Aero-OM, dimethicone

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIMETICONE

Available from:

OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal

ATC code:

A02AF02

INN (International Name):

DIMETICONE 100 mg/ml

Pharmaceutical form:

ORAL DROPS, SOLUTION

Composition:

DIMETICONE 100 mg/ml

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-11-21

Patient Information leaflet

PROVA Nº 2
ORDEM DE FABRICO:
05-112597
ESPECIFICAÇÃO N.º:
1244L-3
FIBRA:
148
OPERADOR:
RM
DATA: 12/05/10
DIMENSÕES:
105 X 148
GRAMAGEM:
60G/M
2
CLIENTE:   OM PHARMA S.A.
CÓD.  2055405056
DESIGNAÇÃO:  
LIT  AERO OM INGLÊS
CÓD. LECTUS  319
CORES:
PRETO
Dimeticone
Tablets / oral drops (emulsion)
COMPOSITION:
Tablets:
Each tablet contains 40 mg of activated dimethylpolysiloxane.
Oral Drops (emulsion):
100 ml drops contains 10 g of activated dimethylpolysiloxane.
PRESENTATION:
Tablets: Packs of 20, 60 and 100 units.
Oral drops (emulsion): Bottle of 25 ml.
PHARMACOTHERAPEUTIC CATEGORY:
Group VII - 6 - d, antiflatulent.
MARKETING AUTHORIZATION HOLDER/MANUFACTURER:
OM PHARMA, S.A.
R. da Indústria, 2 – Quinta Grande
2610-088 – Amadora – Lisboa – Portugal
INDICATIONS:
Aerophagy and meteorism with ali their manifestations: abdominal
distension,
subcostal, epigastric and hypochondriac pain. Dyspnea an palpitation
(espe-
cially in cardiac and asthmatic patients) due to the raising of the
diaphragm. In
abdominal kidney and bone radiology.
In paediatrics: difficulty in burping and food regurgitation when
burping, in
infants, abdominal distension in children, flatulent colic.
CONTRA-INDICATIONS AND ADVERSE EFFECTS:
No known contra-indications or adverse effects.
INTERACTIONS:
No known interactions.
SPECIAL PRECAUTIONS:
Tablets should be chewed and not swailowed whole.
Diabetic patients or patients with low sugar diet have to be informed
that AERO-OM
contains saccharose (435 mg per tablet or 18 mg per drop).
EFFECTS ON PREGNANT WOMEN, INFANTS, CHILDREN, OLDER PEOPLE AND
PATIENTS
WITH SPECIAL ILLNESS:
No known contra-indications.
EFFECTS ON DRIVING ABILITY AND MACHINE OPERATIONS:
Non existent.
EXCIPIENTS:
Tablets: saccharose, povidone, colloidal anhydrous silica, magnesium
stearate, vanillin.
Oral drops (emulsion): saccharose, amaranth (E123), strawberry oil,
potassium
sorbate, purified water.
POSOLOGY:
a) Tablets:
Adult: two tablets or more after each meal.
b) Drops:
Infants: 10 drops, 3 or 4 times a

Summary of Product characteristics

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.

NAME OF THE MEDICINAL PRODUCT 
Aero-OM

, dimethicone 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Aero-OM - tablets : each tablet contains 40 mg of dimeticone 
Aero-OM - Oral emulsion : each millilitre contains 100 mg of dimeticone 

3.

PHARMACEUTICAL FORM 
Tablet and Oral emulsion 

4.

CLINICAL PARTICULARS 

4.1

THERAPEUTIC INDICATIONS 
Aerophagia and meteorism with all manifestations forms, namely distension and 
abdominal pain. Preparation for abdominal, renal and bone radiology. 
In  pediatrics :  Symptoms  cause  by  the  swallowing  of  gas  and  Adjuvant  in  the 
management of recurrent abdominal pain or infant colic. 

4.2.

POSOLOGY AND METHOD OF ADMINISTRATION 
ADULTS : 2 tablets 4 times daily after meals_ _
CHILDREN UNDER 12 MONTHS : 5 to 10 drops 3 or 4 daily 
CHILDREN WITH 12 MONTHS AND OLDER : 10 drops or one tablet 3 or 4 times daily 
The tablets must be chewed and not swallowed entire. 

4.3.

CONTRAINDICATIONS 
Contra-indications are unknown for dimethicone. 

4.4.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
The tablets have to be chewed and not swallowed entire. 

4.5.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
Unknown. 

4.6

PREGNANCY AND LACTATION 
Contra-indications  are  unknown  in  Aero-OM  administration  during  pregnancy 
and lactation. 

4.7.

EFFECTS ON ABILITY TO DRIVE  AND USE MACHINES 
Unknown. 

4.8.

UNDESIREABLE EFFECTS 
Unkown. 

Page 2 of 3 
4.9.

OVERDOSE 
Cases of overdose are unknown. 

5.

PHARMACOLOGICAL PROPERTIES 

5.1.

PHARMACODYNAMIC PROPERTIES 
Aero-OM belongs to pharmacotherapeutic group VII-6.d : antiflatulents. 
Whatever  their  origin,