Olanzapine Qualigen 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Qualigen 2.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further 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 you, because it may harm 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 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 sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. 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 taking OLANZAPINE QUALIGEN

Do not take OLANZAPINE QUALIGEN

• If you are allergic to olanzapine or 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 taking 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 occurs after taking OLANZAPINE QUALIGEN, 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.
• 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 starting treatment with 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-like symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you suffer from 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.

Children and adolescents

Patients under 18 years of age must not take OLANZAPINE QUALIGEN.

Taking OLANZAPINE QUALIGEN with other medicines

Only take other medicines together with OLANZAPINE QUALIGEN if authorized by your doctor. You may experience 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.

Alcohol and OLANZAPINE QUALIGEN

Do not drink alcohol while taking OLANZAPINE QUALIGEN, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 taken OLANZAPINE QUALIGEN during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows 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 them before taking this medicine.

3. How to take Olanzapine Qualigen

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again. Ask your doctor or pharmacist if you have any doubts.

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

You should take your OLANZAPINE QUALIGEN 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 QUALIGEN coated tablets are for oral use. You must swallow the OLANZAPINE QUALIGEN tablets whole with water.

If you take more OLANZAPINE QUALIGEN than you should

Patients who have taken more OLANZAPINE QUALIGEN 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 or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the package and tablets.

If you forget to take OLANZAPINE 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 OLANZAPINE QUALIGEN

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

If you stop taking OLANZAPINE 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 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 attention immediately.
• a combination of fever, rapid breathing, sweating, muscle rigidity, 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, restlessness, tremor, muscle stiffness or spasms (including eye movements), speech disturbances, constipation, dry mouth, skin rash, weakness, excessive fatigue, 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, 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 muscular disorder presenting as unexplained muscle pain, 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.

OLANZAPINA 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 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).

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 Medicines: http://www.notificaRAM.es/.

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

5. Storage of Olanzapine Qualigen

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

Do not use Olanzapine 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, 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 OLANZAPINE QUALIGEN

• The active substance is olanzapine. Each tablet contains 2.5 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), soya lecithin (E-322) and xanthan gum (E-415).

Appearance of the product and contents of the pack

Olanzapine Qualigen 2.5 mg is presented as film-coated tablets. The tablets are round and white.

Packaged in packs of 28 tablets.

Other presentations:

Olanzapine Qualigen 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 Health Products (AEMPS) http://www.aemps.gob.es/.