Groprinosin Forte

Leaflet attached to the packaging: patient information

Groprinosin Forte, 1000 mg, granules for oral solution

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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, 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 there is no improvement or the patient feels worse after 5 to 14 days, 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 there is no improvement or the patient feels worse after 5 to 14 days, 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 serum or urine in the past. Groprinosin Forte may cause a temporary increase in uric acid levels in the serum and urine.
• If the patient has had kidney or gallstones 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 symptoms of an allergic reaction are 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 inform 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, they should inform their doctor or pharmacist 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).

In these cases, the doctor may decide to use Groprinosin Forte .

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 using 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 sucrose and isomalt (E 953).

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Groprinosin Forte contains sucrose, which may have a harmful effect on teeth.

3. How to take Groprinosin Forte

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a doctor, pharmacist or nurse. If in doubt, the patient should consult their doctor, pharmacist or nurse.
The medicine should be taken orally.
The dose is determined 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 taken several times a day.

Adults, including the elderly (over 65 years)

The recommended daily dose is 50 mg/kg body weight per day (usually 1 g, i.e. 1 sachet

• 3 - 4 times a day). Do not take more than 4 sachets per day.

Children over 1 year of age

The recommended dose is usually 50 mg/kg body weight per day, given in several divided doses.

Method of administration

The contents of one sachet should be dissolved in 1/2 glass of lukewarm water, mixed and drunk.

Duration of treatment

The treatment usually lasts from 5 to 14 days. After the symptoms have subsided, the medicine should be continued for another 1 to 2 days.

Using a higher dose of Groprinosin Forte than recommended

No cases of overdose have been reported. 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 close to the time of the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Groprinosin Forte

Treatment with Groprinosin Forte should be stopped 1-2 days after the symptoms have subsided.
If there are any further doubts about taking this medicine, the patient 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 may cause an allergic reaction, but severe allergic reactions to Groprinosin Forte are very rare.

The patient should immediately consult a doctor if they experience any of the following symptoms:

• sudden wheezing,
• swelling of the eyelids, face, lips or tongue,
• difficulty breathing,
• 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, urea levels in the blood - these may be shown by laboratory blood tests ordered by the doctor,
• 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 (angioedema), hives, allergic reaction, anaphylactic reaction, anaphylactic shock, skin redness (erythema).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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.
Store in a temperature 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 month.
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 (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One sachet contains 1000 mg of inosine pranobex.
• The other ingredients are: povidone K-30, isomalt (E953), sucralose (E955), lemon flavor (maltodextrin, sucrose, modified starch (E1450), ascorbic acid (E300), natural flavoring substances).

What Groprinosin Forte looks like and what the pack contains

Granules, white to creamy in color, with a lemon flavor and aroma.
Groprinosin Forte is packaged in sachets made of Paper/PE/Aluminum/PE, placed in a cardboard box.
One sachet contains 1.8 g of granules for oral solution .
The box contains 10, 20, 30 or 50 sachets and a patient leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
To obtain more detailed information about the medicine, 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
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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