Egolanza

Leaflet accompanying the packaging: patient information

Egolanza, 5 mg, film-coated tablets

Egolanza, 10 mg, film-coated tablets

Egolanza, 20 mg, film-coated tablets

Olanzapine

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the patient 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 their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 hearing, seeing, or feeling things that do not exist in reality, having beliefs that are not based on reality, being overly suspicious, and withdrawing from contact with others. 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 difficulty breathing. If such symptoms occur, the patient should inform their doctor.
• if the patient has been previously diagnosed with eye problems, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions:
Before starting treatment with 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 the occurrence of unusual movements, especially in the face or tongue. If such a symptom occurs after taking Egolanza, the patient should inform their doctor.
• 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 patient should immediately contact their doctor.
• In patients taking Egolanza, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or help in establishing a diet plan.
• In patients taking Egolanza, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Egolanza and during treatment, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• The patient should tell their doctor if they or their family members have had blood clots, 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 they may have experienced electrolyte loss due to prolonged severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urine-inducing medicines). If the patient has dementia and has had a stroke or "mini" stroke, they or their caregiver should inform their doctor. In people over 65 years of age, as a precaution, the doctor may routinely check blood pressure.

Children and adolescents

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

Egolanza and other medicines

Patients taking Egolanza may only take other medicines with their doctor's consent. Taking Egolanza in combination with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor about taking:

• 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

While taking Egolanza, the patient 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, or 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 during breastfeeding, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Egolanza in the last trimester of pregnancy (the 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 patient should contact their doctor.

Driving and operating machines

While taking Egolanza, there is a risk of drowsiness. If this occurs, the patient should not drive or operate any tools or machines. The patient should inform their doctor.

Egolanza contains lactose

If the doctor has determined that the patient has an intolerance to certain 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. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will decide how many tablets and for how long the patient should take Egolanza. The daily dose of Egolanza is between 5 mg and 20 mg. If the symptoms of the disease recur, the patient should inform their doctor. However, the patient should not stop taking Egolanza unless their 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 a glass of 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 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 in 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, the patient should immediately contact their doctor or go to the hospital. The patient should show their doctor the packaging of the tablets.

Missing a dose of Egolanza

The patient should take the tablet as soon as possible. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Egolanza

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 the patient suddenly stops taking Egolanza, 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 patient should immediately inform their doctor if they experience:

• unusual 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, and redness of the leg). Blood clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If the patient experiences any of these symptoms, they should immediately consult their 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: may occur more often 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 slow 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 patient should inform their doctor. 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,
• at the beginning of treatment, transient increases 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,
• 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,
• nosebleeds,
• abdominal bloating,
• drooling,
• memory loss or forgetfulness,
• urinary incontinence,
• inability to urinate,
• hair loss,
• absence or decreased menstrual bleeding,
• changes in the breasts in men and women, such as milk production 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 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 (over 65 years of age) 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 parkinsonian 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, enlarged lymph nodes, elevated liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 precautions for storage.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging: EXP. The expiration date refers to the last day of the specified month.
The medicine should not be used if obvious signs of deterioration are visible (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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. Each Egolanza tablet contains 5 mg, 10 mg, or 20 mg of the active substance. The amount is stated on the packaging.
• Other ingredients are: Egolanza, 5 mg, film-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, film-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).
Egolanza, 20 mg, film-coated tablets
Tablet core: microcrystalline cellulose, lactose monohydrate (163.94 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 contents of the packaging

Appearance:

Egolanza, 5 mg, film-coated tablets

Yellow, oval, biconvex, film-coated with a dividing line embossed on one side and a stylized letter E and code 402 on the other side.
The tablet can be divided into equal doses.

Egolanza, 10 mg, film-coated tablets

Yellow, round, biconvex, film-coated tablets with a stylized letter E and code 404 on one side.

Egolanza, 20 mg, film-coated tablets

Yellow, round, biconvex, film-coated tablets with a stylized letter E and code 406 on one side
Packaging sizes:
Egolanza, 5 mg, film-coated tablets
28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, or 112 tablets packaged in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
Egolanza, 10 mg, film-coated tablets
28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, or 112 tablets packaged in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
Egolanza, 20 mg, film-coated tablets
28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, or 112 tablets packaged in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
Not all packaging 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 film-coated tablets
Czech Republic:Egolanza 5 mg, 10 mg, 15 mg, 20 mg
Hungary:Egolanza 5 mg, 10 mg, 15 mg, 20 mg film tablet
Lithuania: Egolanza 5 mg, 10 mg, 15 mg, 20 mg coated tablets
Latvia:Egolanza 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
Poland:Egolanza
Romania:Egolanza 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: