Egolanza

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Egolanza

10 mg, coated tablets
Olanzapine

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Egolanza and what is it used for
• 2. Important information before taking Egolanza
• 3. How to take Egolanza
• 4. Possible side effects
• 5. How to store Egolanza
• 6. Contents of the packaging and other information

1. What is Egolanza and what is it used for

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

• 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. People with this disease may also experience depression, anxiety, or tension;
• Moderate to severe episodes of mania, a disease with symptoms of excitement or euphoria.

It has been shown that Egolanza 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 Egolanza

When not to take Egolanza:

Warnings and precautions:

Before starting to use Egolanza, you should discuss it with your doctor, pharmacist, or nurse.

• Egolanza is not recommended for use in elderly patients with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines in this group may cause the occurrence of abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Egolanza, the doctor should be informed.
• Very rarely, these types of medicines cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, you should immediately contact your doctor.
• In patients taking Egolanza, weight gain has been observed. The patient's weight should be checked systematically. If necessary, consider consulting a dietitian or getting help with setting a diet plan.
• In patients taking Egolanza, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before using Egolanza and during its use, the doctor should perform blood tests to determine blood sugar levels and the levels of certain lipids.
• 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 the patient has any of the following diseases, they should immediately inform their doctor:

• stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• disorders related to the pituitary gland
• intestinal obstruction (paralytic)
• liver or kidney disease
• blood diseases
• heart disease
• diabetes
• seizures
• If the patient knows that they may have experienced salt loss due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (diuretic medicines).

If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver/relative) should tell their doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may check blood pressure.

Children and adolescents

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

Egolanza and other medicines

People taking Egolanza may only use other medicines with the consent of their doctor. Using Egolanza 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 Egolanza.

Using Egolanza with alcohol

People taking Egolanza should not drink alcohol in any form, as it may cause drowsiness when combined with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Egolanza should not be taken by women who are breastfeeding, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Egolanza in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the child experiences any of these symptoms, the doctor should be contacted.

Driving and using machines

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

Egolanza contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Egolanza

This medicine should always be taken as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
The doctor will decide how many tablets and how long to take Egolanza. The daily dose of Egolanza is 5 to 20 mg. If the symptoms of the disease recur, you should inform your doctor. However, you should not stop taking Egolanza unless your doctor decides to do so.
Egolanza 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 during meals or not. Egolanza is taken orally. The tablet should be swallowed whole, washed down with water.

Use in children and adolescents

Egolanza should not be used in patients under 18 years of age.

Taking a higher dose of Egolanza than recommended

In patients who have taken a higher dose of Egolanza than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced consciousness. Other symptoms include:
severe 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, heart rhythm disorders. If any of these symptoms occur, you should immediately contact your doctor or go to the hospital. You should show the doctor the packaging of the tablets.

Missing a dose of Egolanza

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

Stopping the use of Egolanza

Even if you feel better, you should not stop taking the tablets. It is important to take Egolanza for as long as your doctor recommends.
If you suddenly stop taking Egolanza, the following symptoms may occur: sweating, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Egolanza before stopping treatment.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Egolanza 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 seek medical attention immediately;
• Simultaneously: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Very common side effects: may occur in more than 1 in 10 patients:

• weight gain,
• drowsiness,
• increased prolactin levels (a hormone that stimulates milk production) 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 occur in up to 1 in 10 patients:

• changes in the number of certain blood cells and lipid levels in the blood,
• at the beginning of treatment, a transient increase in liver enzyme activity,
• increased blood sugar and urine levels,
• increased levels of uric acid and creatine phosphokinase in the blood,
• increased appetite,
• dizziness,
• restlessness,
• tremors,
• constipation,
• dry mouth,
• rash,
• weakness,
• extreme fatigue,
• water retention in the body causing swelling of the hands, feet, or ankles,
• fever,
• joint pain,
• sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: 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 the 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,
• slow heart rate,
• sensitivity to sunlight,
• nosebleeds,
• abdominal bloating,
• drooling,
• memory loss or forgetfulness,
• urinary incontinence,
• inability to urinate
• 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: may occur in up to 1 in 1000 patients:

• decreased body temperature,
• heart rhythm disorders,
• sudden death from an unknown cause,
• pancreatitis causing severe abdominal pain, fever, and nausea,
• liver disease characterized by yellowing of the skin and white parts of the eyes,
• muscle disease characterized by unexplained muscle pain and weakness,
• prolonged and (or) painful erection.

During treatment with Egolanza in elderly patients with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. There have also been reports of deaths in this patient group.
In patients with Parkinson's disease, taking Egolanza may worsen side effects.
Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, flu-like symptoms with a rash on the face occur initially, followed by a widespread rash, high fever, enlarged lymph nodes, elevated liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia) in blood tests.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Egolanza

There are no special precautions for storage.
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 specified month.
Do not use this medicine if you notice obvious signs of deterioration (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste containers. 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 Egolanza contains

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

What Egolanza looks like and what the packaging contains

Appearance:
Yellow, round, biconvex, film-coated tablets with the marking of a stylized letter E and the code 404 on one side.
Packaging sizes:
28, 42, 49, or 56 tablets packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the 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., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20100485

Parallel import authorization number: 174/22

This medicinal product is authorized in the Member States of the European Economic Area 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, plévele dengtos tabletés
Poland:Egolanza
Romania:Egolanza, 10 mg, comprimate filmate
Date of leaflet approval: 15.04.2022
[Information about the trademark]