Neotac

Package leaflet: Information for the user

Neotac, 50 mg/ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Contents of the leaflet:

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

1. What Neotac is and what it is used for

Neotac is an antiviral and immunostimulant medicine (it enhances the function of the immune system).
Indications: as an adjunctive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
If there is no improvement after 5–14 days, or if you feel worse, consult your doctor.

2. Important information before using Neotac

When not to use Neotac

• 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: 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 if tests have shown increased levels of uric acid in the blood.

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

• If the patient has previously experienced gout attacks or elevated levels of uric acid. Neotac may cause transient increases in uric acid levels in blood and urine.
• If the patient has previously had kidney or gallstones.
• If the patient has impaired kidney function. In such cases, the doctor will monitor the patient closely. If 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, or swelling of the face, lips, throat or tongue, treatment must be stopped immediately and medical advice sought.

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

Neotac with other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. It is especially important to inform the doctor about the following medicines, as they may interact with Neotac:

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines affecting the immune system, e.g. those used after organ transplantation;
• zidovudine (AZT) used in the treatment of HIV-infected patients.

In the above cases, the doctor may decide whether Neotac treatment is necessary.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Neotac should not be used during pregnancy or breastfeeding unless otherwise advised by a doctor.

Driving and operating machinery
It is unlikely that Neotac will affect the ability to drive or operate machinery.

Neotac contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).

Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
1 ml of the medicine contains 0.650 g of sucrose. This should be taken into account in patients with diabetes.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Neotac

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.
Neotac is 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 administered several times a day.
To measure the recommended volume, use the measuring spoon provided with the packaging.

Adults, including elderly patients (over 65 years of age):
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, equivalent to 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 medicine should be administered in 3 equal divided doses throughout the day, according to the table below:

Child's body weight Dose (ml of syrup)
Administer 3 times
daily
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, use the 10 ml measuring spoon provided with the packaging, graduated in 2.5 ml increments.

Duration of treatment
Depending on the patient's health condition, treatment usually lasts from 5 to 14 days. After symptoms resolve, the medicine is usually continued for an additional 1 to 2 days.

Taking more Neotac than recommended
Cases of overdose have not been reported to date. If in doubt, contact your doctor immediately.

Missing a dose of Neotac
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping Neotac treatment
If treatment is discontinued, the expected therapeutic effect may not be achieved, or 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Any medicine may cause an allergic reaction; however, severe allergic reactions to Neotac occur very rarely.
You should consult a doctor immediately if any of the following symptoms occur:

• sudden onset of wheezing
• difficulty breathing
• swelling of the eyelids, face or lips
• rash or itching (especially if affecting the whole body).

Other possible adverse effects of Neotac are listed below:
Very common (affects more than 1 in 10 patients):
increased blood uric acid levels, increased urinary uric acid levels.
Common (affects up to 1 in 10 patients):
nausea, vomiting, upper abdominal discomfort, increased liver enzyme activity, increased blood urea levels, itching, rash, headache, dizziness, fatigue (tiredness), malaise (weakness), joint pain.
Uncommon (affects up to 1 in 100 patients):
diarrhea, constipation, nervousness, drowsiness or difficulty sleeping (insomnia), increased urine volume (polyuria).
Frequency not known (cannot be estimated from available data):
abdominal pain, angioedema (swelling of the face, lips, eyelids or throat, possibly causing breathing difficulties), urticaria, allergic reaction, anaphylactic reaction (allergic reaction affecting the whole body), erythema (skin redness).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Neotac medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Store below 25°C.
The shelf-life after first opening the bottle is 5 months.
Medicines must 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 packaging and other information

What Neotac contains
The active substance in 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 flavour [containing, among others: propylene glycol (E 1520) and ethanol], purified water.
What Neotac looks like and contents of the pack
Neotac is a syrup with a citrus fruit odour.
The packaging consists of an amber glass bottle containing 180 ml of syrup, closed with a cap made of PP (outer layer) and LDPE (inner layer). The packaging also includes a 10 ml measuring spoon made of PP, graduated every 2.5 ml.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Bankowa 4
44-100 Gliwice
tel.: +48 889 388 538
[Logo of the Marketing Authorisation Holder]
Manufacturer
ABC Farmaceutici S.P.A.
Canton Moretti 29,
Loc. S. Bernardo
10090 Ivrea (TO), Italy