Patient information leaflet

AXIL 800 mg granules for oral solution, 400 mg oral solution

Pidotimod
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AXIL is and what it is used for
What you need to know before taking AXIL
How to take AXIL
Possible side effects
How to store AXIL
Contents of the pack and other information

1. What AXIL is and what it is used for

AXIL contains a substance called pidotimod, composed of amino acid chains, which is able to activate and
stimulate the body's immune defenses. This medicine helps prevent and treat infections,
particularly of the respiratory and urinary tracts, in people who have a weakened immune system.

2. What you should know before taking AXIL

Do not take AXIL

if you are allergic to pidotimod or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AXIL.
In individuals predisposed to allergic reactions (atopic subjects) or with a history of allergic reactions, this preparation should be administered with caution.
In patients with congenital immunodeficiency (hyper-IgE syndromes), the medicine should be used with caution.

Other medicines and AXIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This product may interfere with medicines that block or stimulate the activity of blood cells that play a key role in the immune system (lymphocytes).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a precaution, it is recommended to avoid using AXIL during the first three months of pregnancy and during breastfeeding.
No studies on fertility in humans have been conducted.

Driving and using machines
AXIL does not impair the ability to drive vehicles or operate machinery.

AXIL 800 mg oral granules for oral solution contains:

sodium: this medicine contains 75.9 mg of sodium (the main component of table salt) per sachet. This corresponds to 3.8% of the maximum daily dietary intake recommended for an adult.
sunset yellow (E110), carmine red A (E124), which may cause allergic reactions;
sucrose: if your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

AXIL 400 mg oral solution contains:

sodium: this medicine contains less than 1 mmol (23 mg) of sodium per bottle, i.e. it is essentially “sodium-free”;
sorbitol: this medicine contains 2500 mg of sorbitol in each vial;
carmine red A (E124), which may cause allergic reactions;
sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take AXIL

This medicinal product is for oral use.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is:
Adults:
One 800 mg sachet twice daily, or as prescribed by the physician.
Children over 3 years:
One 400 mg bottle twice daily, or as prescribed by the physician.
No dose adjustment is necessary in the elderly.
Take AXIL away from meals.
If you take more AXIL than you should
If you take more AXIL than you should, contact your doctor immediately. The doctor will provide
appropriate treatment.
If you forget to take AXIL
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

abdominal pain
diarrhoea
rash

Rare side effects (may affect up to 1 in 1,000 people)

swelling of the face, tongue and trachea causing severe breathing difficulties, which is a sign of a serious allergic reaction (angioedema)
small itchy spots on the skin (urticaria)
allergic skin inflammation (allergic dermatitis)
itching

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AXIL

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AXIL contains
AXIL 800 mg granules for oral solution:
One sachet contains:

The active substance is pidotimod.
The other components are: mannitol, poloxamers, polyacrylate dispersion 30 percent, ethylcellulose, sodium saccharin, orange flavour, anhydrous sodium carbonate, colloidal hydrated silica, sunset yellow (E110), carmine red A (E124), sucrose.

AXIL 400 mg oral solution:
One single-dose bottle contains:

The active substance is pidotimod.
The other components are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol 70% solution, fruit-flavoured aromatic solution, anthocyanin 55, carmine red A (E124), purified water.

Description of the appearance of AXIL and contents of the pack
800 mg granules for oral solution containing pidotimod. The pack contains 10 sachets of granules.
400 mg single-dose oral solution containing pidotimod. The pack contains 10 single-dose bottles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Polichem S.r.l. - Via G. Marcora, 11 - 20121 Milan
Manufacturer:
Sachets
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi plant - Rozzano (MI)
Oral bottles
Doppel Farmaceutici S.r.l. - Cortemaggiore (PC) plant
Marketing Authorisation Holder's Distributor
Valeas S.p.A. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan