Eloprine Forte

Package Leaflet: Information for the User

Eloprine Forte 500 mg/ 5 ml, Syrup

Inosine Pranobex

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of Contents of the Leaflet

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

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

Eloprine Forte contains the active substance inosine pranobex, which has antiviral and immunostimulating properties. Eloprine Forte contains the active substance inosine pranobex, which inhibits the growth of pathogenic viruses for humans in the Herpes group in vitro. Indications for use of Eloprine Forte Supportively in patients with reduced immunity, in case of recurrent upper respiratory tract infections. In the treatment of herpes labialis and facial skin caused by the herpes simplex virus. Eloprine 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 the patient feels worse, they should consult a doctor.

2. Important information before taking Eloprine Forte

When not to take Eloprine Forte:

Warnings and precautions

Before starting treatment with Eloprine Forte, the patient should discuss it with their doctor or pharmacist.

• If the patient has had gout attacks or increased uric acid levels in the blood and urine in the past. Eloprine Forte may cause a temporary increase in uric acid levels in the blood and urine.
• If the patient has had kidney stones in the past.
• If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient.
• If the treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and monitor kidney and liver function.

Children

This medicine should not be used in children under 1 year of age.

Eloprine Forte 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. They should especially inform their doctor about the following medicines, as they may interact with Eloprine Forte syrup:

• medicines used to treat gout (allopurinol or other medicines);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplantation or with atopic dermatitis);
• azidothymidine (a medicine used to treat patients infected with the HIV virus).

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. This medicine should not be taken during pregnancy and breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the risks.

Driving and using machines

It is unlikely that Eloprine Forte will affect the ability to drive and use machines.

Eloprine Forte contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, sodium, and propylene glycol, which is a component of the liquid strawberry flavor

Eloprine Forte contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions). Eloprine Forte also contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. 1 ml of Eloprine Forte syrup contains 650 mg of sucrose. This should be taken into account in patients with diabetes. Eloprine Forte contains less than 1 mmol (23 mg) of sodium per 10 ml, which means the medicine is considered "sodium-free". Eloprine Forte contains propylene glycol, which is a component of the liquid strawberry flavor. The medicine contains 1.484 mg of propylene glycol per 1 ml of syrup. The maximum amount of propylene glycol in a single dose is 14.84 mg (10 ml). The liquid strawberry flavor, which is a component of the medicine, contains citral, among other ingredients.

3. How to take Eloprine Forte

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The medicine should be taken orally. Adults, including the elderly (over 65 years) The recommended daily dose is 50 mg/kg body weight per day (0.5 ml of syrup per 1 kg body weight per day), usually 3 g (i.e. 30 ml of syrup) per day, divided into 3 or 4 doses. 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 usually 50 mg/kg body weight per day (0.5 ml of syrup per 1 kg body weight per day) in 3 or 4 divided doses. The following table shows the dosage based on the patient's body weight. * To measure the recommended volume, the patient should use the measuring cup provided with the packaging. Duration of treatment Treatment usually lasts from 5 to 14 days. After the symptoms have subsided, the medicine is usually continued for another 1 to 2 days. Use in children This medicine should not be used in children under 1 year of age.

Overdose of Eloprine Forte

So far, no cases of overdose have been reported. In case of any doubts or discomfort, the patient should immediately consult their doctor.

Missed dose of Eloprine Forte

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

Stopping treatment with Eloprine Forte

If treatment is stopped, the expected therapeutic effect may not be achieved or the symptoms of the disease may worsen. In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eloprine Forte can cause side effects, although not everybody gets them.

Other possible side effects of Eloprine Forte are listed below.

Common (occurring in 1 to 10 people in 100):

• transient increase in uric acid levels in the blood and urine;
• increased activity of liver enzymes or urea levels in the blood;
• nausea with or without vomiting;
• abdominal pain;
• itching of the skin;
• skin rash;
• headache;
• dizziness;
• fatigue or malaise;
• joint pain.

Uncommon (occurring in 1 to 10 people in 1,000):

• diarrhea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);
• increased urine production (polyuria).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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, more information can be collected on the safety of the medicine.

5. How to store Eloprine Forte

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton and bottle after: "EXP". The expiry date refers to the last day of the month. 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 Eloprine Forte contains

• The active substance of the medicine is inosine pranobex (a complex containing inosine and salts of 4-acetamidobenzoic acid with N,N-2-dimethylamino-2-propanol in a molar ratio of 1:3). 1 ml of syrup contains 100 mg of inosine pranobex. 5 ml of syrup contains 500 mg of inosine pranobex.
• Other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, citric acid monohydrate, sodium hydroxide, liquid strawberry flavor, purified water.

What Eloprine Forte looks like and what the pack contains

Eloprine Forte is a clear, colorless or straw-colored syrup with a characteristic strawberry flavor and aroma. The syrup is available in a 150 ml brown glass bottle, placed in a cardboard box with a measuring cup and patient leaflet.

Marketing authorization holder and manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Poland tel.: 24 357 44 44 fax: 24 357 45 45 e-mail: [email protected]

Date of last revision of the leaflet: