Olanzapine Flas Qualigen 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Patient Information Leaflet

Olanzapina Flas Qualigen 20 mg orodispersible tablets EFG

Please read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olanzapina Flas Qualigen is and what it is used for
2. What you need to know before taking Olanzapina Flas Qualigen
3. How to take Olanzapina Flas Qualigen
4. Possible side effects
5. How to store Olanzapina Flas Qualigen
6. Contents of the pack and other information

1. What Olanzapina Flas Qualigen is and what it is used for

Olanzapina Flas Qualigen contains the active substance olanzapine. This medicine belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing 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, a condition characterized by symptoms of excitement or euphoria.

This medicine 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 starting to take Olanzapine Flas Qualigen

Do not take Olanzapina Flas Qualigen

• If you are allergic to olanzapine or to any of the other components of this medicine (listed in section 6). 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

Talk to your doctor or pharmacist before starting to take Olanzapina Flas Qualigen

• The use of Olanzapina Flas Qualigen 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 happens after taking Olanzapina Flas Qualigen, 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 Olanzapina Flas Qualigen. 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 this medicine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Olanzapina Flas Qualigen 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 suffer from any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (TIA) (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 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 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 Olanzapina Flas Qualigen.

Other medicines and Olanzapina Flas Qualigen

Only use other medicines at the same time as this medicine if authorized by your doctor. You may experience drowsiness if Olanzapina Flas Qualigen is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform 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 Flas Qualigen may need to be adjusted.

Use of Olanzapina Flas Qualigen with alcohol

You should not drink alcohol while taking this medicine, 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 should not take this medicine while breastfeeding, as small amounts may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapina Flas Qualigen 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 when taking this medicine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Flas Qualigen contains lactose, aspartame, and sodium.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 2.12 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take OLANZAPINE FLAS QUALIGEN

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 tablets of this medicine you should take and for how long. The daily dose of Olanzapine Flas Qualigen ranges from 5 mg to 20 mg. Consult your doctor if your symptoms return, but do not stop taking this medicine unless instructed by your doctor.

Olanzapine Flas Qualigen tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time each day. They may be taken with or without food. The orodispersible tablets of Olanzapine Flas Qualigen are for oral administration.

Olanzapine Flas Qualigen tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack at the edges and separate one blister, gently breaking it along the perforations surrounding it.
2. Gently peel back the backing of the blister.
3. Carefully remove the tablet.
4. 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 into 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 Flas Qualigen than you should

Patients who have taken more Olanzapine Flas Qualigen 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, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the nearest hospital if you experience any of the symptoms listed above. Show the doctor the packaging of the medicine.

You may also contact your pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Olanzapine Flas Qualigen

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 Flas Qualigen

Do not stop treatment simply because you feel better. It is very important to continue taking this medicine for as long as your doctor advises.

If you stop taking Olanzapine Flas Qualigen suddenly, symptoms such as sweating, difficulty sleeping, 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 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 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 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 experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position. 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 levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; 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. mouth and throat swelling, 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; loss of ability to urinate; hair loss; absence or reduction of menstrual periods; 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 a decrease in normal 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 pains and prolonged and/or painful erection.

Very rare adverse effects 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 observed in blood tests, and increased levels of a type of white blood cell in the blood (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.

Olanzapina Flas Qualigen may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or nurse, 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Flas Qualigen

Keep this medicine out of 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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or in household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Olanzapina Flas Qualigen

The active substance is olanzapine. Each orodispersible tablet of Olanzapina Flas Qualigen contains 20 mg of active substance.

The other components are lactose monohydrate, calcium silicate, low-substituted hydroxypropyl cellulose (E-463), crospovidone, aspartame (E-951), orange flavour, banana flavour (contains sodium), colloidal anhydrous silica (E-551) and magnesium stearate (E-470). See section 2 Olanzapina Flas Qualigen contains lactose, aspartame and sodium.

Appearance of Olanzapina Flas Qualigen 20 mg and contents of the pack

Olanzapina Flas Qualigen 20 mg orodispersible tablets are yellow.

Olanzapina Flas Qualigen 20 mg orodispersible tablets are available in packs of 28 tablets.

Other presentations:

Olanzapina Flas Qualigen 5 mg orodispersible tablets: packs of 28 tablets.

Olanzapina Flas Qualigen 10 mg orodispersible tablets: packs of 28 and 56 tablets.

Olanzapina Flas Qualigen 15 mg orodispersible tablets: packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the most recent revision of this leaflet: 04/2024

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.es/