Active ingredients: Mepartricin
Ipertrofan 40 mg gastro-resistant tablets
Why is Ipertrofan used? What is it for?
Ipertrofan contains mepartricin belonging to the class of medicines used to treat diseases of the prostate, a gland that produces seminal fluid in humans.
Ipertrofan is used for the treatment of disorders related to benign prostatic hypertrophy, a disease that causes the prostate to enlarge and can cause an obstruction of the channel through which urine passes, making it difficult to escape.
Contraindications When Ipertrofan should not be used
Do not take Ipertrofan
- if you are allergic to mepartricin or any of the other ingredients of this medicine (listed in the section "What Ipertrofan contains").
Precautions for use What you need to know before taking Ipertrofan
It is advisable that the treatment be continued for at least 30 days even in the presence of rapid improvement.
Talk to your doctor before taking Ipertrofan.
Children and adolescents
It is not indicated for use in children and adolescents as safety and efficacy have not been established in this patient group.
Interactions Which drugs or foods can modify the effect of Ipertrofan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ipertrofan with food, drink and alcohol
Ipertrofan should be taken with food, preferably with the evening meal.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
The drug is not indicated in female patients.
Driving and using machines
The product does not affect the ability to drive or use machines.
Ipertrofan contains lactose.
If you have been told by your doctor that you have "intolerance to some sugars (eg lactose), contact your doctor before taking this medicine.
Dose, Method and Time of Administration How to use Ipertrofan: 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 one tablet per day, preferably with the evening meal.
Complete therapy typically involves one or more courses of 30 days each.
Use in children and adolescents
It is not indicated for use in children and adolescents as safety and efficacy have not been established in this patient group.
Overdose What to do if you have taken an overdose of Ipertrofan
If you take more Ipertrofan than you should
There are no known overdose phenomena.
In case of accidental intake of higher than recommended doses, contact your doctor or the nearest hospital immediately.
If you forget to take Ipertrofan
Do not take a double dose to make up for a forgotten tablet.
If you stop using Ipertrofan
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 Ipertrofan
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects affecting the stomach and intestines have been observed and reported during treatment with Ipertrofan:
- gastralgia (pain in the pit of the stomach)
- nausea
- He retched
- diarrhea.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not store above 30 ° C.
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 Expiry.
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.
What Ipertrofan contains
- The active ingredient is mepartricin
- The other ingredients are: pregelatinised maize starch; talc; magnesium stearate; lactose (see section 2 "Ipertrofan contains lactose"); methacrylic acid copolymer; triethyl citrate; polysorbate 80; sodium lauryl sulfate; titanium dioxide (E 171); yellow iron oxide (E 172); polyvinyl alcohol; pullulan; polyethylene glycol 6000.
What Ipertrofan looks like and contents of the pack
Yellow gastro-resistant tablets packed in aluminum blisters of 10 tablets.
Each pack contains 2 blisters of 10 tablets.
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
IPERTROFAN 40 MG GASTRORESISTANT TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains: Active ingredient:
Mepartricin 40 mg
Excipients with known effects:
lactose 192.5 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of functional disorders of benign prostatic hyperplasia.
04.2 Posology and method of administration
One tablet per day (preferably with the evening meal).
Comprehensive therapy typically involves one or more 30-day courses, according to medical advice.
04.3 Contraindications
Individual ascertained hypersensitivity to the product.
04.4 Special warnings and appropriate precautions for use
It is advisable that the treatment be continued for at least 30 days even in the presence of rapid improvement.
Keep out of reach of children.
To be sold upon presentation of a prescription.
IPERTROFAN 40 mg gastro-resistant tablets contain lactose; Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions or incompatibilities with other drugs have been reported.
04.6 Pregnancy and lactation
The drug is not indicated in female patients.
04.7 Effects on ability to drive and use machines
The product has no effect on the ability to drive and use machines.
04.8 Undesirable effects
Only rarely, during prolonged treatments, can gastralgia, nausea, vomiting and diarrhea occur.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There are no known overdose phenomena.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs used in benign prostatic hypertrophy. ATC code: G04CX03
Mepartricin, active principle of IPERTROFAN, is the semi-synthetic derivative of an antibiotic with a polyene structure, isolated in the Research Laboratories of the SPA from the culture media of a strain of Streptomyces aureofaciens. Regardless of its now known antifungal and antiprotozoal activities, mepartricin orally it has proved particularly useful in improving the functionality of the urethroprostate-bladder complex in subjects suffering from benign prostatic hyperplasia. The mechanism of action, free from direct hormonal effects, is due to the strong property of the compound to bind in form irreversible with intestinal sterol fractions at the level of the enterohepatic circle; since the increased deposition of cholesterol, estrogens and androgens in the lumen of the glandular acini represents a contributing factor in the determinism of benign prostatic hyperplasia, a decrease in the hormonal pool leads to particularly favorable modifications of the symptomatological process typical of the disease.
05.2 "Pharmacokinetic properties
From a pharmacokinetic point of view, mepartricin, similarly to other polyenes, does not show systemic absorption, as demonstrated by specific studies conducted in this regard.
05.3 Preclinical safety data
Toxicological studies have shown a LD 50 per os in mice and rats greater than 4000 mg / kg; the subacute (rats-dogs) and chronic (dogs and rats treated for 6 months) toxicity tests, conducted per os, never showed alterations attributable to the administration of the substance. Mepartricin was also devoid of teratogenic activity (rats and rabbits per os), of effects on fertility and peri-postnatal toxicity (rats per os) and of mutagenicity (Ames test, DNA damage and repair test evaluated by mitotic crossingover and gene conversion in Saccharomyces cerevisiae, micronucleus test, cytogenetic test in human lymphocytes, chromosomal aberrations in CHO cells).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Pregelatinised starch, talc, magnesium stearate, lactose, methacrylic acid copolymer, triethyl citrate, polysorbate 80, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172), polyvinyl alcohol, pullulan, polyethylene glycol 6000.
06.2 Incompatibility
There are no known chemical or physico-chemical incompatibilities.
06.3 Period of validity
24 months.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Aluminum / aluminum blister
IPERTROFAN 40 mg gastro-resistant tablets: box of 20 tablets
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
SPA - Antibiotic Products Company S.p.A. - Via Biella, 8 - 20143 MILAN.
08.0 MARKETING AUTHORIZATION NUMBER
IPERTROFAN 40 mg gastro-resistant tablets 20 cpr A.I.C. 025412026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
AIC Decree
IPERTROFAN 40 mg gastro-resistant tablets 20 cpr
31/10/1994
Renewal: 1/6/2010.
