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SAB SIMPLEX 69.19MG/1ML 30ML
Package leaflet: information for the user
Sab Simplex, 69.19 mg/mL oral drops, suspension
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sab Simplex is and what it is used for 2. What you need to know before you use Sab Simplex 3. How to use 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 Indications
Symptomatic treatment of flatulence. An additional aid for preparing for the diagnostic examination of the gastrointestinal tract. An aid to reduce foam in the gastrointestinal tract after the accidental ingestion of washing preparations.
2. What you need to know before you use Sab Simplex Do not take Sab Simplex
- if you are allergic to the active substance (simethicone) or any of the other ingredients of this medicine (listed in section 6).
Other medicines and Sab Simplex
Interaction with other medicines has not been observed. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Sab Simplex may be used during pregnancy and breast-feeding.
Driving and using machines
Sab Simplex has no influence on the ability to drive and use machines.
3. How to use Sab Simplex
Unless prescribed otherwise, use the following doses: Infants: Add 15 drops (0.6 mL) to all bottled food. Sab Simplex mixes well with different liquids, including milk. The suspension may be given to breast-fed infants with a small spoon prior to breastfeeding. Young children: 15 drops (0.6 mL) during or after a meal. If necessary, 15 drops may be given before bedtime as well. The following doses are used in schoolchildren and adults to treat gases and satiety. Schoolchildren: 20-30 drops (0.8-1.2 mL). Adults: 30-45 drops (1.2-1.8 mL). Take a dose every 4-6 hours and increase the dose, if necessary. It is recommended to take Sab Simplex after a meal and before bedtime. Shake the bottle well before use! For dripping, turn the bottle bottom side up and tap lightly against the bottom with a finger. Radiological examinations: on the evening before the examination, take 15-30 mL (3-6 teaspoons) of the suspension. Sonography: 15 mL (3 teaspoons) on the evening before the examination and 15 mL (3 teaspoons) 3 hours before the examination. Endoscopy: take 2.5-5 mL (^-1 teaspoons) before the examination. In the future, gas pools may be removed through an instrument channel with a few millilitres of the Sab Simplex suspension. After an accidental ingestion of washing preparations: the dose depends on the quantity of ingested washing preparation. As a minimum dose: 5 mL (1 teaspoon) of suspension. Duration of treatment depends on complaints. It may be used for long-term treatment.
Gas pools exist in the gastrointestinal tract as a tiny-bubbled inactive foam. The absorption of gases through the mucous membrane is obstructed. Simethicone, the active substance of Sab Simplex, breaks down the tiny-bubbled foam and gases are eliminated naturally or absorbed through the intestinal mucosa. The active substance itself is not absorbed but is eliminated in an unchanged form. Gas pools form in the gastrointestinal tract for several reasons, such as unhealthy diet, indigestion, aerophagia (“swallowing of air”). In infants and young children, flatulence is often caused by drinking too quickly. Adding Sab Simplex to bottled food in the specified quantity helps prevent unpleasant complaints. Simethicone removes gas pools by physical means, does not react chemically, and is pharmacologically and physiologically inert (inactive). Simethicone does not affect gastric acidity, act on digestive and absorption processes, or provoke topical irritation. The chemically and physiologically intert active substance is not absorbed after oral administration but is eliminated in an unchanged form. It may be used in patients with diabetes, as it does not contain carbohydrates. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
No side effects have been reported. If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly viawww.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Sab Simplex
Keep this medicine out of the sight and reach of children. Do not store at a temperature higher than 30 °C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sab Simplex contains
- The active substance is simeothicone. - The other ingredients are sodium citrate, citric acid monohydrate, sodium cyclamate, saccharin sodium, carbomer, hypromellose, raspberry flavouring, vanilla flavouring, polyethylene glycol monostearyl ethers and distilled water. Preservatives are sodium benzoate and sorbic acid.
What Sab Simplex looks like and contents of the pack
1 mL of suspension (approx. 25 drops) contains 69.19 mg of simethicone (dimethicone 350 - silicon dioxide 92.5:7.5). The suspension is white to greyish white or yellowish, slightly viscous, with vanilla and raspberry flavouring. An amber bottle with a dropper, sealed with a white polypropylene screw cap. The bottle contains 30 mL of suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Brüssel Belgium
Famar Orleans 5 avenue de Concyr 45071 Orleans Cedex 2 France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Pfizer Luxembourg SARL Estonian branch Phone: +372 666 7500
This leaflet was last revised in May 2018.
For more up-to-date information, scan the QR code on the package with your smartphone. The same information is also available at www.ravimiamet.ee, the Medicines Registry.