Package leaflet: Information for the patient

ELOPRINE FORTE, 1000 mg, tablets
Inosinum pranobexum
Please read carefully the entire leaflet before taking the medicine, as 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, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement within 5 to 14 days, or if your condition worsens, contact your doctor.

Table of contents

What Eloprine Forte is and what it is used for
Important information before taking Eloprine Forte
How to take Eloprine Forte
Possible side effects
How to store Eloprine Forte
Contents of the pack and other information

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

Eloprine Forte is an antiviral and immunostimulating agent (it enhances 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 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 only be used in patients previously diagnosed with herpes simplex virus infection.
If there is no improvement within 5 to 14 days, or if your condition worsens, consult your doctor.

2. Important information before taking Eloprine Forte

When not to take Eloprine Forte

if the patient is allergic to the active substance (inosine pranobex) or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: skin rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue.
if the patient currently has an attack of 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 treatment with Eloprine Forte, discuss this with your doctor or pharmacist:

if the patient has had gout attacks or elevated uric acid levels – the medicine may cause transient increases in blood and urine uric acid levels;
if the patient has had kidney stones (nephrolithiasis);
if the patient has impaired kidney function – during treatment with Eloprine Forte, the doctor will regularly perform blood tests and monitor kidney function;
if treatment is long-term (lasting 3 months or longer), the doctor will order regular blood tests as well as monitoring of kidney and liver function;
if symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue. In such a case, treatment must be stopped immediately and the patient should contact a doctor.

Children
This medicine should not be used in children during the first year of life.
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.
In particular, tell the doctor if the patient is taking:

medicines for the treatment of gout (e.g. allopurinol or other xanthine oxidase inhibitors);
medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
medicines that suppress immune system function (so-called immunosuppressants, used in organ transplant patients or in atopic dermatitis);
zidovudine (a medicine used in the treatment of AIDS).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Eloprine Forte should not be taken during pregnancy or breastfeeding without consulting a doctor, who will assess whether the benefits of using this medicine in the mother outweigh the risks to the child.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery.
If headache, dizziness or drowsiness occur, the patient should not drive, operate machinery, or perform any other tasks requiring concentration. See also section 4.
Eloprine Forte contains mannitol
One Eloprine tablet contains 160 mg of mannitol, which may have a mild laxative effect.

3. How to take Eloprine Forte

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults, including elderly people (over 65 years of age)
The recommended dose is 50 mg per kg of body weight per day. Usually, the dose is 3 tablets (3 g) per day (i.e. 1 tablet three times a day). Do not take more than 4 tablets per day.
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, given in several divided doses.
For children who cannot swallow tablets, Eloprine Forte syrup is recommended.
Method of administration
This medicine is for oral use.
The tablet should be taken with a large amount of fluid, preferably water. If you have difficulty swallowing the whole tablet, to make it easier to take the medicine, the tablet may be crushed and dissolved in a small amount of water.
Duration of treatment
Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for 1 to 2 days after symptoms have resolved.
Taking more Eloprine Forte than recommended
There is no data available regarding overdose with Eloprine Forte.
If you have any doubts or feel unwell, contact your doctor.
Missed dose of Eloprine Forte
If you miss a dose, take it as soon as possible and continue treatment as before.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should consult a doctor immediately if any of the following symptoms occur:

sudden onset of wheezing,
difficulty breathing,
swelling of the eyelids, face or lips,
rash or itching (especially if affecting the whole body).

The following adverse reactions may occur
Very common (occurring in more than 1 in 10 patients):

increased concentration of uric acid in blood, increased concentration of uric acid in urine.

Common (occurring in no more than 1 in 10 patients):

increased liver enzyme activity, increased blood urea nitrogen concentration;
nausea with or without vomiting;
discomfort in the upper abdomen;
itching, skin rash;
headache, dizziness;
fatigue, malaise;
joint pain.

Uncommon (occurring in no more than 1 in 100 patients):

diarrhoea;
constipation;
nervousness;
drowsiness or difficulty sleeping (insomnia);
excessive urine production (polyuria).

Frequency not known (cannot be estimated from available data):

pain in the upper abdomen;
swelling of the face, lips, eyelids or throat (angioedema), urticaria, allergic reaction, systemic allergic reaction (anaphylactic reaction);
skin redness (flushing).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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 packaging and other information

What Eloprine Forte contains

The active substance is inosine pranobex (a complex containing inosine and 2-hydroxypropyl dimethyl ammonium 4-acetamidobenzoate in a molar ratio of 1:3). Each tablet contains 1000 mg of inosine pranobex.
Other ingredients are: mannitol, potato starch, povidone K-25, magnesium stearate.

What Eloprine Forte looks like and contents of the pack
White to light cream, elongated, biconvex tablets with a score line on one side.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not ensure equal dose division.
Packaging contains 10, 20 or 30 tablets in a cardboard box.
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]