Isoprinosine

Package Leaflet: Information for the Patient

ISOPRINOSINE, 500 mg, tablets

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 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 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 an attack of gout or if tests have shown increased uric acid levels in your blood.

Warnings and precautions

Before starting treatment with Isoprinosine, discuss 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 monitor you closely.
• If treatment is long-term (3 months or longer). Your doctor will recommend regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form.
• If you have experienced 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.

Isoprinosine and other medicines

Tell your doctor 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 Isoprinosine:

• 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, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Isoprinosine contains mannitol and wheat starch

Isoprinosine tablets contain 67 mg of mannitol, which may have a mild laxative effect.
Isoprinosine tablets contain trace amounts of wheat starch. The medicine is suitable for patients with coeliac disease. Patients with a wheat allergy (other than coeliac disease) should not take this medicine.

3. How to take Isoprinosine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Isoprinosine is for oral use only. Swallow the tablet with a sufficient amount of liquid. If you have difficulty swallowing the whole tablet, you can crush it and dissolve it in a small amount of liquid to make it easier to take.
The dose is determined based on the patient's body weight and 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 dose is 50 mg per kg of body weight per day.
Usually, the daily dose is 6 tablets (3 g) per day (i.e. 2 tablets 3 times a day).
The maximum daily dose is 8 tablets (4 g) per day (i.e. 2 tablets 4 times a day).
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, given in divided doses.
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 per kg of body weight per day, divided into equal doses given every 4 hours.
Duration of treatment
Depends on the patient's response to treatment and is determined individually by the doctor. Usually, the duration of treatment is from 5 to 14 days. After the symptoms have resolved, the treatment is usually continued for another 1 to 2 days.

Overdose of Isoprinosine

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

Missing a dose of Isoprinosine

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 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 on 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 unknown.

• 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):
diarrhoea, constipation, drowsiness or difficulty sleeping (insomnia), nervousness, increased urine output (polyuria).
Unknown frequency (cannot be estimated from the available data):
abdominal pain, swelling of the face, lips, eyelids or throat (angioedema), hives, allergic reaction, anaphylactic reaction, dizziness, skin redness (flushing).

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 Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isoprinosine

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that 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 is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One tablet contains 500 mg of inosine pranobex.
• The other ingredients are: mannitol, wheat starch, povidone, magnesium stearate.

What Isoprinosine looks like and contents of the pack

Isoprinosine is a white or almost white, odourless or almost odourless tablet with a line on one side.
Isoprinosine tablets are packaged in blisters and are available in cartons with a patient leaflet.
Pack sizes: 10 tablets (1 blister), 20 tablets (2 blisters) or 50 tablets (5 blisters).
Each blister contains 10 tablets.
Not all pack sizes may be marketed.

Marketing authorisation 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 authorisation holder in Poland:
Ewopharma AG Sp. z o.o.
ul. Leszno 14
01-192 Warsaw
Tel. 22 620 11 71
Date of last revision of the leaflet: 06/2020