Virumed junior

Patient Information Leaflet

Virumed Junior, 312.5 mg/ml, powder for oral suspension
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.
‐ Keep this leaflet. You may need to read it again.
‐ If you need advice or more information, please contact your doctor or pharmacist.
‐ If you experience any side effects, including any not listed in this leaflet, tell your doctor or
pharmacist. See section 4.
‐ If there is no improvement after 5 to 14 days, or if you feel worse, contact your doctor.

Leaflet Contents

1. What Virumed Junior is and what it is used for
2. Important information before taking Virumed Junior
3. How to take Virumed Junior
4. Possible side effects
5. How to store Virumed Junior
6. Contents of the pack and other information

1. What Virumed Junior is and what it is used for

Virumed Junior is an antiviral and immunostimulant medicine (it stimulates the immune system).

Virumed Junior is indicated for:
‐ supportive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory
tract infections.
‐ treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes
simplex). Virumed Junior may only be used in patients previously diagnosed with herpes simplex
virus infection.

If there is no improvement after 5 to 14 days, or if you feel worse, consult your doctor.

2. Important information before taking Virumed Junior

When not to use Virumed Junior
‐ Do not use this medicine if you are allergic to 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.
‐ Do not use this medicine if you currently have an acute attack of gout (severe joint pain with
swelling and redness of the skin, or effusion in large joints), or if tests have shown increased
levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Virumed Junior, discuss with your doctor or pharmacist:
‐ If you have previously experienced gout attacks or elevated levels of uric acid in the blood or
urine. Virumed Junior may cause transient increases in uric acid levels in blood and urine.
‐ If you have previously had kidney stones.
‐ If you have impaired kidney function. In such cases, your doctor will monitor you closely.
‐ If treatment is long-term (3 months or longer), your doctor will order regular blood tests and
monitor kidney and liver function. Long-term treatment may lead to the formation of kidney stones.
‐ If you notice symptoms of an allergic reaction such as rash, itching, difficulty breathing, or
swelling of the face, lips, throat or tongue. In such a case, stop treatment immediately and contact
your doctor.

Children
Do not use this medicine in children under 1 year of age.

Virumed Junior with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take. Especially inform your doctor or pharmacist about the following medicines, as they
may interact with Virumed Junior:
‐ Medicines used to treat gout (allopurinol or others);
‐ Medicines that increase uric acid excretion, including diuretics (which increase urine production),
e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
‐ Medicines that suppress the immune system (so-called immunosuppressants, used in organ
transplant recipients or in atopic dermatitis);
‐ Zidovudine (a medicine used in the treatment of HIV-infected patients).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,
you should consult your doctor or pharmacist before using this medicine.
Do not take Virumed Junior during pregnancy or breastfeeding unless otherwise advised by your
doctor. Your doctor will assess whether the benefits of treatment outweigh the potential risks.

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

Virumed Junior contains sorbitol (E420)
This medicine contains 126.7 mg of sorbitol (E420) per ml of suspension, equivalent to 101.4 mg /0.8 ml
suspension; 152.0 mg /1.2 ml suspension; 202.7 mg /1.6 ml suspension; 304.1 mg /2.4 ml suspension;
354.8 mg /2.8 ml suspension. Sorbitol is a source of fructose. If you (or your child) have previously
been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic
disorder in which the body cannot break down fructose, consult your doctor before taking this
medicine or giving it to your child.

Virumed Junior contains methyl parahydroxybenzoate (E 218) and propyl
parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Virumed Junior

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
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 daily dose is 50 mg per kg of body weight per day (0.16 ml per 1 kg of body weight per day), usually 9.6 ml of suspension (3 g) per day, given in 3 or 4 divided doses. The maximum dose is 12.8 ml of suspension (4 g) per day.

Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, usually 0.16 ml per 1 kg of body weight per day, given in 3 or 4 equal divided doses throughout the day.

The table below shows dosing according to the patient's body weight.

