OLANZAPINE SUN 5 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Olanzapine SUN orodispersible tablets

Do not take Olanzapine SUN orodispersible tablets

• If you are allergic (hypersensitive) to olanzapine or any of the other components of this medication (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 eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine SUN orodispersible tablets

• Olanzapine orodispersible tablets are not recommended for use in elderly patients with dementia, as they may have serious side effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine orodispersible tablets, tell your doctor.
• Very rarely, medications 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 orodispersible tablets. 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) have been observed in the blood of patients taking Olanzapine orodispersible tablets. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine orodispersible tablets 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 the formation of blood clots.

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

• Stroke or transient cerebral ischemia (temporary stroke 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 salt loss due to prolonged and intense diarrhea and vomiting or 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 transient cerebral ischemia.

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

Children and adolescents

Patients under 18 years of age should not take Olanzapine orodispersible tablets.

Using Olanzapine SUN orodispersible tablets with other medications

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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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 SUN orodispersible tablets may need to be changed.

Taking Olanzapine SUN orodispersible tablets with alcohol

You should not drink alcohol if you have been given Olanzapine orodispersible tablets, 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 medication. You should not take this medication during pregnancy unless your doctor recommends it.

You should not take this medication while breastfeeding, as small amounts of Olanzapine SUN may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine orodispersible tablets in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

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

Olanzapine SUN orodispersible tablets contain aspartame

Patients who cannot take phenylalanine should note that Olanzapine orodispersible tablets contain aspartame, which is a source of phenylalanine. It may be harmful to people with phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly

Patients who cannot take mannitol should note that Olanzapine SUN orodispersible tablets contain mannitol. It may produce a mild laxative effect because it contains mannitol.

3. How to take Olanzapine SUN orodispersible tablets

Follow 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 Olanzapine orodispersible tablets you should take and for how long. The daily dose of Olanzapine orodispersible tablets ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine unless your doctor tells you to.

You should take your Olanzapine orodispersible tablets 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. Olanzapine orodispersible tablets are for oral administration.

Olanzapine orodispersible tablets should be placed in the mouth, where they dissolve rapidly with saliva, so they can be easily swallowed. Removing the orodispersible tablet from the mouth intact is difficult. Because the orodispersible tablet is fragile, it should be taken immediately after opening the blister pack. Alternatively, you can also dissolve the tablet in a glass of water or other suitable beverage (orange juice, apple juice, milk, or coffee) immediately before administration.

With some beverages, the mixture may change color and possibly become cloudy. It should be drunk immediately. The orodispersible tablets break easily, so you should handle them carefully. Do not touch the tablets with wet hands, as they may break.

If you take more Olanzapine SUN orodispersible tablets than you should

Patients who have taken more Olanzapine orodispersible tablets 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 notice any of the above symptoms. It is recommended to show the medication package to the doctor.

Consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount used.

If you forget to take Olanzapine SUN orodispersible tablets

Take your tablet as soon as you remember. Do not take two doses in one day.

If you stop taking Olanzapine SUN orodispersible tablets

Do not stop treatment when you feel better. It is very important that you continue taking Olanzapine while your doctor tells you to.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• 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 sweating, 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, go to the 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):

• Weight gain
• Drowsiness
• Increased levels of prolactin 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 sitting or lying position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (may affect up to 1 in 10 people):

• Changes in the levels of some blood cells, circulating fats, and temporary increases in liver enzymes at the start of treatment
• Increased levels of sugar in blood and urine
• Increased levels of uric acid and creatine phosphokinase in the blood
• Increased appetite
• Dizziness
• Fatigue
• Tremors
• Unusual movements (dyskinesia)
• Constipation
• Dry mouth
• Hives
• Loss of strength
• Extreme fatigue
• Fluid retention that can lead to swelling of hands, ankles, or feet.
• Fever
• Joint pain
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare 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, most often related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stuttering
• Slow heartbeat
• Sensitivity to sunlight
• Nosebleeds
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence
• Loss of urination ability
• Hair loss
• Absence or increase of menstrual periods
• Changes in the breasts in men and women, such as abnormal milk production or abnormal growth

Very rare side effects (may affect up to 1 in 1000 people):

• Decrease in normal body temperature
• Abnormal heart rhythm
• Sudden and unexplained death
• Pancreatitis, which can cause stomach pain, fever, and dizziness.
• Liver disease, which manifests as yellowing of the skin and the white part of the eyes.
• Muscle disease, manifested as unexplained pains and aches.
• Prolonged and/or painful erections

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking problems. Deaths have been reported in this particular group of patients.

Olanzapine orodispersible tablets may worsen the symptoms of patients with Parkinson's disease.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Olanzapine SUN orodispersible tablets

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

Do not use this medication after the expiration date shown on the packaging and blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Package contents and further information Composition of Olanzapine SUN orodispersible tablets

• The active ingredient is olanzapine. Each orodispersible tablet contains 5 mg of active ingredient.
• The other components are: mannitol, crospovidone, aspartame, talc, and magnesium stearate.

Appearance of Olanzapine SUN orodispersible tablets and package contents

Olanzapine SUN 5 mg orodispersible tablets EFG are presented in the form of orodispersible tablets, yellowish in color, slightly speckled, round, with the inscription "OV1" in low relief on one of their faces and smooth on the other face.

This medication is available in packages of 7, 10, 14, 28, 30, 35, 56, and 70 tablets.

Not all package sizes may be marketed.

T

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia SA,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.:+34 93 342 78 90

This medicinal product is authorized in the EEA member states under the following names:

Austria - Olanzapine Ranbaxy 5 mg Orodispersible Tablets

France - Olanzapine SUN 5 mg, Comprime Orodispersible

Germany - Olanzapine Basics 5 mg Orodispersible Tablets

Netherlands - Olanzapine SUN 5 mg Orodispersible Tablets

Poland - Olanzapine Lekam 5mg Tablets for Oral Dispersion

Spain - Olanzapina SUN 5mg Buccal Dispersible Tablets EFG

Romania - Olanzapina Terapia 5mg Orodispersible Tablets

Date of last revision of this leaflet: July 2020

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/