Active ingredients: Pidotimod
Pigitil 800 mg granules for oral solution
Pigitil 400 mg oral solution
Indications Why is Pigitil used? What is it for?
Pigitil is a drug that contains a substance called pidotimod that can activate and stimulate the body's immune defenses. This medicine is used as an immunostimulating therapy in people with reduced immune defenses during respiratory and urinary tract infections.
Contraindications When Pigitil should not be used
Do not take Pigitil if you are allergic to the active substance or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Pigitil
Talk to your doctor or pharmacist before taking Pigitil:
- if you suffer from a disease called 'hyper-IgE syndrome' which results in very high levels of Ig-E antibodies in the blood;
- if you are an "atopic" person (predisposed to developing allergic reactions) or have already suffered from allergic-type reactions.
Interactions Which drugs or foods can modify the effect of Pigitil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially those that block or stimulate the activity of particular blood cells called lymphocytes, because Pigitil can interfere with the proper functioning of these medicines.
Pigitil with foods
Food can interfere with the effectiveness of the medicine, so Pigitil 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.
The use of Pigitil is not recommended in the first three months of pregnancy.
Driving and using machines
Pigitil does not affect the ability to drive or use machines.
Pigitil contains:
Pigitil 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) and cochineal red A (E 124): can cause allergic reactions.
Sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pigitil 400 mg oral solution contains:
Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per vial, i.e. it is essentially sodium-free.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: they can cause allergic reactions (even delayed).
Sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cochineal red A (E 124): may cause allergic reactions.
Dose, Method and Time of Administration How to use Pigitil: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 1 sachet of 800 mg twice a day or according to medical prescription.
Children over 3 years of age
The recommended dose is 1 vial of 400 mg twice a day or as directed by a doctor.
If you forget to take Pigitil
Do not take a double dose to make up for a forgotten dose.
Overdose What to do if you have taken too much Pigitil
There have been no reports of overdose following treatment with Pigitil.
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 Pigitil
To date, no undesirable effects have been reported following treatment with pidotimod.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 after "EXP".
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.
Other Information
What Pigitil contains
Pigitil 800 mg granules for oral solution
The active ingredient is pidotimod. Each sachet contains 800 mg of pidotimod.
The other ingredients are: 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.
Pigitil 400 mg oral solution
The active ingredient is pidotimod. Each vial contains 400 mg of pidotimod, in 7 ml of solution.
The other ingredients are: 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.
What Pigitil looks like and contents of the pack
Pigitil 800 mg granules for oral solution:
10 sachets of 800 mg in lithographed cardboard box.
Pigitil 400 mg oral solution:
10 single-dose vials of 400 mg in a lithographed cardboard box.
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
PIGITIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pigitil 800 mg granules for oral solution
One sachet contains:
Active principle: pidotimod 800 mg
Excipients with known effects: sodium, sunset yellow (E 110), cochineal red A (E 124) and sucrose.
Pigitil 400 mg oral solution
One single-dose vial contains:
Active principle: pidotimod 400 mg
Excipients with known effects: sodium, sodium methyl parahydroxybenzoate, propyl parahydroxybenzoate
sodium and cochineal red A (E 124).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral solution.
Oral solution, single dose.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
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
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.
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 Pigitil 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.
Pigitil 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) and cochineal red A (E 124): can cause allergic reactions.
Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
Pigitil 400 mg oral solution contains
Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per vial, i.e. it is essentially sodium-free.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: they can cause allergic reactions (even delayed).
Sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Cochineal red A (E 124): may cause allergic reactions.
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 breastfeeding
Although reproductive cycle studies with Pigitil in animals have not shown any effect, however, as with other drugs, its use in the first three months of pregnancy is not recommended.
04.7 Effects on ability to drive and use machines
Pigitil 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 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. .
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pigitil 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
Pigitil 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. Pigitil 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
Pigitil 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 ) and sucrose.
Pigitil 400 mg oral solution: one single-dose vial contains sodium chloride, sodium saccharin, edetate disodium, tromethamine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol 70% solution, forest fruit aromatic solution, anthocyanin 55, cochineal red A (E 124 ) and 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
Pigitil 800 mg granules for oral solution:
10 sachets of 800 mg; triple laminated paper / aluminum / polythene sachets sealed by heat sealing, in a lithographed cardboard box containing the package leaflet.
Pigitil 400 mg oral solution:
10 single-dose vials of 400 mg; 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.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
FIDIA FARMACEUTICI S.P.A. - Via Ponte della Fabbrica 3 / A, 35031 Abano Terme- Padua
08.0 MARKETING AUTHORIZATION NUMBER
10 sachets of granules for oral solution mg 800 A.I.C. n. 027889031
10 single-dose vials of 400 mg A.I.C. n. 027889043
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
