Olanzapine Normon 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina NORMON 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, consult 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Olanzapina NORMON contains the active substance olanzapine. Olanzapina NORMON belongs to the therapeutic group known as 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 feel depressed, anxious, or tense.
• Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.

Olanzapina NORMON 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 Olanzapina NORMON

Do not take Olanzapina NORMON

• 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 a 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 taking Olanzapina NORMON

• Use of Olanzapina NORMON 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 NORMON, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina NORMON. 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 Olanzapina NORMON. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Olanzapina NORMON and regularly during treatment.
• If you or a family member 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 reduced blood flow to the brain (transient ischemic attack 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 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 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 Olanzapina NORMON.

Other medicines and Olanzapina NORMON

Only use other medicines together with Olanzapina NORMON if your doctor authorizes it. You may feel drowsy if Olanzapina NORMON 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 Olanzapina NORMON may need to be adjusted.

Alcohol and Olanzapina NORMON

Do not drink alcohol while taking Olanzapina NORMON, as combining it with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You must not take this medicine while breastfeeding, as small amounts of Olanzapina NORMON may pass into breast milk.

The following symptoms may occur in newborn babies whose mothers have been treated with Olanzapina NORMON 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 Olanzapina NORMON. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina NORMON contains lactose

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

3. How to take Olanzapine NORMON

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Olanzapine NORMON orodispersible 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. Olanzapine NORMON orodispersible tablets are for oral administration.

Olanzapine NORMON orodispersible tablets dissolve easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1 & 2. Hold the blister by the edges

1. Carefully remove the tablet to avoid breaking it.
2. 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 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 NORMON than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Show the doctor the container with the tablets.

Patients who have taken more Olanzapine NORMON 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 possible symptoms 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 container with the tablets.

If you forget to take Olanzapine NORMON

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 NORMON

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

If you stop taking Olanzapine NORMON suddenly, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting. 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 affecting up to 1 in 10 people), especially of the face or tongue.

• blood clots in the veins (an uncommon adverse effect affecting 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 mental confusion or drowsiness (frequency cannot be estimated from the 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 standing 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, circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased blood levels of uric acid and creatine phosphokinase; increased appetite; dizziness; restlessness; tremor; abnormal 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 (acetone in blood and urine) or coma; seizures, mostly occurring in patients with 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; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in both 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 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). DRESS initially 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 increased levels of a type of white blood cell (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 patient group.

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

Reporting of adverse effects

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

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.

Olanzapine NORMON should be stored in its original packaging to protect it from light and moisture.

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

6. Contents of the pack and other information

Composition of Olanzapina NORMON

• The active substance is olanzapine. Each Olanzapina NORMON orodispersible tablet contains 10 mg of active substance.
• The other components are crospovidone (type A), monohydrate lactose, colloidal anhydrous silica, hydroxypropylcellulose, peppermint flavor (consisting of peppermint essential oil, terpene-free peppermint essential oil, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.

Appearance of the product and contents of the pack

Olanzapina NORMON 10 mg orodispersible tablets are yellow.

An orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, making it easier to swallow.

Olanzapina NORMON 10 mg is available in cardboard packs containing 28 and 56 tablets.

OTHER PRESENTATIONS

Olanzapina NORMON 5 mg orodispersible tablets EFG.

Olanzapina NORMON 15 mg orodispersible tablets EFG.

Olanzapina NORMON 20 mg orodispersible tablets EFG.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A
Ronda de Valdecarrizo, 6
28760 Tres Cantos
Madrid
SPAIN

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Olanzapina NORMON 10 mg orodispersible tablets EFG

This leaflet was approved in April 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/.

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73600/P_73600.html.