Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydralazine hydrochloride
A A H Pharmaceuticals Ltd
C02DB02
Hydralazine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050100; GTIN: 5025903001683
DIMENSIONS 52 x 101mm BARCODE 5055382300304 PHARMA CODE 0227 ALMUS CODE A0030a/6 SUPPLIER CODE LL0508AG SUPPLIER CODE 1701578 CLIENT: PROJECT: ITEM(S): Almus UK 12199 / UK Hydralazine Tablets 50mg x 56 Label Leaflet COLOURS USED: Checked by: Paul Adams Queries regarding this artwork, please contact: Steve Hobbs or Paul Adams Date: 11.3.2019 BLACK KEYLINE BRAILLE VARNISH FREE This scale measures 100mm when artwork is 100% 0 10 20 30 40 50 60 70 80 90 100 pmdc design Lower Test Studios Sheardley Lane, Droxford Hampshire SO32 3QY +44 ( 0 ) 1489 878780 www.pmdc.co.uk REVISED ARTWORK FOR MHRA APPROVAL VERSION: 6 (MYLAN) DRAFT ISSUE: 4 REASON FOR CHANGE: FMD Update SUPPLIER ISSUE DATE: 11.3.2019 HYDRAL- AZINE #50 MG TABLETS HYDRAL- AZINE #50 MG TABLETS Location is fixed here for Variable Data Coding (maximum five lines) along with 2D Data Matrix code. Prompt words ( (1) according to previously agreed translation), variable batch data and 2D Data Matrix code will be online printed in the following order (or matrix first then test)and layout: Standard font size is 2.0mm for online printed batch data. Keep this section as part of the artwork in keyline colour. Keep this flap blank and varnish free for online printing. Information box: *PC: 00000000000000 *SN: 00000000000000 Lot: 0000000000 EXP: MM/YYYY Variable Data Information box for online printing - United Kingdom * Will be printed only after serialisation go live Keep this section as part of the Artwork in Keyline colour. Variable Data area will be left blank for online printing. Version: 1422541 DIMENSIONS 52 x 101mm BARCODE 5055382300304 PHARMA CODE 0227 ALMUS CODE A0030a/6 SUPPLIER CODE LL0508AG SUPPLIER CODE 1701578 CLIENT: PROJECT: ITEM(S): Almus UK 12199 / UK Hydralazine Tablets 50mg x 56 Label Leaflet COLOURS USED: Checked by: Paul Adams Queries regarding this artwork, please contact: Steve Hobbs or Paul Adams Date: 11.3.2019 BLACK KEYLINE BRAILLE VARNISH FREE This scale measures 100mm when artwork is 100% 0 10 20 30 40 50 60 70 80 90 100 pmdc design Lower Tes Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydralazine 50 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg hydralazine hydrochloride. Excipient(s) with known effect: Each tablet contains 867 mg lactose and 21.9 mg Sunset yellow. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Pink film coated tablets marked “HE 50” on one side and “G” logo on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for: - Moderate to severe hypertension as an adjunct to other antihypertensive agents. Moderate to severe chronic congestive heart failure along with long acting nitrates in patients whose optimal doses of diuretics and cardiac glycosides have proved insufficient and ACE inhibitors are unsuitable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be adjusted to the individual requirements of the patient. Treatment should commence with low doses which, depending on the patient’s response, should be increased stepwise to achieve optimal therapeutic effect, whilst minimising unwanted effects. Due to the complementary mechanism of action, the combination of hydralazine with beta-blockers and diuretics may enable antihypertensive efficacy at lower dose levels and counteract accompanying hydralazine effects such as reflex tachycardia and oedema. _Adults _ HYPERTENSION: the initial dose is 25 mg twice daily. This may be increased gradually to a maximum dose of 200 mg daily. The patient’s acetylator status must be checked prior to increasing the daily dose beyond 100 mg. CHRONIC CONGESTIVE HEART FAILURE: Doses vary greatly between individual patients and are generally higher than those used to treat hypertension. Treatment should be initiated in hospital where the patient’s individual haemodynamic values can be determined with the help of invasive monitoring. Treatment should continue in hospital until the patient has been established on the required maintenance dose. Af Read the complete document