Olanzapine Stada 5 mg film-coated tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the user
Olanzapina Stada 5 mg film-coated tablets EFG
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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Olanzapina Stada is and what it is used for
- What you need to know before taking Olanzapina Stada
- How to take Olanzapina Stada
- Possible adverse effects
- How to store Olanzapina Stada
- Contents of the pack and other information
1. What Olanzapina Stada is and what it is used for
Olanzapina Stada contains the active substance olanzapine. Olanzapine 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, characterized by symptoms such as excitement or euphoria.
Olanzapina Stada 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 Stada
Do not take Olanzapina Stada:
- If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present 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 Stada
- The use of Olanzapina Stada 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 happens after taking Olanzapina Stada, tell 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 to you, contact your doctor immediately.
Weight gain has been observed in patients taking Olanzapina Stada. 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 Stada. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Olanzapina Stada 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 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 have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.
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 Stada.
Taking Olanzapina Stada with other medicines
Only use other medicines together with Olanzapina Stada if your doctor authorizes it. You may experience drowsiness if Olanzapina Stada is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Tell 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 Olanzapina Stada may need to be adjusted.
Drinking alcohol while taking Olanzapina Stada
You must not drink alcohol while taking Olanzapina Stada, as it may cause drowsiness.
Pregnancy, breastfeeding and fertility
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 Stada may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Olanzapina Stada 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 Olanzapina Stada. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina Stada contains lactose and soya lecithin
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains soya oil. It must not be used if you are allergic to peanuts or soya.
3. How to take Olanzapina Stada
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many Olanzapina Stada tablets to take and for how long. The daily dose of Olanzapina Stada ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina Stada unless your doctor tells you to.
You should take your Olanzapina Stada tablets 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. Olanzapina Stada coated tablets are for oral administration. Swallow the Olanzapina Stada tablets whole with water.
If you take more Olanzapina Stada than you should
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken.
Patients who have taken more Olanzapina Stada than recommended 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 possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased 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 medicine packaging.
If you forget to take Olanzapina Stada
Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Olanzapina Stada
Do not stop treatment just because you feel better. It is very important to continue taking Olanzapina Stada for as long as your doctor tells you to.
If you stop taking Olanzapina Stada suddenly, symptoms such as sweating, inability to sleep, 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 everyone will experience them.
Contact your doctor immediately if you experience:
- 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 sweating, 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 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 dizziness or fainting (with slower heartbeats), especially when getting up from lying down or sitting positions. 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; at the beginning of treatment, temporary increases in liver enzymes, increased blood and urine sugar levels, 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 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 (acetone in blood and urine) or coma, seizures—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, inability to urinate, hair loss, absence or reduced menstrual periods, and changes in the breast gland in both 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 lowered 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 (jaundice), 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 increased levels of 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 walking difficulties. Some deaths have been reported in this particular patient group.
Olanzapina Stada may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any type of 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 via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olanzapine Stada
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required. Store in the original container.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Olanzapine STADA
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The active substance is olanzapine. Each tablet contains 5 mg of active substance.
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The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, soya lecithin (E322), xanthan gum, and purified water.
Nature of the product and contents of the pack
Olanzapine STADA 5 mg is presented as film-coated tablets. The tablets are round, white, with the inscription “5” on one side.
It is available in packs of 28 tablets.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Laboratorio STADA, S.L. Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain
Date of the most recent review of this leaflet: April 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es