OLANZAPINE SANDOZ 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Sandoz 5 mg orodispersible tablets EFG

Olanzapine Sandoz 10 mg orodispersible tablets EFG

olanzapine

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 and other information

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

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

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

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not real, mistaken beliefs, unusual suspiciousness and becoming withdrawn. People with these diseases may also feel depressed, tense or anxious.
• Manic episodes of moderate to severe intensity, a disorder characterized by symptoms of excitement or euphoria.

Olanzapine 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 Sandoz

Do not take Olanzapine Sandoz

• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may appear as a rash, itching, swelling of the face or lips or difficulty breathing. If this happens, tell your doctor.
• if you have been previously diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Olanzapine Sandoz.

• olanzapine is not recommended for patients over 65 years old with dementia as they may have serious side effects.
• medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, consult your doctor.
• rarely, medicines of this type can cause a combination of fever, rapid breathing, sweating, muscle stiffness and a state of drowsiness or drowsiness. If this happens to you, consult your doctor immediately.
• weight gain has been detected in patients taking olanzapine. You and your doctor should check your weight regularly. If necessary, your doctor may refer you to a nutritionist or help plan a diet.
• high levels of sugar and fats (triglycerides and cholesterol) have been detected in the blood of patients taking olanzapine. Your doctor should perform blood tests to control your blood sugar level and certain fat levels before starting to take olanzapine and regularly during treatment.
• tell your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with the formation of blood clots.

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

• stroke or lack of blood flow to the brain (transient stroke symptoms).
• Parkinson's disease.
• prostate problems.
• intestinal blockage (paralytic ileus).
• liver or kidney disease.
• blood disorders.
• heart disease.
• seizures.
• diabetes.
• seizures.
• if you think you may have loss of salts due to having diarrhea and vomiting (feeling sick) or due to the use of diuretic medications (pills to urinate).

If you suffer from dementia, you or your caregiver/family member should inform your doctor if you have ever had a stroke or 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

Patients under 18 years old should not take olanzapine.

Taking Olanzapine Sandoz with other medicines

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

Only use other medicines at the same time as olanzapine if your doctor authorizes it, as you may feel a certain sensation of sleepiness if you combine olanzapine with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

In particular, tell your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to modify your dose of olanzapine.

Taking Olanzapine Sandoz with alcohol

You should not drink alcohol if you have been given olanzapine as the combination can 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 may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used olanzapine during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby has any of these symptoms, it is possible that you need to contact your doctor.

Driving and using machines

There is a risk of feeling dizzy while taking olanzapine. If this happens to you, do not drive or use tools and machines. Tell your doctor.

Olanzapine Sandoz contains lactose

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

3. How to take Olanzapine Sandoz

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

Your doctor will tell you how many olanzapine tablets you should take and for how long. The daily dose of olanzapine ranges from 5 to 20 mg.

Consult your doctor if you suffer from symptoms again but do not stop taking olanzapine unless your doctor tells you to.

Olanzapine tablets should be taken once a day, following your doctor's instructions. Try to take the tablets at the same time every day. It does not matter if you take them with or without food.

Olanzapine tablets are for oral administration.

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

1 and 2. Hold the blister on the edges.

1. Gently push the tablet.
2. Put the tablet in your mouth. It will dissolve directly, so it can be easily swallowed.

It can also be placed in a cup or glass filled with water, orange juice, apple juice, milk or coffee, stirring. With some drinks, the mixture may change color and take on a cloudy appearance. It should be drunk immediately.

If you take more Olanzapine Sandoz than you should

Patients who have taken more olanzapine 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 be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness and a state of drowsiness or drowsiness, slowing of respiratory rate, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you have any of the above symptoms. Show the doctor the package with the tablets.

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.

If you forget to take Olanzapine Sandoz

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

If you stop taking Olanzapine Sandoz

Do not stop taking olanzapine even if you feel better.

It is important that you continue taking olanzapine while your doctor tells you to.

If you stop taking olanzapine suddenly, symptoms such as sweating, insomnia, tremors, anxiety or nausea and vomiting may appear. Your doctor may suggest reducing the dose gradually 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, olanzapine can have side effects, although not everybody gets them.