*To measure the recommended volume, use the syringe provided in the package.
Administration method
Oral administration.
The suspension should be taken with an adequate amount of water. The prepared suspension is white to off-white in color, with a banana flavor and odor.
Suspension preparation instructions
The medicine is in powder form. Before use, it must be mixed with water. To prepare 30 ml of suspension, add 15 ml of boiled water cooled to room temperature to the bottle:

1. Shake the bottle vigorously to loosen the powder, then open the bottle.
2. Add 10 ml of water (2 syringe volumes) using the syringe provided in the package. Close the bottle.
3. Invert the bottle and shake vigorously (for no less than 1 minute) until a homogeneous suspension is formed. Open the bottle.
4. Add 5 ml of water (1 syringe volume) using the syringe provided in the package. Close the bottle.
5. Invert the bottle and shake vigorously (for no less than 1 minute) until a homogeneous suspension is formed. Open the bottle.
6. Insert the adapter provided in the package into the neck of the bottle.

Dose measurement:

1. Shake the bottle for 1 minute immediately before each use.
2. Open the bottle.
3. Take the syringe and insert it into the adapter opening.
4. Invert the bottle.
5. Fill the syringe with the required amount of suspension by pulling the plunger down.
6. Rotate the bottle back to the upright position.
7. Remove the syringe from the adapter.
8. Place the tip of the syringe into the mouth and slowly push the plunger.
9. Wash the syringe with water and allow it to dry before next use.
10. Close the bottle with the cap – leave the adapter in the bottle.

Duration of treatment
The treatment usually lasts from 5 to 14 days. After symptoms have subsided, the medication should still be continued for another 1 to 2 days.
Use of a higher than recommended dose of Virumed Junior
Cases of overdosage with inosine pranobex have not been reported so far. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of Virumed Junior
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not use a double dose to make up for a missed dose.
Discontinuation of Virumed Junior
If treatment with Virumed Junior is discontinued, the desired therapeutic effect may not be achieved, or symptoms of the disease may worsen.
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.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking
Virumed Junior are rare.
You should stop using the medicine and consult a doctor immediately if any of the following symptoms occur:
‐ sudden onset of wheezing,
‐ difficulty breathing,
‐ swelling of the eyelids, face or lips,
‐ rash or itching (especially if affecting the whole body).

Other possible adverse reactions of Virumed Junior are listed below.
Very common (affects more than 1 in 10 people):
‐ increased blood uric acid levels, increased urinary uric acid levels.

Common (affects no more than 1 in 10 people):
‐ increased liver enzyme activity or increased blood urea nitrogen levels – these may be detected in blood laboratory tests ordered by a doctor,
‐ headache,
‐ dizziness,
‐ fatigue, malaise,
‐ nausea with or without vomiting,
‐ discomfort in the upper abdomen,
‐ skin itching,
‐ skin rash (as the only symptom),
‐ joint pain,
‐ increased blood urea concentration.

Uncommon (affects no more than 1 in 100 people):
‐ drowsiness or difficulty sleeping (insomnia),
‐ diarrhoea,
‐ constipation,
‐ polyuria (increased urine volume),
‐ nervousness.

Frequency not known (cannot be estimated from available data):
‐ angioedema (severe allergic reaction causing swelling of the face, lips, tongue or throat), hypersensitivity, urticaria, anaphylactic reaction (sudden, life-threatening systemic allergic reaction),
‐ upper abdominal pain,
‐ skin redness (erythema).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can 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 Virumed Junior

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the stated month.
Powder for oral suspension
No special storage instructions are required for this medicine.
Prepared suspension
Store in the original container at a temperature between 15°C and 25°C. The shelf life of the prepared suspension is 15 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Virumed Junior contains
‐ The active substance is inosine pranobex (a complex containing inosine and
4-acetamidobenzoate 2-hydroxypropyldimethylammonium in a molar ratio of 1:3).
Each ml of suspension contains 312.5 mg of inosine pranobex.
‐ Other ingredients: maltodextrin, sorbitol (E420), banana flavouring [flavouring preparations, maltodextrin, gum arabic (E414)], sucralose, povidone K-30, potassium citrate, colloidal anhydrous silica, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate.

What Virumed Junior looks like and contents of the pack
A white to off-white powder with banana flavour and odour.
Virumed Junior is supplied in a 60 ml amber glass bottle (Type III). The bottle is closed with a plastic cap made of polypropylene (PP) with a polyethylene (PE) liner and a tamper-evident seal. The pack also contains a 5 ml oral syringe (composed of LDPE container, LDPE plunger, polystyrene cap) with graduation marks and a PE adapter for drawing up the suspension.
The labelled bottle is packed in a cardboard box with a patient leaflet, the oral syringe, and the syringe adapter.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice