Olanzapine PensA 5 mg orodispersible tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Olanzapina Pensa 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 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 you should not give it 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 adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Olanzapina Pensa is and what it is used for
- What you need to know before taking Olanzapina Pensa
- How to take Olanzapina Pensa
- Possible adverse effects
- How to store Olanzapina Pensa
- Contents of the pack and other information
1. What OLANZAPINE PENSA is and what it is used for
Olanzapine Pensa contains the active substance olanzapine. Olanzapine Pensa belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also experience depression, anxiety, or tension.
- Moderate to severe manic disorder, a condition characterized by symptoms of excitement or euphoria.
Olanzapine Pensa 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 Pensa
Do not take Olanzapina Pensa
- If you are allergic to olanzapine or to 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 Olanzapina Pensa.
- The use of Olanzapina Pensa 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 Olanzapina Pensa, 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 happens, contact your doctor immediately.
- Weight gain has been observed in patients taking Olanzapina Pensa. 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 Pensa. 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, 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 and vomiting, or from using 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 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 Pensa.
Taking Olanzapina Pensa with other medicines
Only use other medicines together with Olanzapina Pensa if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Pensa 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), as your dose of Olanzapina Pensa may need to be adjusted.
Olanzapina Pensa and alcohol
Do not drink alcohol while taking Olanzapina Pensa, 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 Pensa may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken olanzapine 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 Pensa. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina Pensa contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.
3. HOW TO TAKE OLANZAPINE PENSA
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many Olanzapine Pensa tablets you should take and for how long. The recommended daily dose of Olanzapine Pensa ranges from 5 to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine Pensa unless your doctor tells you to do so.
You should take your Olanzapine Pensa 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. Olanzapine Pensa orodispersible tablets are intended for oral administration.
Olanzapine Pensa tablets break easily and should therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
1 and 2. Hold the blister pack by the edges.
- Gently push the tablet out to avoid breaking it.
- Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.
Alternatively, the tablet can be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. It should be drunk immediately.
If you take more Olanzapine Pensa than you should
Patients who have taken more Olanzapine Pensa 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 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 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 medicine packaging.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91.562.04.20.
If you forget to take Olanzapine Pensa
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 Pensa
Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Pensa for as long as your doctor prescribes it.
If you stop taking Olanzapine Pensa suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, 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 experiences 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), especially 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 attention 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 feel dizziness or fainting (with slower heartbeats), especially when standing up from lying 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, 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, 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—most cases are related to a history of seizures (epilepsy)—muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, slow pulse, photosensitivity, nosebleeds, abdominal distension, memory loss or forgetfulness, urinary incontinence, inability to urinate, hair loss, absence or reduced menstrual periods, and changes in the breast gland in men and women such as abnormal production of breast milk or abnormal growth, and excessive salivation.
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 (jaundice), muscle disorder presenting as unexplained muscle pain, and prolonged and/or painful erection.
Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. DRESS initially presents with flu-like symptoms, facial rash that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes 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 Pensa may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects:
If you experience any adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of OLANZAPINE PENSA
Keep this medicine 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 refers to the last day of the month indicated.
Olanzapine Pensa must be stored in its original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Olanzapina Pensa
The active substance is olanzapine. Each orodispersible tablet of Olanzapina Pensa contains 5 mg of the active substance.
- The other components are crospovidone (type A), lactose monohydrate, colloidal anhydrous silica, hydroxypropylcellulose, peppermint flavour (consisting of peppermint essential oil, terpene-free peppermint essential oil, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.
Appearance of Olanzapina Pensa and pack sizes
The orodispersible tablets of Olanzapina Pensa 5 mg are yellow.
Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, making it easier to swallow.
Olanzapina Pensa 5 mg is available in packs containing 28 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Pharmathen S.A., Dervenakion 6, 15351, Pallini, Attiki, Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
ES: Olanzapina Pensa 5 mg orodispersible tablets EFG
IT: Olanzapina Pensa Pharma
This leaflet has been revised 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 Medical Devices (AEMPS) http://www.aemps.gob.es/