Groprinosin forte

Patient Information Leaflet

GROPRINOSIN FORTE, 1000 mg, tablets
Inosinum pranobexum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
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 contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform 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.

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 immunostimulatory medicine (it enhances immune system function).
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.
In the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex).

Groprinosin Forte may only be used in patients who have previously been 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 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 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, consult a doctor or pharmacist if:

• The patient has previously experienced gout attacks or elevated levels of uric acid in the blood or urine. Groprinosin Forte may cause transient increases in uric acid levels in the blood and urine.
• The patient has previously had kidney stones.
• The patient has impaired kidney function. In such cases, the doctor will monitor the patient closely.
• The treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and monitor kidney and liver function. Kidney stones may develop during prolonged treatment.
• 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 during the first year of life.

Groprinosin Forte and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Especially 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 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 a doctor or pharmacist before using this medicine.
Groprinosin Forte should not be taken during pregnancy or breastfeeding unless explicitly prescribed 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.

3. How to use Groprinosin Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
The tablet should be swallowed with an adequate amount of liquid, preferably water. If you have difficulty swallowing the whole tablet, to facilitate administration, the tablet may be crushed and dissolved in a small amount of liquid.

Recommended dose
Adults, including elderly patients (over 65 years of age)
The recommended dose is 50 mg/kg body weight per day.
The usual daily dose is 3 tablets (3 g) per day (i.e. 1 tablet three times a day).
The maximum daily dose is 4 tablets (4 g) per day (i.e. 1 tablet four times a day).

Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, administered in several divided doses.
For children unable to swallow tablets, it is recommended to use Groprinosin Forte syrup.

Duration of treatment
The usual duration of treatment is between 5 and 14 days.
After symptoms have subsided, the medicine should still be continued for another 1 to 2 days.

Taking more Groprinosin Forte than recommended
Cases of overdose have not been reported to date. If in doubt, contact your doctor immediately.

If you forget to take 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 treatment
If treatment is discontinued prematurely, the expected therapeutic effect may not be achieved, or disease symptoms may worsen.

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 not everybody will experience them.
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 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 Forte are listed below:
Very common (occurs in more than 1 in 10 patients):

• increased blood uric acid concentration, increased urinary uric acid concentration.

Common (occurs in no more than 1 in 10 people):

• increased liver enzyme activity, increased blood urea nitrogen concentration,
• nausea with or without vomiting,
• abdominal pain,
• skin itching,
• skin rash (as the only symptom),
• headache,
• dizziness,
• fatigue or malaise,
• joint pain.

Uncommon (occurs in no more than 1 in 100 people):

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

Frequency not known (cannot be estimated from available data):
Pain in the upper abdomen, swelling of the face, lips, eyelids or throat may cause difficulty in breathing (angioedema), urticaria, allergic reaction, sudden systemic allergic reaction (anaphylactic reaction), anaphylactic shock, dizziness, skin redness (flushing).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 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.
Do not store above 25°C.
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.
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. Package contents and other information

What Groprinosin Forte contains

• The active substance is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). Each tablet contains 1000 mg of inosine pranobex.
• Other ingredients: potato starch, povidone K-25, magnesium stearate.

What Groprinosin Forte looks like and contents of the pack
Oval, white or almost white, biconvex tablets, 20 mm long and 10 mm wide, with a dividing line on one side and an embossed letter F on the other side.
The tablet can be divided into equal doses.
Groprinosin Forte is packed in PVC/PE/PVDC/Aluminium blisters placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81

For more detailed information about the 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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