Flatulex 42 mg 50 chewable tablets

What is Flatulex and when is it used?

Flatulex is a medicine used to treat symptoms caused by excessive gas production and accumulation in the gastrointestinal area, such as flatulence, a feeling of fullness, frequent belching of air and a feeling of pressure in the abdominal area.

Your doctor may also prescribe it before an X-ray or ultrasound examination of the abdominal area, as Flatulex prevents accumulation of intestinal gases that can cause disturbing shadows in the images.

Swallowing air when eating too quickly or after eating gassy foods can cause the normal air content in the intestine to increase up to 10 times. Fine bubbles of foam or gas bubbles surrounded by mucus form, and the air trapped in this way can no longer escape naturally or be absorbed by the body. Thanks to its defoaming properties, Flatulex destroys this foam that causes discomfort in the gastrointestinal area and the gas released can escape.

Flatulex is available as a chewable tablet or as a drip solution. In addition to the main active ingredient simeticone, the chewable tablets also contain fennel, caraway and peppermint oil as flavorings. The drops are particularly suitable for infants and small children, but also for older people and, since they are artificially sweetened, also for diabetics.

What precautions should be taken?

If you have a tendency to flatulence, the success of the treatment can be improved by also paying attention to a correct, balanced diet. The food should be high in fiber and flatulent vegetables should be avoided. When eating, it is important to chew thoroughly, as this will avoid eating too quickly and the resulting swallowing of air.

Stress, nervousness and lack of exercise also have an unfavorable influence on digestive performance.

If the symptoms persist despite a lifestyle that avoids flatulence, you should see a doctor so that organic (physical) causes can be ruled out.

In the case of infants, care should be taken not to drink too quickly. If the infant receives the bottle (bottle), make sure that the suction hole is not too large.

If you suffer from an intolerance to fructose or table sugar (fructose intolerance, sucrase-isomaltase insufficiency) or glucose-galactose malabsorption, you should not take Flatulex chewable tablets.

If you suffer from sorbic acid/sorbate intolerance, you should not take Flatulex drops.

Diabetic note

Flatulex chewable tablets:

This medicine contains 0.55 g of usable carbohydrates per single dose. This corresponds to approximately 0.05 bread units (BE).

Flatulex drops:

Are artificially sweetened and suitable for diabetics.

When should Flatulex not be taken/used?

If you suffer from an intestinal obstruction or are prone to it or if you are hypersensitive (allergic) to any of the ingredients in Flatulex chewable tablets or Flatulex drops. The chewable tablets are unsuitable for diabetics.

When should you be careful when taking/using Flatulex?

When used as intended, no special precautionary measures need to be taken.

Inform your doctor, pharmacist or druggist if you

• suffer from other illnesses,
• Have allergies or
• Take other medicines (including those you bought yourself!) or use externally!

Can Flatulex be taken/used during pregnancy or while breastfeeding?

If you are pregnant or breastfeeding, you should only take Flatulex after consulting your doctor.

How do you use Flatulex?

For flatulence problems, adults and adolescents aged 14 and over usually take 1-2 chewable tablets or 2-4 pumps of drops after each meal and before going to bed, children and adolescents aged 6 - 14 years take 1 chewable tablet or 2 pumps, toddlers and children from 1 – 6 years 1-2 pumps. Newborns and small children up to 1 year of age are given Flatulex drops either by teaspoon before breastfeeding or added to the bottle.

When taking Flatulex to prepare for a diagnostic examination in the abdominal area, unless otherwise prescribed, adults and adolescents aged 14 and over should take 2 chewable tablets or 4 pumps 3-4 times a day on the two days before the examination and the same dose in the morning on the day of the examination fasting or possibly again immediately before the examination. Children and adolescents aged 0 to 14 receive 2-4 pumps per dose with the same administration schedule.

If necessary, the dose can be increased. The duration of intake depends on the course of the symptoms. Flatulex can be taken for a longer period of time if necessary.

When taking the chewable tablets, make sure that they are chewed well.

The Flatulex drops should be shaken before use. They are advantageously taken mixed with liquid. The drops mix easily with formula or other liquids, such as milk; they can also be added to pulpy foods.

Stick to the dosage stated in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

Notes on handling the dosing pump

Remove the screw cap from the bottle and screw the dosing pump included in the plastic bag onto the neck of the bottle. Turn the pump mechanism in the direction of position I (see cover) until it stops. Then activate the dosing pump by pressing it down until liquid comes out. Do not use the first two pumps yet.

The bottle must always be held vertically when operating the dosing pump. The dosing pump can be closed by turning the pump mechanism towards position 0 (see cover).

To compensate for the rejection of the first two pumps when starting up the dosing pump and for the remaining amount when the bottle is emptied, the pump bottle contains correspondingly more dripping solution.

What side effects can Flatulex have?

Flatulex is not absorbed by the body and is excreted unchanged. Flatulex is therefore extremely well tolerated.

Individual cases

Immune system diseases:

Allergic reactions such as skin redness, hives, angioedema and itching.

If you notice any side effects, contact your doctor, pharmacist or druggist. This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

The medicine may only be used until the date marked “EXP” on the container.

Use-by period after opening

Flatulex drops: Do not use for longer than 13 weeks after first opening.

Storage instructions

Store at room temperature (15 – 25 °C).

Keep out of reach of CHILDREN.

More information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What is included in Flatulex?

Active ingredients

1 chewable tablet contains: 42 mg simeticone.

1 ml drip solution (=2 pumps) contains: 41.2 mg simeticone

Excipients

1 chewable tablet contains: caraway, fennel and peppermint oil, other excipients.

1 ml drip solution (=2 pumps) contains: sodium cyclamate, saccharin sodium, vanillin and others as flavorings, preservatives: E 200 (sorbic acid), E202 (potassium sorbate), other excipients.

Approval number

29792, 42045 (Swissmedic)

Where can you get Flatulex? Which packs are available?

In pharmacies and drugstores, without medical prescription.

Chewable tablets: Pack of 50 chewable tablets.

Drops: bottle with dosing pump of 50 ml.

Authorization holder

Bayer (Switzerland) AG, 8045 Zurich.