Isoprinosine

Package Leaflet: Information for the Patient

ISOPRINOSINE, 50 mg/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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Isoprinosine and what is it 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 is Isoprinosine and what is it used for

Isoprinosine syrup contains the active substance inosine pranobex, which has antiviral and immunostimulating properties.
The indications for use of Isoprinosine are:

• skin and mucous membrane infections caused by herpes simplex virus type I (cold sore) or type II (genital herpes) and varicella-zoster virus;
• other viral infections (e.g. subacute sclerosing panencephalitis);
• supporting treatment in patients with impaired immune function.

2. Important information before taking Isoprinosine

When not to take Isoprinosine

• If you are allergic (hypersensitive) to the active substance (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 a gout attack or if tests have shown increased uric acid levels in your blood.

Warnings and precautions

Before starting treatment with Isoprinosine, discuss it with your doctor or pharmacist:

• If you have had gout attacks or increased uric acid levels in the past. Isoprinosine may cause a temporary increase in uric acid levels in the blood and urine.
• If you have had kidney stones in the past.
• If you have kidney function disorders. In this case, your doctor will closely monitor you.
• If treatment is long-term (3 months or longer). Your doctor will recommend regular blood tests and will monitor your kidney and liver function. During long-term treatment, kidney stones may form.
• If you have observed symptoms of an allergic reaction, such as rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue. In this case, you should stop treatment and contact your doctor immediately.

Isoprinosine and other medicines

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

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics, such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation;
• zydovudine (AZT, azidothymidine) used to treat AIDS.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Isoprinosine has no influence or negligible influence on the ability to drive and use machines.

Isoprinosine syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

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 you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Isoprinosine syrup contains sodium

A dose of 10 ml of syrup contains 4.38 mg of sodium. This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.
Isoprinosine syrup contains ethanol (alcohol) as a component of the plum flavor. This is a small amount, less than 100 mg per dose.

3. How to take Isoprinosine

This medicine should always be taken exactly as directed by your doctor. If you are unsure, 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 is divided into equal single doses taken several times a day.
Adults, including the elderly
The recommended daily dose is 50 mg per kg of body weight per day (1 ml per 1 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 is usually 4 full measuring spoons* taken 3 to 4 times a day.
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day (1 ml per 1 kg of body weight per day) in 3 or 4 equal divided doses per day.
The following table shows the dosage based on the patient's body weight.
*To measure the recommended volume, use the plastic measuring spoon provided with the packaging. 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 doctor may increase the dose to 100 mg per kg of body weight per day, divided into equal doses taken every 4 hours.
Duration of treatment
Depends on the patient's response to treatment and is determined individually by the doctor. The duration of treatment is usually from 5 to 14 days. After the symptoms have subsided, the administration of the medicine is usually continued for another 1 to 2 days.

Overdose of Isoprinosine

No cases of overdose have been reported to date. If you have any doubts, you should contact your doctor immediately.

Missed dose of Isoprinosine

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

Stopping treatment with Isoprinosine

If you stop treatment, 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, Isoprinosine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Isoprinosine and are listed as very common, common, uncommon, or of unknown frequency.
Any medicine may cause an allergic reaction.
You should immediately consult your doctorif you experience any of the following symptoms:

• sudden onset of wheezing,
• difficulty breathing,
• swelling of the eyelids, face, or lips,

• rash or itching (especially if it affects the whole body).

Reported side effects:

Very common (occurring in more than 1 in 10 patients):
increased uric acid levels in the blood or urine.
Common (occurring in 1 to 10 in 100 patients):
increased liver enzyme activity, increased urea levels in the blood, rash, itching, joint pain, vomiting, nausea, abdominal discomfort, fatigue (tiredness), weakness (malaise), headache, dizziness.
Uncommon (occurring in 1 to 100 in 1,000 patients):
diarrhea, constipation, drowsiness or difficulty sleeping (insomnia), nervousness, increased urine output (polyuria).
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, dizziness, flushing of the skin (erythema).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform 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
Jerozolimskie Avenue 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 this medicine.

5. How to store Isoprinosine

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 carton and on the label after EXP. The expiry date refers to the last day of the month.
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 Isoprinosine 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 ml of syrup contains 50 mg of inosine pranobex. One measuring spoon (5 ml) of syrup contains 250 mg of inosine pranobex.
• The other ingredients of the medicine 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 is in a brown glass bottle with a plastic measuring spoon, in a cardboard box.

Marketing authorization holder

Ewopharma International, s.r.o.
Prokopa Veľkého 52
811 04 Bratislava
Slovakia

Manufacturer

Lusomedicamenta – Sociedade Tecnica Farmaceutica, S.A.
Estrada Consiglieri Pedroso, 66, 69-B, Queluz de Baixo, 2730-055 Barcarena
Portugal
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Ewopharma AG Sp. z o.o.
Leszno 14 Street
01-192 Warsaw
Phone: 22 620 11 71
Date of last revision of the leaflet: