Egolanza

Package Leaflet: Information for the Patient

Egolanza, 5 mg, coated tablets

Egolanza, 10 mg, coated tablets

Olanzapine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 true, 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 you are 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, tell your doctor.
• If you have previously had eye problems, such as certain types of glaucoma (increased eye pressure).

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

• Egolanza is not recommended for use in elderly patients with dementia, as it may cause serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If you experience such a symptom after taking Egolanza, tell your 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, contact your doctor immediately.
• Patients taking Egolanza have been observed to have weight gain. You should regularly check your weight. If necessary, consider consulting a dietitian or help in establishing a diet plan.
• Patients taking Egolanza have been observed to have high blood sugar and high lipid levels (triglycerides and cholesterol). Before taking Egolanza and during treatment, your doctor should perform blood tests to determine blood sugar and lipid levels.
• Tell your doctor if you or your family have had blood clots, as similar medicines have been associated with blood clot formation. If you have any of the following conditions, tell your doctor immediately:
• stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• thyroid disorders
• intestinal obstruction (paralytic)
• liver or kidney disease
• blood diseases
• heart disease
• diabetes
• seizures
• If you know that you may have had an electrolyte imbalance due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (diuretics). If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver/relative) should tell your doctor. As a precaution, in people over 65 years of age, the doctor may monitor 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 take other medicines with the consent of their doctor. Taking Egolanza in combination with antidepressant, sedative, or sleeping medicines 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, 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) - 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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 your child experiences any of these symptoms, contact your doctor.

Driving and Operating Machines

Egolanza may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machines and devices. Tell your doctor.

Egolanza Contains Lactose

If your doctor has informed you that you have an intolerance to some sugars, you should contact your doctor before taking this medicinal product.

3. How to Take Egolanza

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Egolanza. The daily dose of Egolanza is 5 to 20 mg. If symptoms of the disease recur, tell your doctor. However, do not stop taking Egolanza unless your doctor tells you to.
Egolanza should be taken once a day as directed by your doctor. Try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food. Egolanza tablets are taken orally. Swallow the tablet 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 a Higher Dose of Egolanza than Recommended

In patients who took a higher dose of Egolanza than recommended, the following symptoms occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, 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, contact your doctor immediately or go to the hospital. Show your doctor the package of tablets.

Missing a Dose of Egolanza

Take the tablet as soon as you remember. Do not take a double dose to make up for the missed tablet.

Stopping Treatment with Egolanza

Even if you feel better, do 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 questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Egolanza can cause side effects, although not everybody gets them.
Tell your doctor immediately 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 (uncommon side effects 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 notice any of these symptoms, seek medical attention immediately;
• Simultaneously: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency 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 slowed 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, tell your 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,
• transient increased activity of liver enzymes at the beginning of treatment,
• increased blood sugar and urine sugar 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
• drooling
• memory loss or forgetfulness
• urinary incontinence,
• inability to urinate
• hair loss,
• absence or decreased menstruation,
• 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 unexplained death,
• 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 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, 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 you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to Store Egolanza

There are no special precautions for storage.
Keep 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 you notice obvious signs of deterioration (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack 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 packaging of the medicine.
• 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 Contents of the Pack

Appearance:

Egolanza, 5 mg, coated tablets

Yellow, oblong, biconvex coated tablets with a dividing line engraved on one side and the marking in the form 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 in the form of a stylized letter E and code 404 on one side.
Pack 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 pack 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