Olanzapine Combix 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Combix 2.5 mg film-coated tablets EFG

Olanzapine

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet:

1. What Olanzapina Combix is and what it is used for
2. What you need to know before taking Olanzapina Combix
3. How to take Olanzapina Combix
4. Possible adverse effects
5. How to store Olanzapina Combix
6. Contents of the pack and other 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 condition whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and becoming withdrawn. People suffering from 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 having considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme changes in mood.

2. What you need to know before taking Olanzapina Combix

Do not take Olanzapina Combix

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of Olanzapina Combix. The allergic reaction may manifest 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

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Combix, inform 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 occurs, contact your doctor immediately.

The use of Olanzapina Combix in elderly patients with dementia is not recommended, as it may lead to serious adverse effects.

If you have any of the following conditions, inform 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 ischemic 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 ischemic attack.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Olanzapina Combix must not be used in patients under 18 years of age.

Interaction of Olanzapina Combix with other medicines

Only use other medicines together with Olanzapina Combix if authorized by your doctor. You may feel drowsiness if Olanzapina 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 Olanzapina Combix may need to be adjusted.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Especially inform your doctor if you are taking medication for Parkinson's disease.

Olanzapina Combix with food, drink and alcohol

You must not drink alcohol while taking Olanzapina Combix, as the combination of Olanzapina Combix and alcohol 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 or pharmacist before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapina Combix may pass into breast milk.

Driving and using machines

Olanzapina Combix may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Olanzapina Combix 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 Combix

Follow exactly the administration instructions for Olanzapine Combix given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapine Combix tablets you should take and for how long. The daily dose of Olanzapine Combix ranges between 5 and 20 mg. Speak with your doctor if your symptoms return, but do not stop taking Olanzapine Combix unless your doctor tells you to.

You should take your Olanzapine 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. Olanzapine Combix tablets are for oral use. Swallow the tablets whole with water.

If you take more Olanzapine Combix than you should

Patients who have taken more Olanzapine Combix 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 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 hospital straight away. Show the doctor the pack of tablets.

If you forget to take Olanzapine 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 Olanzapine Combix

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Combix for as long as your doctor advises.

If you stop taking Olanzapine Combix 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, 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 disorders.
• 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 (ketones in blood and urine) or coma.
• Decrease in normal body temperature.
• Seizures, in most cases related to a history of seizures (epilepsy).
• A combination of fever, rapid breathing, sweating, muscle rigidity, and a state of 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 (jaundice).
• 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 difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. Some deaths have been reported in this particular group of patients.

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 glands, 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 increased levels of a type of white blood cell (eosinophilia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Combix

Keep out of the reach and sight of children.

Do not use Olanzapine Combix after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapina Combix

The active substance is olanzapine. Each Olanzapina Combix tablet contains 2.5 mg of olanzapine.

The other components are:
• Tablet core: lactose monohydrate, crospovidone, hypromellose (E-464), magnesium stearate.
• Coating agent: polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the medicinal product and contents of the pack

Olanzapina Combix 2.5 mg tablets are film-coated, white or almost white, round, biconvex tablets, marked with “ZF28” on one side and smooth on the other.

Olanzapina Combix 2.5 mg is available in packs containing 28 film-coated tablets.

Olanzapina Combix is also available in 5 mg, 7.5 mg and 10 mg tablets in packs containing 28 and 56 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer

Zydus France
Zac Les Hautes Pâtures
Parc d’Activités des Pleupliers
25 rue des Peupliers
92000 Nanterre
France

or

Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint Amant Tallende
France

This patient information leaflet was last revised in February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/