Inuprin

Package leaflet: Information for the patient

INUPRIN, 500 mg, tablets
Inosinum pranobexum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 5 to 14 days, consult a doctor.

Table of contents

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

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

The medicine contains as the active substance inosine pranobex, which exhibits antiviral activity and stimulates immune system function.
Indications for use of the medicine are:

• As an adjunct in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
• In the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). The medicine may only be used in patients previously diagnosed with herpes simplex virus infection. If there is no improvement or if the patient feels worse after 5 to 14 days, consult a doctor.

2. 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),
• if the patient currently has an attack of acute gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or tests have shown increased uric acid levels in the blood.

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

• If the patient has previously experienced gout attacks or elevated serum or urinary uric acid levels. The medicine may transiently increase uric acid levels in serum and urine.
• If the patient has previously had kidney stones (nephrolithiasis).
• 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. Prolonged treatment may lead to the formation of kidney stones.
• If symptoms of an allergic reaction occur, such as rash, itching, breathing difficulties, or swelling of the face, lips, throat, or tongue. In such cases, treatment must be stopped immediately and medical advice sought without delay.

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

Medicines and other drugs
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 about the following medicines, as they may interact with this medicine:

• medicines used to treat gout (allopurinol or other drugs);
• medicines that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that suppress immune system function, so-called immunosuppressants, used in patients after organ transplantation or in atopic dermatitis;
• medicines used in the treatment of AIDS (zidovudine). In these cases, the doctor may decide whether it is necessary to use this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 any potential risks.

Driving and operating machinery
This medicine may affect the ability to drive or 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.

This medicine contains less than 1 mmol (23 mg) of sodium in 8 tablets, meaning the medicine is considered "sodium-free".

3. How to take this medicine

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
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 elderly people (over 65 years of age)
The recommended daily dose is 50 mg/kg body weight per day; usually, the daily dose is 6 tablets (3 g) taken throughout the day (i.e. 2 tablets 3 times daily).
The maximum daily dose is 8 tablets (4 g) per day (i.e. 2 tablets 4 times daily).

Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, administered in several divided doses.
For children who cannot swallow tablets, administration of the medicine in syrup form is recommended.

Method of administration
This medicine is for oral use. The tablet should be taken with an adequate amount of liquid, preferably water.
If difficulty swallowing the whole tablet occurs, to facilitate administration, the tablets may be crushed and dissolved in a small amount of liquid.

Duration of treatment
The usual duration of treatment is 5 to 14 days. After symptoms have resolved, continue taking the medicine for another 1 to 2 days.

Taking more medicine than recommended
Cases of overdose have not been reported so far. If in doubt or if you feel unwell, 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.

Stopping the medicine
If treatment is stopped prematurely, the desired therapeutic effect may not be achieved, or disease symptoms may worsen.

If you have any further questions about 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 everyone experiences them.
Allergic reactions may occur with any medicine; 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 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 (occur in more than 1 in 10 patients):

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

Common (occur in no more than 1 in 10 people):

• 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 no more than 1 in 100 people):

• 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 and breathing), allergic reaction, urticaria, anaphylactic reaction (a sudden, life-threatening allergic reaction affecting the whole body);
• dizziness,
• skin redness (erythema);
• pain 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 of 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 authorization 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is inosine pranobex (a complex containing inosine and 2-hydroxypropyl dimethyl ammonium 4-acetamidobenzoate in a molar ratio of 1:3). Each tablet contains 500 mg of inosine pranobex.
• Other ingredients: microcrystalline cellulose, sodium croscarmellose, polyvinylpyrrolidone K90, magnesium stearate.

What the medicine looks like and contents of the pack
Cylindrical, biconvex, white tablets.
PVC/PVDC/Aluminium blister pack containing 10 tablets, placed in a cardboard box.
Pack contains 10, 20, 30, 40 or 50 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, 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.
Władysława Reymonta 2
05-092 Dziekanów Leśny
Tel. 22 256 86 82
e-mail: [email protected]

Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom
Poland
e-mail: [email protected]