Espumizan 40 mg / 5 ml 100 ml emulsion orally

The instruction
for medical use

of Эспумизан® 40 medicine for children

the Trade name
Эспумизан® 40 for children

the International unlicensed


name Simetikon Lekarstvennaya a form
the Emulsion of 40 mg / 5 ml

Structure




In 100 ml of an emulsion contains
active substance - simetikon 0.8 g


excipients: methylparahydroxybenzoate, a fragrance concentrate with a smell of banana, saccharin sodium salt, sodium cyclomate, polysorbate 80, sodium of a karmelloz, silicon dioxide high-disperse, acid of chlorohydrogen 1 M **, the water purified.
** for establishment rn

the Description
Colourless or almost colourless muddy emulsion with almost uniformly distributed suspended component

Pharmacotherapeutic group
Drugs for treatment of functional disorders of intestines.
The code of automatic telephone exchange

the Pharmacological

Pharmacokinetics In properties the physiological and chemical relations simetikon is inert A03AX13. It is not soaked up and after passing through digestive tract is removed in not changed look again.
The bioavailability
As simetikon is not soaked up, and its action is developed only in a gleam, its bioavailability corresponds to pharmacological availability in the scene of action, that is speed and extent of its release from a dosage form.
A pharmacodynamics
the Mechanism of action
of the Accumulation of gases in digestive tract almost always have the form of the inert foam consisting of small bubbles therefore absorption of gas in the form of inert foam is difficult. In Эспумизане® 40 as active ingredient contains simetikon which represents the stable dimethyl silicone having surface-active properties. It changes surface intention of the vials of gas which are in a bolus and in slime of a digestive tract therefore they break up. The gases which are released at the same time can then be soaked up by a gut wall and also be removed under the influence of an intestines vermicular movement. Active ingredient is not soaked up, and removed in not changed look.
In therapy Эспумизан® 40 it is applied to symptomatic treatment of not physiological accumulation of gases irrespective of their origin.
Reception Эспумизана® 40 before conducting diagnostic tests (ultrasonic and X-ray inspections) of an abdominal cavity and also as additive to suspensions of contrast means helps to reduce the gas generation causing emergence of radiological shadows.
The pharmacodynamics
After oral administration simetikon in digestive tract is characterized by chemical inertness and works purely by the physical principle. It does not interact neither with microorganisms, nor with enzymes. Because of the size of the molecule it is not soaked up.

Indications
- excessive formation and an accumulation of gases in digestive tract (meteorism, intestines swelling, an aerophagia, dyspepsia, infantile or so-called three-months colic)
- the increased gas generation after operations
- preparation for diagnostic tests of an abdominal cavity with obtaining the image and also as additive to suspensions of contrast agents for obtaining the image by means of double contrast study
- as defoaming agent in intoxications tensides (surfactants)
the Route of administration and doses
For dosing is applied to packing a measured spoon. The full measured spoon contains 5 ml Эспумизана® 40 (there correspond 40 mg of a simetikon).
Before the use to shake up!
At a meteorism and feeling of overflow:
Teenagers and adults:
on 2 measured spoons Эспумизана® 40 from 3 to 5 times a day.
Children from 6 to 14 years:
on 1-2 measured spoons Эспумизана® 40 from 3 to 5 times a day.
Children from 1 year to 6 years:
on 1 measured spoon Эспумизана® 40 from 3 to 5 times a day.
Babies:
on 1 measured spoon Эспумизана® 40 during each feeding from a small bottle either to or after each chest feeding.
Эспумизан® 40 accept in time or after a meal, if necessary also before going to bed.
Use duration in the therapeutic purposes depends on development of symptomatology.
If necessary Эспумизан® 40 it is possible to accept also during longer span.
For preparation for researches with obtaining the image:
One day before carrying out a research accept 3 times a day on 2 measured spoons Эспумизана® 40 and 2 measured spoons – in the morning in day of carrying out a research.
As additive to suspensions of contrast agents:
For obtaining the image by means of double contrast study –
4 - 8 measured spoons Эспумизана® 40 on 1 liter of contrast mix.
As antidote in intoxications tensides (in poisonings with detergents):
Depending on weight of poisoning:
adults — 10–20 measured spoons Эспумизана® 40,
children — 2–10 measured spoons Эспумизана® 40.
Note:
At emergence of an abdominal pain and/or if they do not stop, it is necessary to perform medical examination.
Эспумизан® 40 does not contain sugar and therefore approaches sick diabetes and to patients with disturbance of food.

Side effects
the Undesirable phenomena connected with use Эспумизана® 40 still were not observed.

Contraindications
- hypersensitivity to active ingredient, methylparahydroxybenzoate (paragroup allergy) or to any other excipients.

Medicinal interactions
Cases of interaction Эспумизана® 40 with other medicines are still not known.

Special instructions
there is
no Pregnancy and the period of a lactation
of Restriction on reception Эспумизана® 40 at pregnancy and in the period of a lactation are absent.

The feature of influence on ability to driving and service
of Эспумизан® 40 cars does not influence reaction. The ability to driving of transport and also to service of cars is not limited.

Overdose
intoxication Cases after use of a simetikon are still not known. In the chemical and biological relation simetikon is completely inert. Also in large numbers simetikon it is transferred without problems.

A form of release and packing
On 100 ml of drug in bottles from brown glass with sealing laying and the screwing-up cap.
On a bottle together with the instruction for medical use in the state and Russian languages put in a pack cardboard

Storage conditions
to Store at a temperature not above 25 °C.
To store out of children's reach!


3 years
not to use a period of storage after expiry date!

Prescription status
Without prescription


AG BERLIN-HEMI Producer
(MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany

the Owner of the registration certificate

BERLIN-HEMI AG (MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers concerning quality of products (goods): Representative office of JSC Berlin-Hemi AG in RKNomer of phone number: +7 727 2446183, 2446184, 2446185 Fax number: +7 727 2446180 E-mail address: Kazakhstan@berlin-chemie.com