Groprinosin Forte

Leaflet attached to the packaging: patient information

Groprinosin Forte, 500 mg/ 5 ml, syrup

Inosine pranobex

Read the 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 patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

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

Groprinosin Forte is an antiviral and immunostimulant medicine (stimulates the activity of the immune system).
Groprinosin Forte contains the active substance – inosine pranobex, which inhibits in vitro
the multiplication of pathogenic viruses for humans from the Herpesgroup.

Indications for use of Groprinosin Forte:

Supportively in people with weakened immunity, in case of recurring upper respiratory tract infections.
In the treatment of cold sores and facial skin caused by the herpes simplex virus. Groprinosin Forte can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.
If after 5 to 14 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Groprinosin Forte

When not to take Groprinosin 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 acute gout attack (severe joint pain with swelling and redness of the skin or effusion in the large joints) or tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting treatment with Groprinosin Forte, the patient should discuss it with their doctor or pharmacist.

• If the patient has had gout attacks or increased uric acid levels in the blood or urine in the past. Groprinosin Forte may cause a temporary increase in uric acid levels in the blood and urine.
• If the patient has had kidney stones in the past.
• If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient. If the treatment is long-term (3 months or longer), the doctor will order regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form.
• If allergic reaction symptoms have been observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue. In such cases, treatment should be stopped immediately and a doctor consulted.

Children

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

Groprinosin 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.
In particular, the doctor should be informed about the following medicines, as they may interact with Groprinosin Forte:

• medicines used to treat gout (allopurinol or other medicines);
• medicines that increase uric acid excretion, including diuretics (which increase 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 patients infected with the HIV virus).

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 taking this medicine.
Groprinosin Forte should not be taken during pregnancy and breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

It is unlikely that Groprinosin Forte will affect the ability to drive and use machines.

Groprinosin Forte contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), liquid maltitol (E 965) and sodium

Groprinosin Forte contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late-type reactions).
Groprinosin Forte contains maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine may have a mild laxative effect. The caloric value is 2.3 kcal/g of maltitol.
Groprinosin Forte contains less than 1 mmol (23 mg) of sodium per 30 ml, which means the medicine is considered "sodium-free".

3. How to take Groprinosin Forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.

Adults, including the elderly (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, given in 3 or 4 divided doses. The maximum dose is 4 g of inosine pranobex per day (i.e. 40 ml of syrup per day).

Children over 1 year of age

The recommended dose is usually 50 mg/kg body weight per day (0.5 ml of syrup per 1 kg body weight per day) in 3 or 4 equal divided doses given throughout the day.
The following table shows the dosage depending on the patient's body weight.

Patient's body weight Daily dosage

* To measure the recommended volume, the 20 ml measuring cup provided with the packaging should be used, with a scale every 2.5 ml.

Duration of treatment

Treatment usually lasts from 5 to 14 days. After the symptoms have subsided, the medicine is usually continued for another 1 to 2 days.

Use in children

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

Using a higher dose of Groprinosin Forte than recommended

No cases of overdose have been reported to date. If there are any doubts or the patient feels unwell, they should immediately consult a doctor.

Missing a dose of Groprinosin Forte

If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Groprinosin Forte

If treatment is stopped, the expected therapeutic effect may not be achieved or the symptoms of the disease may worsen.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Groprinosin Forte can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, but severe allergic reactions after taking Groprinosin Forte are very rare.
The patient should immediately consult their doctor if they experience any of the following symptoms:

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

Other possible side effects of Groprinosin Forte are listed below:

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 in the blood, increased urea levels in the blood,
• headache,
• dizziness,
• fatigue, malaise,
• nausea, vomiting,
• discomfort in the upper abdomen,
• itching of the skin,
• skin rash (as the only symptom),
• joint pain.

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

• drowsiness or difficulty sleeping (insomnia),
• diarrhea,
• constipation,
• polyuria (increased urine production),
• nervousness.

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

• abdominal pain,
• swelling of the face, lips, eyelids or throat may cause difficulty breathing (angioedema),
• hives, allergic reaction, anaphylactic reaction affecting the whole body (anaphylactic reaction), anaphylactic shock,
• redness of the skin (flush).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Groprinosin Forte

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after "Expiry date (EXP)".
The expiry date stated is the last day of the given month.
The medicine should not be stored at temperatures above 25°C. It should not be stored in the refrigerator or frozen.
The shelf life after opening the bottle is 6 months.
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 Groprinosin Forte contains

• The active substance of the medicine is inosine pranobex. One ml of syrup contains 100 mg of inosine pranobex.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), liquid maltitol (E 965) (maltitol, sorbitol), sodium saccharin (E 954), sucralose (E 955), sodium hydroxide, citric acid monohydrate, purified water, raspberry flavor L-144739 (sugars, propylene glycol, ethanol, natural flavoring substances) and raspberry flavor 10721-31 (diethyl malonate, ethyl acetate, acetaldehyde, trans-2-hexenal, β-Damascenone, maltodextrin, arabic gum).

What Groprinosin Forte looks like and what the pack contains

Groprinosin Forte is a clear, colorless syrup with a raspberry flavor and aroma.
Groprinosin Forte is available in bottles containing 150 ml of syrup.
The bottle is made of orange glass, class III, with a PP cap and a HDPE ring and a PE sealing plug, with a child-resistant closure and a 20 ml measuring cup made of PP, scaled every 2.5 ml, all in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Manufacturer:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
GEDEON RICHTER ROMANIA S.A.
99-105, Cuza Voda Street
540306 Targu-Mures
Romania
To obtain more detailed information, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: June 2025

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