Viruzine forte

Package leaflet: Information for the user

Viruzine Forte, 500 mg/5 ml, syrup
Inosinum pranobexum
Please read carefully all the information in this leaflet before taking 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, please consult your 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 or if your condition worsens after 5 to 14 days, you should contact your doctor.

Contents of the leaflet

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

1. What Viruzine Forte is and what it is used for

Viruzine Forte is an antiviral and immunostimulatory medicine (it stimulates the immune system).
Viruzine Forte contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses of the Herpes group.
Indications for the use of Viruzine Forte:

• as an adjunct in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections,
• in the treatment of cold sores and facial skin herpes caused by herpes simplex virus (Herpes simplex). Viruzine Forte may only be used in patients who have previously been diagnosed with herpes simplex virus infection.

If there is no improvement or if your condition worsens after 5 to 14 days, consult your doctor.

2. Important information before using Viruzine Forte

When not to use Viruzine Forte

• If the patient is allergic (hypersensitive) to the active substance (pranobex of inosine) 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.
• If the patient currently has an attack of gout (severe joint pain with swelling and redness of the skin, and effusion in large joints), or tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Viruzine Forte, discuss this with your doctor or pharmacist:

• if the patient has previously had gout attacks or elevated uric acid levels, as the medicine may cause transient increases in serum and urinary uric acid levels;
• if the patient has previously had kidney stones;
• if the patient has impaired kidney function. In such cases, the doctor will closely monitor the patient;
• if treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function. Kidney stones may form during prolonged treatment;
• if symptoms of an allergic reaction are observed, 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.

Viruzine Forte and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist about the following medicines, as they may interact with Viruzine Forte:

• allopurinol or other medicines used in the treatment of gout;
• medicines increasing uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines affecting the immune system, e.g. those used after organ transplantation;
• zidovudine used in the treatment of AIDS.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Viruzine Forte should not be taken during pregnancy or breastfeeding unless the doctor considers that the benefits of using the medicine outweigh the possible risks.

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

Viruzine Forte contains propylene glycol (E 1520)
The medicine contains 474 mg of propylene glycol in 5 ml of syrup. Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests in such patients.

Viruzine Forte contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
The medicine may cause allergic reactions (delayed-type reactions are possible).

Viruzine Forte contains sucrose
5 ml of Viruzine Forte syrup contains 2.80 g of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, meaning the medicinal product is considered "sodium-free".

3. How to use Viruzine Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults, including elderly patients (over 65 years of age)
The recommended dose is 50 mg per kg body weight per day (0.5 ml per kg body weight per day), usually
10 ml of syrup 3 or 4 times daily.
The maximum dose is 4 g of inosine pranobex (i.e. 40 ml of syrup) per day.
Children above 1 year of age
The recommended dose is 50 mg per kg body weight per day (0.5 ml per kg body weight per day). The medicine
should be administered 3 times daily according to the table below:

* To measure the recommended volume, use the measuring device provided with the packaging.
Duration of treatment
The usual duration of treatment is 5 to 14 days. After symptoms have subsided, the medication is usually continued for an additional 1 to 2 days.
Use of a higher than recommended dose of Viruzine Forte
Cases of overdose have not been reported to date. If in doubt, consult your doctor immediately.
Missed dose of Viruzine Forte
If a dose of this medicine is missed, 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 a missed dose.
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 medicinal product can cause adverse reactions, although not everyone experiences them.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking the medicine
Viruzine Forte are very rare.
Immediate medical advice must be sought 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).

The following adverse reactions may occur:

• Very common (occurring in more than 1 in 10 patients): increased concentration of uric acid in blood, increased concentration of uric acid in urine.
• Common (occurring in no more than 1 in 10 patients): increased liver enzyme activity, increased blood urea concentration, rash, itching, joint pain, vomiting, nausea, epigastric discomfort, fatigue (tiredness), weakness (malaise), headache, dizziness.
• Uncommon (occurring in no more than 1 in 100 patients): diarrhoea, constipation, somnolence or difficulty sleeping (insomnia), nervousness, increased urine volume (polyuria).
• Frequency not known (cannot be estimated from the available data): epigastric pain, swelling of the face, lips, eyelids or throat (angioedema), urticaria, allergic reaction, sudden systemic allergic reaction (anaphylactic reaction), skin redness (erythema).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 enables better assessment of the safety profile of the medicinal product.

5. How to store Viruzine Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25 °C. Do not store in the refrigerator or freeze.
Period of validity after first opening the bottle: 9 months.
Medicines must 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 packaging and other information

What Viruzine Forte contains

• The active substance in the medicine is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One ml of syrup contains 100 mg of inosine pranobex. 5 ml of syrup contains 500 mg of inosine pranobex.
• Other ingredients (excipients) are: sucrose, citric acid monohydrate, sodium hydroxide, propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), raspberry flavour (containing propylene glycol), banana flavour (containing ethanol, propylene glycol), purified water.

What Viruzine Forte looks like and contents of the pack
Colourless to yellow syrup with a banana-raspberry taste.
Brown glass bottle (type III) with an aluminium cap with a tamper-evident ring and
a PE seal, in a cardboard box, containing 100 ml or 150 ml of syrup.
A measuring device is included with the packaging.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A."
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel.: 22 742 00 22
e-mail: [email protected]