Groprinosin

Package leaflet: Information for the patient

Groprinosin, 250 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 information leaflet or
as directed by a 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 any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 14 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

1. What Groprinosin is and what it is used for

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

2. Important information before using Groprinosin

When not to use Groprinosin

• 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, discuss this with your doctor or pharmacist.

• If the patient has previously experienced gout attacks or elevated uric acid levels in blood or urine. Groprinosin 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 prolonged (3 months or longer), the doctor will order regular blood tests and monitor kidney and liver function. Kidney stones may form during long-term 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
Do not use this medicine in children under 1 year of age.
Groprinosin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor about the following medicines, as they may interact with Groprinosin:

• 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 immunosuppressants, 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Groprinosin during pregnancy and 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 will affect the ability to drive or operate machinery.
Groprinosin contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, ethanol and sodium
Groprinosin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
Groprinosin also contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.
1 ml of Groprinosin contains 650 mg of sucrose. This should be taken into account in patients with diabetes.
Groprinosin contains sucrose, which may be harmful to teeth.
Groprinosin contains approximately 2.5% v/v ethanol (alcohol), i.e. up to 1600 mg per maximum daily dose for adult patients (80 ml of syrup), equivalent to 40 ml of beer or about 17 ml of wine per maximum daily dose. This should be taken into account when administering to pregnant or breastfeeding women, children, and patients at risk, such as those with liver disease or epilepsy.
Harmful for patients with alcohol-related disorders.
The medicine contains less than 1 mmol (23 mg) of sodium per 80 ml, meaning the medicine is considered "sodium-free".

3. How to use Groprinosin

This medicine should always be taken exactly as described in the patient 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 people (over 65 years of age)
The recommended daily dose is 50 mg/kg body weight per day (1 ml of syrup per 1 kg body weight per day), usually 3 g (i.e. 60 ml of syrup) per day, administered in 3 or 4 divided doses. The maximum dose is 4 g of pranobex per day (i.e. 80 ml of syrup/day).

Children over 1 year of age
The usual recommended dose is 50 mg/kg body weight per day (1 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 the dosing according to the patient's body weight.
Child's body weight Dosage/day

* To measure the recommended volume, use the measuring spoon supplied with 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
Cases of overdose have not been reported so far. If in doubt or if feeling unwell, contact your doctor
immediately.
Missed dose of Groprinosin
If a dose is missed, it should be taken as soon as remembered, unless the time for the next dose
is approaching. A double dose should not be taken to make up for the missed dose.
Discontinuation of Groprinosin treatment
If treatment is discontinued, the expected 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 they do not occur in everyone.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking the medicine
Groprinosin are very rare.
You should consult a doctor immediately if any of the following symptoms occur:

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

Other possible adverse reactions of Groprinosin are listed below:
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 activity of liver enzymes in blood, increased concentration of blood urea nitrogen,
• headache,
• dizziness,
• fatigue, malaise,
• nausea, vomiting,
• discomfort in the epigastrium,
• skin itching,
• skin rash (as the only symptom),
• joint pain.

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

• somnolence or difficulty sleeping (insomnia),
• diarrhoea,
• constipation,
• polyuria (increased volume of urine excreted),
• nervousness.

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

• epigastric pain, swelling of the face, lips, eyelids or throat (angioedema), urticaria, allergic reaction, systemic 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 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 Groprinosin medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: "EXP".
The expiry date refers to the last day of the stated month.
Store below 25°C.
After first opening the bottle, do not store for longer than 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Groprinosin contains

• The active substance is inosine pranobex. One ml of syrup contains 50 mg of inosine pranobex.
• Other ingredients are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water, sodium saccharin, glycerol, 96% ethanol, and raspberry flavour L-144739 (sugar, propylene glycol, ethanol, natural flavouring substance).

What Groprinosin looks like and contents of the pack
Groprinosin is a clear, colourless or slightly pink syrup with a raspberry flavour and odour.
Groprinosin is available in amber glass bottles containing 120 ml or 150 ml of syrup. The bottle is placed in a cardboard carton with an enclosed patient information leaflet and a 20 ml dosing measure marked in 2.5 ml increments.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

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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