Leaflet: information for the user

Olanzapina Sandoz 5 mg buccodispersible tablets EFG

Olanzapina Sandoz 10 mg buccodispersible tablets EFG

olanzapine

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 Sandoz is and for what it is used

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

3.How to take Olanzapina Sandoz

4.Possible side effects

5.Storage of Olanzapina Sandoz

6.Contents of the pack and additional information

Olanzapina Sandoz contains the active ingredient olanzapina. It belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

• schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion and becoming withdrawn. People who suffer from these diseases may also be depressed, tense or anxious,
• mild to severe manic episodes, a disorder characterized by symptoms of excitement or euphoria.

Olanzapina has 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 Sandoz

- 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 eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Sandoz.

• olanzapina is not recommended for use in elderly patients with dementia as they may have severe adverse effects,
• medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking olanzapina, consult your doctor,
• in rare cases, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this occurs, consult your doctor immediately,
• weight gain has been detected in patients taking olanzapina. 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 olanzapina. Your doctor should perform blood tests to control your blood sugar level and certain fat levels before starting to take olanzapina and regularly during treatment,
• consult your doctor if you or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

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

If you have 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 a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take olanzapina.

Taking Olanzapina Sandoz with other medications

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

Only use other medications at the same time as olanzapina if your doctor authorizes it, as you may feel a certain sense of drowsiness if you combine olanzapina with antidepressants or medications for anxiety or to help sleep (tranquilizers).

Specifically, consult your doctor if you are taking:

• medications 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 olanzapina dose.

Taking Olanzapina Sandoz with alcohol

You should not drink alcohol if you have been administered olanzapina as the combination may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

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

The following symptoms may occur in newborns, from mothers who have used olanzapina 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 experiences any of these symptoms, it may be necessary to contact your doctor.

Driving and operating machinery

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

Olanzapina Sandoz contains lactose

This medication 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again before using this medication.

Your doctor will tell you how many olanzapine tablets to take and for how long. The daily dose of olanzapine 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.

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 because they can disintegrate.

1 and 2.Hold the blister pack by the edges.

3.Gently push the tablet.

4.Place the tablet in your mouth. It will dissolve directly, so it can be easily swallowed.

You can also pour the tablet into 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. It should be consumed immediately.

If you take more Olanzapina 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 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 packaging with the tablets to the doctor.

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.

If you forget to take Olanzapina Sandoz

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

If you interrupt treatment with Olanzapina Sandoz

Do not stop taking olanzapine even if you think you are feeling better.

It is essential that you continue taking olanzapine as long as your doctor tells you to.

If you stop taking olanzapine suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

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

Like all medications, olanzapine may have side effects, although not everyone will experience 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 (a rare 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 your doctor immediately,
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (rare side effects that can affect up to 1 in 1000 people).

Very frequent side effects (can affect more than 1 in 10 people) include:

• weight gain,
• drowsiness,
• increased levels of prolactin 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 seated position. This usually passes on its own, but if not, consult your doctor.

Frequent side effects (can affect up to 1 in 10 people) include:

• changes in levels of some blood cells and circulating lipids,
• temporary increases in liver enzymes, especially at the beginning of treatment, increased levels of sugar in the blood and urine,
• increased levels of uric acid and creatine phosphokinase in the blood,
• feeling more irritable,
• sensation of dizziness,
• restlessness,
• tremors,
• unusual movements (dyskinesias),
• constipation,
• dry mouth,
• skin rash,
• loss of strength,
• excessive fatigue,
• fluid retention that causes inflammation of the 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 (can 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 the 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,
• stammering,
• 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 breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (can affect up to 1 in 1,000 people) include:

• decrease in normal body temperature,
• abnormal heart rhythm,
• sudden death without explanation,
• inflammation of the pancreas, which causes severe stomach pain, fever, and discomfort,
• liver disease with yellowing of the skin and white areas,
• muscle disorder that presents 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, for its acronym in English). DRESS initially manifests with symptoms similar to the flu, with skin rash on the face that then spreads to other areas, fever, lymph node swelling, 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 walking difficulties. 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 medication.

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 and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olanzapina Sandoz

Olanzapina Sandoz 5 mg:

The active ingredient is olanzapina. Each buccal dispersible tablet contains 5 mg of olanzapina.

Olanzapina Sandoz 10 mg:

The active ingredient is olanzapina. Each buccal dispersible tablet contains 10 mg of olanzapina.

The other components are: crospovidone (Type A), lactose monohydrate, colloidal anhydrous silica, hydroxypropylcellulose, peppermint aroma (contains peppermint oil, peppermint oil without terpenes, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.

Appearance of the product and packaging size

Olanzapina Sandoz 5 mg are yellow-colored, round, biconvex tablets, with approximately a diameter of 6 mm and 2.6 mm in thickness.

Olanzapina Sandoz 10 mg are yellow-colored, round, flat tablets, with approximately a diameter of 8.2 mm and 2.4 mm in thickness.

Buccal dispersible tablets are the technical name for a tablet that dissolves directly in the mouth, so it can be easily ingested.

The buccal dispersible tablets are packaged in blisters of PA/ALU/PVC/ALU inserted in cardboard boxes.

Packaging sizes:

1, 14, 28, 35, 56, 70, and 98 buccal dispersible tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with 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 review of this prospectus:June 2020

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