ANTIFLAT 41.2MG/1ML GTT 50ML

ATC code: A03AX13 

Active substances: Simethicone

Vendor, principal: Lannacher. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ANTIFLAT 41.2MG/1ML 50ML

Package leaflet: Information for the user

Antiflat 41.2 mg/mL oral suspension

Simeticone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take 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.
- You must talk to a doctor if you do not feel better or if you feel worse after a couple of days.

What is in this leaflet

1. What Antiflat is and what it is used for
2. What you need to know before you take Antiflat
3. How to take Antiflat
4. Possible side effects
5. How to store Antiflat
6. Contents of the pack and other information

1. What Antiflat is and what it is used for

Dyspepsia, wrong diet, food generating gases and air swallowing cause the generation and accumulation of gas. Excess gas accumulates in the digestive tract as small inactive gas bubbles. Therefore gas absorption through intestinal mucosa is impaired or even completely inhibited. Simeticone is the active substance contained in the Antiflat oral suspension that causes the gas bubbles to dissolve and then the released gas can be passed in the usual way.
After administration of Antiflat oral suspension the symptoms are usually rapidly reduced and the pressure in gastrointestinal tract reduces.
Antiflat oral suspension is used:
- in case of excessive gas generation and accumulation in gestrointestinal tract (bloating), including functional disorders like flatulence and feeling of fulness;
- as a preparatory measure during gastrointestinal diagnostic investigation, for improvement of visibility during ultrasound and x-ray investigation to remove the gas bubbles limiting the field of view.
- as an ancillary preparation to reduce foam in the gastrointestinal tract after accidental ingestion of washing agents.

2. What you need to know before you take Antiflat Do not take Antiflat:

- if you are allergic to simeticone or any of other ingredients of this medicine (listed in section 6).

Warnings and precautions

- If symptoms do not improve or expected results are not achieved after taking Antiflat oral suspension, talk to your doctor for further advice.

Other medicines and Antiflat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Although no interactions have been observed with simeticone, its possible effect on the absorption of other active substances cannot be excluded due to the surface-active effect of simeticone.

Antiflat with food and drink

Antiflat oral suspension may be taken during or after meal. It may be added to hot or cold drink (like tea, water, milk), also into drinking bottle.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As simeticone is not absorbed in the gastrointestinal tract, Antiflat oral suspension may be administered during pregnancy and breast-feeding.
Administration should not exceed three days and should be followed by a 14-day dose-free period.

Driving and using machines

No effect has been observed.

3. How to take Antiflat

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Antiflat oral suspension is suitable for infants, elderly people and patients with dentures.
Antiflat oral suspension is suitable for diabetics.
The recommended dose for excess gas formation:
- infants and toddlers: 1 mL (2 presses or 16 drops) will be added into feeding bottle/food during each meal;
- children: 1 mL (2 presses or 16 drops) with a sip of water during or after meal; additional 1 ml (2 presses or 16 drops) may be taken at bedtime if required;
- adults: 1-2 mL (2-4 presses or 16-32 drops) with a sip of water during or after meal; additional 2 presses may be taken at bedtime if required.
When using as preparatory means for gastrointestinal diagnostic investigation in adults, 2-3 mL (4-6 presses or 32-48 drops) are taken after every meal on the day before and in the morning of the investigation day.
When using as an antidote for poisoning caused by washing agents the dose should be adjusted corresponding to the severity of poisoning. Minimal recommended dose is 5 mL (10 presses or 80 drops) of Antiflat oral suspension.
Treatment duration
Treatment duration depends on the course and character of symptoms. Antiflat oral suspension may be administered continuously if required.
If the symptoms do not improve or the expected result is not achieved after taking Antiflat, contact your doctor for further instructions.
Method of administration
Antiflat oral suspension may be taken during or after meal. It may be added to hot or cold drink (like tea, water, milk), also into drinking (feeding) bottle.
Antiflat oral suspension should be shaken before administration.

Instructions for handling the measuring pump:

1. Remove the screw cap.
2. Screw the measuring pump on the bottle neck.
3. Shake.
4. Set the pump into position I (see cap) and press until liquid emerges. Do not use the liquid that emerged with the first two presses.
5. Hold the bottle in upright position during pumping.
Corresponding amount of suspension has been added to the bottle to compensate the liquid losses accompanying the activation of the measuring pump and the remnants remaining in the bottle.
To close the measuring pump, turn it to the right, into position O (see cap).
Instructions for handling the syringe:
1. Shake the bottle.
2. Remove the threaded cap.
3. Press the syringe plunger completely into the syringe and insert the upper end of the syringe into the bottle neck.
4. Hold the bottle with the syringe vertically down and pull the plunger until the marking of required amount of ml. Repeat if required.
5. Remove the plunger completely after each use and clean all syringe parts thoroughly under flowing water. After drying assemble the parts.
Instructions for handling the dropper:
1. Shake the bottle.
2. Remove the screw cap.
3. Hold the bottle with the dropper vertically down for pulling the suspension.

If you take more Antiflat than you should

If you have or a child has taken more Antiflat oral suspension than you or he/she should, tell your doctor or pharmacist.

If you forget to take Antiflat

Do not take a double dose to make up for a forgotten dose.

If you stop taking Antiflat

Tell your doctor or pharmacist if you want to stop taking Antiflat oral suspension.
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 observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Antiflat

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Antiflat oral suspension may be used during up to 6 months after the first opening.
Do not use this medicine after the expiry date that is stated on the bottle and 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 Antiflat contains

- The active substance is simeticone. One mL (2 presses or 16 drops) of suspension contains 41.2 mg of simeticone.
- The other excipients are sorbinic acid, potassium sorbate, sodium cyclamate, sodium saccharin, macrogol 6000, aluminium magnesium silicate type IIA, hydoxyethyl cellulose, polyoxyethylene-25-glyceryl trioleate, banana flavouring (flavouring components: maltodextrin, kummiaraabik, propylene glycol, maltol, ethyl maltol), citric acid anhydrous (E330), purified water.

What Antiflat looks like and contents of the pack

Antiflat oral suspension is milky, opaque, 50 mL and 100 mL in brown glass bottle with measuring device, either measuring pump or dropper or measuring spoon or syringe and oral administration adapter.
Measuring spoon for measuring 1-4 mL.
Syringe for measuring 0-3 mL.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Covalent OÜ Pämu mnt 102c,
Tallinn 11312,
Tel: +3726600945 Fax: +3726600946

This leaflet was last revised in June 2015.