Pranosin forte

Package Leaflet: Information for the Patient

Pranosin Forte

100 mg/ml, Syrup

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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Pranosin Forte and what is it used for
• 2. Important information before taking Pranosin Forte
• 3. How to take Pranosin Forte
• 4. Possible side effects
• 5. How to store Pranosin Forte
• 6. Contents of the pack and other information

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

Pranosin Forte syrup contains the active substance inosine pranobex, which:

• has antiviral and immunostimulating effects (increasing immunity);
• inhibits the growth of pathogenic viruses for humans in the Herpes group in vitro.

Indications for use
As a supportive treatment in people with weakened immunity, in cases of recurrent upper respiratory tract infections.
In the treatment of cold sores and facial skin caused by the herpes simplex virus. Pranosin Forte can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.
If after 5 to 14 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Pranosin Forte

When not to take Pranosin Forte

• if the patient is allergic to the active substance (inosine pranobex) or 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 acute gout attack (severe joint pain with swelling and redness of the skin or effusion in the large joints) or tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting treatment with Pranosin Forte, the patient should discuss it with their doctor or pharmacist:

• if the patient has had gout attacks or increased uric acid levels in the past, as Pranosin Forte 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; 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 a rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue, treatment should be stopped immediately and the doctor consulted. If treatment is long-term (lasting 3 months or more), the doctor will order regular blood tests and kidney and liver function tests. During long-term treatment, kidney stones may form.

Children

Pranosin Forte should not be used in children under 1 year of age.

Pranosin Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
They should especially inform their doctor or pharmacist if they are taking any of the following medicines, 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), such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation;
• azidothymidine (AZT) used to treat AIDS.

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.
Pranosin Forte should not be taken during pregnancy and breastfeeding without consulting a doctor. The doctor will assess whether the benefits of taking the medicine outweigh the risks to the child.

Driving and using machines

Pranosin Forte has no or negligible influence on the ability to drive and use machines. See also section 4.

Pranosin Forte contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the 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)

The medicine may cause allergic reactions (possible late reactions).

Pranosin Forte contains ethanol, which is part of the raspberry flavor

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 have noticeable effects.

Pranosin Forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose of syrup, which means the medicine is considered "sodium-free".

3. How to take Pranosin Forte

This medicine should always be taken exactly as described in this 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 medicine should be taken orally.
Recommended dose
The 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
The recommended daily dose is 50 mg of inosine pranobex per kilogram of body weight per day (0.5 ml of syrup per 1 kg of body weight per day), usually 30 ml of syrup (i.e., 3 g of inosine pranobex) per day, taken 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 over 1 year of age
The recommended dose for children over 1 year of age is 50 mg of inosine pranobex per kilogram of body weight per day (0.5 ml of syrup per 1 kg of body weight per day) in 3 or 4 equal divided doses taken throughout the day.
The following table shows the dosage based on the patient's body weight.
To measure the correct dose of the medicine, the patient should use the measuring cup or oral syringe provided with the packaging.

What to do if a higher dose of Pranosin Forte is taken

There have been no reported cases of overdose. If in doubt, the patient should immediately consult their doctor.

What to do if a dose of Pranosin Forte is missed

If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. A double dose should not be taken to make up for a missed dose.

What to do if treatment with Pranosin Forte is interrupted

If treatment is interrupted, 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, Pranosin Forte can cause side effects, although not everybody gets them.

The patient should immediately consult their doctor if 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).

Other possible side effects of Pranosin Forte

Very common (more than 1 in 10 patients):
increased uric acid levels in the blood, increased uric acid levels in the urine.
Common (less than 1 in 10 patients):
increased liver enzyme activity, increased urea levels in the blood, rash, itching, joint pain, nausea, vomiting, abdominal discomfort, fatigue (weakness), malaise (weakness), headache, dizziness.
Uncommon (less than 1 in 100 patients):
diarrhea, constipation, nervousness, sleepiness or difficulty falling asleep (insomnia), increased urine output (polyuria).
Frequency not known (cannot be estimated from the available data):
abdominal pain, angioedema (swelling of the face, lips, eyelids, or throat, which may cause difficulty breathing), hives, allergic reaction, anaphylactic reaction (allergic reaction affecting the whole body), dizziness, flushing (redness of the skin).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pranosin Forte

The medicine should be stored 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 month.
Store in a temperature below 30°C. Do not store in the refrigerator or freeze.
The shelf life after opening the bottle is 3 years.
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 Pranosin Forte 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). 1 ml of syrup contains 100 mg of inosine pranobex.
• The other ingredients are: sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium hydroxide (to adjust pH), raspberry flavor (containing: propylene glycol, flavoring 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, colorless or yellow liquid with a raspberry odor.
The packaging consists of a 100 ml brown glass type III bottle with an aluminum cap with a tamper-evident closure and a polyethylene foam seal (LDPE) or a polypropylene and polyethylene cap (HDPE) with a tamper-evident closure and a polyethylene foam seal (LDPE). The polypropylene and polyethylene cap has a child-resistant closure. The single pack includes a 15 ml polypropylene measuring cup with a 2.5 ml scale, allowing the measurement of 2.5 ml to 15 ml of syrup, or an 8 ml oral syringe made of low-density polyethylene (LDPE) and polystyrene with a 0.5 ml scale, allowing the measurement of 1 ml to 8 ml of syrup. The bottle with the cap and measuring cup or oral syringe is placed in a cardboard box with the patient leaflet.

Marketing authorization holder:

Zakład Farmaceutyczny "Amara" sp. z o. o.
Stacyjna 5 Street
30-851 Kraków
Phone: +48 12 657 40 40
amara@amara.pl

Manufacturer:

Farmaceutyczna Spółdzielnia Pracy "GALENA"
Dożynkowa 10 Street
52-311 Wrocław
Phone: +48 71 71 06 201

Date of last revision of the leaflet: