Eloprine Forte

Package Leaflet: Information for the Patient

ELOPRINE FORTE, 1000 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 for the patient or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 to 14 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Eloprine Forte and what is it 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 pack and other information

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

Eloprine Forte is an antiviral and immunostimulant medicine (stimulating the immune system).
Eloprine Forte contains the active substance - inosine pranobex, which inhibits in vitro
the multiplication of pathogenic viruses for humans in the Herpesgroup.

Indications for use of Eloprine Forte

Supportively in people with weakened immunity, in case of recurring upper respiratory tract infections.
In the treatment of herpes labialis and facial skin caused by the herpes simplex virus (Herpes
simplex).
Eloprine Forte can only be used in patients who have been previously diagnosed with herpes simplex virus infection.
If there is no improvement or the patient feels worse after 5 to 14 days, they should consult their 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 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 acute gout attack (severe joint pain with swelling and redness of the skin or effusion in large joints) or tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting to take Eloprine Forte, the patient should discuss it with their doctor or pharmacist:

• if the patient has had gout attacks or increased uric acid levels - the medicine may cause a temporary increase in uric acid levels in the blood and urine;
• if the patient has had kidney stones;
• if the patient has kidney function disorders - during treatment with Eloprine Forte, the doctor will regularly check the blood and monitor kidney function;
• if the treatment is long-term (lasting 3 months or longer), the doctor will order regular blood tests and monitoring of kidney and liver function;
• if symptoms of an allergic reaction are observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In such a case, treatment should be stopped immediately and a doctor consulted.

Children

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

Eloprine Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Particularly, the patient should inform their doctor if they are taking:

• medicines for the treatment of gout (e.g., allopurinol or other xanthine oxidase inhibitors);
• medicines that increase uric acid excretion, including diuretics (increasing urine production), e.g., 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 AIDS).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
This medicine should not be taken during pregnancy and breastfeeding without consulting a doctor, who will assess whether the benefits of using this medicine in the mother outweigh the risk to the child.

Driving and using machines

The medicine may affect the ability to drive and use machines.
If the patient experiences headache, dizziness, or drowsiness, they should not drive vehicles, operate machines, or perform other activities that require concentration. See also section 4.

Eloprine Forte contains mannitol

One tablet of Eloprine Forte 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 package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Adults, including the elderly (over 65 years)
The recommended dose is 50 mg per kg of body weight per day. The usual dose is 3 tablets (3 g)
per day (i.e., 1 tablet 3 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 divided doses.
For children who cannot swallow tablets, Eloprine Forte syrup is recommended.

Method of administration

The medicine should be taken orally.
The tablet should be swallowed with a large amount of liquid, preferably water. If the patient has difficulty swallowing the whole tablet, to facilitate taking the medicine, the tablet can 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 the symptoms of the disease have subsided.

Taking a higher dose of Eloprine Forte than recommended

There is no data on overdosing with Eloprine Forte.
In case of any doubts or discomfort, the patient should consult their doctor.

Missing a dose of Eloprine Forte

If a dose is missed, the patient should take it as soon as possible
and continue treatment.
The patient should not take a double dose to make up for the missed dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eloprine Forte can cause side effects, although not everybody gets them.
The patient should immediately consult their doctorif they experience any of the following symptoms:

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

Side effects that may occur

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

• increased uric acid levels in the blood, increased uric acid levels in the urine.

Common(occurring in less than 1 in 10 patients):

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

Uncommon(occurring in less than 1 in 100 patients):

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

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

• abdominal pain;
• swelling of the face, lips, eyelids, or throat (angioedema), hives, allergic reaction, anaphylactic reaction;
• skin redness (erythema).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Eloprine Forte

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the blister pack and carton 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. 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 pack and other information

What Eloprine Forte contains

• The active substance of the medicine is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One tablet contains 1000 mg of inosine pranobex.
• The 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-colored, elongated, biconvex tablets with a dividing line on one side.
The dividing line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.
The pack contains 10, 20, or 30 tablets in a cardboard box.

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: