Olanzapine Combix 7.5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapina Combix 7.5 mg film-coated tablets EFG
Olanzapine
Read the entire leaflet carefully before you start taking this medicine.
- 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Olanzapina Combix is and what it is used for
- Before taking Olanzapina Combix
- How to take Olanzapina Combix
- Possible side effects
- How to store Olanzapina Combix
- Further information
1. What Olanzapina Combix is and what it is used for
Olanzapina Combix belongs to a group of medicines called antipsychotics.
Olanzapina Combix is indicated for the treatment of a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, tense, or anxious.
Olanzapina Combix is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes marked irritability. It is also a mood stabilizer that helps prevent extreme changes in mood.
2. Before taking Olanzapine Combix
Do not take Olanzapine Combix
- if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of Olanzapine Combix. 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).
Take special care with Olanzapine Combix
- If you or a family member has a history of blood clots, these medicines may be associated with their formation.
- Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapine Combix, 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.
The use of Olanzapine Combix in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
If you have any of the following conditions, tell your doctor as soon as possible:
- Diabetes
- Heart disease
- Liver or kidney disease
- Parkinson's disease
- Epilepsy
- Prostate problems
- Intestinal blockage (paralytic ileus)
- Blood disorders
- Stroke or transient ischaemic attack (temporary stroke-like symptoms).
If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Olanzapine Combix must not be taken by patients under 18 years of age.
Use of other medicines
Only take other medicines at the same time as Olanzapine Combix if your doctor authorizes it. You may feel drowsy if Olanzapine Combix is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
You must inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapine Combix may need to be adjusted.
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Especially inform your doctor if you are taking medication for Parkinson's disease.
Taking Olanzapine Combix with food and drink
You should not drink alcohol while taking Olanzapine Combix, as the combination of Olanzapine Combix and alcohol may cause drowsiness.
Pregnancy and breastfeeding
Tell your doctor as soon as possible if you are pregnant or think you might be pregnant. You should not take this medicine during pregnancy unless your doctor recommends it. You should not take this medicine while breastfeeding, as small amounts of Olanzapine Combix may pass into breast milk.
Newborns of mothers who have taken Olanzapine Combix during the last trimester of pregnancy may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.
Driving and using machines
Olanzapine Combix may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.
Important information about some of the ingredients of Olanzapine Combix
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Olanzapina Combix
Follow exactly the instructions for administering Olanzapina Combix given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Your doctor will tell you how many Olanzapina Combix tablets you should take and for how long. The daily dose of Olanzapina Combix ranges from 5 to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina Combix unless your doctor tells you to do so.
You should take your Olanzapina Combix 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 Combix tablets are for oral administration. Swallow the Olanzapina Combix tablets whole with water.
If you take more Olanzapina Combix than you should
Patients who have taken more Olanzapina Combix than they should 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 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 immediately or go to the nearest hospital. Show the doctor the pack of tablets.
If you forget to take Olanzapina Combix
Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Olanzapina Combix
Do not stop treatment simply because you feel better. It is very important that you continue taking Olanzapina Combix for as long as your doctor tells you to.
If you stop taking Olanzapina Combix 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, Olanzapina Combix may produce adverse effects, although not everyone experiences them.
Very common adverse effects: affecting 1 in every 10 patients
- Weight gain.
- Somnolence.
- Increased levels of prolactin in the blood.
Common adverse effects: affecting between 1 and 10 in every 100 patients
- Changes in levels of certain blood cells and circulating lipids.
- Increased blood and urine sugar levels.
- Increased appetite.
- Dizziness.
- Agitation.
- Tremor.
- Muscle rigidity or spasms (including eye movements).
- Speech disturbances.
- Unusual movements (especially of the face or tongue).
- Constipation.
- Dry mouth.
- Skin rash.
- Loss of strength.
- Excessive fatigue.
- Fluid retention causing swelling of the hands, ankles, or feet.
- In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeat), especially when standing up from a lying or sitting position.
This sensation usually resolves spontaneously, but if it does not, inform your doctor.
- Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.
Uncommon adverse effects: affecting between 1 and 10 in every 1,000 patients
- Slow pulse.
- Sensitivity to sunlight.
- Urinary incontinence.
- Hair loss.
- Absence or reduction of menstrual periods.
- Changes in the mammary gland in men and women, such as abnormal production of breast milk or abnormal growth.
- Restless legs syndrome.
- Excessive salivation.
Other possible adverse effects: frequency cannot be estimated from available data
- Allergic reaction (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.
- Decrease in normal body temperature.
- Seizures; in most cases, these are related to a history of seizures (epilepsy).
- A combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or somnolence.
- Muscle spasms in the eyes causing circular eye movements.
- Abnormal heart rhythm.
- Sudden unexplained death.
- Blood clots such as deep vein thrombosis in the legs and blood clots in the lungs.
- 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.
- Difficulty urinating.
- Prolonged and/or painful erection.
- Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg); these clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.
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 patient group.
Olanzapina Combix may worsen symptoms in patients with Parkinson's disease.
Rarely, women who take this type of medication for a long period of time may experience milk secretion from the mammary gland, absence of menstrual periods, or irregular menstruation. If this condition persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina Combix during the last stage of pregnancy (third trimester) may experience tremor, somnolence, or lethargy.
Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial skin rash that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olanzapine Combix
Keep out of the reach and sight of children.
Do not use Olanzapine Combix after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Information provided
Composition of Olanzapina Combix
The active substance is olanzapine. Each Olanzapina Combix tablet contains 7.5 mg of olanzapine.
The other components are monohydrate lactose, crospovidone, hypromellose (E-464), magnesium stearate, coating agent (polyvinyl alcohol, titanium dioxide (E-171), talc, soybean lecithin (E-322), xanthan gum (E-415)).
Appearance of the product and contents of the pack
Olanzapina Combix 7.5 mg tablets are film-coated, white or almost white, round, biconvex tablets, marked “ZF30” on one side and smooth on the other.
Olanzapina Combix 7.5 mg is available in packs containing 56 film-coated tablets.
Olanzapina Combix is also available in 5 mg tablets in packs containing 28 film-coated tablets and in 10 mg tablets in packs containing 28 or 56 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid), Spain
Manufacturer
Zydus France
25, parc d’activités des Peupliers
92000 Nanterre
France
or
Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint Amant Tallende
France
This leaflet was last reviewed in February 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/