Methyldopa 125mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Methyldopa (anhydrous)

Dostępny od:

The Boots Company Plc

Kod ATC:

C02AB01

INN (International Nazwa):

Methyldopa (anhydrous)

Dawkowanie:

125mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02050200

Ulotka dla pacjenta

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Methyldopa Tablets
125, 250, 500mg x 56’s (UK)
148x210 (Reel Fed)
50971964
Leaflet for Blisters
4751
T. Hull
05/07/19
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
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NON PRINTING COLOURS
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DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
FMD info
NA (not a carton)

No

Yes

Details
METHYLDOPA 125MG, 250MG & 500MG 56 TABLETS - UK
Black
Profile
BBBA5440
S.Anson
12.07.19
23.07.19
S.Anson
148 x 210
7.5pt
Accord Barnstaple
n/a
n/a
3
Version 2
01.11.2017
_Continued top of next column_
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TO TAKE YOUR MEDICINE.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
INDEX
1
WHAT METHYLDOPA TABLETS ARE
AND WHAT THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6
FURTHER INFORMATION
1
WHAT METHYLDOPA TABLETS ARE AND WHAT
THEY ARE USED FOR
Methyldopa belongs to a group of medicines called
antihypertensives, which lower blood pressure.
Methyldopa tablets are used to treat high blood
pressure (hypertension).
2
BEFORE YOU TAKE
DO NOT TAKE Methyldopa tablets and TELL your
doctor if you:
•
are ALLERGIC (hypersensitive) to methyldopa or any of
the other ingredients (see section 6)
•
have LIVER DISEASE
•
have HIGH BLOOD PRESSURE due to a TUMOUR NEAR THE
KIDNEY (phaeochromocytoma)
•
suffer from DEPRESSION
•
are ta

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
METHYLDOPA TABLETS BP 125mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Methyldopa PhEur equivalent to anhydrous
methyldopa
125mg.
Excipient with known effect: Each tablet contains 0.002mg of Sunset
yellow
(E110).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow film-coated tablets.
Yellow, circular, biconvex film-coated tablets, impressed “C” on
one face and
the identifying letters “MA” on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
Since methyldopa is largely excreted by the kidneys, patients with
impaired renal function may respond to comparatively low doses.
Withdrawal of methyldopa which is followed by return of hypertension,
usually within 48 hours, is not complicated generally by an overshoot
of
blood pressure.
Therapy with methyldopa may be initiated in most patients already on
treatment with other antihypertensive agents by terminating these
antihypertensive medications gradually if required (see manufacturers
recommendations on stopping these drugs). Following such previous
antihypertensive therapy, methyldopa should be limited to an initial
dose
of not more than 500mg daily and increased as required at intervals of
not less than two days.
A thiazide may be added at any time during methyldopa therapy and is
recommended if therapy has not been started with a thiazide or if
effective control of blood pressure cannot be maintained on 2g of
methyldopa daily.
Methyldopa may also be used concomitantly with the combination of
amiloride hydrochloride and hydrochlorothiazide or beta-blocking
agents, such as timolol maleate.
When methyldopa is given to patients on other antihypertensives the
dose of these agents may need to be adjusted to effect a smooth
transition.
_ADULTS AND CHILDREN OVER 12 YEARS: _Initially 250mg two or three
times a
day, for two days. Thereafter, usually increased