EGOLANZA 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Egolanza, 5 mg, coated tablets
3. Egolanza, 10 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Egolanza and what is it used for
5. Important information before taking Egolanza
   1. Children and adolescents
   2. Egolanza and other medicines
   3. Taking Egolanza with alcohol
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and operating machinery
   6. Egolanza contains lactose
6. How to take Egolanza
   1. Use in children and adolescents
   2. Taking more than the recommended dose of Egolanza
   3. Missing a dose of Egolanza
   4. Stopping Egolanza treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Egolanza
9. Package contents and other information
   1. What Egolanza contains
   2. What Egolanza looks like and what the package contains
   3. Egolanza, 5 mg, coated tablets
   4. Egolanza, 10 mg, coated tablets
   5. Marketing authorization holder
   6. Manufacturer
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names
   9. Date of last revision of the leaflet: 22.10.2022

Leaflet attached to the packaging: patient information

Egolanza, 5 mg, coated tablets

Egolanza, 10 mg, coated tablets

Olanzapine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• 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.
• If the patient experiences any side effects, including any 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. Package contents 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 hearing, seeing, or feeling things that do not exist in reality, having beliefs that contradict 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 manic episodes, 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:

• 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 a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, the doctor should be informed.
• If the patient has previously had eye problems, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions:
Before starting Egolanza, the patient should discuss it with their doctor, pharmacist, or nurse.

• Egolanza is not recommended for patients over 65 years of age with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines in this group may cause 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, the doctor should be contacted immediately.
• Patient weight should be checked regularly while taking Egolanza. If necessary, consider consulting a dietitian or help in establishing a diet plan.
• Patient blood tests should be performed before and during Egolanza treatment to determine blood sugar and lipid levels.
• The doctor should be informed if the patient or their family 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, they should inform their doctor immediately:
• 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 they may have experienced salt loss due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urinary medicines). If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver/relative) should inform the doctor. As a precaution, doctors may monitor blood pressure in people 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

People taking Egolanza may only take other medicines with their doctor's consent. Taking Egolanza with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness.
The doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed about the use of:

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

Taking 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 taking this medicine.
Egolanza should not be taken by breastfeeding women, 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 difficulties, and feeding problems. If the child experiences any of these symptoms, the doctor should be contacted.

Driving and operating machinery

Egolanza may cause drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machinery or mechanical devices. The doctor should be informed.

Egolanza contains lactose

If the doctor has informed the patient that they have an intolerance to some sugars, the patient should contact their doctor before taking this medicinal product.

3. How to take Egolanza

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
The doctor will decide the dose and duration of Egolanza treatment. The daily dose of Egolanza is 5 to 20 mg. If symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Egolanza unless the doctor decides to do so.
Egolanza should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. Egolanza tablets should be taken orally. The tablet should be swallowed whole with water.
The 5 mg tablet can be divided into equal doses.

Use in children and adolescents

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

Taking more than the recommended dose of Egolanza

In patients who have taken more than the recommended dose of Egolanza, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, speech difficulties, involuntary movements (especially of the face and tongue), and decreased 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, the doctor should be contacted immediately or the patient should go to the hospital. The doctor should be shown the packaging of the tablets.

Missing a dose of Egolanza

As soon as the patient remembers, they should take the tablet. A double dose should not be taken to make up for the missed tablet.

Stopping Egolanza treatment

Even if the patient feels better, they should not stop taking the tablets. It is essential to take Egolanza for as long as the doctor recommends.
If Egolanza treatment is stopped suddenly, the following symptoms may occur: sweating, insomnia, tremors, anxiety, nausea, or vomiting. The doctor may recommend gradually reducing the dose of Egolanza before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Egolanza can cause side effects, although not everybody gets them.
The doctor should be informed immediately if the following occur:

• 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). Clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, the doctor should be consulted immediately;
• 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 occur more frequently than in 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 resolve on their own, but if they persist, the doctor should be informed. Common side effects: may occur with a frequency of up to 1 in 10 patients:
• changes in the number of certain blood cells and lipid levels in the blood,
• transient increases in liver enzyme activity at the start of treatment,
• 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,
• loss of strength,
• 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 with a frequency of 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,
• nasal bleeding
• abdominal bloating
• salivation
• memory loss or forgetfulness
• urinary incontinence,
• inability to urinate
• hair loss,
• absence or decrease of menstrual periods,
• breast changes in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement. Rare side effects: may occur with a frequency of 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 whites of the eyes,
• muscle disease characterized by unexplained muscle pain and weakness,
• prolonged and (or) painful erections. In elderly patients with dementia treated with Egolanza, 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 exacerbate side effects.

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, 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 any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be informed. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Egolanza

There are no special storage instructions.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Do not use this medicine if obvious signs of deterioration are observed (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Egolanza contains

• The active substance of Egolanza is olanzapine. Each Egolanza tablet contains 5 mg or 10 mg of the active substance. The amount is stated on the medicine packaging.
• Other ingredients are: Egolanza, 5 mg, coated tabletsTablet core: microcrystalline cellulose, lactose monohydrate (40.98 mg), hydroxypropyl cellulose, crospovidone, magnesium stearate. Coating: hypromellose, quinoline yellow (E 104), Opadry-Y-1-7000 White (hypromellose, titanium dioxide (E 171), macrogol 400).

Egolanza 10 mg, coated tablets
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 package contains

Appearance:

Egolanza, 5 mg, coated tablets

Yellow, oblong, biconvex coated tablets with a dividing line engraved on one side and the marking of a stylized letter E and code 402 on the other side.
The tablet can be divided into equal doses.

Egolanza, 10 mg, coated tablets

Yellow, round, biconvex coated tablets with the marking of a stylized letter E and code 404 on one side.
Package sizes:
Egolanza, 5 mg, coated tablets
28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, or 112 tablets packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
Egolanza, 10 mg, coated tablets
28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, or 112 tablets packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
Not all package sizes may be marketed.

Marketing authorization holder

EGIS Pharmaceuticals PLC
H-1106 Budapest, Keresztúri út 30-38
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
H-1165 Budapest, Bökényföldi út 118-120.
Hungary

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

Bulgaria:Egolanza 5 mg, 10 mg, 15 mg, 20 mg филмирани таблетки
Czech Republic:Egolanza 5 mg, 10 mg, 15 mg, 20 mg
Hungary:Egolanza 5 mg, 10 mg, 15 mg, 20 mg filmtabletta
Lithuania: Egolanza 5 mg, 10 mg, 15 mg, 20 mg apvalkotās tabletes
Latvia:Egolanza 5 mg, 10 mg, 15 mg, 20 mg plévele dengtos tabletés
Poland:Egolanza
Romania:Egolanza 5 mg, 10 mg, 15 mg, 20 mg comprimate filmate

Date of last revision of the leaflet: 22.10.2022