INUPRIN

Patient Information Leaflet

INUPRIN, 50 mg/ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this Patient Information Leaflet or as directed
by your doctor or pharmacist.

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

Table of contents

1. What the medicine is and what it is used for
2. What you need to know before taking it
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 the medicine is and what it is used for

This medicine contains inosine pranobex as the active substance, which has antiviral activity and stimulates the immune system.
Indications
The medicine is indicated for use in adults and children over 1 year of age.

• 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). The medicine may be used only in patients who have previously been diagnosed with herpes simplex virus infection.

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

2. Important information before using the medicine

When not to use the medicine

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

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

• If the patient has previously experienced gout attacks or elevated serum or urinary uric acid levels. The medicine may cause transient increases in serum and urinary uric acid levels.
• If the patient has previously had kidney or gallstones.
• If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely. If treatment lasts for 3 months or longer, the doctor will order regular blood tests and monitor kidney and liver function. Kidney stones may form during prolonged treatment. If symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue, treatment must be stopped immediately and medical advice sought.

Children
This medicine should not be given to children under 1 year of age.
Medicines 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.
Especially inform the doctor about the following medicines, as they may interact with this medicine:

• Medicines used in the treatment of gout (allopurinol or other medicines);
• Medicines increasing uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• Medicines that suppress the immune system, so-called immunosuppressive agents, used in patients after organ transplantation or in atopic dermatitis;
• Medicines used in HIV infection (zidovudine). In such cases, the doctor will assess whether the benefits of treatment outweigh the potential risks. Pregnancy and breastfeeding If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

This medicine should not be taken 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
This medicine may affect the ability to drive and operate machinery. If headache, dizziness or drowsiness occur, the patient should not drive, operate machinery or perform any other tasks requiring concentration. See also section 4.
The medicine contains sucrose, glycerol (E422), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and sodium.
This medicine contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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.
This medicine contains glycerol (E422). The medicine may cause headache, gastrointestinal disturbances and diarrhoea.
This medicine contains 20.70 mg of propylene glycol (E1520) in 1 ml of syrup.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). The medicine may cause allergic reactions (including delayed-type reactions).
This medicine contains less than 1 mmol (23 mg) of sodium in 80 ml, meaning the medicine is considered "sodium-free".

3. How to take the medicine

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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 administered several times a day.

Adults, including elderly people (over 65 years of age)
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, given 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).
The maximum dose of 80 ml per day must not be exceeded.

Children over 1 year of age
The usual recommended dose is 50 mg/kg body weight per day (1 ml of syrup per 1 kg body weight per day), given in 3 or 4 equal divided doses throughout the day.

The following table shows the dosing according to the patient's body weight.

*To measure the recommended volume, use the dosing device included in the package, marked in 2.5 ml increments.
Duration of treatment
The treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for 1 to 2 days after symptoms have subsided.
Use in children
This medicine should not be used in children under 1 year of age.
Use of a higher than recommended dose of the medicine
Cases of overdose have not been reported so far. If you have any doubts or experience any adverse effects, contact your doctor immediately.
Missed dose
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.
Discontinuation of the medicine
If treatment is discontinued, the intended therapeutic effect may not be achieved, or symptoms of the disease may worsen.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking this medicine are very rare.
You should stop taking the medicine and consult a doctor immediately if any of the following symptoms occur:

• sudden 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 (occur in more than 1 in 10 patients):

• increased blood uric acid levels, increased urinary uric acid levels.

Common (occur in up to 1 in 10 patients):

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

Uncommon (occur in up to 1 in 100 patients):

• diarrhoea,
• constipation,
• nervousness,
• drowsiness or difficulty sleeping (insomnia),
• increased urine volume (polyuria).

Frequency not known (cannot be estimated from available data):

• angioedema (a serious allergic reaction causing swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing), allergic reaction,
• urticaria, anaphylactic reaction (a sudden, life-threatening allergic reaction affecting the whole body);
• dizziness,
• skin redness (erythema);
• discomfort in the upper abdomen.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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. +48 22 49 21 301
Fax +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the medicine for no more than 6 months after first opening the container.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the stated month.
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 the medicine contains

• The active substance is inosine pranobex.
• The other components are: sucrose, glycerol (E422), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), raspberry flavour AR0616/G: flavouring substances, flavouring 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, colourless to pale yellow syrup with a raspberry smell and taste. It is available in a brown PET bottle with an HDPE screw cap with tamper-evident ring, supplied with a PP measuring cup of 10 ml capacity, graduated every 2.5 ml, all contained in a cardboard box.
Pack size: One bottle containing 150 ml of syrup.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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