Patient Information Leaflet

Groprinosin Forte, 500 mg/5 ml, syrup
Inosinum pranobexum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your doctor or pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 5 to 14 days, consult your doctor.

Contents of the leaflet

What Groprinosin Forte is and what it is used for
What you need to know before taking Groprinosin Forte
How to take Groprinosin Forte
Possible side effects
How to store Groprinosin Forte
Contents of the pack and other information

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

Groprinosin Forte is an antiviral and immunostimulatory medicine (it stimulates the immune system).
Groprinosin Forte contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses from the Herpes group.
Indications for Groprinosin Forte:
As an adjunctive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
For the treatment of cold sores and facial skin herpes caused by herpes simplex virus (Herpes simplex). Groprinosin Forte may be used only in patients previously diagnosed with herpes simplex virus infection.
If there is no improvement or if you feel worse after 5 to 14 days, consult your doctor.

2. Important information before using Groprinosin Forte

When not to use Groprinosin Forte

If the patient is allergic to inosine pranobex or to 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 gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or tests have shown increased levels of uric acid in the blood.

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

If the patient has previously experienced attacks of gout or elevated levels of uric acid in blood or urine. Groprinosin 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 closely monitor the patient. If treatment is long-term (3 months or longer), the doctor will order regular blood tests and monitor kidney and liver function. Kidney stones may form during prolonged treatment.
If symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue. In such cases, treatment must be stopped immediately and medical advice sought.

Children
Groprinosin Forte should not be used in children under 1 year of age.
Groprinosin Forte and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
In particular, inform the doctor about the following medicines, as they may interact with Groprinosin Forte:

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 immune system function (so-called immunosuppressive drugs, used in organ transplant patients 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 Groprinosin Forte during pregnancy or breastfeeding unless otherwise advised by a doctor. The doctor will assess whether the benefits of treatment outweigh the potential risks.
Driving and operating machinery
It is unlikely that Groprinosin Forte will affect the ability to drive or operate machinery.
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 (including delayed-type reactions).
Groprinosin Forte contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.
Groprinosin Forte contains less than 1 mmol (23 mg) of sodium per 30 ml, meaning the medicine is considered "sodium-free".

3. How to use Groprinosin Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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, administered 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 above 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.
Child's body weight Daily dosage

10 - 14 kg	3 x 2.5 ml of syrup*
15 - 20 kg	3 x 2.5 to 3.5 ml of syrup*
21 - 30 kg	3 x 3.5 to 5 ml of syrup*
31 - 40 kg	3 x 5 to 7.5 ml of syrup*
41 - 50 kg	3 x 7.5 to 9 ml of syrup*

* To measure the recommended volume, use the measuring cup included in the package
with a capacity of 20 ml and graduations every 2.5 ml.
Duration of treatment
Treatment usually lasts from 5 to 14 days. After symptoms have subsided, the drug is usually
continued for another 1 to 2 days.
Use in children
This medicinal product should not be used in children under 1 year of age.
Use of a higher than recommended dose of Groprinosin Forte
Cases of overdose have not been reported to date. If you have any doubts or experience any adverse
effects, contact your doctor immediately.
Missed dose of Groprinosin Forte
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for the missed dose.
Stopping treatment with Groprinosin Forte
If treatment is discontinued prematurely, the desired therapeutic effect may not be achieved, or
disease symptoms may worsen.
If you have any further doubts 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.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking
Groprinosin Forte occur very rarely.
You should consult a doctor immediately if any of the following symptoms occur:

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

Other possible adverse reactions of Groprinosin Forte are listed below:
Very common (occurring in more than 1 in 10 patients):

increased blood uric acid levels, increased urinary uric acid levels.

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

increased liver enzyme activity in blood, increased blood urea nitrogen levels,
headache,
dizziness,
fatigue, malaise,
nausea, vomiting,
upper abdominal discomfort,
skin itching,
skin rash (as the only symptom),
joint pain.

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

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

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

upper abdominal pain,
swelling of the face, lips, eyelids or throat which may cause breathing difficulties (angioedema),
urticaria, allergic reaction, sudden generalized allergic reaction (anaphylactic reaction), anaphylactic shock,
skin redness (erythema).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Groprinosin Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: "Expiry date (EXP)".
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not store in a refrigerator or freeze.
Shelf life after first opening the bottle: 6 months.
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 pack and other information

What Groprinosin Forte contains

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

What Groprinosin Forte looks like and contents of the pack
Groprinosin Forte is a clear, colourless syrup with a raspberry flavour and odour.
Groprinosin Forte is available in bottles containing 150 ml of syrup.
The bottle is made of amber glass of class III, with a PP screw cap with HDPE tamper-evident ring and a PE sealing liner, child-resistant closure, and comes with a PP measuring cup with a capacity of 20 ml, graduated every 2.5 ml, all contained in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
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