Active ingredients: Pidotimod
AXIL 800 mg granules for oral solution
AXIL 400 mg / 7 ml oral solution
Indications Why is Axil used? What is it for?
AXIL contains a substance called pidotimod, formed by chains of amino acids, capable of activating and stimulating the body's immune defenses. This medicine helps prevent and treat infections, especially of the respiratory and urinary tract in people who have a weak immune system .
Contraindications When Axil should not be used
Do not take AXIL
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Axil
Talk to your doctor or pharmacist before taking AXIL.
In subjects predisposed to allergic reactions (atopic) or with a history of allergic reactions, the preparation must be administered with caution.
In patients with congenital immune deficiencies (hyper-IgE syndromes) the drug should be used with caution.
Interactions Which drugs or foods can change the effect of Axil
Other medicines and AXIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The product may interfere with drugs that block or stimulate the activity of blood cells which play a very important role in the immune system (lymphocytes).
AXIL with food, drink and alcohol
Since there is an "interference of food on the absorption of the product," AXIL should be taken between meals.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Even if studies carried out in animals have not shown any effects, as with other drugs, their use in the first three months of pregnancy is not recommended.
Driving and using machines
AXIL does not affect the ability to drive or use machines.
AXIL 800 mg granules for oral solution contains:
- sodium, this medicine contains 3.3 mmol (75.9 mg) sodium per sachet. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet;
- sunset yellow (E110), cochineal red A (E124), which can cause allergic reactions;
- sucrose, so if you are intolerant to any sugar, contact your doctor before taking this medicine.
AXIL 400 mg oral solution contains:
- sodium, this medicinal product contains 0.2 mmol (4.6 mg) sodium per vial, i.e. it is essentially sodium-free;
- sorbitol, so if you are intolerant to any sugar, contact your doctor before taking this medicine;
- cochineal red A (E124), which can cause allergic reactions;
- sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed).
Dose, Method and Time of Administration How to use Axil: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults:
1 sachet of 800 mg twice a day or according to medical prescription.
Children over 3 years old:
1 vial of 400 mg twice daily or according to medical prescription.
Overdose What to do if you have taken an overdose of Axil
There are no known effects to be attributed to overdose of AXIL.
If you forget to take AXIL
Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Axil
To date, there have been no undesirable effects in patients treated with AXIL.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine. .
Expiry and Retention
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 which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What AXIL contains
AXIL 800 mg granules for oral solution:
One sachet contains:
The active ingredient is pidotimod 800 mg.
The other ingredients are: mannitol, poloxamers, polyacrylate dispersion 30 percent, ethylcellulose, sodium saccharin, orange flavor, anhydrous sodium carbonate, colloidal hydrated silica, sunset yellow (E110), cochineal red A (E124), sucrose.
AXIL 400 mg oral solution:
One single-dose vial contains:
The active ingredient is pidotimod 400 mg.
The other ingredients are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, 70% sorbitol solution, wild berries aromatic solution, anthocyanin 55, cochineal red A (E124), purified water.
Description of what AXIL looks like and contents of the pack
Pidotimod 800 mg granules for oral solution. The package contains 10 sachets of granules.
Single-dose oral solution of 400 mg of pidotimod. The pack contains 10 single-dose vials.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
AXIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
AXIL 800 mg granules for oral solution
One sachet contains:
• active principle: pidotimod 800 mg
AXIL 400 mg oral solution
One single-dose vial contains:
• active principle: pidotimod 400 mg
Excipients with known effects:
AXIL 800 mg granules for oral solution
Sodium, sunset yellow (E 110), cochineal red A (E 124) and sucrose.
AXIL 400 mg oral solution
Sodium, sorbitol, cochineal red A (E 124), sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral solution, oral solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
AXIL is indicated in adults over 3 years of age for immunostimulating therapy in subjects with documented cell-mediated immunosuppression in the course of respiratory and urinary tract infections.
04.2 Posology and method of administration
Dosage
Pediatric population (children over 3 years)
1 vial of 400 mg twice a day or according to medical prescription.
Adults
1 sachet of 800 mg twice a day or according to medical prescription.
Method of administration
Oral use.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Since there is an "interference of food on" absorption of the product, the administration of AXIL should take place between meals.
In patients with hyper-IgE syndromes the drug should be used with caution.
In atopic subjects or with a history of allergic reactions, the preparation must be administered with caution.
