SAB simplex flatulence, bloating oral suspension
Package size:4 x 30 ml
sab simplex. Active ingredient: Simethicone. Indications: For the symptomatic treatment of gas-related gastrointestinal complaints, e.g., flatulence (meteorism), bloating; for preparation for examinations in the abdominal region, such as X-rays and sonography (ultrasound examination) and for preparation for gastroduodenoscopies (endoscopy of the stomach and intestines); for increased gas formation after surgery; for detergent poisoning.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
Instructions for use: Information for the user
sab simplex
69.19 mg/ml
oral suspension
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 wish to read this again later.
- Ask your pharmacist if you need more information or advice.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or if you feel worse after one day, talk to your doctor.
What's in this leaflet:
1. WHAT SAB SIMPLEX IS AND WHAT IT IS USED FOR
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE SAB SIMPLEX
3. HOW TO TAKE SAB SIMPLEX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SAB SIMPLEX
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SAB SIMPLEX IS AND WHAT IT IS USED FOR
Sab Simplex, oral suspension, is a medication for treating functional disorders of the gastrointestinal tract. Simethicone, the active ingredient in Sab Simplex, is a surfactant (defoaming agent) that dissolves excessive air/gas accumulation in the gastrointestinal tract.
Sab Simplex is used:
- for the symptomatic treatment of gas-related gastrointestinal discomfort, e.g., bloating (flatulence), fullness;
- to prepare for examinations of the abdominal region, such as X-rays and sonography (ultrasound examination), and to prepare for gastroduodenoscopies (endoscopy of the stomach and intestines);
- for increased gas formation after surgery;
- for detergent poisoning.
2. WHAT YOU SHOULD KNOW BEFORE TAKING SAB SIMPLEX:
Sab Simplex must not be taken if ...
Do not take Sab Simplex if you are allergic to simethicone or any of the other ingredients of this medicine listed in section 6.
Warnings and precautions
: If you experience new and/or persistent abdominal discomfort, you should consult a doctor so that the cause of the discomfort and any underlying condition requiring treatment can be identified.
Taking Sab Simplex with other medicines:
No interactions with other medicines are known.
Pregnancy and breastfeeding:
There are no concerns about taking Sab Simplex during pregnancy and breastfeeding.
Driving and using machines:
Sab Simplex has no influence on the ability to drive or use machines.
Sab Simplex contains sodium:
Several teaspoons of Sab Simplex are required to prepare for examinations in the abdominal area and, if necessary, in cases of detergent poisoning. 1 teaspoon (5 ml) contains 0.6 mmol sodium (13.8 mg sodium). If you are on a low-sodium diet, you should take this into account.
3. HOW TO TAKE SAB SIMPLEX?
Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the usual dose is:
For gas-related gastrointestinal discomfort, e.g., bloating, feeling of fullness
: Infants and bottle-fed babies:
Add 15 drops (0.6 ml) of sab simplex to each bottle. sab simplex mixes easily with other liquids, e.g., milk.
For breastfed infants, sab simplex can also be given with a small spoon before each feeding.
Toddlers:
Toddlers take 15 drops (0.6 ml) of sab simplex with or after meals. If necessary, another 15 drops of sab simplex can be taken before bedtime.
For the treatment of bloating and a feeling of fullness, the following dosage recommendations apply to school-age children and adults:
School-age children: 20 to 30 drops (0.8 to 1.2 ml)
Adults: 30 to 45 drops (1.2 to 1.8 ml)
This dose should be taken every 4 to 6 hours and can be increased if necessary.
Sab Simplex is taken with or after meals, and if needed, also before bedtime.
Shake the bottle well before use! To dispense drops, hold the bottle vertically downwards and tap the bottom lightly with your finger. Tilting the bottle will slow the drop rate.
For the following applications, administration is best done after removing the dropper insert from the 30 ml or 100 ml bottle.
X-ray examinations
: To prepare for an X-ray examination, take 3 to 6 teaspoons (15 to 30 ml) of Sab Simplex the evening before the examination.
Sonography (ultrasound examinations)
: To prepare for sonography, it is recommended to take 3 teaspoons (15 ml) of Sab Simplex the evening before and another 3 teaspoons (15 ml) approximately 3 hours before the start of the sonography.
Endoscopies (gastrointestinal endoscopies)
: Take 1/2 to 1 teaspoon (2.5 to 5 ml) of Sab Simplex before endoscopies. Any further medication to eliminate bothersome foam bubbles can be administered through the instrument channel of the endoscope using a few milliliters of Sab Simplex.
Detergent poisoning:
In cases of detergent poisoning, the dosage depends on the severity of the poisoning. A minimum dose of 1 teaspoon (5 ml) of Sab Simplex is recommended.
Duration of use:
Sab Simplex can be taken for extended periods if necessary and in consultation with your doctor or pharmacist.
If you have taken more Sab Simplex than you should:
The active ingredient in Sab Simplex, simethicone, dissolves the foam in the gastrointestinal tract through purely physical means and is chemically and biologically inactive. No adverse effects have been observed to date with an overdose of Sab Simplex
.
If you forget to take Sab Simplex:
Continue taking it as described in the dosage instructions.
If you stop taking Sab Simplex:
In this case, the symptoms may recur.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
No side effects have been observed to date in connection with the use of Sab Simplex.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist.
You can also report side effects directly via the following reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.
Federal Institute for Drugs and Medical Devices
, Department of Pharmacovigilance,
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
5. HOW TO STORE SAB SIMPLEX?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after ###EXP###. The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What sab simplex contains
The active ingredient is: Simethicone (Dimethicone 350 - Silicon dioxide in a 92.5:7.5 ratio)
1 ml (approx. 25 drops) of oral suspension contains 69.19 mg simethicone (Dimethicone 350 - Silicon dioxide in a 92.5:7.5 ratio).
The other ingredients are:
Carbomer 974, citric acid monohydrate, hypromellose, anhydrous sodium citrate, sodium benzoate, sodium cyclamate, macrogol stearyl ether (Ph. Eur.), saccharin sodium, sorbic acid (Ph. Eur.), raspberry flavor 60373 H&R, vanilla flavor 200817, and purified water. Sab
Simplex
is a white to grayish-white liquid in a brown glass bottle with a screw cap. The 30 ml and 100 ml bottles have a dropper insert.
Sab Simplex is available in the following pack sizes:
Pack containing 1 dropper bottle with 30 ml oral suspension;
Multipack containing 4 dropper bottles, each containing 30 ml oral suspension;
Pack containing 1 dropper bottle with 100 ml oral suspension; Hospital
packs.
Marketing Authorisation Holder :
Pfizer Pharma GmbH,
Linkstr. 10,
10785 Berlin, Germany
Manufacturer:
Famar Orleans,
5, avenue de Concyr
, 45071 Orleans Cedex 2,
Spain. This leaflet was last revised in July 2026.
Source: Package insert information.
Version: 09/2026
Active ingredient: Simethicone.
Indications:
For the symptomatic treatment of gas-related gastrointestinal complaints, e.g., flatulence (meteorism), bloating; for preparation for examinations in the abdominal region, such as X-rays and sonography (ultrasound examination) and for preparation for gastroduodenoscopies (endoscopy of the stomach and intestines); in cases of increased gas formation after surgery; in cases of detergent poisoning.