LEFAX

LEFAX Pump Liquid

Important notes (mandatory information)

Lefax Pump-Liquid Suspension. Active ingredient: Simethicone. Areas of application: for excessive gas formation and gas accumulation in the gastrointestinal tract (meteorism) with gastrointestinal complaints such as flatulence, a feeling of fullness and tension in the upper abdomen, for the symptomatic treatment of infant colic (3-month colic), for increased gas formation after operations, for the preparation of diagnostic examinations in the abdominal area to reduce gas shadows (sonography, X-ray) and as an immediate measure in case of swallowing and poisoning with liquid soaps (surfactants).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lefax Pump-Liquid 41.2 mg/ml Suspension
Active ingredient: Simethicone

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 4 weeks, talk to your doctor.

This package leaflet contains

1. WHAT IS LEFAX PUMP-LIQUID AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LEFAX PUMP-LIQUID?
3. HOW TO TAKE LEFAX PUMP-LIQUID?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LEFAX PUMP-LIQUID?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LEFAX PUMP-LIQUID AND WHAT IS IT USED FOR?

Lefax Pump-Liquid is an anti-foaming medicine. Lefax Pump-Liquid is used for excessive gas formation and gas accumulation in the gastrointestinal tract (meteorism) with gastrointestinal complaints such as flatulence, a feeling of fullness and tension in the upper abdomen, for the symptomatic treatment of infant colic (3-month colic), for increased gas formation after operations, for the preparation of diagnostic examinations in the abdominal area to reduce gas shadows (sonography, X-ray) and as an immediate measure in case of swallowing and poisoning with liquid soaps (surfactants).

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LEFAX PUMP-LIQUID?

Lefax Pump-Liquid must not be taken if you are allergic to simethicone or any of the other ingredients of Lefax Pump-Liquid listed in section 6.

Special care should be taken when taking Lefax Pump-Liquid

If you have new and/or persistent abdominal pain, you should see a doctor so that the cause of the pain and any underlying condition that may require treatment can be identified.

Pregnancy and breast-feeding

There are no concerns about taking Lefax Pump-Liquid during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Important information about certain ingredients of Lefax Pump-Liquid

Lefax Pump-Liquid contains sorbic acid and potassium sorbate, which can cause localized skin irritation (e.g. contact dermatitis).

Interactions with other medicines

Interactions with other medicines are not known.

3. HOW TO TAKE LEFAX PUMP-LIQUID?

agreement with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

For gas-related gastrointestinal complaints

Age	Single dose
Infants	1 – 2 pump strokes (equivalent to 0.5 – 1 ml suspension)
Children 1 – 6 years	2 pump strokes (equivalent to 1 ml suspension)
Children aged 7 – 14 years	2 – 4 pump strokes (equivalent to 1 – 2 ml suspension)
Adolescents and adults	4 pump strokes (equivalent to 2 ml suspension)

Take the single dose 3 - 5 times a day. Infants receive Lefax Pump-Liquid with each milk meal.

To prepare for diagnostic examinations in the abdominal area

The recommended dosage is 4 - 6 pump strokes of Lefax Pump-Liquid (equivalent to 6 - 9 ml suspension) 3 times a day on the day before the examination and 4 - 6 pump strokes of Lefax Pump-Liquid (equivalent to 2 - 3 ml suspension) on the morning of the examination day. As an additive to contrast medium suspensions, 8 - 16 pump strokes of Lefax Pump-Liquid (equivalent to 4 - 8 ml suspension) are added to 1 liter of contrast medium for double contrast imaging.

As an immediate measure in case of poisoning with surfactants (hand dishwashing detergent, laundry detergent, fabric softener and liquid soaps)

Depending on the severity of the poisoning, adults receive 1 - 2 tablespoons (10 - 20 ml suspension) of Lefax Pump-Liquid. Children receive 1/2 - 2 teaspoons (2.5 - 10 ml suspension) of Lefax Pump-Liquid. In any case, medical treatment is required after the immediate measure.

Method of administration

Take the suspension with or after meals and, if necessary, also before going to bed, undiluted or with a little liquid. Lefax Pump-Liquid, which is particularly indicated for infants and bottle-fed children, the elderly and denture wearers, can be easily mixed with bottle feeds and other liquids, e.g. milk. For infants, the suspension can be given directly into the bottle. Breastfeeding mothers can give Lefax Pump-Liquid to the infant before breastfeeding, for example with a teaspoon. It is important to make sure that Lefax Pump-Liquid is shaken vigorously before use!

Duration of use

The duration of use depends on the course of the symptoms. You can take Lefax Pump-Liquid for a longer period of time if necessary. Please talk to your doctor or pharmacist if you have the impression that the effect of Lefax Pump-Liquid is too strong or too weak.

If you have taken more Lefax Pump-Liquid than you should

Poisoning by Lefax Pump-Liquid is not known to date. The active ingredient simethicone is not absorbed into the bloodstream. Even large amounts of Lefax Pump-Liquid are well tolerated.

If you forget to take Lefax Pump-Liquid

Do not take twice the amount if you have forgotten to take the previous dose, but continue taking as described.

If you stop taking Lefax Pump-Liquid

The symptoms may recur.

Instructions for handling the dosing pump

1. Remove the screw cap from the bottle.
2. Screw on the dosing pump. By turning in the direction of the printed arrow, the dosing pump is unlocked (position I), by turning against the direction of the arrow, the dosing pump can be locked again (position 0).
3. Hold the bottle upright when pumping.
4. When using for the first time, pump until the suspension comes out. Discard the first two pump strokes.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Lefax Pump-Liquid can have side effects, although not everybody gets them. In the context of the use of Lefax Pump-Liquid after approval, hypersensitivity reactions such as itching, hives, skin redness and angioedema have been identified. A statement on the frequency cannot be estimated on the basis of the available data (frequency not known).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LEFAX PUMP-LIQUID?

Keep this medicine out of the reach of children! Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C! Lefax Pump-Liquid has a shelf life of 3 months after first opening the bottle!

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lefax Pump-Liquid contains

The active ingredient is: Simethicone. 1 ml suspension (2 pump strokes) contains 41.2 mg simethicone. The other ingredients are: sorbic acid (Ph.Eur.) (E 200), potassium sorbate (Ph.Eur.) (E 202), macrogol 6000, aluminium magnesium silicate, hytellose, sodium cyclamate, poly(oxyethylene)-25-glycerol trioleate, banana flavour, citric acid, saccharin sodium, purified water.

What Lefax Pump-Liquid looks like and contents of the pack

Lefax Pump-Liquid is a milky suspension with a characteristic banana smell. Lefax Pump-Liquid is available in brown glass bottles with screw cap (PE) and attached dosing pump with 50 ml or 100 ml suspension.

Pharmaceutical entrepreneur

Bayer Vital GmbH
51368 Leverkusen
Germany

Manufacturer

Haupt Pharma Amareg GmbH
Donaustaufer Straße 378
93055 Regensburg
Germany

This package leaflet was last revised in June 2013.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Simethicone. Areas of application: for excessive gas formation and gas accumulation in the gastrointestinal tract (meteorism) with gastrointestinal complaints such as flatulence, a feeling of fullness and tension in the upper abdomen, for the symptomatic treatment of infant colic (3-month colic), for increased gas formation after operations, for the preparation of diagnostic examinations in the abdominal area to reduce gas shadows (sonography, X-ray) and as an immediate measure in case of swallowing and poisoning with liquid soaps (surfactants).