Olanzapine +pharma

Package Leaflet: Information for the User

Olanzapine +pharma, 5 mg, tablets

Olanzapine +pharma, 10 mg, tablets

Olanzapine

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Olanzapine +pharma and what is it 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 is Olanzapine +pharma and what is it 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 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 experience depression, anxiety, or tension.
• Moderate to severe manic episodes - disease states whose symptoms are agitation or euphoria.

Olanzapine has been shown to prevent 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 Olanzapine +pharma

When not to take Olanzapine +pharma

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be manifested by a rash, itching, swelling of the face, lip swelling, or difficulty breathing. If such symptoms occur, you should inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting treatment with Olanzapine +pharma, you should discuss it with your doctor or pharmacist.

• Olanzapine +pharma is not recommended for use in elderly patients with dementia, as it may cause very serious side effects.
• Medicines in this group can cause abnormal movements, especially in the face or tongue. If you experience such a symptom after taking Olanzapine +pharma, you should inform your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, you should contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. You should have your weight checked regularly. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• High blood sugar and high lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Before taking Olanzapine +pharma and during treatment, your doctor should perform blood tests to determine your blood sugar and lipid levels.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

If you have any of the following conditions, you should immediately inform your doctor:

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

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

Olanzapine +pharma is not intended for use in patients under 18 years of age.

Olanzapine +pharma and other medicines

People taking Olanzapine +pharma may only take other medicines with the consent of their doctor.
Taking Olanzapine +pharma in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor if you are taking:

• medicines used to treat 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 Olanzapine +pharma.

Olanzapine +pharma with alcohol

You should not drink alcohol after taking Olanzapine +pharma, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Olanzapine +pharma should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Olanzapine +pharma in the last trimester (last months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If you notice such symptoms in your child, you should contact your doctor.

Driving and using machines

Olanzapine +pharma may cause drowsiness. If drowsiness occurs, you should not drive vehicles or operate any machines and devices. You should inform your doctor.

Olanzapine +pharma contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Olanzapine +pharma

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Olanzapine +pharma. The daily dose of Olanzapine +pharma is 5 to 20 mg. If the symptoms of the disease recur, you should inform your doctor. However, you should not stop taking Olanzapine +pharma unless your doctor decides to do so.
Olanzapine +pharma tablets should be taken once a day as directed by your doctor. You should try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food.
Olanzapine +pharma tablets are taken orally. The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Olanzapine +pharma than recommended

In patients who have taken a higher dose of Olanzapine +pharma than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased 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, and heart rhythm disorders. You should contact your doctor immediately or go to the hospital if you experience any of these symptoms. You should show your doctor the package with the tablets.

Missing a dose of Olanzapine +pharma

As soon as you remember, you should take a tablet. You should not take a double dose to make up for the missed dose.

Stopping treatment with Olanzapine +pharma

If you feel better, you should not stop taking the tablets. It is important to take Olanzapine +pharma for as long as your doctor recommends.
If you suddenly stop taking Olanzapine +pharma, you may experience the following symptoms: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Olanzapine +pharma before stopping treatment.
If you have any further questions about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should tell your doctor immediately if you experience:

• 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 (an uncommon side effect 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 breathing difficulties. If you notice any of these symptoms, you should seek medical attention immediately.
• 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 common side effects(which may affect more than 1 in 10 people):
weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, you should inform your doctor.
Common side effects(which may affect up to 1 in 10 people):
changes in the number of certain blood cells, lipid levels in the blood, and transient increases in liver enzyme activity at the beginning of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase activity in the blood, increased appetite, dizziness, restlessness, trembling, movement disorders (dyskinesia), constipation, dry mouth, weakness, extreme fatigue, water retention in the body 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 side effects(which may affect up to 1 in 100 people):
allergic reactions (e.g., swelling in the mouth and throat, itching, rash), diabetes or worsening of its course, rarely with ketoacidosis (presence of ketone bodies in the blood and urine) or coma, seizures, usually in patients who have had seizures (epilepsy) in the past, muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slow heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, drooling, memory loss or lack of memory, 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(which may affect up to 1 in 1,000 people):
decreased body temperature, heart rhythm disorders, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease characterized by a change in skin and white eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
Very rare side effects(which may affect up to 1 in 10,000 people):
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 fever, swollen lymph nodes, elevated liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia) in blood tests.
In elderly patients with dementia treated with olanzapine, the following have been reported: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, redness of the skin, and walking disturbances. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, Olanzapine +pharma may worsen side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Olanzapine +pharma

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.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Olanzapine +pharma contains

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

What Olanzapine +pharma looks like and contents of the pack

Olanzapine +pharma 5 mg tablets: round, yellow, biconvex, with a score line on one side. The tablet can be divided into equal doses.
Olanzapine +pharma 10 mg tablets: round, yellow, biconvex.
Olanzapine +pharma is available in cardboard boxes containing 28, 30, and 56 tablets.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

PolandOlanzapine +pharma
Date of last revision of the leaflet:June 2022