AXIL 800 mg granules for oral solution contains:
sodium, this medicine contains 3.3 mmol (75.9 mg) sodium per sachet. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet;
sunset yellow (E 110), cochineal red A (E 124), which can cause allergic reactions;
sucrose, so if you are intolerant to any sugar, contact your doctor before taking this medicine.
AXIL 400 mg oral solution contains:
sodium, this medicinal product contains 0.2 mmol (4.6 mg) sodium per vial, i.e. it is essentially sodium-free;
sorbitol, so if you are intolerant to any sugar, contact your doctor before taking this medicine;
cochineal red A (E 124), which can cause allergic reactions;
sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed).
04.5 Interactions with other medicinal products and other forms of interaction
The product may interfere with drugs that block or stimulate lymphocyte activity.
04.6 Pregnancy and lactation
Fertility and Pregnancy
Data on the use of pidotimod in pregnant women do not exist or are limited (less than 300 exposed pregnancies).
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precaution, it is preferable to avoid the use of AXIL during the first trimester of pregnancy.
Feeding time
It is unknown whether pidotimod or its metabolites are excreted in human milk. As a precaution, it is preferable to avoid the use of AXIL while breastfeeding.
04.7 Effects on ability to drive and use machines
AXIL does not affect the ability to drive or use machines.
04.8 Undesirable effects
To date, no undesirable effects have been reported in patients treated with pidotimod.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, ATC code: L03AX05.
Axil consists of pidotimod (D.C.I.), an immunostimulating substance that acts by stimulating and regulating the cellular immune response.
By partially replacing or enhancing thymic functions, pidotimod induces maturation and the assumption of full immunocompetence by the deficient T lymphocyte which, in physiological conditions, is entrusted with the role of coordinator of specific immunity.
Furthermore, pidotimod stimulates the macrophages which are essentially responsible for picking up the antigen and presenting it on their membrane in association with the histocompatibility antigens.
To the efficiency of the specific immune defenses, cellular and antibody, the defense capacity of the organism against infectious agents is recognized.
05.2 Pharmacokinetic properties
Pharmacokinetic studies in healthy volunteers have demonstrated rapid oral absorption, oral bioavailability equal to 45% of the administered dose, half-life of 4 hours, urinary elimination of the unchanged substance equal to 95% of the administered intravenous dose.
05.3 Preclinical safety data
Axil has a very low acute toxicity: the LD50 by i.v. it is> 4000 mg / kg in mice,> 4000 mg / kg in rats and> 2000 mg / kg in dogs.
Chronic toxicity studies conducted on rats and dogs by oral and parenteral routes with treatments up to 6 months did not show any toxic effect up to doses equal to 40-50 times the maximum therapeutic daily dose per kg. Axil is not mutagenic, is not teratogenic in rats and rabbits, does not affect male and female fertility and has no peri- and postnatal toxicity in rats.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Axil 800 mg granules for oral solution
One sachet contains: mannitol, poloxamers, polyacrylate dispersion 30 percent, ethylcellulose, sodium saccharin, orange flavor, anhydrous sodium carbonate, colloidal hydrated silica, sunset yellow (E 110), cochineal red A (E 124), sucrose.
Axil 400 mg oral solution
One single-dose vial contains: sodium chloride, sodium saccharin, edetate disodium, tromethamine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, 70% sorbitol solution, wild berries aromatic solution, anthocyanin 55, cochineal red A (E 124), purified water.
06.2 Incompatibility
They are not known.
06.3 Period of validity
3 years in intact packaging, properly stored.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Axil 800 mg granules for oral solution: triple laminated paper / aluminum / polythene sachets sealed by heat sealing, in a lithographed cardboard box containing the leaflet.
10 sachets 800 mg.
Axil 400 mg oral solution: single-dose type III glass vials, closed with a polyethylene cap and sealed with a plastic cap in a lithographed cardboard box containing the package leaflet.
10 single-dose vials 400 mg.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
POLICHEM SRL
Via G. Marcora, 11 - 20121 MILAN
Sales dealer
VALEAS spa - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan
08.0 MARKETING AUTHORIZATION NUMBER
10 sachets of 800 mg A.I.C. granules for oral solution n. 027633039
10 single-dose vials of 400 mg A.I.C. n. 027633041
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: January 16, 1993
Date of most recent renewal: January 16, 2008
