Inuprin

Package Leaflet: Information for the Patient

INUPRIN, 500 mg, tablets

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 a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• 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 there is no improvement or the patient feels worse after 5 to 14 days, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Indications for use of the medicine are:

• Supportively in patients with reduced 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. The medicine should only be used in patients who have been previously diagnosed with a herpes simplex virus infection. If there is no improvement or the patient feels worse after 5 to 14 days, 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),
• if the patient currently has an acute attack of gout (severe joint pain with swelling and redness of the skin or the accumulation of fluid in the large joints).

Warnings and precautions

Before starting to take 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 blood or urine in the past. The medicine 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 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 allergic reaction symptoms are observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In such cases, 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 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. In particular, the doctor should be informed about the following medicines, as they may interact with this medicine:

• 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, and indapamide;
• immunosuppressive medicines used in patients after organ transplantation or with atopic dermatitis;
• medicines used to treat AIDS (azidothymidine). In these cases, the doctor may decide to use the medicine.

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 or breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

The medicine may affect the ability to drive and use 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. The medicine contains less than 1 mmol (23 mg) of sodium per 8 tablets, which means it 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 a doctor or pharmacist. If in doubt, the patient should consult their 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 the elderly (over 65 years):

The recommended daily dose is 50 mg/kg body weight per day, usually 6 tablets (3g) per day (i.e., 2 tablets 3 times a day). The maximum daily dose is 8 tablets (4g) per day (i.e., 2 tablets 4 times a day).

Children over 1 year of age:

The recommended dose is 50 mg/kg body weight per day, given in divided doses. For children who cannot swallow tablets, the medicine is recommended to be given in syrup form.

Method of administration:

The medicine should be taken orally. The tablet should be swallowed with a sufficient amount of liquid, preferably water. If the patient has difficulty swallowing the whole tablet, the tablets can be crushed and dissolved in a small amount of liquid to facilitate administration.

Duration of treatment:

Usually, the duration of treatment is from 5 to 14 days. After the symptoms have resolved, the medicine should be continued for another 1 to 2 days.

Overdose

There have been no reported cases of overdose. If the patient has any doubts or feels unwell, they should contact their doctor immediately.

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 the patient has any further doubts about taking this medicine, they should consult their 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 this medicine are very rare.

The patient should stop taking the medicine and consult their doctor immediatelyif they 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 blood urea nitrogen levels,
• 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)

• 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);
• upper abdominal pain.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. 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. +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store the medicine

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 stated.

There are no special precautions for storing the medicine.

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 (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One tablet contains 500 mg of inosine pranobex.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, polyvinylpyrrolidone K90, magnesium stearate.

What the medicine looks like and contents of the pack

The tablets are cylindrical, biconvex, and white.

PVC/PVDC/Aluminum blister pack of 10 tablets in a cardboard box.

The pack contains 10, 20, 30, 40, or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Solinea Sp. z o.o. Sp. K.

Elizówka 65

21-003 Ciecierzyn

Tel. 81 463 48 82

Fax 81 463 48 86

e-mail biuro@solinea.pl

Manufacturer

Mako Pharma Sp. z o.o.

ul. Kolejowa 231A

05-092 Dziekanów Polski

Tel. 22 256 86 82

e-mail biuro@makopharma.pl

Medicofarma S.A.

ul. Tarnobrzeska 13

26-613 Radom

Polska

e-mail: kontakt@medicofarma.pl

Date of last revision of the leaflet: 18.03.2022