Olanzapine Alter 2.5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Olanzapina Alter 2.5 mg film-coated tablets EFG
Olanzapina Alter 5 mg film-coated tablets EFG
Olanzapina Alter 10 mg film-coated tablets EFG
Olanzapine
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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Olanzapina Alter is and what it is used for
- What you need to know before taking Olanzapina Alter
- How to take Olanzapina Alter
- Possible side effects
- How to store Olanzapina Alter
- Contents of the pack and other information
1. What Olanzapina Alter is and what it is used for
Olanzapina Alter 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 feeling things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, anxious, or tense.
- Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.
Olanzapine 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 Alter
Do not take Olanzapina Alter
- 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 this medicine.
- The use of olanzapine 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 olanzapine, 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 occurs, contact your doctor immediately.
- Weight gain has been observed in patients taking olanzapine. 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 sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting olanzapine 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 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 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 transient lack of 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 olanzapine.
Taking Olanzapina Alter with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Only take other medicines together with olanzapine if your doctor authorizes it. You may feel increased drowsiness if olanzapine is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).
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 olanzapine dose may need to be adjusted.
Taking Olanzapina Alter with alcohol
Do not drink alcohol while taking olanzapine, as it 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 olanzapine may pass into breast milk. Consult your doctor or pharmacist before using any medicine.
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 problems, and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking olanzapine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina Alter contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Olanzapine Alter
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many olanzapine tablets to take and for how long. The daily dose of olanzapine ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking olanzapine unless instructed by your doctor.
You should take your olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. Olanzapine coated tablets are for oral administration. Swallow the tablets whole with water.
If you take more Olanzapine Alter than you should
Patients who have taken more olanzapine 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 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 medicine package.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Olanzapine Alter
Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Olanzapine Alter
Do not stop treatment just because you feel better. It is very important that you continue taking this medicine for as long as your doctor advises.
If you stop taking olanzapine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you 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 have:
- 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 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 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 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 (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 (acetone 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 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 (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests 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 difficulty walking. Some deaths have been reported in this particular group of patients.
Olanzapine may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olanzapine Alter
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
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.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Olanzapine Alter
- The active substance is olanzapine. Each tablet contains 2.5 mg; 5 mg; or 10 mg of olanzapine. The exact amount is shown on the packaging of the medicine.
- The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), sodium carboxymethylstarch (Type A) (from potato), and magnesium stearate.
Tablet coating: macrogol 6000, sepifilm LP-761 white (hydroxypropylmethylcellulose, microcrystalline cellulose, stearic acid, and titanium dioxide).
Nature of the product and contents of the pack
Olanzapine Alter 2.5 mg: film-coated tablets, white in colour and round.
Packaged in packs of 28 tablets.
Olanzapine Alter 5 mg: film-coated tablets, white in colour, biconvex, unmarked, approximately 8.2 mm in diameter, with the imprint “5” on one side.
Packaged in packs of 28 tablets.
Olanzapine Alter 10 mg: film-coated tablets, white in colour, biconvex, unmarked, approximately 11.2 mm in diameter, with the imprint “10” on one side.
Packaged in packs of 28 and 56 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain
or
Laboratorios Alter, S.A
C/ Zeus, 6
Polígono Industrial R2
28880 Meco (Madrid)
Spain
Date of the most recent revision of this leaflet: May 2020.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/