Olanzapina Stada

Package Leaflet: Information for the User

Olanzapina STADA, 5 mg, coated tablets

Olanzapina STADA, 10 mg, coated tablets

Olanzapinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Olanzapina STADA and what is it used for
• 2. Important information before taking Olanzapina STADA
• 3. How to take Olanzapina STADA
• 4. Possible side effects
• 5. How to store Olanzapina STADA
• 6. Contents of the pack and other information

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

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

• Schizophrenia: a disease characterized by the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. The patient may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes, a disease with symptoms of excitement or euphoria.

It has been shown that Olanzapina STADA prevents the recurrence of these symptoms in patients with bipolar affective disorder, who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olanzapina STADA

When not to take Olanzapina STADA

• If the patient is allergic to olanzapine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or difficulty breathing. If the patient has experienced such symptoms, they should inform their doctor.
• If the patient has previously been diagnosed with eye diseases, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting to take Olanzapina STADA, the patient should discuss it with their doctor or pharmacist.

• Olanzapina STADA is not recommended for use in elderly patients with a diagnosis of dementia, as it may cause severe side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapina STADA, the patient should inform their doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the patient should contact their doctor immediately.
• In patients taking Olanzapina STADA, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consideration should be given to consulting a dietitian or helping to establish a diet.
• In patients taking Olanzapina STADA, high blood sugar and lipid (triglyceride and cholesterol) levels have been observed. Before taking Olanzapina STADA and regularly during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipids.
• The patient should tell their doctor if they or anyone in their family has had blood clots, as the use of this type of medicine has been associated with their formation.

The patient should immediately inform their doctor if they have any of the following diseases:

• stroke or "mini" stroke (transient symptoms of stroke),
• Parkinson's disease,
• prostate disorders,
• intestinal obstruction (paralytic),
• liver or kidney disease,
• blood disorders,
• heart disease,
• diabetes,
• seizures,
• if the patient knows they may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urinary medicines).

If the patient has dementia and has had a stroke or "mini" stroke, the patient or their caregiver should inform their doctor. As a precaution, in people over 65 years of age, the doctor may regularly check blood pressure.

Children and adolescents

Olanzapina STADA is not intended for use in patients under 18 years of age.

Olanzapina STADA and other medicines

A patient taking Olanzapina STADA may only take other medicines with the consent of their doctor. Taking Olanzapina STADA in combination with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness. The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should tell their doctor about:

• medicines used in Parkinson's disease,
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - it may be necessary to change the dose of Olanzapina STADA.

Taking Olanzapina STADA with alcohol

The patient should not drink alcohol while taking Olanzapina STADA, as alcohol in combination with the medicine may cause drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should not take this medicine if they are breastfeeding, as small amounts of Olanzapina STADA may pass into breast milk. In newborns whose mothers took Olanzapina STADA in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If the patient notices such symptoms in their child, they should contact their doctor.

Driving and operating machinery

If the patient is taking Olanzapina STADA, there is a risk of drowsiness. If the patient feels drowsy, they should not drive or operate any machinery or mechanical equipment. The patient should inform their doctor about this.

Olanzapina STADA contains lactose.

If the doctor has informed the patient that they have an intolerance to some sugars, the patient should contact their doctor before taking this medicine.

Olanzapina STADA contains soy lecithin.

Do not use if the patient has a known hypersensitivity to peanuts or soy.

3. How to take Olanzapina STADA

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will decide how many tablets and how long to take Olanzapina STADA. The daily dose of Olanzapina STADA is from 5 mg to 20 mg. If the symptoms of the disease recur, the patient should inform their doctor. However, the patient should not stop taking Olanzapina STADA until their doctor decides to do so. Olanzapina STADA should be taken once a day, as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. The tablets should be taken orally, swallowed whole with water.

Taking a higher dose of Olanzapina STADA than recommended

In patients who have taken a higher dose of Olanzapina STADA than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, abnormal movements (especially in the face and tongue), and reduced consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disturbances. If any of these symptoms occur, the patient should immediately contact their doctor or go to the hospital. The patient should show the doctor the packaging of the tablets.

Missing a dose of Olanzapina STADA

The patient should take the tablet as soon as they remember. The patient should not take a double dose on the same day to make up for the missed dose.

