Neotac

Package Leaflet: Information for the Patient

Neotac, 50 mg/ml, Syrup

Inosine Pranobex

Read the Package Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 there is no improvement or the patient feels worse after 5 to 14 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Neotac and What is it Used For
• 2. Important Information Before Using Neotac
• 3. How to Use Neotac
• 4. Possible Side Effects
• 5. How to Store Neotac
• 6. Contents of the Pack and Other Information

1. What is Neotac and What is it Used For

Neotac is an antiviral and immunostimulant medication (it stimulates the activity of the immune system).
Indications: as a supportive treatment in patients with reduced immunity, in cases of recurrent upper respiratory tract infections.
If there is no improvement or the patient feels worse after 5-14 days, they should consult their doctor.

2. Important Information Before Using Neotac

When Not to Use Neotac

• If the patient is allergic to the active substance (inosine pranobex) or any of the other ingredients of this medication (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 if tests have shown increased uric acid levels in the blood.

Warnings and Precautions

Before starting to use Neotac, 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. Neotac may cause temporary increases in uric acid levels in the blood and urine.
• If the patient has had kidney or gallstones in the past.
• If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient. If the treatment is long-term (3 months or longer), the doctor will recommend regular blood tests

and will monitor kidney and liver function.
If symptoms of an allergic reaction are observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In such cases, treatment should be stopped immediately and a doctor consulted.

Children

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

Neotac and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to use. They should especially inform their doctor about the medications listed below, as they may interact with Neotac:

• allopurinol or other medications used to treat gout;
• medications that increase uric acid excretion, including diuretics, such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, and indapamide;
• medications that affect the immune system, such as those used after organ transplants;
• azidothymidine (AZT) used to treat HIV-infected patients.

In these cases, the doctor may decide whether to use Neotac.

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 using this medication.
Neotac should not be used during pregnancy and breastfeeding, unless the doctor advises otherwise.

Driving and Using Machines

It is unlikely that Neotac will affect the ability to drive and use machines.

Neotac Contains Sucrose, Methyl Parahydroxybenzoate (E 218), and Propyl Parahydroxybenzoate

(E 216).
Sucrose
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
1 ml of the medication contains 0.650 g of sucrose. This should be taken into account in patients with diabetes.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medication may cause allergic reactions (possible late reactions).

3. How to Use Neotac

This medication should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medication 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.
To measure the recommended volume, the measuring cup provided with the packaging should be used.
Adults, including the elderly (over 65 years):
1 ml of syrup per kg of body weight per day (usually 60 ml of syrup per day in 3 or 4 divided doses). The maximum daily dose is 80 ml of syrup, which is 4 g of inosine pranobex per day.
Children over 1 year of age
1 ml of syrup per kg of body weight per day. The medication should be administered in 3 equal divided doses per day, according to the following table:

Child's Body Weight Dose (ml of Syrup)

Administer 3 Times a Day

10–14 kg
5 ml
15–20 kg
5 to 7.5 ml
21–30 kg
7.5 to 10 ml
31–40 kg
10 to 15 ml
41–50 kg
15 to 17.5 ml
To measure the recommended volume, the measuring cup provided with the packaging (10 ml capacity, with 2.5 ml graduations) should be used.
Duration of Treatment
Depending on the patient's health status, treatment usually lasts from 5 to 14 days. After the symptoms have subsided, the medication is usually continued for another 1 to 2 days.

Using More Than the Recommended Dose of Neotac

No cases of overdose have been reported. If there are any doubts, the patient should immediately consult their doctor.

Missing a Dose of Neotac

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.

Stopping the Use of Neotac

If treatment is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen. If there are any further doubts about using this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Neotac can cause side effects, although not everyone will experience them.
Any medication can cause an allergic reaction, but severe allergic reactions to Neotac are very rare.
The patient should immediately consult their doctorif 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 Neotac are Listed Below:

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):
nausea, vomiting, discomfort in the upper abdomen, increased liver enzyme activity, increased urea levels in the blood, itching, rash, headache, dizziness, fatigue (weakness), malaise (weakness).
Uncommon (less than 1 in 100 patients):
diarrhea, constipation, nervousness, sleepiness or difficulty sleeping (insomnia), increased urine output (polyuria).
Frequency not known (cannot be estimated from 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), 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. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Neotac

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiry date stated on the packaging after "Expiry Date" or "EXP". The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
The shelf life after opening the bottle is 5 months.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Neotac Contains

The active substance of Neotac is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3).
One ml of syrup contains 50 mg of inosine pranobex.
The other ingredients are: sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerol, lemon flavor [containing, among others, propylene glycol (E 1520) and ethanol], purified water.

What Neotac Looks Like and What the Pack Contains

Neotac is a syrup with a citrus fruit smell.
The packaging of Neotac is an orange glass bottle containing 180 ml of syrup, closed with a PP (outer layer) and LDPE (inner layer) cap. The packaging also includes a 10 ml PP measuring cup with 2.5 ml graduations.

Marketing Authorization Holder

TACTICA Pharmaceuticals Sp. z o. o.
ul. Bankowa 4
44-100 Gliwice
phone: +48 889 388 538
[Logo of the marketing authorization holder]

Manufacturer

ABC Farmaceutici S.P.A.
Canton Moretti 29,
Loc. S. Bernardo
10090 Ivrea (TO) Italy

Date of the Last Revision of the Leaflet