Pranosin

Package Leaflet: Information for the Patient

Pranosin

50 mg/ml, syrup

Inosine Pranobex

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Pranosin and what is it used for

Pranosin syrup contains the active substance inosine pranobex, which has antiviral and immunostimulant properties (increasing resistance).

Indications for use

Supportively in patients with reduced immunity, in case of recurring upper respiratory tract infections.

If after 5 to 14 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Pranosin

When not to take Pranosin

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

Warnings and precautions

Before starting treatment with Pranosin, discuss it with your doctor or pharmacist:

• if you have had gout attacks or increased uric acid levels in the past, as Pranosin may cause transient increases in uric acid levels in the blood and urine;
• if you have had kidney stones in the past;
• if you have kidney function disorders; during treatment with Pranosin, your doctor should regularly check your blood and monitor kidney function. If you experience symptoms of an allergic reaction, such as: rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue; then stop treatment and consult your doctor. If treatment is long-term (lasting 3 months or more), your doctor will prescribe regular blood tests and kidney and liver function tests. During long-term treatment, kidney stones may form.

Children

Do not give Pranosin to children under 1 year of age.

Pranosin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics (increasing urine production), such as furosemide, torasemide, acetylsalicylic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation;
• zydovudine (AZT, azidothymidine) used to treat AIDS.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pranosin has no influence or negligible influence on the ability to drive and use machines.

Pranosin contains sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, and sodium

Sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

1 ml of Pranosin contains 625 mg of sucrose. This should be taken into account in patients with diabetes.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

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

Etanol (a component of the raspberry flavor)

This medicine contains 0.006 mg of alcohol (ethanol) per 1 ml of syrup. The amount of alcohol in 1 ml of this medicine is equivalent to less than 0.011 ml of beer or 0.004 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 20 ml of syrup, which means that the medicine is considered "sodium-free".

3. How to take Pranosin

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

Take the medicine 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 (1 ml of syrup per 1 kg of body weight per day), usually 60 ml of syrup per day, given in 3 or 4 divided doses, i.e., 20 ml of syrup 3 times a day or 15 ml of syrup 4 times a day.

Maximum dose is 80 ml of syrup, 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 (1 ml of syrup per 1 kilogram of body weight per day) in 3 or 4 equal divided doses given throughout the day.

The following table shows the dosage based on the patient's body weight.

To measure the correct dose, use the measuring cup provided with the packaging.

Duration of treatment

Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for 1 to 2 days after the symptoms of the disease have disappeared.

Overdose of Pranosin

No cases of overdose have been reported so far. In case of any doubts, consult your doctor immediately.

Missed dose of Pranosin

If you miss a dose, 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 the missed dose.

Stopping treatment with Pranosin

If you stop treatment, the expected therapeutic effect may not be achieved, or the 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 side effects

Like all medicines, Pranosin can cause side effects, although not everybody gets them.

Consult your doctor immediately if you 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

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 you experience any side effects, including those not listed in this package leaflet, tell your 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

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, you can help provide more information on the safety of this medicine.

5. How to store Pranosin

Keep the medicine out of the sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the label and carton after:

Expiry date. The expiry date refers to the last day of the month stated.

Shelf life after first opening the bottle is 2 years.

Medicines should 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 contains

• The active substance 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 50 mg of inosine pranobex.
• The other ingredients are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium citrate (E331), sodium hydroxide (to adjust pH), raspberry flavor (containing: flavoring substances, propylene glycol, lactic acid, acetic acid, ethanol, water, ascorbic acid), purified water.

What Pranosin looks like and contents of the pack

Pranosin syrup is a clear, colorless or slightly yellow syrup with a raspberry odor and sweet taste.

The packaging consists of a 150 ml brown glass bottle, type III, with an aluminum screw cap with a tamper-evident seal and a low-density polyethylene seal. The packaging also includes a 15 ml measuring cup made of polypropylene with a 2.5 ml scale. The bottle with the screw cap and measuring cup is placed in a cardboard box with the patient information leaflet.

Marketing authorization holder:

Zakład Farmaceutyczny "Amara" sp. z o. o.

ul. Stacyjna 5

30-851 Kraków

Tel. +48 12 657 40 40

amara@amara.pl

Manufacturer:

Farmaceutyczna Spółdzielnia Pracy "GALENA"

ul. Krucza 62

53-411 Wrocław

Date of last revision of the package leaflet: