Olanzapine Vir 5 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Olanzapina Vir 5 mg orodispersible tablets EFG
Read the entire leaflet carefully before you start 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 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 the effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Olanzapina Vir is and what it is used for
- What you need to know before taking Olanzapina Vir
- How to take Olanzapina Vir
- Possible side effects
- How to store Olanzapina Vir
- Contents of the pack and other information
1. What Olanzapina Vir is and what it is used for
Olanzapina Vir contains the active substance olanzapine. Olanzapina Vir 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 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.
Olanzapina Vir 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 Olanzapina Vir
Do not take Olanzapina Vir
- If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of Olanzapina Vir (see 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 starting to take Olanzapina Vir.
- The use of Olanzapina Vir is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
- Medicines of this type may cause unusual movements, especially of the face or tongue. If this happens after you have taken Olanzapina Vir, tell 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 occurs, contact your doctor immediately.
- Weight gain has been observed in patients taking Olanzapina Vir. 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 nutritionist.
- Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapina Vir. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start treatment 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, tell your doctor as soon as possible:
- Stroke or reduced blood flow to the brain (transient ischemic attack).
- 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 salts due to prolonged severe diarrhea and vomiting, or due to taking diuretic medicines (water tablets).
If you suffer from 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 Olanzapina Vir.
Taking other medicines and Olanzapina Vir
Only take other medicines together with Olanzapina Vir if your doctor has approved it. You may feel increased drowsiness if you combine Olanzapina Vir with antidepressants or medicines for anxiety or sleep (tranquilizers).
Tell your doctor 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 Olanzapina Vir may need to be adjusted.
Drinking alcohol with Olanzapina Vir
Do not drink alcohol while taking Olanzapina Vir, 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 must not take this medicine while breastfeeding, as small amounts of Olanzapina Vir may pass into breast milk.
The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapina Vir during the third trimester of pregnancy (last three months of pregnancy): tremor, 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 when taking Olanzapina Vir. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina Vir 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 Olanzapine VIR
Follow exactly the dosing instructions for Olanzapine VIR given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Your doctor will tell you how many Olanzapine VIR tablets to take and for how long. The daily dose of Olanzapine VIR ranges from 5 to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine VIR unless your doctor tells you to.
Olanzapine VIR 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. Olanzapine VIR orodispersible tablets are for oral use.
Olanzapine VIR tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
1 and 2. Hold the blister pack at the ends and separate one blister, gently breaking it along the perforations surrounding it.
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Gently remove the tablet.
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Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.
Alternatively, you may place the tablet in a cup or glass containing water, orange juice, apple juice, milk, or coffee, to allow it to dissolve. With some beverages, the mixture may change color and possibly become cloudy. It should be drunk immediately.
If you take more Olanzapine VIR than you should
Patients who have taken more Olanzapine VIR 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 rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the packaging with the tablets.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount taken.
If you forget to take Olanzapine VIR
Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Olanzapine VIR
Do not stop treatment just because you feel better. It is very important to continue taking Olanzapine VIR for as long as your doctor instructs.
If you stop taking Olanzapine VIR suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or 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, Olanzapina Vir can produce adverse effects, although not everyone will experience them.
Contact your doctor immediately if you have:
- Unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue.
- Blood clots in the veins (an uncommon adverse effect that 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 attention immediately.
- A combination of fever, rapid breathing, sweating, muscle rigidity, 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 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, circulating lipids, and temporary increases at the beginning of treatment in liver enzymes; increased levels of sugar in blood and urine; increased levels of uric acid and creatine phosphokinase in blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; 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 rigidity or spasms (including eye movements); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the mammary gland in men and women such as abnormal production of breast milk or abnormal 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 malaise; liver disease, with yellowing of the skin and whites of the eyes; 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 observed in blood tests, and increased levels of a type of white blood cells (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.
Olanzapina Vir may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Olanzapine Vir Storage
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of OlanzapinaVir
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The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg of active substance.
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The other components are: crospovidone (type A), lactose monohydrate, colloidal silicon dioxide (anhydrous), hydroxypropylcellulose, mint flavour (containing: peppermint oil, terpene-free peppermint oil, eucalyptus, menthone, isomenthone, mentyl acetate, menthol), talc, magnesium stearate.
Appearance of the product and contents of the pack
Olanzapina Vir 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets. Orodispersible is the technical term used for tablets that dissolve directly in the mouth, facilitating swallowing.
Olanzapina Vir 5 mg, 10 mg, 15 mg and 20 mg are available in packs containing 28 tablets.
Marketing Authorization Holder and Manufacturer
Holder:
C/Industria Quimica Y Farmaceutica Vir, S.A
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid) Spain
Manufacturer:
Pharmathen, S.A Dervenakion 6,
15351, Pallini, Attiki
Greece
Pharmathen Internacional, S.A Sapes Industrial Park
Block 5
69300 Rodopi
Greece
This medicinal product is authorized in the European Economic Area member states under the following names:
Portugal: Olanzapina Eurogenus
Spain: Olanzapina Vir orodispersible tablets EFG
This leaflet was approved in April 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/