Olanzapine Lekam

Package Leaflet: Information for the Patient

OLANZAPINE LEKAM, 5 mg

OLANZAPINE LEKAM, 10 mg

OLANZAPINE LEKAM, 15 mg

OLANZAPINE LEKAM, 20 mg

orally disintegrating tablets
Olanzapine

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

• You should 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. 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 Olanzapine Lekam and what is it used for

2. Important information before taking Olanzapine Lekam

3. How to take Olanzapine Lekam

4. Possible side effects

5. How to store Olanzapine Lekam

6. Contents of the pack and other information

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

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

• Schizophrenia, a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are not based on reality, being overly suspicious, and withdrawing from contact with others. Patients with this disease may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes, which are conditions characterized by excitement or euphoria.

It has been shown that Olanzapine Lekam 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 Olanzapine Lekam

When not to take Olanzapine Lekam

Warnings and precautions

Before taking Olanzapine Lekam, you should consult your doctor or pharmacist.

• Olanzapine Lekam is not recommended for use in elderly patients with dementia, as it may cause serious side effects.
• Medicines of this type may cause abnormal movements, especially in the face or tongue. If you experience such symptoms after taking Olanzapine Lekam, you should inform your doctor.
• Very rarely, medicines of this type can cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If you experience such symptoms, you should contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapine Lekam, so 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 starting Olanzapine Lekam and regularly 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, as similar medicines have been associated with the formation of blood clots.

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

• Stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate disorders
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know that you may have lost electrolytes due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urine-inducing medicines).

If you have dementia and have ever had a stroke or "mini" stroke, you or your caregiver should inform your doctor.
In order to be cautious, in people over 65 years of age, the doctor may routinely check blood pressure.

Children and adolescents

Olanzapine Lekam orally disintegrating tablets are not intended for use in patients under 18 years of age.

Olanzapine Lekam and other medicines

People taking Olanzapine Lekam orally disintegrating tablets may only take other medicines with the consent of their doctor. Taking Olanzapine Lekam in combination with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness.
You should inform 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 inform your doctor about taking:

• medicines used in Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Olanzapine Lekam may be necessary.

Olanzapine Lekam with alcohol

While taking Olanzapine Lekam orally disintegrating tablets, you should not drink alcohol, as olanzapine 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 before taking this medicine. You should not take Olanzapine Lekam during breastfeeding, as small amounts of it may pass into breast milk.
The following symptoms may occur in newborns whose mothers took Olanzapine Lekam in the last trimester (last three months) of pregnancy: tremors, muscle stiffness and/or weakness, drowsiness, excitement, breathing problems, and feeding difficulties.
If your child experiences any of these symptoms, you should contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking Olanzapine Lekam. If you experience this symptom, you should not drive vehicles or operate machines.
You should inform your doctor.

Olanzapine Lekam contains aspartame

Patients who cannot take phenylalanine should be aware that Olanzapine Lekam orally disintegrating tablets contain aspartame, which is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Patients who cannot take mannitol must be aware that Olanzapine Lekam contains mannitol.

3. How to take Olanzapine Lekam

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 Olanzapine Lekam tablets you should take and for how long you should take them. The daily dose of Olanzapine Lekam is 5 to 20 mg. If symptoms recur, you should consult your doctor, but you should not stop taking Olanzapine Lekam unless your doctor advises you to do so.
Olanzapine Lekam should be taken once a day, as directed by your doctor. If possible, you should take the tablets at the same time every day. The tablets can be taken with or without food. Olanzapine Lekam is taken orally.
The Olanzapine Lekam tablet should be placed in the mouth, where it will quickly dissolve in saliva and can be easily swallowed. It is difficult to remove the tablet from the mouth in its intact form. Since the tablet is fragile, it should be taken immediately after removal from the blister pack. The tablet can also be dissolved in a full glass of water or other liquid (orange juice, apple juice, milk, or coffee) immediately before administration. With some liquids, the mixture may change color and become cloudy. It should be taken immediately.

