Isoprinosine syrup 60 ml

Trade Name:

Isoprinosine syrup 

Inosine pranobex 250 mg/5 ml

60 ml

Composition:

Inosine pranobex 250 mg/5 ml

Inactive ingredients:

Sucrose, sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), strawberry flavoring(propylene glycol (E1520), flavoring components), purified water.

Properties:

Isoprinosine syrup contains an active substance inosine pranobex, which has antiviral activity and stimulates the immune system.

Indications:

-As an adjuvant in the treatment of recurrent upper respiratory tract infections in immunocompromised patients.

Dosage and administration:

-Always take this medicine exactly as described in this leaflet or as your doctor has told you. 

-Dosage is determined on the basis of lean body weight of the patient and the severity of the disease. 

-Adults, including the elderly:

The recommended dose is 50 mg/kg of body weight daily (1 ml per 1 kg body weight daily), in 3 or 4 divided doses. Maximum dose is 4 g daily (means 80 ml of syrup daily).

Do not exceed the maximum dose of 80 ml daily.

-Children over the age of 1 year:

The recommended dose is 50 mg/kg of body weight daily, usually 1 ml per 1 kg body weight in 3 or 4 divided doses daily.

The following table shows the dosage depending on the patient’s body weight.

10-14 kg 3 x 5 ml

15-20 kg 3 x 5 – 7.5 ml

21-30 kg 3 x 7.5 – 10 ml

31-40 kg 3 x 10 – 15 ml

41-50 kg 3 x 15 – 17.5 ml

-The duration of treatment is usually 5-14 days. After symptoms subside, continue the treatment for 1-2 days.

-The medicine should not be used in children under 1 year of age.

-Do not take a double dose to make up for a forgotten dose.

Side effects:

• Isoprinosine can cause an allergic reaction. Stop using this medicine and contact your doctor if you experience:

– sudden onset of wheezing;

– difficulty in breathing;

– swelling of the eyelids, face or lips;

– rash or itching (especially if they concern the whole body).

Side effects are presented below:

Very common:

– increased uric acid in the blood, increased levels of uric acid in the urine.

Common:

– headache, vertigo;

– itching, rash;

– joint pain (arthralgia);

– vomiting, nausea, discomfort in the upper abdomen;

– fatigue, feeling unwell;

– increased blood urea, elevation of transaminases and alkaline phosphatase in the blood.

Uncommon:

– nervousness;

– somnolence, difficulty in sleeping (insomnia);

– diarrhea, constipation;

– increased urine volume (polyuria).

Frequency unknown:

– angioedema (serious allergic reaction which causes swelling of the face, lips, tongue or throat.

This can cause difficulty in swallowing and breathing), hypersensitivity, urticaria, anaphylactic reaction (sudden life-threatening allergic reaction affecting the entire body);

– redness of the skin (erythema);

– pain in the upper abdomen.

Contraindications:

– Allergy to inosine pranobex or any of the other ingredients of this medicine. Symptoms of an allergic reaction may include: rash, itching, difficulty breathing, swelling face, lips, throat or tongue.

– If you are currently suffering from gout.

– If you have increased levels of uric acid in the blood.

Warnings and precautions:

• Talk to your doctor or pharmacist before taking Isoprinosine:

– If you have ever had gout or increased levels of uric acid in the blood. Isoprinosine may cause a temporary increase of uric acid in your blood and urine.

– If in the past you had kidney stones.

– If you have kidney problems. In this case, your doctor will closely monitor you.

– If signs of an allergic reaction have been observed, such as a rash, pruritus, difficulty in breathing, swelling of the face, lips, throat or tongue. In this case, you should stop treatment immediately and contact your doctor.

– If the treatment is long-term (3 months or longer). Your doctor will recommend regular blood count and will monitor your renal function and liver function. Renal stones may form during long-term treatment.

• Children:

The medicine should not be used in children under 1 year of age.

• Other medicines and Isoprinosine:

Tell your doctor or pharmacist if you are using, have recently used or might use any of these medicines:

– allopurinol or medicines used to treat gout;

– medicines that increase the excretion of uric acid, including diuretics, e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;

– medicines that affect the immune system, e.g. used after organ transplantation or in atopic dermatitis;

– zidovudine used to treat AIDS.

• Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Isoprinosine should not be administered during pregnancy or breast-feeding unless your doctor decides the benefits outweigh the potential risk.

• Driving and using machines:

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

• If you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 5 ml of syrup contains 3250 mg of sucrose. This should be taken into account in patients with diabetes mellitus.

Storage:

Store in a cool dry place. Do not freeze.

Package:

Carton box holds an amber glass bottle 60 ml, measuring cup and an insert leaflet