Patient Information Leaflet

Virumed, 1000 mg, powder for oral solution in sachet
Inosinum pranobexum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 to 14 days, or if your condition worsens, contact your doctor.

Table of Contents

What Virumed is and what it is used for
Important information before taking Virumed
How to take Virumed
Possible side effects
How to store Virumed
Contents of the pack and other information

1. What Virumed is and what it is used for

Virumed is an antiviral and immunostimulant medicine (it stimulates the immune system).
Virumed is intended for use in adults:

as an adjunctive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
for the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Virumed may be used only in patients previously diagnosed with herpes simplex virus infection.
If there is no improvement after 5 to 14 days, or if your condition worsens, consult your doctor.

2. Important information before using Virumed

When not to use Virumed

If the patient is allergic to inosine pranobex or any of the other ingredients of this
medicinal product (listed in section 6). Symptoms of an allergic reaction may include: rash, itching,
difficulty breathing, swelling of the face, lips, throat, or tongue.
If the patient currently has an acute attack of gout (severe joint pain with swelling
and redness of the skin, or effusion in large joints).
If tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Virumed, discuss this with your doctor or pharmacist.

If the patient has previously experienced gout attacks or elevated levels of
uric acid in the blood or urine. Virumed may cause transient increases in uric acid levels in the blood and urine.
If the patient has previously had kidney stones.
If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely.
If treatment is long-term (3 months or longer), the doctor will order regular blood tests
and monitor kidney and liver function. Long-term treatment may lead to the formation of kidney stones.
If symptoms of an allergic reaction occur, such as rash, itching, difficulty
breathing, or swelling of the face, lips, throat, or tongue. In such a case, treatment must be stopped immediately
and medical advice sought.

Children and adolescents
Do not use this medicinal product in children and adolescents under 18 years of age. Other medicinal products containing inosine pranobex in appropriate formulations are available for these patients.

Virumed with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use. Especially inform your doctor or pharmacist about the following medicines, as they may interact with Virumed:

Medicines used in the treatment of gout (allopurinol or other medicines);
Medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
Medicines that suppress immune system function (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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take Virumed during pregnancy or breastfeeding unless otherwise advised by a doctor. The doctor will assess whether the benefits of treatment outweigh the potential risks.

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

Virumed contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine contains 2935 mg of sucrose per sachet. 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 use Virumed

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician 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, usually 3 sachets (i.e. 3 g) per day,
divided into 3 or 4 doses. The maximum dose is 4 sachets (i.e. 4 g) per day.
Method of administration
Oral use.
Dissolve the contents of one sachet in 1/2 glass of lukewarm water, mix and drink immediately after
preparation. The prepared solution will be clear or slightly cloudy, colorless, with a blackcurrant odor.
Duration of treatment
The treatment usually lasts from 5 to 14 days. After symptoms have subsided, continue taking the medicine for another 1 to 2 days.
Use of a higher than recommended dose of Virumed
Cases of inosine pranobex overdose have not been reported to date. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of Virumed
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Virumed
If treatment with Virumed is discontinued, the expected therapeutic effect may not be achieved or symptoms may worsen.
If you have any further questions about 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 the medicine
Virumed are rare.
You should stop taking the medicine and consult a doctor immediately if any of the following symptoms occur:
‐ sudden onset of wheezing,
‐ difficulty breathing,
‐ swelling of eyelids, face or lips,
‐ rash or itching (especially if affecting the whole body).

Other possible adverse reactions of Virumed are listed below.
Very common, occurring in more than 1 in 10 people
‐ increased blood uric acid levels, increased uric acid levels in urine.
Common, occurring in 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 levels.
Uncommon, occurring in no more than 1 in 100 people
‐ drowsiness or difficulty falling asleep (insomnia),
‐ diarrhoea,
‐ constipation,
‐ polyuria (increased urine output),
‐ nervousness.
Frequency not known (cannot be estimated based on 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 any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at 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 to provide more information on the safety of the medicine.

5. How to store Virumed

Keep this medicine out of 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 stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Virumed contains
‐ The active substance is inosine pranobex (a complex containing inosine and
4-acetamidobenzoate 2-hydroxypropyl dimethylammonium in a molar ratio of 1:3).
Each sachet contains 1000 mg of inosine pranobex.
‐ Other ingredients: potassium citrate, sucrose, colloidal anhydrous silica, sucralose,
blackcurrant flavour Cassis "NAP-F", code 426 [natural flavouring preparations, natural substances improving taste and odour, flavouring substances improving taste and odour, maltodextrin, mannitol (E421), gluconolactone, modified starch, sorbitol (E420), gum arabic (E414), colloidal anhydrous silica].

What Virumed looks like and contents of the pack
White or almost white powder with a blackcurrant odour.
Virumed is packed in sachets made of Aluminium/Paper/PE.
One sachet contains 4000 mg of powder for oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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