VIRUXAN KIDS Syrup 50mg/ml 150ml
Leaflet: information for the user
Viruxan® Kids 50 mg/ml syrup
Viruxan® Kids 50 mg/ml syrup
inosine acedoben dimepranol (inosine acedoben dimepranol)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
Keep this leaflet. You may need to read it again. If you need any further information or advice, ask your doctor or pharmacist. If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 7 days or your condition worsens, you should seek medical attention.
The name of your medicine is Viruxan Kids 50 mg/ml syrup; from now on, throughout this leaflet, it will be called Viruxan Kids or Viruxan Kids syrup.
What this leaflet contains:
1. What is Viruxan Kids syrup and what is it for?
2. What you need to know before you take Viruxan Kids syrup
3. How to take Viruxan Kids syrup
4. Possible side effects
5. How to store Viruxan Kids syrup
6. Contents of the pack and other information
1. What Viruxan Kids syrup is and what it is used for
This is a drug that can be included in immunocompetent adolescents and adults as a non-specific immunomodulatory agent in standard treatment of viral respiratory infections of the upper respiratory tract (e.g. acute rhinopharyngitis, acute pharyngitis, acute laryngitis, acute laryngopharyngitis).
2. What you need to know before you take Viruxan Kids syrup
Do not take Viruxan Kids syrup
if you are allergic (hypersensitive) to inosine acedoben dimepranol or any of the other ingredients of this medicine (listed in section 6);
if you have an acute attack caused by gout;
if you have abnormally high levels of uric acid (can be detected by laboratory tests).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Viruxan Kids syrup.
Take special care when using Viruxan Kids syrup and tell your doctor:
if you have a history of gout or elevated uric acid levels
if you have a history of kidney stones;
if you suffer from kidney disease (you need to be monitored);
If you are on long-term treatment, you will need to have regular blood tests and kidney and liver function tests. Kidney stones may form in patients on long-term treatment.
if you notice signs of an allergic reaction, such as rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. In this case, you should stop treatment immediately and see your doctor.
Other medicines and Viruxan Kids syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you are taking any of the medicines listed below, pay special attention to your doctor, as they may interact with Viruxan Kids syrup:
allopurinol or other gout medications;
diuretics (dehydration drugs);
medicines that suppress the immune system, e.g. after an organ transplant; zidovudine (azidothymidine) - a medicine used to treat AIDS.
However, it is possible that you can take Viruxan Kids syrup, and your doctor will determine what is most appropriate for your condition.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Do not take Viruxan Kids syrup if you are pregnant or breastfeeding, unless specifically prescribed by your doctor.
Driving and using machines
Viruxan Kids syrup is unlikely to affect your ability to drive or operate machinery.
Viruxan Kids syrup contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose and ethanol
Viruxan Kids syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Viruxan Kids syrup contains sucrose.
1 ml of syrup contains 650 mg of sugar (sucrose). This should be taken into account in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains sodium. A single dose of Viruxan Kids syrup over 10 ml contains more than 1 mmol sodium. This should be taken into consideration by patients on a controlled sodium diet.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
3. How to take Viruxan Kids
Always take Viruxan Kids syrup exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dosage depends on your body weight (excluding fat tissue) and the severity of your condition. The daily dose is divided equally during waking hours.
Adults and elderly patients
The dosage is determined based on the patient's body weight.
The usual dose is 50 mg/kg body weight (1 ml/kg) daily, administered in 3-4 equally divided doses during the day. One measuring spoon (5 ml) of the syrup contains 250 mg inosine acedoben dimepranol.
Children over 1 year of age
The usual dose is 50 mg/kg body weight (1 ml/kg) daily, administered in 3-4 equally divided doses during the day or in accordance with the table below:
Body weight
Daily dosage
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 depends on your response to treatment.
If you take more Viruxan Kids syrup than you should
There have been no reports of overdose so far. If you are unsure about anything or do not feel well, contact your doctor as soon as possible.
If you forget to take Viruxan Kids syrup
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Viruxan Kids syrup
If you stop treatment, the desired effect will not be achieved or the symptoms may get worse again. Consult your doctor before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below have been experienced by people taking Viruxan Kids and are listed as very common, common or uncommon.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor immediately if you experience:
• sudden wheezing/whistling in the chest,
• difficulty breathing,
• swelling of the eyelids, face or lips,
• rash or itching (especially affecting the whole body).
The following side effects have been reported:
Very common (may affect more than 1 in 10 people):
Temporarily increased levels of uric acid in the blood and urine.
Common (may affect up to 1 in 10 people):
Increased levels of liver enzymes and urea (a waste product) in the blood, skin rash, itching, joint pain, vomiting, nausea, stomach pain, fatigue, weakness (malaise), headache, dizziness (vertigo).
Uncommon (may affect up to 1 in 100 people):
Diarrhea, constipation, drowsiness or inability to sleep (insomnia), nervousness, increased urine output (polyuria).
Not known (frequency cannot be estimated from the available data):
Abdominal pain, swelling of the face, lips, eyelids or throat (angioedema), hives, allergic reaction affecting the whole body allergic reaction (anaphylactic reaction), unsteadiness (dizziness), redness of the skin (erythema).
Reporting side effects
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly by:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
tel.:+359 2 8903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Viruxan Kids syrup
Keep out of the reach of children.
Store below 25°C. Do not use Viruxan Kids syrup for longer than 6 months after initial opening.
Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What does Viruxan Kids 50 syrup contain?
The active substance is inosine acedoben dimepranol. 1 ml of syrup contains 50 mg of inosine acedoben dimepranol. One spoonful (5 ml) of syrup contains 250 mg of inosine acedoben dimepranol.
The other ingredients are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, flavoring (plum), purified water, sodium citrate.
What Viruxan Kids 50 syrup looks like and what the pack contains
Clear, almost colorless syrup with a plum aroma.
Viruxan Kids syrup is supplied in dark glass bottles containing 150 ml of syrup, packaged in cardboard boxes with a patient information leaflet and a measuring spoon.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ewopharma International, s.r.o., Slovakia
Manufacturer
Lusomedicamenta Sociedade TecnicaFarmaceutica, SA, Portugal
