Groprinosin Forte

Package Leaflet: Information for the Patient

GROPRINOSIN FORTE, 1000 mg, tablets

Inosine pranobex

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any 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. Package contents and other information

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

Groprinosin Forte is an antiviral and immunostimulant medicine (stimulating the immune system's activity).
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 (Herpes simplex).
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 to take Groprinosin Forte, the patient should discuss it with their doctor or pharmacist if:

• they have had gout attacks or increased uric acid levels in their blood or urine in the past. Groprinosin Forte may cause a temporary increase in uric acid levels in the blood and urine.
• they have had kidney stones in the past.
• they have kidney function disorders. In such cases, the doctor will closely monitor the patient.
• treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form.
• allergic reaction symptoms have been 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 tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
They should inform their doctor especially about the medicines listed below, as they may interact with Groprinosin Forte:

• medicines used to treat gout (allopurinol or other medicines);
• medicines that increase uric acid excretion, including diuretics (increasing 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).

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 explicitly recommended by a doctor. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

It is unlikely that Groprinosin Forte will affect the ability to drive or use machines.

3. How to take Groprinosin Forte

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.
The tablet should be swallowed with a sufficient amount of liquid, preferably water. If the patient has difficulty swallowing the whole tablet, to facilitate taking the medicine, the tablets can be crushed and dissolved in a small amount of liquid.

Recommended dose

Adults, including the elderly (over 65 years)
The recommended dose is 50 mg/kg body weight per day.
Usually, the daily dose is 3 tablets (3 g) per day (i.e., 1 tablet 3 times a day).
The maximum daily dose is 4 tablets (4 g) per day (i.e., 1 tablet 4 times a day).
Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, given in divided doses.
For children who cannot swallow tablets, it is recommended to administer Groprinosin Forte in syrup.

Duration of treatment

Usually, the duration of treatment is from 5 to 14 days.
After the symptoms have subsided, the medicine should be continued for another 1 to 2 days.

Using a higher than recommended dose of Groprinosin Forte

No cases of overdose have been reported so far. In case of any doubts, the patient should contact their doctor immediately.

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 for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Groprinosin Forte

If treatment is stopped, the expected therapeutic effect may not be achieved, or the disease symptoms may worsen.
In case of 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 can cause an allergic reaction, but severe allergic reactions to Groprinosin Forte are very rare.
The patient should consult their doctor immediately if they experience any of the following symptoms:

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

Other possible side effects of Groprinosin Forte are listed below:

Very common (occurs in more than 1 in 10 patients)

• increased uric acid levels in the blood, increased uric acid levels in the urine.

Common (occurs in less than 1 in 10 patients):

• increased liver enzyme activity, increased urea levels in the blood,
• 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 less than 1 in 100 patients):

• diarrhea,
• constipation,
• nervousness,
• sleepiness or difficulty sleeping (insomnia),
• increased urine production (polyuria).

Frequency not known (cannot be estimated from the available data):
Abdominal pain, swelling of the face, lips, eyelids, or throat may cause difficulty breathing (angioedema), hives, allergic reaction, sudden allergic reaction affecting the whole body (anaphylactic reaction), anaphylactic shock, dizziness, skin redness (flushing).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-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 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.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents 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 tablet contains 1000 mg of inosine pranobex.
• The other ingredients are: potato starch, povidone K-25, magnesium stearate.

What Groprinosin Forte looks like and what the package contains

Oval, white to cream-colored, biconvex tablets with a length of 20 mm and a width of 10 mm, with a dividing line on one side and the letter F embossed on the other side of the tablet.
The tablet can be divided into equal doses.
Groprinosin Forte is packaged in PVC/PE/PVDC/Aluminum blisters placed in a cardboard box.
The box contains 10 or 30 tablets and a patient information leaflet.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: (22) 755 50 81
In order 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 the last update of the leaflet:

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