Groprinosin Babi

Package Leaflet: Information for the Patient

Groprinosin Baby, 250 mg/ 5 ml, Syrup

Inosine Pranobex

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Groprinosin Baby and what is it used for
• 2. Important information before taking Groprinosin Baby
• 3. How to take Groprinosin Baby
• 4. Possible side effects
• 5. How to store Groprinosin Baby
• 6. Contents of the pack and other information

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

Groprinosin Baby contains the active substance inosine pranobex, which has antiviral and immunostimulating properties.

Indications for use of Groprinosin Baby are:

• skin and mucous membrane infections caused by herpes simplex virus type I (labial herpes) or type II (genital herpes) and varicella-zoster virus;
• supporting treatment in patients with impaired immunity, in case of recurrent upper respiratory tract infections;
• other viral infections (e.g. subacute sclerosing panencephalitis).

2. Important information before taking Groprinosin Baby

When not to take Groprinosin Baby

• If you are 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 you currently have 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 increased uric acid levels in the blood.

Warnings and precautions

Before starting treatment with Groprinosin Baby, discuss it with your doctor or pharmacist.

• If you have had gout attacks in the past or increased uric acid levels in the serum or urine. Groprinosin Baby may cause a temporary increase in uric acid levels in the serum and urine.
• If you have had kidney or gallstones in the past.
• If you have kidney function disorders. In this case, your doctor will monitor you closely.
• If treatment is long-term (3 months or longer), your doctor will order regular blood tests and monitor kidney and liver function.

During long-term treatment, kidney stones may form.

• If you notice symptoms of an allergic reaction, such as rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue. In this case, stop treatment and contact your doctor immediately.

Children

Do not use this medicine in children under 1 year of age.

Groprinosin Baby and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor about the following medicines, as they may interact with Groprinosin Baby:

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that affect the immune system, e.g. used after organ transplants;
• medicines used to treat AIDS (azidothymidine).

In these cases, your doctor may decide to use Groprinosin Baby.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Groprinosin Baby during pregnancy and breastfeeding, unless your doctor advises you to do so.

Driving and using machines

It is unlikely that Groprinosin Baby will affect your ability to drive or use machines.

Groprinosin Baby contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose and sodium

Groprinosin Baby contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions). Groprinosin Baby also contains sucrose. If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine. 1 ml of Groprinosin Baby contains 650 mg of sucrose. This should be taken into account in patients with diabetes. Groprinosin Baby contains sucrose, which may be harmful to teeth. Groprinosin Baby contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per 80 ml, i.e. the medicine is considered "sodium-free".

3. How to take Groprinosin Baby

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended 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 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 per 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.

Body weight Dosage per day

* To measure the recommended volume, use the dosing syringe provided with the pack, with a scale to facilitate dosing (from 0.5 ml to 5 ml). Dosing in subacute sclerosing panencephalitis In subacute sclerosing panencephalitis, during the acute phase of the disease, the doctor may increase the dose to 100 mg/kg body weight per day, divided into equal doses given every 4 hours. Instructions for dosing using the oral syringe:

• after unscrewing the cap, push the syringe firmly into the opening in the neck of the bottle (fig. 1),
• to fill the syringe, turn the bottle upside down (fig. 2) and then carefully push the syringe plunger down, drawing the syrup to the desired mark on the scale (fig. 3),
• 3),
• after measuring the correct amount of product, turn the bottle back to its original position and carefully unscrew the syringe from the cap and remove it from the bottle (fig. 4),
• place the tip of the syringe in the child's mouth and then slowly press the plunger to empty the syringe,
• after use, close the bottle by screwing the cap and wash and dry the syringe.

The duration of treatment is determined by the doctor. Depending on the patient's health, 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.

Taking a higher dose of Groprinosin Baby than recommended

No cases of overdose have been reported. If you have any doubts or feel unwell, contact your doctor immediately.

Missing a dose of Groprinosin Baby

If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Groprinosin Baby

If treatment is stopped, the expected therapeutic effect may not be achieved or the symptoms of the disease may worsen. Before deciding to stop treatment, consult your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Groprinosin Baby can cause side effects, although not everybody gets them. Any medicine may cause an allergic reaction, but severe allergic reactions after taking Groprinosin Baby are very rare.

Seek medical attention immediately if you experience any of the following symptoms:

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

Other possible side effects of Groprinosin Baby 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 - these may be shown by laboratory tests ordered by your 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 output),
• 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, whole-body allergic reaction (anaphylactic reaction), anaphylactic shock, skin redness (erythema).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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 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, you can help provide more information on the safety of this medicine.

5. How to store Groprinosin Baby

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Do not store in a refrigerator or freeze. After first opening the bottle, store for no more than 6 months. Medicines should 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. Contents of the pack and other information

What Groprinosin Baby contains

• The active substance is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One ml of syrup contains 50 mg of inosine pranobex.
• The other ingredients are: sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water, sodium hydroxide, citric acid monohydrate.

What Groprinosin Baby looks like and contents of the pack

Groprinosin Baby is a clear syrup with a sweet taste. Groprinosin Baby is available in orange glass bottles containing 150 ml of syrup. The bottle is placed in a cardboard box with a patient information leaflet and a dosing syringe with a scale to facilitate dosing (from 0.5 ml to 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 GEDEON RICHTER ROMÂNIA S.A. 99-105, Cuza Vodă Street 540306 Târgu – Mureş Romania For more information about this medicine, 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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