LEFAX

LEFAX extra liquid capsules

Important notes (mandatory information)

Lefax extra 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 extra liquid capsules 125 mg Simethicone soft capsules

Dear customer! You have chosen Lefax extra liquid capsules, 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 extra liquid capsules should be used as prescribed below. Keep the package leaflet. You may want to read it again later. Your doctor or pharmacist will also be able to advise you. If your symptoms worsen or do not improve, you should see a doctor.

This package leaflet contains

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

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

This medical device contains simethicone, a substance with anti-foaming and foam-inhibiting effects. Lefax extra 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 EXTRA LIQUID CAPSULES?

Lefax extra liquid capsules must not be taken if you are hypersensitive (allergic) to simethicone or any of the other ingredients of Lefax extra liquid capsules. If you experience new and/or persistent abdominal pain, you should consult a doctor so that the cause of the symptoms and any underlying condition requiring treatment can be identified.

During pregnancy and breastfeeding

There are no concerns about taking Lefax extra 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 extra liquid capsules with other preparations

Clinically relevant interactions are not known to date.

3. HOW TO TAKE LEFAX EXTRA LIQUID CAPSULES?

Always take Lefax extra 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 extra liquid capsules differently.

For gas-related gastrointestinal complaints

Age	Single dose	Total daily dose
Adults and adolescents aged 14 and over	1 - 2 soft capsules (equivalent to 125 mg to 250 mg simethicone)	3 - 6 soft capsules (equivalent to 375 mg to 750 mg simethicone)

For preparation for imaging examinations

Age	the day before the examination	on the morning of the examination
Adults, adolescents, children aged 6 and over	2 - 3 soft capsules (equivalent to 250 mg to 375 mg simethicone)	1 soft capsule (equivalent to 125 mg simethicone)

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

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

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

What happens if you stop taking Lefax extra 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 extra 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 experience any side effects, please inform your doctor or pharmacist.

5. HOW TO STORE LEFAX EXTRA 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 extra liquid capsules above 25°C!

6. FURTHER INFORMATION

1 soft capsule contains 125 mg simethicone. The other ingredients are: gelatine, glycerol, purified water.

Lefax extra 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

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 05/2018
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.