Olanzapine Normon 20 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Olanzapina NORMON 20 mg orodispersible tablets EFG
Read all of this 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 you must 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 such effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Olanzapina NORMON is and what it is used for
- What you need to know before taking Olanzapina NORMON
- How to take Olanzapina NORMON
- Possible side effects
- How to store Olanzapina NORMON
- Contents of the pack and other information
1. What Olanzapina NORMON is and what it is used for
Olanzapina NORMON contains the active substance olanzapine. Olanzapina NORMON 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 things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
- Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.
Olanzapina NORMON 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 NORMON
Do not take Olanzapina NORMON
- 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 starting to take Olanzapina NORMON
- The use of Olanzapina NORMON 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 NORMON, 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 Olanzapina NORMON. 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 Olanzapina NORMON. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment and regularly during treatment.
- If you or a family member 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 reduced blood flow to the brain (transient ischemic attack symptoms).
- Parkinson's disease
- Prostate problems
- Intestinal blockage (paralytic ileus)
- Liver or kidney disease
- Blood disorders
- Heart diseases
- Diabetes
- Seizures
- If you think you may have loss of body salts due to prolonged severe diarrhea and 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 Olanzapina NORMON.
Other medicines and Olanzapina NORMON
Only take other medicines together with Olanzapina NORMON if authorized by your doctor. You may feel drowsiness if Olanzapina NORMON is combined 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 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 Olanzapina NORMON may need to be adjusted.
Drinking alcohol while taking Olanzapina NORMON
Do not drink alcohol while taking Olanzapina NORMON, 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 NORMON may pass into breast milk.
The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapina NORMON 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 Olanzapina NORMON. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina NORMON 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 NORMON
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many Olanzapine NORMON orodispersible tablets to take and for how long. The daily dose of Olanzapine NORMON ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine NORMON unless your doctor tells you to.
Olanzapine NORMON orodispersible tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. Olanzapine NORMON orodispersible tablets are for oral use.
Olanzapine NORMON orodispersible tablets dissolve easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may dissolve.
1 & 2. Hold the blister pack at the ends
- Carefully remove the tablet to avoid breaking it.
- Place the tablet in the mouth. It will dissolve directly in the mouth, making it very easy to swallow.
The tablet may also be placed in 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 Olanzapine NORMON than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested. Show the doctor the pack with the tablets.
Patients who have taken more Olanzapine NORMON than recommended 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 stiffness, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to hospital if you experience any of the symptoms listed above. Show the doctor the pack with the tablets.
If you forget to take Olanzapine NORMON
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 NORMON
Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine NORMON for as long as your doctor instructs.
If you stop taking Olanzapine NORMON 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 affecting up to 1 in 10 people), especially of the face or tongue.
- blood clots in the veins (an uncommon adverse effect affecting 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 available data).
Very common adverse effects (affecting 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 standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.
Common adverse effects (affecting 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; 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 (affecting 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 production of breast milk or abnormal growth.
Rare adverse effects (affecting 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; 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, swollen lymph nodes, elevated liver enzymes observed 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 difficulty walking. Some deaths have been reported in this particular group of patients.
Olanzapine NORMON 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 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 NORMON
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 is the last day of the month indicated.
Olanzapine NORMON must be stored in the original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater drains 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 will help protect the environment.
6. Package contents and other information
Composition of Olanzapina NORMON
- The active substance is olanzapine. Each orodispersible tablet of Olanzapina NORMON contains 20 mg of active substance.
- The other components are crospovidone (type A), lactose monohydrate, anhydrous colloidal 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 the medicinal product and contents of the pack
Olanzapina NORMON 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.
Olanzapina NORMON 20 mg is available in cardboard packs containing 28, 35, 56 and 70 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON S.A
Ronda de Valdecarrizo, 6
28760 Tres Cantos
Madrid
SPAIN
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Olanzapina NORMON 20 mg orodispersible tablets EFG
This summary of product characteristics was approved in April 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.
You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77420/P_77420.html