Groprinosin

Leaflet attached to the packaging: patient information

Groprinosin, 250 mg/ 5 ml, syrup

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, you should 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 and what is it 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 packaging and other information

1. What is Groprinosin and what is it used for

Groprinosin is an antiviral and immunostimulant medicine (stimulating the activity of the immune system).
Groprinosin contains the active substance – inosine pranobex, which inhibits in vitrothe replication of pathogenic viruses for humans from the Herpesgroup.

Indications for the use of Groprinosin:

Supportively in people with weakened immunity, in case of recurring upper respiratory tract infections.
In the treatment of herpes labialis and facial skin caused by the herpes simplex virus. Groprinosin 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

When not to take Groprinosin

• 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 the large joints) or if tests have shown an increased level of uric acid in the blood.

Warnings and precautions

Before starting treatment with Groprinosin, the patient should discuss it with their doctor or pharmacist.

• If the patient has had gout attacks or increased uric acid levels in the blood or urine in the past. Groprinosin may cause a temporary increase in uric acid levels in the blood and urine.
• If the patient has had kidney stones 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 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 should not be used in children under 1 year of age.

Groprinosin 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, the doctor should be informed about the following medicines, as they may interact with Groprinosin:

• 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 HIV-infected patients).

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 should not be taken during pregnancy and breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

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

Groprinosin contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, ethanol

Groprinosin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late-type reactions).
Groprinosin also contains sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the 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 have a harmful effect on 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), which is equivalent to 40 ml of beer, approximately 17 ml of wine per maximum daily dose. This should be taken into account when used in pregnant or breastfeeding women, children, and people at risk, such as patients with liver disease or epilepsy.
Harmful to people with alcoholism.
The medicine contains less than 1 mmol (23 mg) of sodium per 80 ml, which means the medicine is considered "sodium-free".

3. How to take 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, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.
Adults, including the elderly (over 65 years)
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, given in 3 or 4 divided doses. The maximum dose is 4 g of inosine pranobex per day (i.e. 80 ml of syrup/day).
Children over 1 year of age
The recommended dose is usually 50 mg/kg body weight per day (1 ml of syrup per 1 kg body weight per day) in 3 or 4 equal divided doses per day.

Child's body weight Dosage/per day

* To measure the recommended volume, the measuring cup attached to the packaging with a capacity of 20 ml and a scale every 2.5 ml should be used.

Duration of treatment

Treatment usually lasts from 5 to 14 days. After the symptoms have subsided, the use of the medicine is usually continued for another 1 to 2 days.

Use in children

Groprinosin should not be used in children under 1 year of age.

Using a higher dose of Groprinosin than recommended

No cases of overdose have been reported so far. In case of any doubts or discomfort, the patient should immediately consult a doctor.

Missing a dose of Groprinosin

If a dose of the medicine 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

If treatment is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Groprinosin can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, but severe allergic reactions to Groprinosin are very rare.
The patient should immediately consult their doctor 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 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, increased urea levels in the blood,
• headache,
• dizziness,
• fatigue, malaise,
• nausea, vomiting,
• discomfort in the upper abdomen,
• skin itching,
• 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, facial swelling, lip swelling, eyelid swelling or throat swelling (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 the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Groprinosin

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
After opening the bottle, store for no more than 6 months.
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 packaging and other information

What Groprinosin contains

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

What Groprinosin looks like and what the packaging contains

Groprinosin is a clear, colorless or pinkish syrup with a raspberry flavor and aroma.
Groprinosin is available in orange glass bottles containing 120 ml or 150 ml of syrup. The bottle is placed in a cardboard box with an attached patient information leaflet and a measuring cup with a capacity of 20 ml and a scale every 2.5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
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
To obtain more detailed information, the patient should 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]

Date of last revision of the leaflet:

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