Leaflet: information for the user

Olanzapina NORMON 15 mg buccal dispersible tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Olanzapina NORMON

3. How to take Olanzapina NORMON

4. Possible side effects

5. Storage of Olanzapina NORMON

6. Contents of the pack and additional information

Olanzapina NORMONcontainsthe active ingredient olanzapina. Olanzapina NORMONbelongs to the therapeutic group known as antipsychoticsand is indicated for the treatment of the following diseases:

Olanzapina NORMONhas demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina NORMON

• if you are allergic to olanzapina or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, 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 Olanzapina NORMON.

• Olanzapina NORMON is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina NORMON, tell your doctor.
• In rare cases, medications of this type may produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of 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 check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina NORMON. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina NORMON and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor as medications 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 (symptoms of a 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 electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretics (water pills).

If you have 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, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina NORMON.

Other medications and Olanzapina NORMONOlanzapina NORMON

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

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

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 Olanzapina NORMON dose may need to be modified.

Use of Olanzapina NORMON with alcohol

You should not drink alcohol while taking Olanzapina NORMON as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take this medication while breastfeeding as small amounts of Olanzapina NORMON may pass into breast milk.

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

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

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina NORMON. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina NORMON contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

The buccal tablets of Olanzapina NORMON disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

1 & 2.Hold the blister by the ends

3.Carefully remove the tablet to avoid breaking it.

4.Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also place the tablet in a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. You should drink it immediately.

If you take more Olanzapina NORMON than you should

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

Patients who have taken more Olanzapina NORMON than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms.Contact your doctor or go to the hospital immediately if you experience any of the symptoms specified above. Show the doctor the packaging with the tablets.

If you forget to take Olanzapina NORMON

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina NORMON

Do not stop treatment simply because you feel better. It is very important that you continue taking Olanzapina NORMON as your doctor tells you to.

If you stop taking Olanzapina NORMON suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (a rare side effect that can 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, seek immediate medical attention.

• 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).

Frequent side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased blood prolactin levels. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased blood sugar and urine levels; increased blood uric acid and creatine phosphokinase levels; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation 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.

Rare side effects (which can 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 the 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; nasal bleeding; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; 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 (which can affect up to 1 in 1000 people) include a decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

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

OlanzapineNORMONmay worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Olanzapina NORMON should be stored in the original packaging to protect it from light and humidity.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of OlanzapineNORMON

• The active ingredient is olanzapine. Each buccal dispersible tablet of Olanzapina NORMON contains 15 mg of active ingredient.
• The other components are crospovidone (type A), lactose monohydrate, anhydrous colloidal silica, hydroxypropylcellulose, peppermint essence (consists 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 packaging

Olanzapina NORMON 15 mg buccal dispersible tablets are yellow.

A buccal dispersible tablet is the technical name for a tablet that dissolves directly in the mouth to be swallowed more easily.

Olanzapina NORMON 15 mgis presented in carton containers containing28, 35, 56 and 70tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMONS.A

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid

SPAIN

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainOlanzapina NORMON 15 mg buccal dispersible tabletsEFG

This leaflet has been approved inApril 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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