TRILOBAL 40 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

GINKGO BILOBA

제공처:

Intersan GmbH

INN (국제 이름):

GINKGO BILOBA

복용량:

40 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

승인 상태:

Withdrawn

승인 날짜:

2012-03-01

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trilobal Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Trilobal tablet contains 40mg of ginkgo biloba extract (standardised to 24% (9.6mg) ginkgo-heterosides and 6%
(2.4mg) ginkgolide and bilobalide).
Each tablet also contains 82.5mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Round, brick red coloured biconvex film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The symptomatic treatment of peripheral arterial occlusive disease (POAD) of the lower limbs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One Trilobal 40mg tablet three times daily with meals.
After three months of treatment, the justification for continuing use should be reviewed.
USE IN CHILDREN:
Trilobal should not be used in children under 12 years of age.
4.3 CONTRAINDICATIONS
Hepatic insufficiency or inflammation of the gastrointestinal tract.
Hypersensitivity to Ginkgo biloba extracts.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product should be used with caution in patients with hepatic or gastrointestinal dysfunction. Steatorrhoea may
affect absorption.
This product is not an antihypertensive and cannot replace medication prescribed for the treatment of arterial
hypertension.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose – galactose
malabsorption should not take this medication.
IRISH MEDICINES BOARD
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_Date Printed 14/11/2011_
_CRN 2070740_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Concurrent administration of antibiotics may alter the absorption and