GROPRINOSIN FORTE

Patient Information Leaflet

Groprinosin Forte, 1000 mg, granules for oral solution
Inosinum pranobexum
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
You should 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 adverse reactions, 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 you feel worse, consult your doctor.

Table of Contents

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

Groprinosin Forte is an antiviral and immunomodulatory 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 herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Groprinosin Forte may only be used in patients previously diagnosed with herpes simplex virus infection.
If there is no improvement after 5 to 14 days, or if you feel worse, 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 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 acute 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 serum or urine. Groprinosin Forte may cause transient increases in serum and urinary uric acid levels.
• If the patient has previously had kidney or gallstones.
• If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely.
• 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
Do not use this medicine in children under 1 year of age.
Groprinosin Forte 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. Especially inform your doctor or pharmacist 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).

In the above cases, the doctor may decide whether treatment with Groprinosin Forte is necessary.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might 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 sucrose and isomalt (E 953).
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Groprinosin Forte contains sucrose, which may have harmful effects on teeth.

3. How to use Groprinosin Forte

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The medicine should be taken orally.
The dose is based on the patient's body weight and depends on the severity of the disease.
The daily dose should be divided into equal single doses administered several times a day.

Adults, including elderly patients (over 65 years of age)
The recommended daily dose is 50 mg/kg body weight per day (usually one single dose of 1 g, i.e. 1 sachet, 3–4 times daily). Do not take more than 4 sachets per day.

Children above 1 year of age
The usual recommended dose is 50 mg/kg body weight per day, given in several divided doses.

Administration method
Dissolve the contents of one sachet in half a glass of lukewarm water, mix well, and drink.

Duration of treatment
The treatment usually lasts from 5 to 14 days. After symptoms have subsided, continue taking the medicine for another 1 to 2 days.

Taking more Groprinosin Forte than recommended
There have been no reported cases of overdose so far. If you have any doubts or feel unwell, contact your doctor immediately.

Missing a 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 a missed dose.

Stopping Groprinosin Forte
Stop taking Groprinosin Forte 1–2 days after symptoms have resolved.
If you have any further questions about the use of this medicine, 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
Groprinosin Forte are very rare.
You should consult a doctor immediately if any of the following symptoms occur:

• sudden onset of wheezing,
• swelling of the eyelids, face, lips, or tongue,
• difficulty breathing,
• 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 – these may be detected by blood laboratory tests ordered by a doctor,
• 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 (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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 Forte

Keep this medicine out of sight and reach of children.
Store below 25°C. Store in the original packaging to protect from moisture.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Groprinosin Forte contains

• The active substance is inosine pranobex (a complex containing inosine and 4-acetamidobenzoate of 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). Each sachet contains 1000 mg of inosine pranobex.
• Other ingredients: povidone K-30, isomalt (E953), sucralose (E955), lemon flavour (maltodextrin, sucrose, modified starch (E1450), ascorbic acid (E300), natural flavouring substances).

What Groprinosin Forte looks like and contents of the pack
A white or almost white granulate with lemon taste and odour.
Groprinosin Forte is packed in sachets made of Paper/PE/Aluminium/PE, placed in a cardboard box.
Each sachet contains 1.8 g of granules for oral solution.
Not all pack sizes may be marketed.

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

For further information about this medicinal product, 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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