Olanzapine Flas Qualigen 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olanzapina Flas Qualigen 10 mg orodispersible tablets EFG

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 others, 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 they are 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 Olanzapine Flas Qualigen is and what it is used for

Olanzapine 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 whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes, a disorder 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 taking Olanzapine Flas Qualigen

Contraindications
Do not use Olanzapine Flas Qualigen if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6).

Special warnings and precautions for use
Talk to your doctor or pharmacist before using Olanzapine Flas Qualigen if you have or have had any of the following conditions:

• Diabetes or risk factors for diabetes: High blood sugar levels have been reported in patients taking olanzapine. Your doctor may order blood tests to monitor your glucose levels. Symptoms of high blood sugar include increased thirst and more frequent urination.
• Weight gain: Olanzapine may cause significant weight gain. Your doctor will monitor your weight regularly.
• Hyperlipidemia (high cholesterol or triglycerides): Your doctor may perform blood tests to check your lipid levels.
• Seizures or epilepsy: Olanzapine may lower the seizure threshold.
• Low white blood cell count (neutropenia): Rarely, olanzapine may cause a reduction in white blood cells. Inform your doctor immediately if you develop signs of infection such as fever, sore throat, or other infections.
• Stroke: Elderly patients with dementia-related psychosis treated with antipsychotics like olanzapine may be at an increased risk of stroke.
• Neuroleptic Malignant Syndrome (NMS): A rare but serious condition characterized by high fever, muscle stiffness, confusion, and changes in heart rate and blood pressure. Seek immediate medical attention if you experience these symptoms.
• Tardive dyskinesia: Long-term use may cause involuntary movements of the face or tongue. Inform your doctor if you notice such symptoms.
• Orthostatic hypotension (low blood pressure upon standing): May cause dizziness or fainting, especially during initiation of treatment.
• Cognitive and motor impairments: Olanzapine may affect your ability to drive or operate machinery.

Use in elderly patients
Elderly patients with dementia-related psychosis have an increased risk of death and stroke when treated with antipsychotics. Olanzapine is not approved for the treatment of dementia-related behavioral disorders.

Use in children and adolescents under 18 years
The safety and efficacy of olanzapine in pediatric patients have not been established. Use in this age group is not recommended.

Use during pregnancy and breastfeeding

• Pregnancy: Olanzapine may be used during pregnancy only if clearly needed. Newborns exposed to olanzapine in the third trimester may experience extrapyramidal symptoms or withdrawal symptoms.
• Breastfeeding: Olanzapine passes into breast milk. Breastfeeding is not recommended during treatment.

Driving and use of machines
Olanzapine may cause drowsiness, dizziness, or blurred vision. Do not drive or operate machinery until you know how this medicine affects you.

Lactose intolerance
Olanzapine Flas Qualigen contains lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Talk to your doctor or pharmacist if you have any other medical conditions or are taking other medications, including over-the-counter drugs or herbal supplements, as they may interact with olanzapine.

Do not take Olanzapine Flas Qualigen

• 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 Olanzapine Flas Qualigen

• The use of Olanzapine 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 Olanzapine 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 Olanzapine 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 sugar and fats (triglycerides and cholesterol) in the blood 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 Olanzapine 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 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 or vomiting, or due to the use of 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 a transient ischemic attack.

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 Flas Qualigen.

Other medicines and Olanzapine Flas Qualigen

Only use other medicines together with this medicine if authorized by your doctor. You may feel drowsiness if Olanzapine Flas Qualigen 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 Olanzapine Flas Qualigen may need to be adjusted.

Drinking alcohol while taking Olanzapine Flas Qualigen

You must 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 must 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 Olanzapine 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 while taking this medicine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine Flas Qualigen contains lactose, aspartame, and sodium.

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

This medicine contains 1.06 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 properly eliminate it.

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

3. How to take Olanzapine Flas Qualigen

Follow exactly the instructions for using 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 between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking this medicine unless your doctor tells you to.

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. You may take them with or without food. The Olanzapine Flas Qualigen orodispersible tablets 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 by 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.

Alternatively, the tablet may 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 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 or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the packaging with the tablets.

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 just because you feel better. It is very important that you continue taking this medicine for as long as your doctor instructs.

If you stop taking Olanzapine Flas Qualigen 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 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), 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 attention immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of 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 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 (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 decreased 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 (jaundice); a muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection (priapism).

Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS presents 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 an increase in 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, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 the 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 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. Contents of the pack and other information

Composition of Olanzapina Flas Qualigen

The active substance is olanzapine. Each Olanzapina Flas Qualigen orodispersible tablet contains 10 mg of active substance.

The other components are monohydrate lactose, 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 10 mg and pack contents

Olanzapina Flas Qualigen 10 mg orodispersible tablets are yellow.

Olanzapina Flas Qualigen 10 mg orodispersible tablets are available in packs of 28 and 56 tablets.

Other presentations:

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

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

Olanzapina Flas Qualigen 20 mg orodispersible tablets: packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 review 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/