Virumed Iunior

Leaflet accompanying the packaging: patient information

Virumed Junior, 312.5 mg/ml, powder for oral suspension

Inosine pranobex

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
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Keep this leaflet, you may need to read it again.
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If you need advice or additional information, consult a doctor or pharmacist.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
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If after 5 to 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Virumed Junior is intended for use:

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as a supportive treatment in people with weakened immunity, in cases of recurrent upper respiratory tract infections.
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in the treatment of cold sores and facial skin caused by the herpes simplex virus. Virumed Junior can only be used in patients who have previously been diagnosed with a herpes simplex virus infection.
If after 5 to 14 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Virumed Junior

When not to take Virumed Junior

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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.
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If the patient is currently experiencing an acute gout attack (severe joint pain with swelling and redness of the skin) or if tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting treatment with Virumed Junior, the patient should discuss it with their doctor or pharmacist:
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If the patient has a history of gout attacks or increased uric acid levels in the blood or urine. Virumed Junior may cause temporary increases in uric acid levels in the blood and urine.
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If the patient has a history of kidney stones.
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If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient.
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If the treatment is long-term (3 months or longer), the doctor will order regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form.
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If symptoms of an allergic reaction have been observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In such cases, treatment should be stopped immediately and the doctor consulted.

Children

Virumed Junior should not be used in children under 1 year of age.

Virumed Junior and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the doctor or pharmacist should be informed about the following medicines, as they may interact with Virumed Junior:
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medicines used to treat gout (allopurinol or other medicines);
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medicines that increase uric acid excretion, including diuretics (which increase urine production), such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
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medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplants or with atopic dermatitis);
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zydovudine (a medicine used to treat patients infected with HIV).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Virumed Junior should not be taken during pregnancy or breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

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

Virumed Junior contains sorbitol (E420)

The medicine contains 126.7 mg of sorbitol (E420) per ml of suspension, which corresponds to 101.4 mg/0.8 ml of suspension; 152.0 mg/1.2 ml of suspension; 202.7 mg/1.6 ml of suspension; 304.1 mg/2.4 ml of suspension; 354.8 mg/2.8 ml of suspension. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.

Virumed Junior contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to take Virumed Junior

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their 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 taken several times a day.

Adults, including elderly patients

The recommended daily dose is 50 mg/kg body weight per day (0.16 ml/kg 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/kg body weight per day, usually 0.16 ml/kg body weight per day, given in 3 or 4 equal divided doses per day.
The following table shows the dosing based on the patient's body weight.
*To measure the recommended volume, the measuring cup provided with the packaging should be used.

Method of administration

Oral administration.
The suspension should be taken with a sufficient amount of water. The prepared suspension is white to off-white, with a banana flavor and aroma.

Instructions for preparing the suspension

The medicine is in the form of a powder. Before use, it should be mixed with water. To prepare 30 ml of suspension, 15 ml of boiled and then cooled to room temperature water should be added to the bottle:

• 1. Shake the bottle vigorously to loosen the powder, then open the bottle.
• 2. Add 10 ml of water (2 volumes of the measuring cup) using the measuring cup provided with the packaging. Close the bottle.
• 3. Turn the bottle upside down and shake vigorously (for at least 1 minute) until a uniform suspension is formed. Open the bottle.
• 4. Add 5 ml of water (1 volume of the measuring cup) using the measuring cup provided with the packaging. Close the bottle.
• 5. Turn the bottle upside down and shake vigorously (for at least 1 minute) until a uniform suspension is formed. Open the bottle.
• 6. Insert the adapter provided with the packaging into the neck of the bottle.

Dosing:

• 1. Shake the bottle for 1 minute immediately before each use.
• 2. Open the bottle.

• 3. Take the measuring cup and insert it into the adapter opening.
• 4. Turn the bottle upside down.
• 5. Fill the measuring cup with the appropriate amount of suspension by pulling the plunger down.
• 6. Turn the bottle right side up.
• 7. Remove the measuring cup from the adapter.
• 8. Insert the tip of the measuring cup into the mouth and slowly press the plunger.
• 9. Rinse the measuring cup with water and let it dry before reusing.
• 10. Close the bottle with the cap – leave the adapter in the bottle.

Duration of treatment

The duration of treatment is usually 5 to 14 days. After the symptoms have subsided, the medicine should be continued for another 1 to 2 days.

Using more than the recommended dose of Virumed Junior

There have been no reports of overdose with inosine pranobex. If there are any doubts or discomfort, the patient should immediately consult their doctor.

Missing a dose of Virumed Junior

If a dose is missed, it should be taken as soon as possible, unless it is close to the time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Virumed Junior

If treatment with Virumed Junior is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen.
If there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Virumed Junior can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, but severe allergic reactions to Virumed Junior are rare.

The patient should stop taking the medicine and consult their doctor immediately if they experience any of the following symptoms:

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sudden wheezing,
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difficulty breathing,
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swelling of the eyelids, face, or lips,
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rash or itching (especially if it affects the whole body).
Other possible side effects of Virumed Junior are listed below.

Very common, occurring in more than 1 in 10 people

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increased uric acid levels in the blood, increased uric acid levels in the urine.
Common, occurring in less than 1 in 10 people
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increased liver enzyme activity or urea levels in the blood – these may be shown by laboratory blood tests ordered by the doctor,
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headaches,
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dizziness,
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fatigue, malaise,
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nausea with or without vomiting,
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discomfort in the upper abdomen,
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itching of the skin,
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skin rash (as the only symptom),
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joint pain,
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increased urea levels in the blood.
Uncommon, occurring in less than 1 in 100 people
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drowsiness or difficulty sleeping (insomnia),
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diarrhea,
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constipation,
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polyuria (increased urine production),
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nervousness.

Frequency not known (cannot be estimated from the available data)

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angioedema (a severe allergic reaction causing swelling of the face, lips, tongue, or throat), hypersensitivity, hives, anaphylactic reaction (a sudden, life-threatening allergic reaction affecting the whole body),
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abdominal pain,
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redness of the skin (flushing).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Virumed Junior

The medicine should be stored 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 month.
Powder for oral suspension
There are no special precautions for storage.
Prepared suspension
Store in the original packaging at a temperature between 15°C and 25°C. The shelf life of the prepared suspension is 15 days.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Virumed Junior contains

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The active substance of the medicine is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3).
Each ml of suspension contains 312.5 mg of inosine pranobex.
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The other ingredients are: maltodextrin, sorbitol (E420), banana flavor [flavor and aroma enhancers, maltodextrin, arabic gum (E414)], sucralose, povidone K-30, potassium citrate, colloidal anhydrous silica, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate.

What Virumed Junior looks like and contents of the pack

White to off-white powder, with a banana flavor and aroma.
Virumed Junior is packaged in a 60 ml orange type III glass bottle.
The bottle is closed with a plastic cap made of PP with a PE insert and a tamper-evident seal. The packaging also includes a 5 ml oral measuring cup (consisting of a container made of LDPE, a plunger made of LDPE, and a plug made of polystyrene) with a scale and an adapter made of PE for withdrawing the suspension.
The labeled bottle is packaged in a cardboard box with a patient leaflet, oral measuring cup, and adapter for the measuring cup.

Marketing authorization holder and manufacturer

Marketing authorization 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
Mako Pharma Sp. z o. o.
ul. Kolejowa 231A
05-092 Dziekanów Polski
Date of last revision of the leaflet:04.2024