Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Egolanza
10 mg, coated tablets
Olanzapinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Egolanza is and what it is used for
Important information before taking Egolanza
How to take Egolanza
Possible side effects
How to store Egolanza
Contents of the pack and other information

1. What Egolanza is and what it is used for

Egolanza contains the active substance olanzapine. Egolanza belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

schizophrenia, a disease 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 other people. People with this condition may also experience depression, anxiety, or tension;
moderate to severe manic episodes, a condition characterized by excitement or euphoria.

Egolanza has been shown to prevent 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 Egolanza

When not to take Egolanza:

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, swollen lips or difficulty breathing. If such symptoms occur, inform the doctor immediately.
if the patient has previously been diagnosed with eye problems, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions:
Before starting treatment with Egolanza, discuss this with your doctor, pharmacist or nurse.

Egolanza is not recommended for elderly patients diagnosed with dementia, as it may cause very serious adverse effects.
Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Egolanza, inform your doctor.
Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If any of these symptoms occur, contact your doctor immediately.
Weight gain has been observed in patients taking Egolanza. Patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing a dietary plan.
Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Egolanza. Before starting and during treatment with Egolanza, 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
pituitary gland disorders
intestinal obstruction (paralytic)
liver or kidney disease
blood disorders
heart disease
diabetes
seizures
If the patient knows they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or due to use of diuretics (water pills).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported (by the patient or caregiver/relative) to the doctor.
As a routine precautionary measure, doctors may monitor blood pressure in patients over 65 years of age.

Children and adolescents
Egolanza is not intended for use in patients under 18 years of age.

Egolanza and other medicines
Patients taking Egolanza should only use other medicines with the approval of a doctor. Taking Egolanza together with antidepressants, sedatives or sleeping pills may cause drowsiness.
Inform the doctor about all medicines the patient is currently taking or has 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 Egolanza may be necessary.

Taking Egolanza with alcohol
Patients taking Egolanza must not consume alcohol in any form, as alcohol combined with Egolanza may cause drowsiness.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before taking this medicine.
Breastfeeding women should not take Egolanza, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Egolanza during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the newborn, contact the doctor.

Driving and operating machinery
Egolanza may cause drowsiness. If drowsiness occurs, do not drive motor vehicles or operate any machinery or mechanical equipment. Inform your doctor.

Egolanza contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take Egolanza

This medicine should always be taken as directed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Egolanza. The daily dose
of Egolanza is 5 to 20 mg. If symptoms of the disease recur, inform your doctor.
However, do not stop taking Egolanza unless your doctor advises you to do so.
Egolanza should be taken once daily as directed by the doctor. Try to take the medicine at the same
time each day. It does not matter whether the tablets are taken during meals or not. Egolanza is taken orally.
The tablet should be swallowed whole with water.
Use in children and adolescents
Egolanza should not be used in patients under 18 years of age.
If you take more Egolanza than you should
In patients who have taken an overdose of Egolanza, the following symptoms have occurred:
rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements
(particularly of the facial and tongue muscles), and reduced consciousness. Other symptoms include:
acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever,
rapid breathing, sweating, muscle rigidity, and lethargy or drowsiness, decreased respiratory rate,
choking, high or low blood pressure, and heart rhythm disturbances. If any of these symptoms occur,
contact your doctor immediately or go to hospital. Show the doctor the tablet packaging.
If you forget to take Egolanza
Take the missed tablet as soon as you remember. Do not take a double dose to make up for the
missed tablet.
Stopping Egolanza treatment
Even if the patient feels better, do not stop taking the tablets. It is important to continue taking
Egolanza for as long as your doctor recommends.
If Egolanza treatment is stopped abruptly, the following symptoms may occur: sweating,
insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing
the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist,
or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 reaction, which may affect up to 1 in 10 patients);
blood clots in veins (a less commonly reported adverse reaction, which may affect up to 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 breathing difficulties. If any of these symptoms occur, medical advice should be sought immediately;
Concurrently: 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: may occur in more than 1 in 10 patients:

weight gain,
drowsiness,
increased prolactin levels (a hormone stimulating milk production) in blood.
at the beginning of treatment, dizziness or fainting (with slowed heart function), particularly when rising from a lying or sitting position, may occur. These symptoms usually resolve on their own, but if they persist, you should inform your doctor.

Common adverse reactions: may occur in up to 1 in 10 patients:

changes in the count of certain blood cells and in blood lipid levels,
transient increase in liver enzyme activity at the beginning of treatment,
increased blood and urine glucose levels,
increased levels of uric acid and creatine phosphokinase in blood,
increased appetite,
dizziness,
restlessness,
tremor,
constipation,
dryness of the oral mucosa,
rash,
weakness,
extreme fatigue,
fluid retention causing swelling of hands, feet, or ankles,
fever,
joint pain,
sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.

Less common adverse reactions: may occur in up to 1 in 100 patients:

hypersensitivity (e.g. swelling of the mouth and throat, itching, rash),
diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma,
seizures, usually in patients with a history of seizures (epilepsy),
muscle stiffness or spasms (including muscles responsible for eye movements),
restless legs syndrome,
speech disorders,
stuttering,
slowed heart function,
photosensitivity,
nosebleeds,
abdominal distension,
salivation,
memory loss or forgetfulness,
urinary incontinence,
inability to urinate,
hair loss,
absence or reduction of menstruation,
breast changes in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.

Rare adverse reactions: may occur in up to 1 in 1000 patients:

decreased 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 aches and pains,
prolonged and (or) painful erection.

During treatment with Egolanza 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. Cases of death have also been reported in this patient group.
In patients with Parkinson's disease, treatment with Egolanza may worsen adverse reaction symptoms.
Very rare adverse reactions include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and increased 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, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Egolanza

No special storage instructions are required.
Keep the medicine out of the 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.
Do not use this medicine if there are clear signs of deterioration (e.g. discolouration).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Egolanza contains

The active substance is olanzapine (in the form of olanzapine dihydrochloride trihydrate). Each Egolanza tablet contains 10 mg of olanzapine.
Other ingredients are:
Tablet core: microcrystalline cellulose, monohydrate lactose (81.97 mg), hydroxypropylcellulose, crospovidone, magnesium stearate.
Coating: hypromellose, quinoline yellow (E 104), Opadry-Y-1-7000 White (hypromellose, titanium dioxide (E 171), polyethylene glycol 400).

What Egolanza looks like and contents of the packaging
Appearance:
Yellow, round, biconvex film-coated tablets, marked with a stylized letter
E and the code 404 on one side.
Pack sizes:
28, 42, 49 or 56 tablets packed in blisters OPA/Aluminium/PVC/Aluminium in a cardboard
box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, country of export:
EGIS Pharmaceuticals PLC, 1106 Budapest, Keresztúri út 30-38, Hungary
Manufacturer:
EGIS Pharmaceuticals PLC, 1165 Budapest, Bökényföldi út 118-120., Hungary
Parallel Importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation number in Bulgaria, country of export: 20100485
Parallel Import Authorisation number: 174/22
This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Egolanza, 10 mg, филмирани таблетки
Czech Republic: Egolanza, 10 mg
Hungary: Egolanza, 10 mg, filmtabletta
Lithuania: Egolanza, 10 mg, apvalkotās tabletes
Latvia: Egolanza, 10 mg, plėvele dengtos tabletės
Poland: Egolanza
Romania: Egolanza, 10 mg, comprimate filmate