ELOPRINE FORTE

Package leaflet: Information for the user

Eloprine Forte 500 mg/5 ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 5 to 14 days, consult a doctor.

Contents of the leaflet

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

1. What Eloprine Forte is and what it is used for

Eloprine Forte contains as the active substance inosine pranobex, which exhibits antiviral activity and stimulates immune system function.
Eloprine Forte contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses from the Herpes group.
Indications for use of Eloprine Forte:
As an adjunct in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
In the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Eloprine Forte may be used only in patients previously diagnosed with herpes simplex virus infection.
If there is no improvement or if the patient feels worse after 5 to 14 days, consult a doctor.

2. Important information before using Eloprine Forte

When not to use Eloprine Forte:

• if the patient is 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 the patient currently has an attack of acute gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or tests have shown increased blood uric acid levels.

Warnings and precautions
Before starting Eloprine Forte, discuss this with your doctor or pharmacist.

• If the patient has previously had gout attacks or elevated uric acid levels in blood or urine. Eloprine Forte may cause transient increases in uric acid levels in blood and urine.
• If the patient has previously had kidney stones.
• If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely.
• If treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function.

Children
Eloprine Forte should not be used in children under 1 year of age.
Eloprine Forte and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Especially inform the doctor about the following medicines, as they may interact with Eloprine Forte syrup:

• medicines used to treat gout (allopurinol or other drugs);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines that suppress the immune system (so-called immunosuppressants, used in patients after organ transplantation or in atopic dermatitis);
• zidovudine (a medicine used in the treatment of HIV-infected patients).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take Eloprine Forte syrup during pregnancy or breastfeeding unless otherwise advised by a doctor. The doctor will assess whether the benefits of using the medicine outweigh the risks.
Driving and operating machinery
It is unlikely that Eloprine Forte will affect the ability to drive or operate machinery.
Eloprine Forte contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, sodium, and propylene glycol, which is a component of liquid strawberry flavour
Eloprine Forte contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
Eloprine Forte also contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
1 ml of Eloprine Forte syrup contains 650 mg of sucrose. This should be taken into account in patients with diabetes.
Eloprine Forte contains less than 1 mmol (23 mg) of sodium per 10 ml, meaning the medicine is considered "sodium-free".
Eloprine Forte contains propylene glycol, which is a component of liquid strawberry flavour.
The medicine contains 1.484 mg of propylene glycol in 1 ml of syrup.
The maximum amount of propylene glycol in a single dose is 14.84 mg (10 ml).
Liquid strawberry flavour, a component of the medicine, contains, among others, citral.
3. How to use Eloprine Forte
This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
Adults, including elderly persons (over 65 years of age)
The recommended daily dose is 50 mg/kg body weight per day (0.5 ml of syrup per 1 kg body weight per day), usually 3 g (i.e. 30 ml of syrup) per day, divided into 3 or 4 doses.
The maximum dose is 4 g of inosine pranobex (i.e. 40 ml of syrup) per day.
Children over 1 year of age
The usual recommended dose is 50 mg/kg body weight per day (0.5 ml of syrup per 1 kg body weight per day), given in 3 or 4 equal divided doses throughout the day.
The table below shows dosing according to the patient's body weight.

* To measure the recommended volume, use the dosing syringe provided in the
package.
Duration of treatment
Treatment usually lasts from 5 to 14 days. After symptoms have subsided, the medication is usually continued for another 1 to 2 days.
Use in children
This medicinal product must not be used in children under 1 year of age.
Use of a higher than recommended dose of Eloprine Forte
Cases of overdose have not been reported so far. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of Eloprine Forte
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not use a double dose to make up for a missed dose.
Stopping Eloprine Forte
If treatment is stopped prematurely, the desired therapeutic effect may not be achieved, or symptoms of the disease may worsen.
If you have any further questions regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Other possible adverse reactions of Eloprine Forte are listed below.
Common (occur in 1 to 10 out of 100 people):

• transient increase in blood and urinary uric acid levels;
• elevated liver enzyme activity or increased blood urea nitrogen;
• nausea with or without vomiting;
• abdominal pain;
• skin itching;
• skin rash;
• headache;
• dizziness;
• fatigue or malaise;
• joint pain.

Uncommon (occur in 1 to 10 out of 1,000 people):

• diarrhoea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);
• increased urine volume (polyuria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eloprine Forte
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Eloprine Forte contains

• The active substance is inosine pranobex (a complex containing inosine and salts of 4-acetamidobenzoic acid with N,N-2-dimethylamino-2-propanol in a molar ratio of 1:3). 1 ml of syrup contains 100 mg of inosine pranobex. 5 ml of syrup contains 500 mg of inosine pranobex.
• Other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, citric acid monohydrate, sodium hydroxide, strawberry flavouring liquid, purified water.

What Eloprine Forte looks like and contents of the pack
Eloprine Forte is a clear, colourless or straw-coloured syrup with a characteristic strawberry taste and odour.
Eloprine Forte syrup is supplied in a 150 ml amber glass bottle, placed in a cardboard box with a dosing cup and patient leaflet.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
tel.: 24 357 44 44
fax: 24 357 45 45
e-mail: [email protected]