Isoprinosine

Package leaflet: Information for the patient

ISOPRINOSINE, 50 mg/ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Isoprinosine is and what it is used for

Isoprinosine syrup contains as its active substance inosine pranobex, which has antiviral activity and stimulates the immune system.
Indications for the use of Isoprinosine include:

• Skin and mucous membrane infections caused by herpes simplex virus type I (cold sores) or type II (genital herpes), as well as varicella-zoster virus (chickenpox and shingles);
• Other viral infections (e.g. subacute sclerosing panencephalitis);
• Adjunctive treatment in immunocompromised individuals.

2. Important information before using Isoprinosine

When not to use Isoprinosine

• If the patient is allergic (hypersensitive) to the active substance (inosine pranobex) or to 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 or tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Isoprinosine, discuss this with your doctor or pharmacist:

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

Isoprinosine and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take. Especially inform the doctor about the following
medicines, as they may interact with Isoprinosine:

• allopurinol or other medicines used in the treatment of gout;
• medicines that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines affecting the immune system, e.g. those used after organ transplantation;
• zidovudine (AZT, azidothymidine) used in the treatment of AIDS.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Isoprinosine has no effect or has a negligible effect on the ability to drive vehicles and
operate machinery.
Isoprinosine syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine may cause allergic reactions (delayed-type reactions are possible).
Isoprinosine syrup contains sucrose
1 ml of Isoprinosine syrup contains 650 mg of sucrose. This should be taken into account in patients
with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Isoprinosine syrup contains sodium
A 10 ml dose of syrup contains 4.38 mg of sodium. This should be taken into account in patients
with impaired kidney function and in patients controlling sodium intake in their diet.
Isoprinosine syrup contains ethanol (alcohol) as a plum flavouring component. This is a small amount, less than 100 mg per dose.

3. How to take Isoprinosine

This medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.
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 individual doses administered several times a day.

Adults, including elderly patients
The recommended daily dose is 50 mg per kg of body weight per day (1 ml per kg of 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. This usually corresponds to 4 full measuring spoons*
administered 3 to a maximum of 4 times daily.

Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day (1 ml per kg of body weight per day), given in 3 or 4 equal divided doses throughout the day.

The table below shows the dosing according to the patient's body weight.

*To measure the recommended volume, use the plastic measuring spoon provided with the
package. One full measuring spoon (5 ml) of syrup contains a dose of 250 mg.
Dosage in subacute sclerosing panencephalitis
In subacute sclerosing panencephalitis, during the acute phase of the disease, the physician may increase the dose
up to 100 mg per kg of body weight per day, divided into equal doses administered every 4 hours.
Duration of treatment
Depends on the patient's response to treatment and is determined individually by the physician. Usually,
the duration of treatment lasts from 5 to 14 days. After symptoms subside, administration of the drug is usually
continued for another 1 to 2 days.
Use of a higher than recommended dose of Isoprinosine
Cases of overdose have not been reported so far. In case of any doubts, contact your doctor immediately.
Missed dose of Isoprinosine
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose.
Do not use a double dose to make up for the missed dose.
Discontinuation of Isoprinosine
If treatment is discontinued, the expected therapeutic effect may not be achieved, or symptoms of the disease may worsen.
Before deciding to stop treatment, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions reported in patients taking Isoprinosine, listed according to their frequency: very common, common, uncommon, or frequency not known.
Any medicine may cause an allergic reaction.
You should consult a doctor immediately if any of the following symptoms occur:

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

The following adverse reactions have been reported:
Very common (occurring in more than 1 in 10 patients):
increased blood or urinary uric acid levels.
Common (occurring in 1 to 10 in 100 patients):
increased liver enzyme activity, increased blood urea concentration, rash, itching, joint pain, vomiting, nausea, epigastric discomfort, fatigue, weakness (malaise), headache, dizziness.
Uncommon (occurring in 1 to 10 in 1,000 patients):
diarrhea, constipation, drowsiness or difficulty sleeping (insomnia), nervousness, increased urine volume (polyuria).
Frequency not known (cannot be estimated from available data):
epigastric pain, swelling of the face, lips, eyelids or throat (angioedema), urticaria, allergic reaction, systemic allergic reaction (anaphylactic reaction), dizziness, skin redness (erythema).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Isoprinosine

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use Isoprinosine for more than 6 months after first opening.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle label following the EXP mark. 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Isoprinosine 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. One teaspoon (5 ml) of syrup contains 250 mg of inosine pranobex.
• Other ingredients are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, plum flavor, sodium citrate, purified water.

What Isoprinosine looks like and contents of the pack
150 ml of Isoprinosine syrup in an amber glass bottle with a plastic measuring spoon, in a cardboard box.
Marketing Authorisation Holder
Ewopharma International, s.r.o.
Prokopa Veľkého 52
811 04 Bratislava
Slovakia
Manufacturer
Lusomedicamenta – Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso, 66, 69-B, Queluz de Baixo, 2730-055 Barcarena
Portugal

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o.
ul. Leszno 14
01-192 Warsaw
Tel. 22 620 11 71