Neosine

Package leaflet: Information for the patient

Neosine, 500 mg, tablets
Inosinum pranobexum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken 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 contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 5 to 14 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Neosine is and what it is used for

Neosine is an antiviral and immunostimulatory medicine (it enhances the activity of the
immune system).
Neosine contains the active substance inosine pranobex, which inhibits the replication of
human pathogenic viruses of the Herpes group.
Indications for Neosine

• 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). Neosine may only be used in patients who have previously been diagnosed with herpes simplex virus infection.

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

2. Important information before taking Neosine

When not to take Neosine

• If the patient is allergic to the active substance (inosine pranobex) or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: skin rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue.
• If the patient currently has an acute attack of gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or tests have shown increased blood uric acid levels.

Warnings and precautions
Before starting treatment with Neosine, discuss this with your doctor or pharmacist:

• If the patient has had gout attacks or elevated uric acid levels – the medicine may cause a temporary increase in uric acid concentration in blood and urine;
• If the patient has had kidney stones;
• If the patient has impaired kidney function – during treatment with Neosine, the doctor will regularly monitor blood tests and kidney function;
• If treatment is long-term (lasting 3 months or longer), the doctor will order regular blood tests and monitoring of kidney and liver function.

Children
Neosine should not be used in children during the first year of life.
Neosine with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Especially tell the doctor if the patient is using:

• Medicines for the treatment of gout (e.g. allopurinol or other xanthine oxidase inhibitors);
• Medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. 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);
• Zidovudine (a medicine used in the treatment of AIDS).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Neosine should not be taken during pregnancy or breastfeeding without consulting a doctor, who will assess whether the benefits of using the medicine in the mother outweigh the risks to the child.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery.
If headache, dizziness or drowsiness occur, the patient should not drive, operate machinery, or perform any other tasks requiring concentration. See also section 4.
Neosine contains wheat starch
This medicine contains a very small amount of gluten (derived from wheat starch). Therefore, it is highly unlikely to cause any problems in patients with coeliac disease.
One tablet contains no more than 10.3 micrograms of gluten.
Patients with a wheat allergy (other than coeliac disease) should not take this medicine.

3. How to take Neosine

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dose
Adults, including elderly people (over 65 years of age)
The recommended dose is 50 mg per kg body weight per day – usually 1000 mg, i.e. 2 tablets three times a day.
Do not take more than 8 tablets per day.
Children over 1 year of age
The recommended dose is 50 mg per kg body weight per day, given in several divided doses.
For children who cannot swallow tablets, Neosine syrup is recommended.
Administration method
The tablet should be taken with a large amount of liquid, preferably water. If difficulty swallowing the whole tablet occurs, to facilitate administration, the tablet may be crushed and dissolved in a small amount of water.
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 symptoms have resolved.
Overdose of Neosine
There is no available data regarding overdose with Neosine.
In case of any doubts or feeling unwell, contact your doctor immediately.
Missed dose of Neosine
If a dose is missed, take it as soon as possible and continue the treatment. Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur
Common (in 1 to 10 out of 100 patients):

• transient increase in blood uric acid concentration;
• increased activity of liver enzymes or increased blood urea nitrogen concentration;
• nausea with or without vomiting;
• abdominal pain;
• itching, skin rash;
• headache or dizziness;
• fatigue, malaise;
• joint pain.

Uncommon (occur in 1 to 10 out of 1,000 patients):

• diarrhoea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);
• excessive urine production (polyuria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neosine

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the indicated month.
Lot – means batch number.
EXP – means expiry date.
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 Neosine contains

• The active substance in 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.
• Other ingredients are: wheat starch, mannitol, povidone, magnesium stearate.

What Neosine looks like and contents of the pack
Neosine is a tablet. The tablets are elongated, oval, biconvex, with a division line on one side.
The division line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Pack size: 20 or 50 tablets in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów