Inuprin forte

Package leaflet: Information for the patient

INUPRIN FORTE, 1000 mg, tablets
Inosinum pranobexum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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 after 5 to 14 days, or if you feel worse, contact your doctor.

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 package 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 activity and stimulates the immune system.
Indications for use 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 who have previously been diagnosed with herpes simplex virus infection. If there is no improvement after 5 to 14 days, or if you feel worse, 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 any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has an attack of gout (severe joint pain with swelling and redness of the skin, or effusion in large joints),
• if tests have shown increased blood uric acid levels.

Warnings and precautions
Before starting treatment, discuss this medicine with your 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 stones.
• If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely.
• If treatment lasts 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, breathing difficulties, or swelling of the face, lips, throat, or tongue. In such cases, treatment must be stopped immediately and medical advice sought.

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

Other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use. Especially inform your 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, chlorthalidone, indapamide;
• medicines that suppress the immune system, so-called immunosuppressants, used in organ transplant patients or in atopic dermatitis;
• medicines used to treat AIDS (zidovudine). In the above cases, the doctor may decide whether use of the medicine is necessary.

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 tasks requiring concentration. See also section 4.

The medicine contains less than 1 mmol (23 mg) of sodium in 4 tablets, 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 your 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 administered several times a day.

Adults, including elderly patients (over 65 years of age)
The recommended daily dose is 50 mg/kg body weight per day; usually, the daily dose is 3 tablets (3g) per day (i.e. 1 tablet 3 times a day).
The maximum daily dose is 4 tablets (4g) per day (i.e. 1 tablet 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, administration of the medicine in syrup form is recommended.

Administration method
The medicine should be taken orally. The tablet should be taken with an adequate amount of liquid, preferably water.
If difficulty occurs in swallowing the whole tablet, to facilitate administration, the tablet may be crushed and dissolved in a small amount of liquid.

Duration of treatment
The usual duration of treatment is between 5 and 14 days. After symptoms have resolved, the medicine should still be continued for another 1 to 2 days.

Use of a higher than recommended dose of the medicine
Cases of overdose have not been reported to date. If in doubt or if you feel unwell, contact your doctor immediately.

Missed dose
If a dose is missed, it should be taken as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Interrupting treatment
If treatment is interrupted, the expected therapeutic effect may not be achieved, or symptoms of the disease 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 will experience them.
Any medicine may cause an allergic reaction, but 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 severe 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);
• upper abdominal pain.

Reporting of adverse reactions
If any adverse reactions occur, including any 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
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 pack and other information

What the medicine contains

• The active substance is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). Each tablet contains 1000 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
Cylindrical, biconvex, white tablets, marked "1000" on one side.
PVC/PVDC/Aluminium blister packs containing 10 tablets, placed in a cardboard box.
The pack contains 10, 20, 30, 40 or 50 tablets.

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. Władysława Reymonta 2
05-092 Dziekanów Leśny
Tel. 22 256 86 82
e-mail: [email protected]

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