Olanzapine +pharma

Package leaflet: Information for the user

Olanzapine +pharma, 5 mg, tablets
Olanzapine +pharma, 10 mg, tablets
Olanzapinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Olanzapine +pharma is and what it is used for

Olanzapine +pharma contains the active substance olanzapine. Olanzapine +pharma belongs to a group of medicines called antipsychotics and is used to treat:

• schizophrenia – a disorder characterized by patients hearing, seeing or experiencing things that do not exist in reality, having beliefs that are inconsistent with reality, being excessively suspicious and withdrawing from contact with others. The patient may experience depression, anxiety or tension.
• moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

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

2. Important information before taking Olanzapine +pharma

When not to take Olanzapine +pharma

• if the patient is allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, swelling of the lips or difficulty breathing. If such symptoms occur, inform the doctor immediately.
• if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzapine +pharma, discuss this with your doctor or
pharmacist.

• Use of Olanzapine +pharma is not recommended in elderly patients with dementia, as it may cause very serious adverse reactions.
• Medicines of this class may cause abnormal movements, especially of the face or tongue. If such a symptom occurs after taking Olanzapine +pharma, inform your doctor.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy. If these symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients treated with olanzapine. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• High blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Before starting and during treatment with Olanzapine +pharma, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform the doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the treating doctor immediately:

• stroke or "mini" stroke (transient ischemic attack);
• Parkinson's disease;
• prostate gland disorders;
• intestinal obstruction (paralytic ileus);
• liver or kidney disease;
• blood disorders;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they may have lost body salts due to prolonged, severe diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported
(by the patient or caregiver) to the doctor.
As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.
Children and adolescents
Olanzapine +pharma is not intended for use in patients under 18 years of age.
Olanzapine +pharma and other medicines
Patients taking Olanzapine +pharma should use other medicines only with the doctor's approval.
Concomitant use of Olanzapine +pharma with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• medicines used to treat Parkinson's disease;
• carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Olanzapine +pharma may be necessary.

Olanzapine +pharma and alcohol
Do not drink alcohol after taking Olanzapine +pharma, as this medicine combined with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Breastfeeding women should not take Olanzapine +pharma, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Olanzapine +pharma during the third trimester (last months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If such symptoms are observed in your baby, contact your doctor.
Driving and operating machinery
Olanzapine +pharma may cause drowsiness. If drowsiness occurs, do not drive motor vehicles or operate any machines or mechanical equipment. Inform your doctor.
Olanzapine +pharma contains lactose and sodium
If the doctor has informed the patient of an intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Olanzapine +pharma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Olanzapine +pharma. The daily dose of Olanzapine +pharma ranges from 5 to 20 mg. If symptoms of the illness reappear, inform your doctor. However, do not stop taking Olanzapine +pharma unless your doctor advises you to do so.
Olanzapine +pharma tablets should be taken once daily, as directed by your doctor. Try to take the medicine at the same time each day. It does not matter whether the tablets are taken with or without food.
Olanzapine +pharma tablets are taken orally. Swallow the tablet whole with water.

Taking more Olanzapine +pharma than prescribed
In patients who have taken more than the prescribed dose of Olanzapine +pharma, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behaviour, difficulty speaking, involuntary movements (especially of the facial muscles and tongue), and reduced level of consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation, reduced breathing rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to a hospital if any of these symptoms occur. Show the doctor the medicine packaging.

Missing a dose of Olanzapine +pharma
As soon as you remember, take the missed tablet immediately. Do not take a double dose to make up for the missed dose.

Stopping Olanzapine +pharma treatment
Do not stop taking the tablets just because you feel better. It is important to continue taking Olanzapine +pharma for as long as your doctor has instructed.
If Olanzapine +pharma is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment completely.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should contact your doctor immediately if any of the following occur:

• abnormal movements, especially of the face or tongue (a commonly reported adverse effect, which may affect up to 1 in 10 patients);
• blood clots in the veins (a less commonly reported adverse effect, which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, medical advice should be sought immediately.
• occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy at the same time (the frequency of this adverse effect cannot be determined from available data).

Very common adverse effects (may affect more than 1 in 10 people):
weight gain, drowsiness, and increased blood prolactin levels. In the early stages of treatment, dizziness or fainting (with slowed heart rate) may occur, particularly when rising from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, you should inform your doctor.

Common adverse effects (may affect up to 1 in 10 people):
changes in the count of certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment, increased blood and urine glucose levels, increased blood uric acid and creatine phosphokinase activity, increased appetite, dizziness, restlessness, tremor, movement disorders (dyskinesias), constipation, dry mouth, rash, weakness, extreme fatigue, fluid retention causing swelling of the hands, feet, or ankles, fever, joint pain, and sexual disorders such as decreased libido in men and women or erectile dysfunction in men.

Uncommon adverse effects (may affect up to 1 in 100 people):
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash), diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketones in blood and urine) or coma, seizures, usually in patients who have previously had seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart rate, photosensitivity, nosebleeds, abdominal distension, drooling, memory loss or amnesia, urinary incontinence, difficulty urinating, hair loss, absence or reduction of menstrual periods, breast changes in men and women, such as milk discharge outside of breastfeeding or unusual breast enlargement.

Rare adverse effects (may affect up to 1 in 1,000 people):
reduced body temperature, heart rhythm disturbances, sudden unexplained death, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease manifesting as yellowing of the skin and whites of the eyes, muscle disease presenting as unexplained muscle aches and pain, prolonged and (or) painful erection.

Very rare adverse effects (may affect up to 1 in 10,000 people):
severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and elevated levels of a specific type of white blood cell (eosinophilia).

During treatment with olanzapine in elderly patients diagnosed with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. A number of fatal cases have been reported in this patient group.

In patients with Parkinson's disease, Olanzapine +pharma may worsen adverse effects.

Reporting of adverse effects
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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, https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Olanzapine +pharma

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Olanzapine +pharma contains

• The active substance is olanzapine. Each Olanzapine +pharma tablet contains 5 mg or 10 mg of olanzapine. Additional information on the content of the active substance can be found on the packaging of Olanzapine +pharma.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, and sodium carboxymethyl starch (Type A).

What Olanzapine +pharma looks like and contents of the pack
5 mg Olanzapine +pharma tablets: round, yellow, biconvex tablets with a central dividing line on one side. The tablet can be divided into equal doses.
10 mg Olanzapine +pharma tablets: round, yellow, biconvex tablets.
Olanzapine +pharma is available in cardboard boxes containing 28, 30, or 56 tablets.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland Olanzapine +pharma