OLANZAPINE NORMON 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine NORMON 15 mg orodispersible 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Olanzapine NORMON contains the active substance olanzapine. Olanzapine NORMON belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a disease with symptoms such as excitement or euphoria.

Olanzapine 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 you take Olanzapine NORMON

Do not take Olanzapine NORMON

• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest 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

Consult your doctor or pharmacist before starting to take Olanzapine NORMON

• Olanzapine NORMON is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine NORMON, tell your doctor.
• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapine NORMON. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine NORMON. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine NORMON and regularly during treatment.
• If you or a family member have a history of blood clots, consult your doctor as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• Stroke or lack of blood flow to the brain (transient symptoms of stroke).
• 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 salt loss due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patient under 18 years should not take Olanzapine NORMON.

Other medicines and Olanzapine NORMON

Only use other medicines at the same time as Olanzapine NORMON if your doctor authorizes it. You may feel drowsy if you combine Olanzapine NORMON with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor if you are taking, have recently taken or may need to take any other medicine.

In particular, 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 NORMON may need to be changed.

Using Olanzapine NORMON with alcohol

Do not drink alcohol while taking Olanzapine NORMON as the combination 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 should not take this medicine when you are breastfeeding as small amounts of Olanzapine NORMON may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapine NORMON in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding.

If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine NORMON. If this happens to you, do not drive or use machinery. Consult your doctor.

Olanzapine NORMON contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Olanzapine NORMON

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 from 5 mg to 20 mg. Consult your doctor if you suffer from symptoms again but do not stop taking Olanzapine NORMON unless your doctor tells you to.

Olanzapine NORMON orodispersible tablets should be taken once a day, following the instructions of your doctor. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine NORMON orodispersible tablets are for oral administration.

Olanzapine NORMON orodispersible tablets dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands as they may dissolve.

1 & 2. Hold the blister pack by the ends

1. Remove the tablet carefully to avoid it breaking.
2. Place the tablet in the mouth. It will dissolve directly in the mouth, making it easy to swallow.

You can also put the tablet in a cup or glass of water, orange juice, apple juice, milk or coffee, stirring it. With some drinks, the mixture may change color and appear cloudy. It should be drunk immediately.

If you take more Olanzapine NORMON than you should

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

Patient who have taken more Olanzapine NORMON than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the above symptoms. Show the doctor the package 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 while your doctor tells you to.

If you stop taking Olanzapine NORMON suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (a rare side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see a doctor immediately.

• a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness (the frequency cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually goes away on its own, but if it does not, consult your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes 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 side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases 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 urination ability; hair loss; absence or decrease of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (may affect up to 1 in 1,000 people) include a drop in normal body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later with an extensive rash, fever, swollen 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, a rise in body temperature, skin redness and walking problems. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton 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 should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE Point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine NORMON

• The active substance is olanzapine. Each Olanzapine NORMON orodispersible tablet contains 15 mg of active substance.
• The other ingredients are crospovidone (type A), lactose monohydrate, 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 pack contents

Olanzapine NORMON 15 mg orodispersible tablets are yellow.

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

Olanzapine NORMON 15 mg is available in cartons containing 28, 35, 56 and 70 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON S.A

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid

SPAIN

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

Spain Olanzapine NORMON 15 mg orodispersible tablets EFG

This leaflet was approved in April 2021

Detailed and updated information on this medicine 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 updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77433/P_77433.html.