Virumed

Leaflet attached to the packaging: patient information

Virumed, 1000 mg, powder for oral solution, in a sachet

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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
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If after 5 to 14 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What is Virumed and what is it used for

Virumed is an antiviral and immunostimulant medicine (stimulates the activity of the immune system).
Virumed is intended for use in adults:
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as a supportive treatment in people with weakened immunity, in case of recurrent upper respiratory tract infections.
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for the treatment of herpes labialis and facial skin caused by the herpes simplex virus. Virumed can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.
If after 5 to 14 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Virumed

When not to take Virumed

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If you are 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 you currently have an acute attack of gout (severe joint pain with swelling and redness of the skin or excessive fluid accumulation in the large joints) or if tests have shown elevated uric acid levels in the blood.

Warnings and precautions

Before starting treatment with Virumed, discuss it with your doctor or pharmacist.
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If you have had gout attacks or elevated uric acid levels in the blood or urine in the past. Virumed may cause a temporary increase in uric acid levels in the blood and urine.
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If you have had kidney stones in the past.
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If you have kidney function disorders. In this case, your doctor will closely monitor you.
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If the treatment is long-term (3 months or longer), your 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 you have observed symptoms of an allergic reaction, such as a rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In this case, stop the treatment and consult your doctor immediately.

Children and adolescents

Do not use Virumed in children and adolescents under 18 years of age. Other medicines containing inosine pranobex are available for these patients in suitable forms.

Virumed and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor or pharmacist about the following medicines, as they may interact with Virumed:
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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 transplantation or with atopic dermatitis);
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zidovudine (a medicine used to treat patients infected with HIV).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Virumed during pregnancy or breastfeeding, unless your doctor advises you to do so. Your doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

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

Virumed contains sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. The medicine contains 2935 mg of sucrose. This should be taken into account in patients with diabetes.

Virumed contains sorbitol (E420)

The medicine contains 0.097 mg of sorbitol in each sachet.

3. How to take Virumed

Always take this medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your 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 per kg of body weight per day, usually 3 sachets (i.e., 3 g) per day, taken in 3 or 4 divided doses. The maximum dose is 4 sachets (i.e., 4 g) per day.

Method of administration

Oral administration.
Dissolve the contents of one sachet in 1/2 glass of cold water, mix, and drink immediately after preparation. The prepared solution will be clear or slightly cloudy, colorless, and have a blackcurrant flavor.

Duration of treatment

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

Overdose of Virumed

No cases of overdose with inosine pranobex have been reported. If you have any doubts or feel unwell, contact your doctor immediately.

Missed dose of Virumed

If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Virumed

If you stop taking Virumed, you may not achieve the expected therapeutic effect, or the symptoms of the disease may worsen.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and consult your doctor immediately if you 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 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 blood tests ordered by your 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 available data)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Virumed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Virumed contains

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The active substance of Virumed is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3).
Each sachet contains 1000 mg of inosine pranobex.
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The other ingredients are: potassium citrate, sucrose, colloidal anhydrous silica, sucralose, blackcurrant flavor Cassis "NAP-F", code 426 [natural flavor enhancers, natural flavor and aroma substances, flavor and aroma substances, maltodextrin, mannitol (E421), gluconic acid lactone, modified starch, sorbitol (E420), arabic gum (E414), colloidal anhydrous silica].

What Virumed looks like and contents of the pack

White or off-white powder with a blackcurrant flavor.
Virumed is packaged in sachets made of Aluminum/Paper/PE.
One sachet contains 4000 mg of powder for oral solution.
The box contains 20 or 50 sachets and a patient leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice, Poland
Hermes Pharma Ges.m.b.H.
Schwimmschulweg 1a
9400 Wolfsberg, Austria
Date of last revision of the leaflet:02.2024