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