IMOGAS 240 Milligram Capsules, Soft
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Selebaran informasi
(PIL)
19-05-2024
Karakteristik produk
(SPC)
19-05-2024
Bahan aktif:
DIMETICONE, ACTIVATED
Tersedia dari:
McNeil Healthcare (Ireland) Ltd
INN (Nama Internasional):
DIMETICONE, ACTIVATED
Dosis:
240 Milligram
Bentuk farmasi:
Capsules, Soft
Jenis Resep:
Product not subject to medical prescription
Status otorisasi:
Authorised
Tanggal Otorisasi:
0000-00-00
Karakteristik produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IMOGAS 240 mg, soft capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains
Simeticone 240.00 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule.
Egg-shaped transparent soft capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of abdominal distension (flatulence) in adults and adolescents (from the age of 15 years).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Reserved for use in adults (from the age of 15 years).
Take one capsule at the end of each main meal with a glass of water.
Do not exceed 3 soft capsules per day.
The duration of treatment is restricted to 10 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to simeticone or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If the symptoms persist or worsen, or in the event of prolonged constipation, the patient should seek medical advice.
Simeticone is not recommended for the treatment of infant colic because of limited information on its safety in infants
and children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Interaction studies have not been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
For simeticone no clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to
toxicity to reproduction (see section 5.3).
No effect during pregnancy is anticipated since systemic exposure to simeticone is negligible. Imogas can be used
during pregnancy.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/09/2014_
_CRN 2137348_
_page number: 1_
No effect on the breastfed n
Baca dokumen lengkapnya
