SIMETHICON-

SIMETHICON ratiopharm 85 mg chewable tablets

Important notes (mandatory information)

Simethicon-ratiopharm 85 mg chewable tablets. Active ingredient: Dimethicone-1000-silicon dioxide. Areas of application: for symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and for preparation of examinations in the abdominal area, such as X-rays and sonography. Warning: Contains lactose and sorbitol!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Simethicon-ratiopharm 85 mg chewable tablets
Active ingredient: Dimethicone-1000-silicon dioxide (94.5 : 5.5); syn.: Simethicone

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. 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, contact 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 if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS SIMETHICON-RATIOPHARM 85 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SIMETHICON-RATIOPHARM 85 MG?
3. HOW TO TAKE SIMETHICON-RATIOPHARM 85 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SIMETHICON-RATIOPHARM 85 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SIMETHICON-RATIOPHARM 85 MG AND WHAT IS IT USED FOR?

Simethicon-ratiopharm 85 mg is a defoamer. Simethicon-ratiopharm 85 mg is used for symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and for preparation of examinations in the abdominal area, such as X-rays and sonography.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SIMETHICON-RATIOPHARM 85 MG?

Simethicon-ratiopharm 85 mg must not be taken if you are allergic to simethicone or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Simethicon-ratiopharm 85 mg. If you have new and 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 diagnosed.

Taking Simethicon-ratiopharm 85 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions with other medicines are known.

Pregnancy and breast-feeding

There are no concerns about taking Simethicon-ratiopharm 85 mg during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Simethicon-ratiopharm 85 mg contains lactose and sorbitol

Therefore, please only take Simethicon-ratiopharm 85 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE SIMETHICON-RATIOPHARM 85 MG?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is

For gas-related gastrointestinal complaints:

• Adults and adolescents aged 14 and over: Unless otherwise prescribed by your doctor, take 1 -- 2 chewable tablets 3 -- 4 times a day, chewed.
• Children aged 6 -- 14: Unless otherwise prescribed by your doctor, children should take 1 chewable tablet 3 -- 4 times a day.
• Other dosage forms are available for younger children and infants.

For preparation for imaging examinations

As directed by your doctor. Unless otherwise prescribed, 3 - 4 chewable tablets are taken on the day before the examination and 1 chewable tablet on the morning of the examination, chewed.

Method of administration

For gas-related gastrointestinal complaints: Simethicon-ratiopharm 85 mg is taken after meals, if necessary also before going to bed, well chewed. For the method of administration in the context of sonography/X-ray diagnostics, see above. The chewable tablets should be taken well chewed.

Duration of use

The duration of use depends on the course of the symptoms. Simethicon-ratiopharm 85 mg can be taken over a longer period of time if necessary. Please talk to your doctor or pharmacist if you have the impression that the effect of Simethicon-ratiopharm 85 mg is too strong or too weak.

If you have taken more Simethicon-ratiopharm 85 mg than you should

The active ingredient of Simethicon-ratiopharm 85 mg dissolves the foam in the gastrointestinal tract purely physically and is chemically and biologically completely ineffective. Therefore, poisoning is practically ruled out. Even larger amounts of Simethicon-ratiopharm 85 mg are well tolerated.

If you forget to take Simethicon-ratiopharm 85 mg

Do not take double the amount to make up for a forgotten dose. Continue taking as described in 3. "How to take Simethicon-ratiopharm 85 mg?".

If you stop taking Simethicon-ratiopharm 85 mg

In this case, the symptoms may recur.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Side effects in connection with the use of Simethicon-ratiopharm 85 mg have not been observed so far.

Reporting of side effects

If you notice any side effects, contact 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 about the safety of this medicine.

5. HOW TO STORE SIMETHICON-RATIOPHARM 85 MG?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister packs after "Use by". The expiry date refers to the last day of the specified month. Store in the original package to protect the contents from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Simethicon-ratiopharm 85 mg contains

The active ingredient is: Dimethicone-1000-silicon dioxide (94.5 : 5.5) (syn.: Simethicone). Each chewable tablet contains 85 mg of dimethicone-1000-silicon dioxide (94.5 : 5.5). The other ingredients are: Cellulose powder, lactose, sorbitol, calcium hydrogen phosphate, talc, saccharin sodium, peppermint flavour.

What Simethicon-ratiopharm 85 mg looks like and contents of the pack

White, round tablet with a break notch on one side. Simethicon-ratiopharm 85 mg is available in packs of 20, 50 and 100 chewable tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Dimethicone-1000-silicon dioxide. Areas of application: for symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and for preparation of examinations in the abdominal area, such as X-rays and sonography. Warning: Contains lactose and sorbitol!