Package leaflet: Information for the patient

Ipertrofan 40 mg gastro-resistant tablets

Mepartricin
Please read all of 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ipertrofan is and what it is used for

Ipertrofan contains mepartricin, which belongs to the class of medicines used to treat prostate disorders, a gland in men that produces seminal fluid.
Ipertrofan is used for the treatment of symptoms related to benign prostatic hyperplasia, a condition that causes enlargement of the prostate and may lead to obstruction of the urinary passage, making urination difficult.

2. What you need to know before taking Ipertrofan

Do not take Ipertrofan

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

Warnings and precautions
It is advisable that treatment continues for at least 30 days, even if rapid improvement occurs.
Consult your doctor before taking Ipertrofan.

Children and adolescents
Not recommended for use in children and adolescents, as safety and efficacy have not been established in this patient group.

Other medicines and Ipertrofan
Inform 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 during the evening meal.

Pregnancy, breastfeeding and fertility
This medicine is not indicated for female patients.

Driving and using machines
This product does not affect the ability to drive or operate machinery.

Ipertrofan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Ipertrofan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one tablet per day, preferably with the evening meal.
The full course of treatment generally consists of 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
Overdose symptoms have not been reported.
In case of accidental ingestion of doses higher than recommended, contact your doctor immediately
or go to the nearest hospital.
If you forget to take Ipertrofan
Do not take a double dose to make up for the forgotten tablet.
If you stop treatment with Ipertrofan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects affecting the stomach and intestine have been observed and reported during treatment with Ipertrofan:

gastralgia (pain in the upper abdomen)
nausea
vomiting
diarrhoea

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 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 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 packaging after Exp.
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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Ipertrofan contains

The active substance is mepartricin
The other components 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
Yellow gastro-resistant tablets, packaged in aluminum blisters containing 10 tablets each.
Each package contains 2 blisters of 10 tablets.
Marketing Authorization Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan
Manufacturer
DOPPEL Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto De' Stampi – Rozzano (MI).