Eloprine

Package Leaflet: Information for the User

ELOPRINE, 500 mg, tablets

Inosine pranobex

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or you feel worse, you should consult a doctor.

Table of Contents of the Leaflet

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

1. What is Eloprine and what is it used for

Eloprine contains the active substance inosine pranobex, which has antiviral and immunostimulating properties.
Eloprine contains the active substance inosine pranobex, which inhibits the growth of pathogenic viruses for humans in the Herpes group in vitro.
Indications for the use of Eloprine
As an adjunct in patients with impaired immunity, in the case of recurrent upper respiratory tract infections.
In the treatment of herpes labialis and facial skin caused by the herpes simplex virus.
Eloprine can only be used in patients who have been previously diagnosed with herpes simplex virus infection.
If after 5 to 14 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking Eloprine

When not to take Eloprine:

• if you are allergic to inosine pranobex or any of the other ingredients of this medicine (listed in section 6); symptoms of an allergic reaction may include: rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue;
• if you currently have an acute gout attack (severe joint pain with swelling and redness of the skin or the occurrence of effusion in large joints) or if tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting Eloprine, discuss it with your doctor or pharmacist:

• if you have had gout attacks or increased uric acid levels in the blood or urine in the past; Eloprine may cause a transient increase in uric acid levels in the blood and urine;
• if you have had kidney stones in the past;
• if you have kidney function disorders; in such cases, the doctor will closely monitor you;
• if the treatment is long-term (3 months or longer); the doctor will recommend regular blood tests and will monitor kidney and liver function.

Children

Eloprine should not be used in children under 1 year of age.

Eloprine and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor about the medicines listed below, as they may interact with Eloprine:

• medicines used to treat gout (allopurinol or other medicines);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplantation or with atopic dermatitis);
• azidothymidine (a medicine used to treat patients infected with HIV).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Eloprine during pregnancy and breastfeeding, unless your doctor advises you to do so.
Your doctor will assess whether the benefits of taking the medicine outweigh the risks.

Driving and using machines

It is unlikely that Eloprine will affect your ability to drive or use machines.

Eloprine contains mannitol (E 421)

One Eloprine tablet contains 80 mg of mannitol, which may have a mild laxative effect.

3. How to take Eloprine

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The dose is determined based on the patient's body weight and depends on the severity of the disease.
The daily dose should be divided into equal single doses, taken several times a day.
Adults, including the elderly (over 65 years)
The recommended dose is 50 mg per kg of body weight per day.
Usually, the daily dose is 6 tablets (3 g) per day (i.e., 2 tablets 3 times a day).
The maximum daily dose is 8 tablets (4 g) per day (i.e., 2 tablets 4 times a day).
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, given in several equal divided doses. For children who cannot swallow tablets, it is recommended to administer the medicine in the form of a syrup (250 mg/5 ml or 500 mg/5 ml).
Method of administration
The medicine should be taken orally.
A tablet should be swallowed with a sufficient amount of liquid. If you have difficulty swallowing a whole tablet, to facilitate taking the medicine, the tablets can be crushed and dissolved in a small amount of liquid.
Use in children
Eloprine should not be used in children under 1 year of age.

Taking a higher dose of Eloprine than recommended

No cases of overdose have been reported. If you have any doubts or feel unwell, you should contact a doctor immediately.

Missing a dose of Eloprine

If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping Eloprine treatment

If treatment is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen.
If you have any further doubts about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eloprine can cause side effects, although not everybody gets them.

Other possible side effects of Eloprine are listed below.

Very common (occurring in more than 1 in 10 people):

• transient increase in uric acid levels in the blood and urine;

Common (occurring in less than 1 in 10 people but more than 1 in 100 people):

• increased liver enzyme activity or urea levels in the blood;
• nausea with or without vomiting;
• abdominal pain;
• itching of the skin;
• skin rash;
• headache;
• dizziness;
• fatigue or malaise;
• joint pain.

Uncommon (occurring in less than 1 in 100 people but more than 1 in 1,000 people):

• diarrhea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);

• increased urine output (polyuria).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Eloprine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Eloprine contains

• The active substance of Eloprine is inosine pranobex (a complex containing inosine salt of 4-acetamidobenzoic acid with N,N-2-dimethylamino-2-propanol in a molar ratio of 1:3). One tablet contains 500 mg of inosine pranobex.
• The other ingredients are: mannitol, potato starch, povidone K-25, magnesium stearate.

What Eloprine looks like and contents of the pack

Eloprine is a white or light cream-colored, oblong, biconvex tablet.
The pack contains 10, 20, 30, 50, or 100 tablets in blisters.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: