EX-LAX SENNA PILLS 12mg Milligram Coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CASSIA SENNA
Available from:
Novartis Consumer Health UK Limited
INN (International Name):
CASSIA SENNA
Dosage:
12mg Milligram
Pharmaceutical form:
Coated Tablets
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization date:
0000-00-00
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0030/055/001
Case No: 2067774
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS CONSUMER HEALTH UK LTD
WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EX-LAX SENNA PILLS 12MG SUGAR COATED TABLETS
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 22/06/2009 until 21/04/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/06/2009_
_CRN 2067774_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ex-Lax Senna Pills 12mg Sugar Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg standardised senna dry extract equivalent to 12mg sennosides calculated as sennosides A &
B.
For excipients see section 6.1
3 PHARMACEUTICAL FORM
Sugar coated tablets.
Circular, biconvex, brownish red sugar coated tablets with approximately 6mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of occasional constipation
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The following doses are normally taken at bedtime
Adults and children over 12: 1 tablet
A
Read the complete document
