IPERTROFAN 40 mg Enteric-Coated Tablet

Зміст інструкції

1. Ipertrofan 40 mg gastro-resistant tablets
   1. What is Ipertrofan and what is it used for
   2. What you need to know before taking Ipertrofan
   3. How to take Ipertrofan
   4. Possible side effects
   5. How to store Ipertrofan
   6. Contents of the pack and other information

Ipertrofan 40 mg gastro-resistant tablets

Mepartricina

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ipertrofan is and what it is used for
• 2. What you need to know before you take Ipertrofan
• 3. How to take Ipertrofan
• 4. Possible side effects
• 5. How to store Ipertrofan
• 6. Contents of the pack and other information

1. What is Ipertrofan and what is it used for

Ipertrofan contains mepartricin, belonging to the class of medicines used to treat diseases of the
prostate, a gland in men that produces seminal fluid.
Ipertrofan is used for the treatment of disorders related to benign prostatic hyperplasia, a disease that
causes enlargement of the prostate and can cause an obstruction of the channel through which urine passes,
making its outflow difficult.

2. What you need to know before taking Ipertrofan

Do not take Ipertrofan

• if you are allergic to mepartricin or any of the other ingredients of this medicine (listed in section 6 “What Ipertrofan contains”).

Warnings and precautions
It is advisable that the treatment is continued for at least 30 days even if there is a rapid
improvement.
Consult 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.

Other medicines and Ipertrofan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Ipertrofan with food, drinks and alcohol
Ipertrofan should be taken with food, preferably with the evening meal.

Pregnancy, breastfeeding and fertility
The medicine is not indicated in female patients.

Driving and operating machinery
The product does not affect the ability to drive vehicles or operate machinery.

Ipertrofan contains lactose.
If your doctor has diagnosed you with intolerance to some sugars (for example lactose), contact them before
taking this medicine.

3. How to take Ipertrofan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet a day, preferably with the evening meal.
Complete therapy generally involves one or more cycles 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.

If you take more Ipertrofan than you should
No cases of overdose are known.
In the event of accidental intake of doses higher than the recommended one, immediately contact your
doctor or the nearest hospital.

If you forget to take Ipertrofan
Do not take a double dose to make up for the missed tablet.

If you stop taking Ipertrofan
If you have any doubts 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.
During treatment with Ipertrofan, the following side effects affecting the stomachand intestineshave been observed and reported:

• gastralgia (pain in the epigastrium)
• nausea
• vomiting
• diarrhea.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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.

5. How to store Ipertrofan

Do not store at a temperature above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after Expiry.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ipertrofan contains

• The active ingredient is mepartricine
• The other ingredients are: pregelatinized corn 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.

Description of the appearance of Ipertrofan and contents of the pack
Gastro-resistant tablets of yellow color packaged in aluminum blisters of 10 tablets.
Each pack contains 2 blisters of 10 tablets.

Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 Milan.

Manufacturer
DOPPEL Farmaceutici S.r.l. - Manufacturing facility at Via Volturno, 48 - 20089 Quinto De' Stampi – Rozzano (MI).