Olanzapine Qualigen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Qualigen 5mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you 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 or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

OLANZAPINA QUALIGEN 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whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

OLANZAPINA QUALIGEN 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 Qualigen

Do not take OLANZAPINE 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).
• This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take OLANZAPINE QUALIGEN

• The use of OLANZAPINE 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 to you after taking OLANZAPINE QUALIGEN, tell 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 happens to you, contact your doctor immediately.
• Weight gain has been observed in patients taking OLANZAPINE QUALIGEN. You and your doctor should monitor your weight regularly.
• Increased levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking OLANZAPINE QUALIGEN. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking OLANZAPINE 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 symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or reduced 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 QUALIGEN.

Taking OLANZAPINE QUALIGEN with other medicines

Only use other medicines together with OLANZAPINE QUALIGEN if authorized by your doctor. You may feel increased drowsiness if OLANZAPINE QUALIGEN is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 QUALIGEN may need to be adjusted.

Taking OLANZAPINE QUALIGEN with alcohol

Do not drink alcohol while taking OLANZAPINE QUALIGEN, 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 QUALIGEN may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used OLANZAPINE QUALIGEN 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 has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking OLANZAPINE QUALIGEN. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

OLANZAPINE QUALIGEN contains lactose

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

3. How to take Olanzapina Qualigen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Speak to your doctor or pharmacist if you have any questions.

Your doctor will tell you how many OLANZAPINA QUALIGEN tablets to take and for how long. The daily dose of OLANZAPINA QUALIGEN ranges from 5 to 20 mg. Consult your doctor if your symptoms return, but do not stop taking OLANZAPINA QUALIGEN unless your doctor tells you to do so.

You should take your OLANZAPINA QUALIGEN 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. OLANZAPINA QUALIGEN coated tablets are for oral administration. Swallow the OLANZAPINA QUALIGEN tablets whole with water.

If you take more OLANZAPINA QUALIGEN than you should

Patients who have taken more OLANZAPINA QUALIGEN 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 symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the hospital if you experience any of the symptoms listed above. Show the doctor the package and tablets.

If you forget to take OLANZAPINA QUALIGEN

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking OLANZAPINA QUALIGEN

Do not stop treatment just because you feel better. It is very important to continue taking OLANZAPINA QUALIGEN for as long as your doctor tells you to.

If you stop taking OLANZAPINA 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 experiences 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 sweating, 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 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.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, increased blood and urine sugar levels, increased appetite, dizziness, agitation, tremor, muscle stiffness or spasms (including eye movements), speech disturbances, constipation, dry mouth, skin rash, loss of strength, excessive tiredness, fluid retention causing swelling of the hands, ankles or feet, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men. In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, inform your doctor.

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; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the mammary gland in both men and women, such as abnormal milk production or abnormal breast enlargement, and excessive salivation.

Other adverse effects whose frequency cannot be estimated from available data (not known), include decreased body temperature, abnormal heart rhythm, unexplained sudden 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), muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection.

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 QUALIGEN may worsen symptoms in patients with Parkinson's disease.

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial rash spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es/.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapina Qualigen

Keep this medicine out of the sight and reach of children.

Do not use Olanzapina Qualigen after the expiry date stated on the packaging after EXP. The expiry date is 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 you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OLANZAPINE QUALIGEN

• The active substance is olanzapine. Each tablet contains 5 mg of active substance.
• The other components are: Core: lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropyl cellulose (E-463a), crospovidone, colloidal anhydrous silica (E-551) and magnesium stearate (E-470b). Coating: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soy lecithin (E-322) and xanthan gum (E-415).

Appearance of the medicinal product and contents of the pack

Olanzapine Qualigen 5 mg is presented as film-coated tablets. The tablets are round, white, and marked with the number "5" on one side.

Packaged in packs of 28 tablets.

Other presentations:

Olanzapine Qualigen 2.5 mg film-coated tablets EFG

Olanzapine Qualigen 7.5 mg film-coated tablets EFG

Olanzapine Qualigen 10 mg film-coated tablets EFG

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: July 2021

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