). The allergic reaction may appear 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 taking ZYPREXA VELOTAB
- Use of ZYPREXA VELOTAB 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 VELOTAB, inform your doctor.
- Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this happens, contact your doctor immediately.
- Weight gain has been observed in patients taking ZYPREXA VELOTAB. 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 sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking ZYPREXA VELOTAB. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting ZYPREXA VELOTAB 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 lost salts due to prolonged severe diarrhea or vomiting, or due to taking 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 reduced 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 VELOTAB.
Other medicines and ZYPREXA VELOTAB
Only use other medicines together with ZYPREXA VELOTAB if authorized by your doctor. You may experience increased drowsiness if ZYPREXA VELOTAB is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).
Inform your doctor if you are taking, have recently taken, or might need to take any other medicine.
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 VELOTAB may need to be adjusted.
Use of ZYPREXA VELOTAB with alcohol
You should not drink alcohol while taking ZYPREXA VELOTAB, as combining it with alcohol 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 should not take this medicine while breastfeeding, as small amounts of ZYPREXA VELOTAB may pass into breast milk.
The following symptoms may occur in newborn babies of mothers who have been treated with ZYPREXA VELOTAB during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking ZYPREXA VELOTAB. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
ZYPREXA VELOTAB contains aspartame, sodium methyl parahydroxybenzoate, and sodium propyl parahydroxybenzoate
This medicine contains up to 1.6 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Allergic reactions may include skin rash, itching, or difficulty breathing. These may occur immediately after taking ZYPREXA VELOTAB or some time later.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take ZYPREXA VELOTAB
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.
Your doctor will tell you how many ZYPREXA VELOTAB tablets you should take and for how long. The daily dose of ZYPREXA VELOTAB ranges from 5 mg to 20 mg. Consult your doctor if your symptoms return, but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
ZYPREXA VELOTAB tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. The orodispersible tablets of ZYPREXA VELOTAB are for oral use.
ZYPREXA VELOTAB tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
- Hold the blister pack at the edges and separate one of the blisters by gently breaking along the perforations surrounding it.
- Gently peel back the backing of the blister.
- Carefully remove the tablet.
- Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.
Alternatively, the tablet may be placed into a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some drinks, the mixture may change color and become cloudy. It should be drunk immediately.
If you take more ZYPREXA VELOTAB than you should
Patients who have taken more ZYPREXA VELOTAB than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, 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, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the hospital if you experience any of the symptoms listed above. Show the doctor the packaging of the tablets.
If you forget to take ZYPREXA VELOTAB
Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking ZYPREXA VELOTAB
Do not stop treatment just because you feel better. It is very important that you continue taking ZYPREXA VELOTAB for as long as your doctor tells you to.
If you stop taking ZYPREXA VELOTAB suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to 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 everybody gets them.
Contact your doctor immediately if you experience:
- 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), particularly 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 the 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 feel dizzy or faint (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 levels of blood sugar and sugar in urine; increased levels of uric acid and creatine phosphokinase in blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; 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. swelling of the mouth and throat, 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 gland in both men and women such as abnormal milk production or abnormal breast enlargement.
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 discomfort; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pain, 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 VELOTAB 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 can also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ZYPREXA VELOTAB
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 VELOTAB should be stored in its original packaging to protect it from light and moisture.
Medicines should 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 VELOTAB
- The active substance is olanzapine. Each ZYPREXA VELOTAB orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg of active substance. The exact amount is shown on your ZYPREXA VELOTAB packaging.
- The other components are
gelatin, mannitol (E421), aspartame (E951), sodium methylparahydroxybenzoate (E219) and sodium propylparahydroxybenzoate (E217).
Appearance of the product and contents of the pack
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are yellow.
Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, making it easier to swallow.
ZYPREXA VELOTAB packs contain 28, 35, 56, 70 or 98 tablets. Only certain pack sizes may be marketed.
Marketing Authorization Holder
CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.
Manufacturer
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 medicine is available on the European Medicines Agency website: http://www.ema.europa.eu