SAB

SAB simplex oral suspension

Important notes (mandatory information)

sab simplex. Active ingredient: Simethicone. Areas of application: for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness; for the preparation of examinations in the abdominal area, such as X-rays and sonography (ultrasound examination) and for the preparation of gastroduodenoscopies (gastrointestinal endoscopies); for increased gas formation after operations; for dishwashing detergent poisoning.

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


Patient information: Information for users
sab simplex
69.19mg/ml
Oral suspension
Simethicone

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.
- 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 even worse after one day, contact your doctor.

What is in this package leaflet
1. WHAT IS SAB SIMPLEX AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SAB SIMPLEX?
3. HOW TO TAKE SAB SIMPLEX?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SAB SIMPLEX?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SAB SIMPLEX AND WHAT IS IT USED FOR?

sab simplex, oral suspension, is a medicine for the treatment of functional disorders of the gastrointestinal tract. Simethicone, the active ingredient of sab simplex, is a surfactant (defoamer) that is able to dissolve excessive air/gas accumulations in the gastrointestinal tract.

sab simplex is used
- for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness.
- for the preparation of examinations in the abdominal area, such as X-rays and sonography (ultrasound examination) and for the preparation of gastroduodenoscopies (gastrointestinal endoscopies).
- for increased gas formation after operations.
- for dishwashing detergent poisoning.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SAB SIMPLEX?

sab simplex 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
If you experience 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.

Taking sab simplex together with other medicines
Interactions with other medicines are not known.

Pregnancy and breast-feeding
There are no concerns about taking sab simplex during pregnancy and breast-feeding.

Driving and using machines
sab simplex has no influence on the ability to drive and use machines.

sab simplex contains sodium
For the preparation of examinations in the abdominal area and, if necessary, for dishwashing detergent poisoning, it is necessary to take several teaspoons of sab simplex. 1 teaspoon (5ml) contains 0.6mmol sodium (13.8mg sodium). If you are on a low-salt diet, you should take this into account.

3. HOW TO TAKE SAB SIMPLEX?

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.

Unless otherwise prescribed by your doctor, the usual dose is

For gas-related gastrointestinal complaints, e.g. flatulence, feeling of fullness

Infants and bottle-fed children

15 drops (0.6ml) of sab simplex are added to each bottle. sab simplex mixes easily with other liquids, e.g. with milk.
For infants who are breastfed, sab simplex can also be given with a small spoon before each breastfeeding.

Toddlers

Toddlers take 15 drops (0.6ml) of sab simplex with or after meals. If necessary, 15 drops of sab simplex can also be taken before bedtime.

The following dosage recommendations apply to school children and adults for the treatment of flatulence and feeling of fullness

School children: 20 to 30 drops (0.8 to 1.2ml)
Adults: 30 to 45 drops (1.2 to 1.8ml)
This dose should be taken every 4 to 6 hours and can be increased if necessary.

sab simplex is taken with or after meals, if necessary also before bedtime.

Shake the bottle well before use! To drop, hold the bottle vertically downwards and tap the bottom of the bottle lightly with your finger. The speed of the drops can be reduced by tilting the bottle.

Administration for the following areas of application 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, 3 to 6 teaspoons (15 to 30ml) of sab simplex should be taken on the evening before the examination.

Sonographies (ultrasound examinations)
To prepare for the sonography, it is recommended to take 3 teaspoons (15ml) of sab simplex on the evening before and 3 teaspoons (15ml) about 3 hours before the start of the sonography.

Endoscopies (gastrointestinal endoscopies)
1/2 to 1 teaspoon (2.5 to 5ml) of sab simplex should be taken before endoscopies. Any further medication to eliminate disturbing bubbles can be administered through the instrument channel of the endoscope with a few milliliters of sab simplex.

Dishwashing detergent poisoning
In case of dishwashing detergent poisoning, the dosage depends on the severity of the poisoning. A minimum dose of 1 teaspoon (5ml) of sab simplex is recommended.

Duration of use
sab simplex can also be taken over a longer period of time, if necessary and in consultation with your doctor or pharmacist.

If you have taken more sab simplex than you should
The active ingredient of sab simplex, simethicone, dissolves the foam in the gastrointestinal tract purely physically and is chemically and biologically completely ineffective. No adverse effects have been observed to date in the event of an overdose of sab simplex.
.
If you forget to take sab simplex
Continue taking 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. WHAT SIDE EFFECTS ARE POSSIBLE?

No side effects have been observed in connection with the use of sab simplex to date.

Reporting of side effects
If you notice any side effects, contact 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 about the safety of this medicine.
Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: http://www.bfarm.de

5. HOW TO STORE SAB SIMPLEX?

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 on the label after "Use by". The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What sab simplex contains
The active ingredient is: Simethicone (dimethicone 350 - silicon dioxide in a ratio of 92.5:7.5)
1ml (approx. 25 drops) of oral suspension contains 69.19mg of simethicone (dimethicone 350 - silicon dioxide in a ratio of 92.5:7.5).

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, purified water.

What sab simplex looks like and contents of the pack
sab simplex is a white to gray-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 of 1 dropper bottle with 30ml oral suspension
Multipack of 4 dropper bottles with 30ml oral suspension each
Pack of 1 dropper bottle with 100ml oral suspension
Hospital packs

Pharmaceutical entrepreneur
PFIZER PHARMA GmbH
Linkstr. 10
10785 Berlin
Tel.: 030550055-51000
Fax: 030550054-10000

Manufacturer
Famar Orleans
5, avenue de Concyr
45071 Orleans Cedex 2

This leaflet was last revised in July 2013.

Source: Information from the package leaflet
Status: 09/2015
Active ingredient: Simethicone. Areas of application: for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness; for the preparation of examinations in the abdominal area, such as X-rays and sonography (ultrasound examination) and for the preparation of gastroduodenoscopies (gastrointestinal endoscopies); for increased gas formation after operations; for dishwashing detergent poisoning.