LEFAX

LEFAX intens liquid capsules 250 mg simethicone

Important notes (mandatory information)

Lefax intens liquid capsules, soft capsules. Active ingredient: Simethicone. Areas of application: for the relief and symptomatic treatment of gas-related gastrointestinal complaints such as flatulence (meteorism), feeling of fullness, belching, cramp-like abdominal pain, postoperative gas-related pain and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lefax intens liquid capsules 250 mg simethicone soft capsules

Dear customer! With Lefax intens liquid capsules, you have chosen a product that will help you quickly and reliably with gas-related gastrointestinal complaints. It is very well tolerated. Please read the entire package leaflet carefully, as it contains important information for you. In order to achieve the best possible treatment success, Lefax intens liquid capsules should be used as prescribed below. Keep the package leaflet. You may want to read it again later. In addition, your doctor or pharmacist will advise you. If your symptoms worsen or do not improve, you should see a doctor.

This package leaflet contains

1. WHAT ARE LEFAX INTENS LIQUID CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LEFAX INTENS LIQUID CAPSULES?
3. HOW TO TAKE LEFAX INTENS LIQUID CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LEFAX INTENS LIQUID CAPSULES?
6. FURTHER INFORMATION

1. WHAT ARE LEFAX INTENS LIQUID CAPSULES AND WHAT ARE THEY USED FOR?

This medical device contains simethicone, a substance with anti-foaming and foam-inhibiting effects. Lefax intens liquid capsules are used for the relief and symptomatic treatment of gas-related gastrointestinal complaints such as flatulence (meteorism), feeling of fullness, belching, cramp-like abdominal pain, postoperative gas-related pain and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LEFAX INTENS LIQUID CAPSULES?

Lefax intens liquid capsules must not be taken if you are hypersensitive (allergic) to simethicone or any of the other ingredients of Lefax intens liquid capsules. In the case of new and/or persistent abdominal complaints, you should consult a doctor so that the cause of the complaints and any underlying, treatable condition can be identified.

During pregnancy and breastfeeding

There are no concerns about taking Lefax intens liquid capsules during pregnancy and breastfeeding, as simethicone is excreted unchanged from the intestine and is not absorbed by the body. It is generally advisable to consult a doctor beforehand.

Use in children

Other dosage forms are recommended for children under 14 years of age, e.g. Lefax pump liquid or Lefax chewable tablets.

When taking Lefax intens liquid capsules with other preparations

Clinically relevant interactions are not known to date.

3. HOW TO TAKE LEFAX INTENS LIQUID CAPSULES?

Always take Lefax intens liquid capsules exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Dosage and duration of use

The following information applies unless your doctor has prescribed Lefax intens liquid capsules differently.

o For gas-related gastrointestinal complaints

Age	Single dose	Total daily dose
Adults and adolescents from 14 years of age	1 soft capsule (equivalent to 250 mg simethicone)	4 soft capsules (equivalent to 1000 mg simethicone)

o For preparation for imaging examinations

Age	the day before the examination	on the morning of the examination
Adults and adolescents from 14 years of age	1 – 2 soft capsules (equivalent to 250 mg to 500 mg simethicone)	1 soft capsule (equivalent to 250 mg simethicone)

The duration of use depends on the course of the symptoms. Lefax intens liquid capsules can be taken over a longer period of time if necessary, but not for longer than 30 days. Lefax intens liquid capsules should be taken with or after meals, if necessary also before going to bed. The soft capsules are swallowed whole with sufficient liquid (e.g. 1 glass of water).

What to do if you have taken more Lefax intens liquid capsules than you should?
Even large amounts are well tolerated, as the active ingredient of the soft capsules acts exclusively physically and is completely biologically and chemically inactive.

What to do if you forget to take Lefax intens liquid capsules?
Continue treatment without changing the dosage.

What happens if you stop taking Lefax intens liquid capsules prematurely?
In this case, the symptoms may recur.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

No side effects have been observed to date in connection with the use of Lefax intens liquid capsules. The active ingredient simethicone dissolves the foam in the stomach and intestines and is not absorbed by the gastrointestinal tract. Therefore, no side effects from simethicone are to be expected, even in large amounts. If you do notice any side effects, please inform your doctor or pharmacist.

5. HOW TO STORE LEFAX INTENS LIQUID CAPSULES?

Keep this product out of the reach of children. Do not use after the expiry date printed on the outer carton and blister. Storage instructions: Do not store Lefax intens liquid capsules above 25°C!

6. FURTHER INFORMATION

1 soft capsule contains 250 mg simethicone. The other ingredients are: gelatine, glycerol, purified water.

Lefax intens liquid capsules are available in packs of 20 and 50 soft capsules.

HÄLSA Pharma GmbH
Maria-Goeppert- Straße 5
23562 Lübeck
Germany
info@haelsa.de

Distributor

Bayer Vital GmbH
51368 Leverkusen
Germany

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Simethicone. Areas of application: for the relief and symptomatic treatment of gas-related gastrointestinal complaints such as flatulence (meteorism), feeling of fullness, belching, cramp-like abdominal pain, postoperative gas-related pain and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.