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
Olanzapinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:
1. What Olanzapine Lekam is and what it is 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 Olanzapine Lekam is and what it is 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 condition in which the patient hears, sees or feels things that do not exist in reality, has beliefs contrary to reality, is excessively suspicious and withdraws from contact with other people. Patients with this condition may also experience depression, anxiety or tension.
• Moderate to severe manic episodes, disease states characterized by excitement or euphoria.

It has been shown that Olanzapine Lekam prevents relapse 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 Lekam

When not to take Olanzapine Lekam

• if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, facial swelling, lip swelling or shortness of breath. If such symptoms occur, inform your doctor;
• if you have previously been diagnosed with eye disorders, including certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzapine Lekam, consult your doctor or pharmacist.

• Use of Olanzapine Lekam is not recommended in elderly patients with dementia, as it may cause serious side effects.
• Medicines of this type may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Olanzapine Lekam, inform your doctor.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapine Lekam; therefore, body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing a proper diet.
• High blood sugar levels and high levels of lipids (triglycerides and cholesterol) have been observed in patients taking olanzapine. Before starting treatment with Olanzapine Lekam and regularly during treatment, your doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• Inform your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with blood clot formation.

If you have any of the following conditions, 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 you may have lost electrolytes due to prolonged, severe diarrhoea and vomiting (nausea with vomiting) or due to the use of diuretics (water tablets).

If you suffer from dementia and have ever had a stroke or "mini" stroke, you or your caregiver/relative should inform your doctor.
As a precaution, your doctor may routinely monitor blood pressure in individuals over 65 years of age.

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

Olanzapine Lekam with other medicines
Patients taking Olanzapine Lekam orally disintegrating tablets should only take other medicines with the approval of a doctor. Taking Olanzapine Lekam together with antidepressants, sedatives or sleeping pills may cause drowsiness.
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, inform your doctor if you are taking:

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

Olanzapine Lekam and alcohol
Do not drink alcohol while taking Olanzapine Lekam orally disintegrating tablets, as olanzapine combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. Do not take Olanzapine Lekam during breastfeeding, as small amounts may pass into breast milk.

The following symptoms may occur in newborns whose mothers took Olanzapine Lekam during the third trimester (last three months) of pregnancy: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems.
If your baby shows any of these symptoms, contact your doctor.

Driving and operating machinery
There is a risk of drowsiness while taking Olanzapine Lekam. If this symptom occurs, do not drive or operate machinery. Inform your doctor.

Olanzapine Lekam contains aspartame
Patients who cannot tolerate 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 tolerate mannitol should know that Olanzapine Lekam contains mannitol.

3. How to use Olanzapine Lekam

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The doctor will decide how many Olanzapine Lekam tablets to take and for how long they should be used. The daily dose of Olanzapine Lekam ranges from 5 to 20 mg. If symptoms recur, consult the doctor, but do not stop taking Olanzapine Lekam unless instructed by the doctor.
Olanzapine Lekam should be taken once daily, as directed by the doctor. Tablets should be taken at approximately the same time each day, if possible. The tablets may be taken independently of meals. Olanzapine Lekam is administered orally.
The Olanzapine Lekam tablet should be placed in the mouth, where it will rapidly dissolve in saliva, making it easy to swallow. It is difficult to remove the tablet from the mouth in an intact form. Since the tablet is fragile, it should be taken immediately after removal from the blister. The tablet may also be dissolved in a full glass of water or another beverage (orange juice, apple juice, milk, or coffee) immediately before administration. With certain beverages, the mixture may change colour and become cloudy. It should be consumed immediately.
Olanzapine Lekam orodispersible tablets are fragile and should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Taking more Olanzapine Lekam than prescribed
In patients who have taken more than the prescribed dose of Olanzapine Lekam orodispersible tablets, the following symptoms have been observed: rapid heartbeat, agitation/aggressive behaviour, difficulty speaking, abnormal movements (especially of the facial muscles or tongue), and reduced consciousness. Other possible symptoms include acute confusion, seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or somnolence, decreased respiratory rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical advice or go to hospital if any of these symptoms occur. Show the doctor the tablet packaging.