Taking a higher dose of Olanzapine Lekam than recommended

In patients who have taken a higher dose of Olanzapine Lekam orally disintegrating tablets than recommended, the following symptoms have been observed: rapid heartbeat, excitement/aggressive behavior, difficulty speaking, abnormal movements (especially of the face or tongue), and decreased consciousness. Other possible symptoms include: acute confusion, 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. You should immediately consult a doctor or go to the hospital if you experience any of these symptoms.
You should show the doctor the packaging of the tablets.

Missing a dose of Olanzapine Lekam

If you miss a dose, you should take it as soon as you remember. You should not take two doses in one day.

Stopping treatment with Olanzapine Lekam

You should not stop taking the tablets just because your symptoms improve. It is important to continue taking Olanzapine Lekam orally disintegrating tablets for as long as your doctor has prescribed.
If you suddenly stop taking Olanzapine Lekam orally disintegrating tablets, you may experience: sweating, insomnia, tremors, restlessness, or a feeling of nausea and vomiting. Before ending therapy, your doctor may recommend gradually reducing the dose.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapine Lekam can cause side effects, although not everybody gets them.
You should immediately inform your doctor 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). Clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, you should immediately consult your doctor;
• simultaneously: 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 (may affect more than 1 in 10 people):

• weight gain;
• drowsiness;
• 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 (may affect up to 1 in 10 people):

• changes in the number of certain blood cells, blood lipid levels, and 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;
• tremors;
• movement disorders (dyskinesias);
• constipation;
• dry mouth;
• rash;
• loss of strength;
• extreme fatigue;
• water retention in the body leading to swelling of the hands, ankles, or feet;
• fever;
• joint pain;
• sexual disorders such as decreased libido in both sexes and erectile dysfunction in men.

Uncommon side effects (may affect up to 1 in 100 people):

• hypersensitivity (e.g., swelling in the mouth and throat, itching, rash);
• diabetes or worsening of its course, occasionally with 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;
• increased sensitivity to sunlight;
• nosebleeds;
• abdominal bloating;
• salivation;
• memory loss or confusion;
• urinary incontinence;
• difficulty urinating;
• hair loss;
• absence or decrease of menstruation;
• changes in breast tissue in women and men, such as milk secretion or breast enlargement.

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

• 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 muscle pain of unknown origin;
• prolonged and/or painful erections.

In elderly patients with dementia, the following side effects may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, redness of the skin, and difficulty moving. Several fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease, Olanzapine Lekam orally disintegrating tablets may worsen symptoms.
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 fever, swollen lymph nodes, elevated liver enzymes, and increased eosinophil counts.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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.: 22 49-21-301,
fax: 22 49-2- 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Lekam

The medicine should be stored out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the month.
The medicinal product does not require special storage conditions.
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 Lekam contains

• -The active substance of the medicine is olanzapine. Each tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of the active substance.
• -The other ingredients of the medicine are mannitol, crospovidone, aspartame, talc, and magnesium stearate.

What Olanzapine Lekam looks like and contents of the pack

Olanzapine Lekam orally disintegrating tablets, 5 mg: yellow or light yellow tablets, slightly speckled, round, with the inscription "OV1" on one side and smooth on the other.
Olanzapine Lekam orally disintegrating tablets, 10 mg: yellow or light yellow tablets, slightly speckled, round, with the inscription "OV2" on one side and smooth on the other.
Olanzapine Lekam orally disintegrating tablets, 15 mg: yellow or light yellow tablets, slightly speckled, round, with the inscription "OV3" on one side and smooth on the other.
Olanzapine Lekam orally disintegrating tablets, 20 mg: yellow or light yellow tablets, slightly speckled, round, with the inscription "OV4" on one side and smooth on the other.
Olanzapine Lekam is available in packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Lek-Am Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
tel. (+48) (22) 785 27 60
fax (+48) (22) 785 27 60 ext. 106
Poland

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.,
124 Fabricii Street,
400 632 Cluj Napoca,
Romania

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

Austria, Sweden - Olanzapine Ranbaxy
Netherlands, Spain – Olanzapine SUN
Germany - Olanzapin Basics
Romania – Olanzapina Terapia
France – OLANZAPINE CRISTERS

Date of last revision of the leaflet:

• 03.10.2022