Contact your doctor immediately 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 (an uncommon side effect that can 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, see a doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness and a state of drowsiness or drowsiness (rare side effects that can affect up to 1 in 1000 people).

Very common side effects (may affect more than 1 in 10 people) include:

• weight gain.
• drowsiness.
• increased prolactin levels in the blood.
• in the early stages of treatment, some people may feel weak or dizzy (with a slow heart rate), especially when getting up from a sitting position. This usually goes away on its own, but if it doesn't, consult your doctor.

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

• changes in the levels of some blood cells and circulating lipids.
• temporary increases in liver enzymes, especially at the start of treatment, increased blood sugar and urine levels.
• increased levels of uric acid and creatine phosphokinase in the blood.
• feeling more angry.
• feeling dizzy.
• restlessness.
• tremors.
• unusual movements (dyskinesias).
• constipation.
• dry mouth.
• skin rash.
• loss of strength.
• excessive fatigue.
• fluid retention that causes swelling of the hands, ankles or feet.
• fever.
• joint pain.
• sexual dysfunctions 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. swelling of the mouth and throat, itching, rash).
• diabetes or worsening of diabetes, usually associated with ketoacidosis (ketones in blood and urine) or coma.
• seizures, usually associated with a history of seizures (epilepsy).
• muscle stiffness or spasms (including eye movements).
• restless legs syndrome.
• language alteration.
• stuttering.
• slow heart rate.
• sensitivity to sunlight.
• nosebleeds.
• abdominal distension.
• excessive salivation.
• memory loss or forgetfulness.
• urinary incontinence, loss of ability to urinate.
• hair loss.
• absence or decrease of menstrual periods.
• changes in the mammary gland in men and women such as abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include:

• 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 white areas.
• muscle disorder that appears as unexplained pain.
• prolonged and/or painful erection.

Very rare side effects including severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). 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 observed in blood tests and increased levels of a type of white blood cell (eosinophilia).

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

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

Reporting of side effects

If you experience any side effect, 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 Sandoz

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 and blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Olanzapina Sandoz

Olanzapina Sandoz 5 mg:

The active ingredient is olanzapine. Each orodispersible tablet contains 5 mg of olanzapine.

Olanzapina Sandoz 10 mg:

The active ingredient is olanzapine. Each orodispersible tablet contains 10 mg of olanzapine.

The other components are: crospovidone (Type A), lactose monohydrate, colloidal anhydrous silica, hydroxypropylcellulose, peppermint flavor (contains peppermint oil, terpene-free peppermint oil, eucalyptol, menthone, isomenthone, methyl acetate, menthol), talc, magnesium stearate.

Product Appearance and Package Size

Olanzapina Sandoz 5 mg are yellow, round, biconvex tablets, with an approximate diameter of 6 mm and 2.6 mm thickness.

Olanzapina Sandoz 10 mg are yellow, round, flat tablets, with an approximate diameter of 8.2 mm and 2.4 mm thickness.

Orodispersible tablets is the technical name for a tablet that dissolves directly in the mouth, so it can be easily swallowed.

The orodispersible tablets are packaged in PA/ALU/PVC/ALU blisters inserted in cardboard boxes.

Package sizes:

1, 14, 28, 35, 56, 70, and 98 orodispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion str.,

153 51 Pallini Attiki

Greece

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

LEK S.A.

ul. Domaniewska 50 C,

02-672 Warszawa,

Poland

or

LEK, S.A.

Ul Podlipie, 16

Strykow - PL95-010

Poland

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

Germany: Olanzapin HEXAL 5 mg Schmelztabletten

Olanzapin HEXAL 10 mg Schmelztabletten

Belgium: Olanzapine Sandoz 5 mg, orodispergeerbare tabletten

Olanzapine Sandoz 10 mg, orodispergeerbare tabletten

France: OLANZAPINE SANDOZ 5 mg, comprimé orodispersible

OLANZAPINE SANDOZ 10 mg, comprimé orodispersible

Portugal: Olanzapina Sandoz

Sweden: Olanzapin Sandoz 5 mg munsönderfallande tabletter

Olanzapin Sandoz 10 mg munsönderfallande tabletter

Date of the last revision of this leaflet:June 2020

Detailed and updated 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