If you forget to take Olanzapine Lekam
If a dose is missed, take it as soon as you remember. Do not take two doses within one day.

Stopping Olanzapine Lekam
Do not stop taking the tablets simply because symptoms improve. It is important to continue taking Olanzapine Lekam orodispersible tablets for as long as directed by the doctor.
If Olanzapine Lekam orodispersible tablets are stopped abruptly, symptoms such as sweating, insomnia, tremors, anxiety, nausea, and vomiting may occur. Before ending treatment, the doctor may recommend gradually reducing the dose.

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

4. Possible adverse reactions

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

• abnormal movements, especially of the face or tongue (a frequently reported adverse reaction, which may affect 1 in 10 patients);
• blood clots in the veins (an uncommonly reported adverse reaction, which may affect 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, redness of the leg). Blood clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, seek medical advice immediately;
• simultaneously: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (occur in more than 1 in 10 patients):

• weight gain;
• drowsiness;
• increased blood prolactin levels;
• dizziness or fainting (with slowed heart rate), especially when rising from a lying or sitting position, particularly at the beginning of treatment. These symptoms usually resolve on their own, but if they persist, inform your doctor.

Common adverse reactions (may affect 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 and urine glucose levels;
• increased blood uric acid and creatine phosphokinase activity;
• increased appetite;
• dizziness;
• restlessness;
• tremors;
• movement disorders (dyskinesias);
• constipation;
• dry mouth;
• rash;
• loss of strength;
• extreme fatigue;
• fluid retention 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 adverse reactions (may affect up to 1 in 100 patients):

• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash);
• diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma;
• seizures, usually in patients with a previous history of seizures (epilepsy);
• muscle stiffness or spasms (including eye movements);
• restless legs syndrome;
• speech disorders;
• stuttering;
• slowed heart rate;
• increased sensitivity to sunlight;
• nosebleeds;
• abdominal bloating;
• salivation;
• memory loss or confusion;
• urinary incontinence;
• difficulty urinating;
• hair loss;
• absence or reduction of menstruation;
• changes in breast glands in women and men, such as galactorrhea or breast enlargement.

Rarely reported adverse reactions (may affect up to 1 in 1000 patients):

• lowered 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 manifesting as unexplained muscle pain;
• prolonged and/or painful erection.

When olanzapine is used in elderly patients diagnosed with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and impaired mobility. Several fatal cases have been reported in this specific patient group.
In patients with diagnosed Parkinson's disease, Olanzapine Lekam orally disintegrating tablets may worsen symptoms.
Very rare adverse reactions include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, flu-like symptoms initially appear with a facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and elevated levels of a specific type of white blood cells (eosinophilia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions 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.: 22 49-21-301,
fax: 22 49-2-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Olanzapine Lekam

Keep the medicine 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 specified month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via the sewage system 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 Lekam contains

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

What Olanzapine Lekam looks like and contents of the pack
Olanzapine Lekam, orodispersible tablets, 5 mg: light yellow or yellow tablets, slightly speckled, round, with the imprint "OV1" on one side and smooth on the other side.
Olanzapine Lekam, orodispersible tablets, 10 mg: light yellow or yellow tablets, slightly speckled, round, with the imprint "OV2" on one side and smooth on the other side.
Olanzapine Lekam, orodispersible tablets, 15 mg: light yellow or yellow tablets, slightly speckled, round, with the imprint "OV3" on one side and smooth on the other side.
Olanzapine Lekam, orodispersible tablets, 20 mg: light yellow or yellow tablets, slightly speckled, round, with the imprint "OV4" on one side and smooth on the other side.
Olanzapine Lekam is available in packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
ul. 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
The Netherlands
Terapia S.A.,
124 Fabricii Street,
400 632 Cluj Napoca,
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Sweden – Olanzapine Ranbaxy
Netherlands, Spain – Olanzapine SUN
Germany – Olanzapin Basics
Romania – Olanzapina Terapia
France – OLANZAPINE CRISTERS
03.10.2022