Viruzine Forte

Leaflet attached to the packaging: patient information

Viruzine Forte, 500 mg/ 5 ml, syrup

Inosine pranobex

You should carefully read the contents of the 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Viruzine Forte and what is it 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 packaging and other information

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

Viruzine Forte is an antiviral and immunostimulant medicine (it stimulates the activity of the immune system).
Viruzine Forte contains the active substance - inosine pranobex, which inhibits in vitrothe multiplication of pathogenic viruses for humans, from the Herpesgroup.
Indications for the use of Viruzine Forte:

• as an adjunct in patients with impaired immunity, in the case of recurrent upper respiratory tract infections,
• in the treatment of herpes labialis and facial skin caused by the herpes simplex virus (Herpes simplex). Viruzine Forte 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, you should consult your doctor.

2. Important information before taking Viruzine Forte

When not to take Viruzine Forte

• If you are allergic (hypersensitive) to the active substance (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.
• If you currently have an acute attack of gout (severe joint pain with swelling and redness of the skin, and in large joints, there is an accumulation of effusion) or tests have shown an increased level of uric acid in the blood.

Warnings and precautions

Before starting treatment with Viruzine Forte, you should discuss it with your doctor or pharmacist:

• if you have had gout attacks or increased uric acid levels in the past, as the medicine may cause a transient increase in uric acid levels in the serum and urine,
• if you have had kidney stones in the past,
• if you have kidney function disorders. In such cases, your doctor will closely monitor you,
• if the treatment is long-term (3 months or longer). Your doctor will recommend regular blood tests and will monitor kidney and liver function. During long-term treatment, kidney stones may form,
• 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 such cases, you should immediately stop the treatment and consult your doctor.

Viruzine Forte and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should especially inform your doctor or pharmacist about the following medicines, as they may interact with Viruzine Forte:

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics, such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation;
• azidothymidine used to treat AIDS.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should not take Viruzine Forte during pregnancy and breastfeeding, unless your doctor considers that the benefits of taking this medicine outweigh the possible risks.

Driving and using machines

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

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, you should consult your 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 their doctor's recommendation.
Your doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without their doctor's recommendation. Your doctor may decide to perform additional tests on such patients.

Viruzine Forte contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

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

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 you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medicinal product is considered "sodium-free”.

3. How to take Viruzine Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Adults, including the elderly (over 65 years)
The recommended dose is 50 mg per kg of body weight per day (0.5 ml per kg of body weight per day), usually 10 ml of syrup 3 or 4 times a day.
The maximum dose is 4 g of inosine pranobex (i.e., 40 ml of syrup) per day.
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day (0.5 ml per kg of body weight per day). The medicine should be administered 3 times a day according to the following table:
* To measure the recommended volume, you should use the measuring cup provided with the packaging.
Duration of treatment
Usually, the duration of treatment is from 5 to 14 days. After the symptoms have subsided, the administration of the medicine is usually continued for another 1 to 2 days.

Taking a higher dose of Viruzine Forte than recommended

So far, no cases of overdose have been reported. If you have any doubts, you should immediately consult your doctor.

Missing a dose of Viruzine Forte

If you miss a dose of this medicine, you should take it as soon as you remember, unless it is almost time for the next dose. You should not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, but severe allergic reactions after taking Viruzine Forte are very rare.

You should immediately consult your doctorif you experience any of the following symptoms:

• sudden wheezing,
• difficulty breathing,
• swelling of the eyelids, face, or lips,
• rash or itching (especially if it affects the whole body).

The following side effects may occur:

• Very common (occurring in more than 1 in 10 patients): increased uric acid levels in the blood, increased uric acid levels in the urine.
• Common (occurring in less than 1 in 10 patients): increased liver enzyme activity, increased urea levels in the blood, rash, itching, joint pain, vomiting, nausea, abdominal discomfort, fatigue (tiredness), weakness (malaise), headache, dizziness.
• Uncommon (occurring in less than 1 in 100 patients): diarrhea, constipation, drowsiness or difficulty sleeping (insomnia), nervousness, increased urine output (polyuria).
• Frequency not known (cannot be estimated from the available data): abdominal pain, facial swelling, lip swelling, eyelid swelling or throat swelling (angioedema), hives, allergic reaction, sudden whole-body allergic reaction (anaphylaxis), skin redness (flushing).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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 Viruzine Forte

The medicine should be stored 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 month.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the bottle: 9 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Viruzine Forte contains

• 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). One ml of syrup contains 100 mg of inosine pranobex. 5 ml of syrup contains 500 mg of inosine pranobex.
• The other ingredients of the medicine (excipients) are: sucrose, citric acid monohydrate, sodium hydroxide, propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), raspberry flavor (including propylene glycol), banana flavor (including ethanol, propylene glycol), purified water.

What Viruzine Forte looks like and what the packaging contains

Colorless to yellow syrup with a banana-raspberry flavor.
Brown glass type III bottle with an aluminum cap with a tamper-evident ring and a PE seal, in a cardboard box, containing 100 ml or 150 ml of syrup.
A measuring cup is included with the packaging.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A.”
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel.: 22 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet: