Inuprin

Package Leaflet: Information for the Patient

INUPRIN, 50 mg/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 for the patient, or as directed by the doctor or pharmacist.

• 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 the patient experiences any side effects, including those 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 contact their doctor.

Table of Contents of the Leaflet

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

1. What is the medicine and what is it used for

The medicine contains inosine pranobex as the active substance, which has antiviral and immunostimulating effects.

Indications for Use

The medicine is indicated for use in adults and children over 1 year of age.

• As a supportive treatment in people with weakened immunity, in cases of recurring upper respiratory tract infections.
• In the treatment of herpes simplex virus infections of the lips and facial skin. The medicine can only be used in patients who have previously been diagnosed with herpes simplex virus infection.

If after 5 to 14 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important Information Before Taking the Medicine

When Not to Take the Medicine

• If the patient is 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, tongue, or throat.
• If the patient currently has an acute attack of gout (severe joint pain with swelling and redness of the skin or effusion in the large joints) or if tests have shown increased uric acid levels in the blood.

Warnings and Precautions

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

• If the patient has had gout attacks or increased uric acid levels in the serum or urine in the past. The medicine may cause transient increases in uric acid levels in the serum and urine.
• If the patient has had kidney or gallstones in the past.
• If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient. If treatment lasts for 3 months or longer, the doctor will order regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form. If symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue, treatment should be stopped immediately and the doctor consulted.

Children

The medicine should not be given to children under 1 year of age.

Medicine Interactions

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Medicines used to treat gout (allopurinol or other medicines);
• Medicines that increase uric acid excretion, including diuretics, such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• Immunosuppressive medicines used in patients after organ transplants or with atopic dermatitis;
• Medicines used to treat HIV infections (azidothymidine). In these cases, the doctor will assess whether the benefits of using the medicine outweigh the possible risks.

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.

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

Driving and Operating Machines

The medicine may affect the ability to drive and operate machines. If the patient experiences headache, dizziness, or drowsiness, they should not drive, operate machines, or perform other activities that require concentration. See also section 4.

Excipients

The medicine contains sucrose, glycerol (E422), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and sodium.

The medicine contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

1 ml of the medicine contains 0.65 g of sucrose. This should be taken into account in patients with diabetes.

The medicine contains glycerol (E422). The medicine may cause headache, gastrointestinal disturbances, and diarrhea.

The medicine contains 20.70 mg of propylene glycol (E1520) per 1 ml of syrup.

The medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). The medicine may cause allergic reactions (possible late reactions).

The medicine contains less than 1 mmol (23 mg) of sodium per 80 ml, which means the medicine is considered "sodium-free".

3. How to Take the Medicine

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The medicine should be taken orally.

The recommended dose is determined based on the patient's body weight. The daily dose should be divided into equal single doses taken several times a day.

Adults, including the elderly (over 65 years)

The recommended daily dose is 50 mg/kg body weight per day (1 ml of syrup per 1 kg body weight per day), usually 3 g (i.e., 60 ml of syrup) per day, taken in 3 or 4 divided doses. The maximum dose is 4 g of inosine pranobex per day (i.e., 80 ml of syrup per day).

Do Not Exceed the Maximum Dose of 80 ml per Day.

Children Over 1 Year of Age

The recommended dose is usually 50 mg/kg body weight per day (1 ml of syrup per 1 kg body weight per day) in 3 or 4 equal divided doses per day.

The following table shows the dosage based on the patient's body weight.

*To measure the recommended volume, use the measuring cup provided with the packaging, with a scale of 2.5 ml.

Duration of Treatment

The usual duration of treatment is from 5 to 14 days. It is recommended to take the medicine for an additional 1 to 2 days after the symptoms of the disease have subsided.

Use in Children

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

Overdose

There have been no reported cases of overdose. If there are any doubts or discomfort, the patient should immediately consult their doctor.

Missed Dose

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

Stopping Treatment

If treatment is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen.

If there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Every medicine can cause an allergic reaction, but severe allergic reactions after taking the medicine are very rare.

Stop Taking the Medicine and Consult a Doctor Immediatelyif any of the following symptoms occur:

• 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 but more than 1 in 100 patients):

• increased liver enzyme activity, increased urea levels in the blood,
• nausea with or without vomiting,
• discomfort in the upper abdomen,
• itching of the skin,
• skin rash (as the only symptom),
• headache,
• dizziness,
• fatigue or malaise,
• joint pain.

Uncommon(occurring in less than 1 in 100 patients but more than 1 in 1,000 patients):

• diarrhea,
• constipation,
• nervousness,
• drowsiness or difficulty sleeping (insomnia),
• increased urine output (polyuria).

Frequency Not Known(cannot be estimated from the available data):

• angioedema (a severe allergic reaction that causes swelling of the face, lips, tongue, or throat, which can lead to difficulty swallowing and breathing), allergic reaction,

urticaria, anaphylactic reaction (a sudden, life-threatening allergic reaction that affects the whole body);

• dizziness;
• redness of the skin (flushing);
• discomfort in the upper abdomen.

Reporting Side Effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel. +48 22 49 21 301

Fax +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store the Medicine

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C.

Shelf life after first opening the package: 6 months.

Do not use this medicine after the expiry date stated on the package after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.

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 the Medicine Contains

• The active substance of the medicine is inosine pranobex.
• The other ingredients are: sucrose, glycerol (E422), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), raspberry flavor AR0616/G: flavoring substances, flavoring preparation, propylene glycol (E1520), sodium hydroxide, citric acid, purified water.

What the Medicine Looks Like and Contents of the Pack

The medicine is a clear, colorless to light yellow syrup with a raspberry flavor and aroma, available in a brown PET bottle with an HDPE cap and a PP measuring cup with a scale of 2.5 ml.

Package size: One bottle containing 150 ml of syrup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Solinea Sp. z o.o.

Elizówka, ul. Szafranowa 6

21-003 Ciecierzyn

Tel. 81 463 48 82

Fax 81 463 48 86

e-mail [email protected]

Manufacturer

Mako Pharma Sp. z o.o.

ul. Kolejowa 231A

05-092 Dziekanów Polski

Tel. 22 256 86 82

e-mail [email protected]

Medicofarma S.A.

ul. Tarnobrzeska 13

26-613 Radom

Date of Last Revision of the Leaflet: 05/2024