Olanzapine Lekam

Leaflet accompanying the packaging: Patient information

OLANZAPINE LEKAM, 5 mg

OLANZAPINE LEKAM, 10 mg

OLANZAPINE LEKAM, 15 mg

OLANZAPINE LEKAM, 20 mg

orally disintegrating tablets
Olanzapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell 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 packaging 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 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 other people. Patients with this disease may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes, states of illness whose symptoms are agitation 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 starting treatment with Olanzapine Lekam, you should consult a doctor or pharmacist.

• Olanzapine Lekam is not recommended for use in elderly patients with a diagnosis of 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 a symptom after taking Olanzapine Lekam, you should inform your doctor.
• Very rarely, medicines of this type 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.
• Patient taking Olanzapine Lekam have been observed to have weight gain, so you should regularly check your weight. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• Patient taking olanzapine have been observed to have high blood sugar and lipid levels. Before starting treatment with Olanzapine Lekam and regularly during treatment, your doctor should perform blood tests to determine 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 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 diseases
• Heart disease
• Diabetes
• Seizures
• If you know that you may have experienced electrolyte loss due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urinary medications).

If you have dementia and have ever had a stroke or "mini" stroke, you or your caregiver/relative 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 the age of 18.

Olanzapine Lekam and other medicines

People taking Olanzapine Lekam orally disintegrating tablets may take other medicines only with the consent of a doctor. Taking Olanzapine Lekam 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 about taking:

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

Olanzapine Lekam with alcohol

When 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 a 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: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties.
If your child experiences any of these symptoms, you should contact a doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapine Lekam. If you experience this symptom, you should not drive vehicles or operate machinery.
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 know that Olanzapine Lekam contains mannitol.

3. How to take Olanzapine Lekam

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
The doctor will decide how many Olanzapine Lekam tablets to take and for how long. The daily dose of Olanzapine Lekam is from 5 to 20 mg. If symptoms recur, you should consult a 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, according to the doctor's recommendations. If possible, the tablets should be taken at the same time every day. The tablets can be taken regardless of meals. 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 drink (orange juice, apple juice, milk, or coffee) immediately before administration. With some drinks, the mixture may change color and become cloudy. It should be drunk immediately.
Olanzapine Lekam orally disintegrating tablets are easily broken, so you should handle them carefully. You should not take the medicine with wet hands, as the tablets may disintegrate.

Taking a higher dose of Olanzapine Lekam than recommended

In patients who took a higher dose of Olanzapine Lekam orally disintegrating tablets than recommended, the following symptoms occurred: rapid heartbeat, agitation/aggressive behavior, speech difficulties, 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 disorders. 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 have improved. 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 doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 patients);
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg). Blood 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 a 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 (occurring in more than 1 in 10 patients):

• 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 resolve on their own, but if they persist, you should inform your doctor.

Common side effects (affecting up to 1 in 10 patients):

• 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 activity in the blood;
• increased feeling of hunger;
• 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 (affecting up to 1 in 100 patients):

• 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 galactorrhea or breast enlargement.

Rare side effects (affecting up to 1 in 1000 patients):

• decreased body temperature;
• heart rhythm disorders;
• 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 a diagnosis of dementia, the following may occur when taking olanzapine: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty moving. Several fatal cases have been reported in this particular patient group.
In patients with diagnosed 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 enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia).

Reporting side effects

If you experience any side effects, including those 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.: 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 packaging 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 what the pack contains

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