Olanzapine Normon 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina NORMON 5 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 other people, 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.

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 adverse 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 a therapeutic group 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 condition may also experience depression, anxiety, or tension.
• 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 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 Olanzapina NORMON

• The 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, mainly in the face or tongue. If this occurs after taking Olanzapina NORMON, 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 you experience this, 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 dietitian.

• 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).
• 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 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 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 authorized by your doctor. You may experience drowsiness 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.

Use of Olanzapina NORMON with alcohol

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 might 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 newborns 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 while 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 Olanzapina 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 Olanzapina NORMON orodispersible tablets to take and for how long. The daily dose of Olanzapina NORMON ranges from 5 mg to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina NORMON unless your doctor tells you to.

Olanzapina NORMON orodispersible tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. Olanzapina NORMON orodispersible tablets are for oral use.

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

1 & 2. Hold the blister pack 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. The solution should be drunk immediately.

If you take more Olanzapina NORMON than you should

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

Patients who have taken more Olanzapina NORMON 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 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 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 containing the tablets.

If you forget to take Olanzapina NORMON

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

If you stop taking Olanzapina NORMON

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

If you stop taking Olanzapina NORMON suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, 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 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 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. In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from lying or sitting positions. 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 levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in blood; increased appetite; dizziness; agitation; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; 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; 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 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 pain, 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, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking may occur. Some deaths have been reported in this particular patient group.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly 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 Olanzapina NORMON

• The active substance is olanzapine. Each orodispersible tablet of Olanzapina NORMON contains 5 mg of active substance.
• The other components are crospovidone (type A), lactose monohydrate, colloidal anhydrous silica, hydroxypropylcellulose, peppermint flavour (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 5 mg orodispersible tablets are yellow.

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

Olanzapina NORMON 5 mg is available in cardboard packs containing 28 tablets.

OTHER PRESENTATIONS

Olanzapina NORMON 10 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 5 mg orodispersible tablets EFG

This summary of product characteristics was approved in April 2021

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.gob.es/.

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

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73599/P_73599.html.