Package leaflet: information for the patient

Neosine duo, 1000 mg + 6.25 mg Zn, tablets
Inosinum pranobexum + Zinci gluconas
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Neosine duo is and what it is used for
Important information before taking Neosine duo
How to take Neosine duo
Possible side effects
How to store Neosine duo
Contents of the pack and other information

1. What Neosine duo is and what it is used for

Neosine duo contains two active substances: inosine pranobex and zinc gluconate.
Inosine pranobex has antiviral activity and enhances the body's immunity (stimulates the immune system).
Zinc supports the body's immune system and has anti-inflammatory and antiviral properties.

Indications for use
The medicine is indicated for use in adults and children over 8 years of age.

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 is used in conditions of increased zinc requirement associated with the above indications.

2. Important information before taking Neosine duo

When not to take Neosine duo

If you are allergic to the active substances (inosine pranobex or zinc gluconate) 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 you currently have an acute attack of gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or if tests have shown elevated blood uric acid levels.

Warnings and precautions

Before starting Neosine duo, discuss with your doctor or pharmacist:

If you have had gout attacks or elevated uric acid levels – the medicine may cause transient increases in blood and urinary uric acid concentrations;
If you have had kidney stones;
If you have impaired kidney function – during treatment with Neosine duo, your doctor will regularly monitor blood tests and kidney function;
If treatment is prolonged (lasting 3 months or longer), your doctor will recommend regular blood tests and monitoring of kidney and liver function.

Children
Do not use this medicine in children under 8 years of age.

Neosine duo and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Especially inform your doctor if you are taking:

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, chlortalidone, indapamide;
Medicines that suppress immune system function (so-called immunosuppressive drugs, used in organ transplant patients or in atopic dermatitis);
Zidovudine (a medicine used in the treatment of AIDS);
Iron and calcium salts, as they may reduce zinc absorption, and high doses of zinc may reduce iron and copper absorption;
Chelating agents (medicines used, for example, in lead poisoning, such as D-penicillamine);
Tetracyclines, ofloxacin, and other quinolones (antibiotics used to treat infections, e.g., norfloxacin, ciprofloxacin), as zinc impairs their absorption. Therefore, at least a 3-hour interval should be maintained between taking Neosine duo and these medicines;
Acetylsalicylic acid (the active ingredient in medicines used to reduce fever);
Ibuprofen or indomethacin (analgesic drugs belonging to the group of non-steroidal anti-inflammatory drugs – NSAIDs);
Thiazide diuretics (medicines that increase urine production);
Corticosteroids (medicines used, among others, in the treatment of rheumatic disease);
Other medicines and/or dietary supplements containing calcium, iron, and copper;
Dairy products, which reduce zinc absorption.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Do not take Neosine duo during pregnancy and breastfeeding. Your doctor will assess whether the benefits of using the medicine outweigh the potential risks.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery.
If you experience headache, dizziness, or drowsiness, do not drive, operate machinery, or perform any other tasks requiring concentration.

Neosine duo contains wheat starch and sodium

Wheat starch
This medicine contains very small amounts of gluten (derived from wheat starch) and is classified as "gluten-free". Therefore, it is highly unlikely to cause problems in patients with celiac disease.
One tablet contains no more than 5 micrograms of gluten.
Patients with wheat allergy (other than celiac disease) should not use this medicine.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Neosine duo

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
The medicine should be taken orally.
Recommended dose
The recommended dose of inosine pranobex is 50 mg per kg of body weight per day.
Adults, including elderly people (over 65 years of age):
Usually 1 tablet three times a day. Do not take more than 4 tablets per day. The maximum dose
is 4 g of inosine pranobex per day.
Children above 8 years of age:
Usually ½ tablet 3–4 times a day, according to the table below:

Child's body weight	Dosage
26 to 36 kg	½ tablet 3 times a day
above 36 kg	½ tablet 4 times a day

Duration of treatment

In case of infection, it is important to start treatment as soon as the first symptoms appear. Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for an additional 1 to 2 days after symptoms have subsided.
In children and adolescents with reduced immunity, the medicine should be used for 10 days per month, for 3 consecutive months.

Taking more Neosine duo than recommended
If you take more Neosine duo than recommended, contact your doctor or pharmacist immediately.
Symptoms of overdose:
gastrointestinal disturbances, metallic taste in the mouth, abdominal pain, nausea, vomiting,
drowsiness, headache, anemia (reduced number of red blood cells), and dizziness.

If you forget to take Neosine duo
If you miss a dose of Neosine duo, take it as soon as possible, unless it is almost time for the next dose.
In that case, skip the missed dose and take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
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.
The following adverse reactions may occur
Common (in 1 to 10 out of 100 patients):

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

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

diarrhoea;
constipation;
nervousness;
drowsiness or difficulty sleeping (insomnia);
increased urine output (polyuria).

Very rare (occurring in less than 1 out of 10,000 patients):
At the beginning of treatment, zinc salts may cause gastrointestinal discomfort. These symptoms occur more frequently when zinc is taken on an empty stomach. Symptoms resolve quickly after discontinuation of the medicine.
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 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 duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Neosine duo contains

The active substances in the medicine are inosine pranobex and zinc in the form of zinc gluconate. One tablet contains 1000 mg of inosine pranobex and 6.25 mg of zinc ions.
Other ingredients: wheat starch, povidone 30, sodium carboxymethyl starch (type A), sodium lauryl sulfate, mannitol, magnesium stearate.

What Neosine duo looks like and contents of the pack
Neosine duo is an elongated, oval, biconvex white tablet with a single-scored line on one side. The tablet can be divided into equal doses.
Pack size: 10 or 30 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