Isoprinosine

Package leaflet: Information for the patient

Isoprinosine, 1000 mg, granules for oral solution in sachet
Inosinum pranobexum
Please read carefully all the information in this leaflet before taking the medicine, as it contains information important for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms appear identical.
• If the patient experiences any adverse reactions, including any adverse reactions 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 contains as the active substance inosinum pranobexum, which exhibits antiviral activity and stimulates the immune system.
The indications for use of Isoprinosine are:

• 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 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 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 blood and urine 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's condition.
• If treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function. During prolonged treatment, kidney stones may form.
• If symptoms of an allergic reaction are observed, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue. In such a case, treatment must be stopped immediately and medical advice sought.

Isoprinosine with 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 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 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 her 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 granules for oral solution contain mannitol and sulfur dioxide (E220).
One sachet of Isoprinosine contains 259 mg of mannitol, which may cause a mild laxative effect.
This medicine contains a small amount of sulfur dioxide (a component of the lemon flavour), which rarely
may cause severe hypersensitivity reactions and bronchospasm.

3. How to use Isoprinosine

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Isoprinosine is intended for oral use only.
The dose is 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 3 g per day (i.e. 1 sachet three times a day).
The maximum daily dose is 4 g per day (i.e. 1 sachet four times a day).
Dosing in subacute sclerosing panencephalitis
In subacute sclerosing panencephalitis, during the acute phase of the disease, the physician may increase the dose
to 100 mg per kg of body weight per day (maximum 4 g per day), divided into equal doses
administered every 4 hours.

Administration method

• Open the sachet before use.
• Isoprinosine granules should be dissolved in cool or lukewarm water. Empty the contents of the sachet into a glass of water and stir to ensure proper dissolution of the granules. After dissolving in water, a clear, colourless solution with a lemon scent is formed.
• The prepared solution should be consumed immediately after preparation.
• Do not store the medicine for later use.
• Only water should be used to prepare the solution. This medicine may be taken with or without food.

Duration of treatment
Depends on the patient's response to treatment and is determined individually by the physician. Usually, the duration of treatment ranges from 5 to 14 days. After symptoms subside, 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 or pharmacist immediately.
Missed dose of Isoprinosine
If a dose is missed, 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 Isoprinosine treatment
If treatment is interrupted, the expected therapeutic effect may not be achieved, or symptoms of the disease may worsen. Consult your doctor before deciding to discontinue treatment.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should consult a doctor immediately if any of the following symptoms occur:

• sudden onset of wheezing,
• breathing difficulties,
• 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 (affecting more than 1 in 10 patients):
‐ increased concentration of uric acid in blood;
‐ increased concentration of uric acid in urine.
Common (affecting up to 1 in 10 patients):

• increased activity of liver enzymes;
• increased concentration of urea in blood;
• rash, itching;
• joint pain;
• vomiting, nausea, discomfort in the upper abdomen;
• fatigue (tiredness), weakness (malaise);
• headache, vertigo-type dizziness.

Uncommon (affecting up to 1 in 100 patients):
‐ diarrhoea, constipation;
‐ drowsiness or difficulty sleeping (insomnia), nervousness;
‐ increased urine volume (polyuria).
Frequency not known (cannot be estimated from available data):
‐ abdominal pain;
‐ swelling of the face, lips, eyelids or throat (angioedema);
‐ urticaria, allergic reaction, systemic allergic reaction (anaphylactic reaction);
‐ dizziness;
‐ skin redness (flushing).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 authorisation 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.
Do not use this medicine after the expiry date stated on the outer carton and on the sachet after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system 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 2-hydroxypropyltrimethylammonium 4-acetamidobenzoate in a molar ratio of 1:3). Each sachet contains 1000 mg of inosine pranobex.
• Other ingredients: mannitol, sucralose (E955), povidone K30, lemon flavour [containing, among others, sulfur dioxide (E220)].

What Isoprinosine looks like and contents of the pack
Isoprinosine is a white or almost white granule with a lemon scent, completely soluble in water.
Isoprinosine is packed in sachets and available in cardboard boxes containing 24 sachets.

Marketing Authorisation Holder
Ewopharma International, s.r.o.
Prokopa Vel’kého 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 about this medicinal product, 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