Stopping treatment with Olanzapina STADA

The patient should not stop taking the tablets, even if they feel better. It is important to take Olanzapina STADA for as long as the doctor recommends. If the patient suddenly stops taking Olanzapina STADA, the following symptoms may occur: sweating, insomnia, trembling, anxiety, or nausea and vomiting. The doctor may recommend gradually reducing the dose of Olanzapina STADA before ending treatment. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Olanzapina STADA can cause side effects, although not everybody gets them. The patient should immediately inform their doctor if they experience any of the following symptoms:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 people);
• blood clots in the veins (uncommon side effects that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If the patient notices any of these symptoms, they should immediately consult their doctor;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high body temperature, enlarged lymph nodes, elevated liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia). Very common side effects (may affect more than 1 in 10 people) include:

• weight gain;
• drowsiness;
• increased prolactin levels in the blood. At the beginning of treatment, some people may experience dizziness or fainting (with slow heart rate), especially when getting up from a lying or sitting position. These symptoms usually go away on their own, but if they do not, the patient should inform their doctor.

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

• changes in the number of certain blood cells and lipid levels in the blood, transient increases in liver enzyme activity at the beginning of treatment;
• increased blood sugar and urine levels;
• increased uric acid and creatine phosphokinase levels in the blood;
• increased appetite, dizziness;
• restlessness, trembling;
• movement disorders (dyskinesia), constipation;
• dry mouth, rash;
• loss of strength;
• extreme fatigue;
• water retention in the body, causing swelling of the hands, ankles, or feet;
• fever, joint pain;
• sexual disorders, 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 in the mouth and throat, itching, rash);
• diabetes or its exacerbation, sometimes combined with the occurrence of ketoacidosis (presence of ketone bodies in the blood and urine) or coma;
• seizures, usually in patients who have had seizures (epilepsy) before;
• muscle stiffness or spasms (including eye movements);
• restless legs syndrome;
• speech disorders;
• stuttering;
• slow heart rate;
• sensitivity to sunlight;
• nasal bleeding;
• abdominal bloating;
• salivation;
• memory loss or confusion;
• urinary incontinence;
• difficulty urinating;
• hair loss;
• absence or decrease of menstrual periods;
• changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.

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

• decreased body temperature;
• heart rhythm disturbances;
• sudden, unexplained death;
• pancreatitis causing severe abdominal pain, fever, and nausea;
• liver disease characterized by yellowing of the skin and whites of the eyes;
• muscle disease characterized by unexpected muscle pain;
• prolonged and/or painful erection.

In elderly patients with dementia, the following side effects may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, redness of the skin, and walking difficulties. Several fatal cases have been reported in this particular group of patients. In patients with Parkinson's disease, Olanzapina STADA may worsen the symptoms of the disease.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Olanzapina STADA

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. Blisters:Store in the original packaging to protect from light and moisture. Containers:Store in the original packaging. Keep the container tightly closed to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Olanzapina STADA contains

• The active substance of the medicine is olanzapine. Each Olanzapina STADA tablet contains 5 mg or 10 mg of the active substance.
• The other ingredients are: (tablet core) lactose anhydrous, microcrystalline cellulose, crospovidone (type A), magnesium stearate, and (tablet coating) polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), talc, soy lecithin, xanthan gum.

What Olanzapina STADA looks like and contents of the pack

5 mg coated tablet: round, biconvex, white coated tablet with a diameter of 8 mm, with the inscription "O1" on one side. 10 mg coated tablet: round, biconvex, white coated tablet with a diameter of 10 mm, with the inscription "O3" on one side. Available packs: 28 and 30 coated tablets. Marketing authorization holder:STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

Centrafarm Services B.V., Nieuwe Donk 9, 4879 Etten-Leur, Netherlands Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland LAMP SAN PROSPERO S.p.A., Via della Pace, 25/A, 41030 San Prospero (Modena), Italy PharmaCoDane ApS., Marielundvej 46A, 2730 Herlev, Denmark STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany Stada Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria Eurogenerics N.V., Heizel Esplanade B 22, B-1020 Brussels, Belgium Sanico N.V., Industriezone, Veedijk 59, BE - 2300 Turnhout, Belgium Coripharma ehf., Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland

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

Denmark Olanzapin STADA Austria Olanzapin STADA 5 mg, 10 mg, Filmtabletten Belgium Olanzapine EG 5 mg, 10 mg, filmomhulde tabletten Bulgaria Olanzapin STADA Ireland Olanzapine 5 mg, 10 mg, Film-coated Tablets Italy Olanzapina EG 5 mg and 10 mg compresse rivestite con film Luxembourg Olanzapine EG 5 mg, 10 mg, comprimés pelliculés Poland Olanzapina STADA Sweden Olanzapin STADA 5 mg, 10 mg filmdragerade tabletter

Date of last revision of the leaflet: 09/2022