ISOPRINOSINE

Package leaflet: Information for the patient

ISOPRINOSINE, 500 mg, tablets
Inosinum pranobexum
Please read the entire leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

• Infections of the skin and mucous membranes 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 individuals with reduced immunity.

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 is currently experiencing an 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 a doctor or pharmacist:

• If the patient has previously experienced gout attacks or elevated serum uric acid levels. 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 closely monitor the patient.
• If treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function. With prolonged treatment, kidney stones may form.
• 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 the 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;
• drugs that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• drugs 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 have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Isoprinosine has no effect or negligible effect on the ability to drive or operate machinery.

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. The medicine should not be used by patients with a wheat allergy (other than coeliac disease).

3. How to use Isoprinosine

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Isoprinosine is intended for oral use only. The tablet should be taken with an adequate amount of fluid. If you have difficulty swallowing the whole tablet, to facilitate administration, the tablets may be crushed and dissolved in a small amount of liquid.
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 single doses administered several times a day.

Adults, including elderly patients
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 three times a day).
The maximum daily dose is 8 tablets (4 g) per day (i.e. 2 tablets four times a day).

Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, administered in several 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
This depends on the patient's response to treatment and is determined individually by the doctor. Usually, the duration of treatment ranges from 5 to 14 days. After symptoms have resolved, the medicine 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 to date. In case of any doubts, contact your doctor immediately.

Missed 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 treatment is interrupted, the expected therapeutic effect may not be achieved, or symptoms of the disease may worsen. Before deciding to discontinue 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.
Seek immediate medical advice if any of the following symptoms occur:

• sudden onset of wheezing,
• difficulty in 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 levels, rash, itching, joint pain, vomiting, nausea, epigastric discomfort, fatigue (tiredness), 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Isoprinosine

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after the label EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 salt in a molar ratio of 1:3). Each tablet contains 500 mg of inosine pranobex.
• Other ingredients are: mannitol, wheat starch, povidone, magnesium stearate.

What Isoprinosine looks like and contents of the pack
Isoprinosine is white or almost white, elongated tablets, odourless or with a slight amine odour, with a breakline on one side.
Isoprinosine tablets are packed in blisters and available in cardboard boxes with an enclosed 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 Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso, 66, 69-B, Queluz de Baixo, 2730-055 Barcarena
Portugal
For 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