Neosine duo

Package Leaflet: Information for the Patient

Neosine duo, 1000 mg + 6.25 mg Zn, tablets

Inosine pranobex + Zinc gluconate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

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

Indications for use

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

• As a supportive treatment in people with lowered immunity, in case of recurring upper respiratory tract infections.
• In the treatment of herpes labialis and facial skin caused by the herpes simplex virus.
• The medicine is used in conditions of increased zinc requirements, occurring in the above-mentioned 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 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 attack of gout (severe joint pain with swelling and redness of the skin or also in the large joints, there is an accumulation of fluid).

Warnings and precautions

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

• if you have had gout attacks or increased uric acid levels - the medicine may cause a temporary increase in uric acid levels in the blood and urine;
• if you have had kidney stones;
• if you have kidney function disorders - during the use of Neosine duo, your doctor will regularly check your blood and monitor kidney function;
• if the treatment is long-term (lasts 3 months or longer), your doctor will prescribe regular blood tests and monitoring of kidney and liver function.

Children

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

Neosine duo and other medicines

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

Particularly tell 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 (increasing urine production), e.g. furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplantation or with atopic dermatitis);
• azidothymidine (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 in the treatment of infections, e.g. norfloxacin, ciprofloxacin), as zinc impairs their absorption. Therefore, a minimum of 3-hour intervals should be maintained between taking Neosine duo and the above-mentioned medicines;
• acetylsalicylic acid (a substance found in medicines used to lower fever);
• ibuprofen or indomethacin (painkillers 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 diseases);
• other medicines and/or dietary supplements containing calcium, iron, and copper;
• dairy products reduce zinc absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 using machines

The medicine may affect your ability to drive and use machines.
If you experience headache, dizziness, or drowsiness, do not drive, operate machinery, or perform other activities that require concentration.

Neosine duo contains wheat starch and sodium

Wheat starch
This medicine contains very small amounts of gluten (from wheat starch) and is considered "gluten-free". Therefore, it is very unlikely to cause any problems in patients with celiac disease.
One tablet contains no more than 5 micrograms of gluten.
Patient with wheat allergy (other than celiac disease) should not take this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Neosine duo

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally.

Recommended dose

The recommended dose of inosine pranobex is 50 mg per kg of body weight per day.
Adults, including the elderly (over 65 years):
Usually 1 tablet 3 times a day. Do not take more than 4 tablets per day. The maximum dose is 4 g of inosine pranobex per day.
Children over 8 years of age:
Usually ½ tablet 3-4 times a day, according to the following table:

Duration of treatment

• In case of infection, it is important to start treatment as soon as the first symptoms appear. The treatment usually lasts from 5 to 14 days. It is recommended to take the medicine for another 1 to 2 days after the symptoms of the disease have disappeared.
• In children and adolescents with lowered immunity, the medicine should be taken for 10 days a month, for the next 3 months.

Taking a higher dose of Neosine duo than recommended

If you take more than the recommended dose of the medicine, contact your doctor or pharmacist.
Symptoms of overdose:
gastrointestinal disorders, metallic taste, abdominal pain, nausea, vomiting, drowsiness, headache, dizziness.

Missing a dose of 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 this case, skip the missed dose and take the next one at the right time.
Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur

Frequent(in 1 to 10 out of 100 patients):

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

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

• diarrhea;
• constipation;
• nervousness;
• drowsiness or difficulty falling asleep (insomnia);
• excessive urine production (polyuria).

Rare(in less than 1 out of 10,000 patients):
At the beginning of treatment, zinc salts may cause gastrointestinal disorders. These symptoms occur more frequently if zinc is taken on an empty stomach. The symptoms disappear quickly after stopping the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neosine duo

Keep the medicine out of the 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 month.
Store in a temperature below 25°C.
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 duo contains

• The active substances of 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.
• The other ingredients are: 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 a white, oval, biconvex tablet with a single dividing line on one side. The tablet can be divided into equal doses.
The pack contains 10 or 30 tablets in a cardboard box.

Marketing authorization 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

Date of last revision of the leaflet: