Patient Information Leaflet

Pranosin forte
100 mg/ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any 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.

Leaflet Contents

What Pranosin forte is and what it is used for
What you need to know before taking Pranosin forte
How to take Pranosin forte
Possible side effects
How to store Pranosin forte
Contents of the pack and other information

1. What Pranosin forte is and what it is used for

Pranosin forte syrup contains as the active substance inosine pranobex, which:

exhibits antiviral activity and stimulates immune system function (immunostimulant);
inhibits in vitro replication of human pathogenic viruses from the Herpes group.

Indications
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). Pranosin forte may be used only in patients previously 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 Pranosin forte

When not to use Pranosin forte

if the patient is allergic to the active substance (pranobex of inosine) 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, throat or tongue;
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 with Pranosin forte, discuss this with your doctor or pharmacist:

if the patient has previously had gout attacks or elevated uric acid levels, because Pranosin forte may cause transient increases in blood and urinary uric acid levels;
if the patient has previously had kidney stones;
if the patient has impaired kidney function; during treatment with Pranosin forte, the doctor should regularly order blood tests and monitor kidney function. 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. If treatment is prolonged (lasting 3 months or longer), the doctor will order regular blood tests and monitoring of kidney and liver function. Long-term treatment may lead to the formation of kidney stones.

Children
Pranosin forte should not be used in children under 1 year of age.
Pranosin forte 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 planned for future use.
In particular, inform your doctor or pharmacist if any of the following medicines are being taken, as they may interact with Pranosin forte:

allopurinol or other medicines used to treat gout;
medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
medicines affecting the immune system, e.g. those used after organ transplantation;
zidovudine (AZT) used in the treatment of AIDS.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Pranosin forte during pregnancy or breastfeeding without consulting a doctor. The doctor will assess whether the benefits of treatment for the mother outweigh the risks to the child.
Driving and operating machinery
Pranosin forte has no effect or has negligible effect on the ability to drive or operate machinery. See also section 4.
Pranosin forte 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 Pranosin forte contains 660.40 mg of sucrose. This should be taken into account in patients with diabetes.
Pranosin forte contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
This medicine may cause allergic reactions (including delayed-type reactions).
Pranosin forte contains ethanol, which is part of the raspberry flavouring
This medicine contains 0.12 mg of alcohol (ethanol) in 10 ml of syrup. The amount of alcohol in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
Pranosin forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in a 10 ml dose of syrup, meaning the medicine is considered "sodium-free".

3. How to use Pranosin forte

This medicine should always be taken exactly as described in this patient leaflet or as prescribed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Administer orally.
Recommended dose
The 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
The recommended daily dose is 50 mg of inosine pranobex per kilogram of body weight per day (0.5 ml of syrup per kg of body weight per day), usually 30 ml of syrup (i.e. 3 g of inosine pranobex) daily, given in 3 or 4 divided doses.
The maximum dose is 40 ml of syrup per day (i.e. 4 g of inosine pranobex per day).

Children above 1 year of age
The recommended dose for children above 1 year of age is 50 mg of inosine pranobex per kilogram of body weight per day (0.5 ml of syrup per kg of body weight per day), divided into 3 or 4 equal doses administered throughout the day.

The following table shows dosing according to patient body weight.

Child's body weight	Dosage (ml of syrup)
10-14 kg	3 × 2.5 ml
15-20 kg	3 × 2.5 to 3.5 ml
21-30 kg	3 × 3.5 to 5 ml
31-40 kg	3 × 5 to 7.5 ml
41-50 kg	3 × 7.5 to 9 ml

To measure the correct dose of the medicine, use the dosing spoon or oral syringe provided in the package.
Duration of treatment
Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for another 1 to 2 days after symptoms have subsided.
Use of a higher than recommended dose of Pranosin forte
Cases of overdose have not been reported so far. If in doubt, contact your doctor immediately.
Missed dose of Pranosin forte
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Pranosin forte
If treatment is stopped prematurely, the intended therapeutic effect may not be achieved, or symptoms of the disease may worsen.
If you have any further questions regarding 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.
You should consult a doctor immediately if any of the following symptoms occur:

sudden onset of wheezing,
breathing difficulties,
swelling of the eyelids, face or lips,
rash or itching (especially if affecting the whole body).

Other possible adverse reactions of Pranosin forte
Very common (occurring more frequently than in 1 out of 10 patients):
increased blood uric acid levels, increased urinary uric acid levels.
Common (occurring in no more than 1 out of 10 patients):
increased liver enzyme activity, increased blood urea levels, rash,
itching, joint pain, nausea, vomiting, discomfort in the upper abdomen, fatigue (tiredness),
malaise (weakness), headache, dizziness.
Uncommon (occurring in no more than 1 out of 100 patients):
diarrhea, constipation, nervousness, drowsiness or difficulty sleeping (insomnia), increased urine volume (polyuria).
Frequency not known (cannot be estimated from available data):
upper abdominal pain, angioedema (swelling of the face, lips, eyelids or throat, possibly causing breathing difficulties), urticaria, allergic reaction, anaphylactic reaction (allergic reaction affecting the whole body), dizziness, erythema (skin redness).

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
Phone: +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 to provide more information on the safety of the medicine.

5. How to store Pranosin forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Store below 30°C. Do not store in a refrigerator or freeze.
The shelf life after first opening the bottle is 3 years.
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 Pranosin forte 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). 1 ml of syrup contains 100 mg of inosine pranobex.
Other ingredients are: sucrose, methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216), monohydrate citric acid, sodium hydroxide (for pH adjustment), raspberry flavour (containing: propylene glycol, flavouring substances, lactic acid, acetic acid, ethanol, water, ascorbic acid), purified water.

What Pranosin forte looks like and contents of the pack
Pranosin forte syrup is a clear, colourless or yellow liquid with a raspberry odour.
The pack consists of a 100 ml amber glass bottle of type III. The bottle is fitted
with an aluminium cap with a tamper-evident seal and a liner made of foamed polyethylene (LDPE), or with a cap made of polypropylene and polyethylene (HDPE) with a tamper-evident seal and a liner made of foamed polyethylene (LDPE). The cap made of polypropylene and polyethylene has child-resistant closure. The immediate packaging also contains a measuring cup made of polypropylene with a capacity of 15 ml, marked in 2.5 ml increments, allowing measurement from 2.5 ml to 15 ml of syrup, or an oral syringe made of polyethylene (LDPE) and polystyrene with a capacity of 8 ml, marked in 0.5 ml increments, allowing measurement from 1 ml to 8 ml of syrup. The bottle with the cap and the measuring cup or oral syringe is placed in a cardboard box together with the patient leaflet.

Marketing Authorisation Holder:
Zakład Farmaceutyczny ,,Amara” sp. z o.o.
Stacyjna 5
30-851 Kraków
Tel. +48 12 657 40 40
[email protected]

Manufacturer:
Farmaceutyczna Spółdzielnia Pracy „GALENA”
Dożynkowa 10
52-311 Wrocław
Tel.: +48 71 71 06 201