Ipertrofan 40

Package Leaflet: Information for the Patient

IPERTROFAN 40
mg film-coated tablets

1. What is Ipertrofan 40 and what is it used for

Ipertrofan 40 is a medicine belonging to the group of diuretic medicines, known as thiazide diuretics. The action of Ipertrofan 40 involves reducing the concentration of estrogens in the urine, frequent urination at night, sudden urge to urinate, inability to hold urine, pain while urinating, feeling of incomplete bladder emptying, narrowing of the urine stream, prolonged urination time, interrupted urine stream, dripping of urine from the urethra after urination.

2. What you need to know before taking Ipertrofan 40

1. How to take Ipertrofan 40
2. When not to take Ipertrofan 40
3. Possible side effects
4. Package contents and other information

Table of Contents of the Leaflet:

You should read the contents of the leaflet before taking the medicine, as it contains important information about the medicine. You should consult a doctor, pharmacist, or nurse if you need more information. You should keep this leaflet, so you can refer to it again if needed. If you do not feel well, you should consult a doctor or pharmacist. If any of the side effects worsen or if you experience any side effects not mentioned in the leaflet, you should tell your doctor or pharmacist.

Side Effects

Treatment with Ipertrofan 40 may reveal itself after 4 weeks of treatment.
The action of Ipertrofan 40 does not replace surgical treatment of benign prostatic hyperplasia.
Indications for the use of the medicine are symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia.

Important Information Before Taking Ipertrofan 40

1. When not to take Ipertrofan 40

- if the patient has been found to be hypersensitive (allergic) to the active substance or any of the other ingredients of Ipertrofan 40 (listed in section 6).

Warnings and Precautions

Treatment should be carried out for at least 30 days, even in the case of immediate improvement.
Ipertrofan 40 is intended for adults, exclusively men.

Ipertrofan 40 is intended for adults, exclusively men.

Taking Ipertrofan 40 with food and drink
It is recommended to take the medicine during a meal, preferably in the evening.

Ipertrofan 40 and Other Medicines

No interactions between Ipertrofan 40 and other medicines are known.
Pregnancy, breastfeeding, and fertility
Ipertrofan 40 is not used in women.

Driving and Operating Machines

The medicine does not affect the ability to drive and operate machines.
If the patient has previously been found to have intolerance to certain sugars, the patient should contact a doctor before taking the medicine.

4. Possible Side Effects

Like all medicines, Ipertrofan 40 can cause side effects, although not everybody gets them.

• Common (occurring in 1 to 10 people out of 100): vomiting, diarrhea, abdominal pain, nausea, unwanted gastrointestinal effects, transient and less intense pain. In most cases, they resolved on their own without requiring a break in treatment or a change in dosage.

In case of side effects, you should stop taking the medicine and consult a doctor.

3. How to Take Ipertrofan 40

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist.
Recommended dose for adults:
1 tablet per day, preferably in the evening during a meal.
Ipertrofan 40 is intended for adults, exclusively men.
Treatment should be carried out for at least 30 days, even in the case of immediate improvement.
In case of the most common condition, you should take the next tablet according to the given scheme.
You should assign one tablet as soon as possible and then proceed according to the day of dosing. If you miss taking the next tablet, you should take only one tablet and then continue with the recommended dosing scheme.
Regarding the use of a higher dose of the medicine than recommended, you should immediately consult a doctor.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.

What Ipertrofan 40 Looks Like and What the Package Contains

The package contains 10, 20, or 30 film-coated tablets in aluminum/polyamide/PVC blisters, in a cardboard box.

Qualitative Composition

The active substance of the medicine is meparticina. One film-coated tablet contains 40 mg of meparticina.
Other ingredients: talc, magnesium stearate, lactose, gelatinized starch, talc, magnesium citrate, polysorbate 80, sodium lauryl sulfate, talc, titanium dioxide (E 171), iron oxide (E 172), polyvinyl alcohol, pullulan, macrogol 6000.

5. How to Store Ipertrofan 40

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not take the medicine after the expiration date stated on the box.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

If you experience any side effects, including any possible side effects not mentioned in the leaflet, you should consult a doctor or pharmacist.

Marketing Authorization Holder and Manufacturer

SPA - Societa Prodotti Antibiotici S.p.A
Via Biella 8, 20143 Milan
Italy

Manufacturer:

DOPPEL FARMACEUTICI S.r.l.
Via Volturno, 48
20089 Quinto De’ Stampi, Rozzano (MI)
Italy

Representative of the Marketing Authorization Holder:

Medagro International Sp. z o.o.
ul. Podlesna 83, 05-552 Łazy
Tel. +48(22)702 82 00

Date of Last Update of the Leaflet:

Joanna Rzepkowska
Head of Regulatory Affairs Manager