Methyldopa 250mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
17-10-2022
Summary of Product characteristics
(SPC)
17-10-2022
Active ingredient:
Methyldopa (anhydrous)
Available from:
Accord-UK Ltd
ATC code:
C02AB01
INN (International Name):
Methyldopa (anhydrous)
Dosage:
250mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050200; GTIN: 5012617009494
Patient Information leaflet
148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Methyldopa ,125, 250 & 500 mg,
56 Tablets - UK
148x210 (Reel Fed)
50991367
Leaflet for Blisters
2132
RH
21-05-20
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METHYLDOPA ALL STRENGTHS TABLETS JOINT PIL - UNITED KINGDOM
Black
Profile
BBBA8282
NM
28/05/2020
23/06/2020
NM
148x210
7.5pts
Accord Barnstaple
N/A
04
Version 7
12.02.2020
EU-Artwork-Support@accord-healthcare.com
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
METHYLDOPA 125MG, 250MG
AND 500MG TABLETS
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO
TAKE YOUR MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT METHYLDOPA TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE METHYLDOPA TABLETS
3
HOW TO TAKE METHYLDOPA TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE METHYLDOPA TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT METHYLDOPA TABLETS ARE AND WHAT THEY
ARE USED FOR
Methyldopa belongs to a group of medicines called
antihypertensives, which l
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
METHYLDOPA TABLETS BP 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Methyldopa PhEur equivalent to 250mg anhydrous
methyldopa.
Excipient with known effect: Each tablet contains 0.004mg 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 “MC” on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Use in adults and children over 12 years _
_Initial dosage:_ Usually 250mg two or three times a day, for two
days.
_Adjustment: _Usually adjusted at intervals of not less than two days,
until an
adequate response is obtained. The maximum recommended daily dosage is
3g.
Many patients experience sedation for two or three days when therapy
with
Methyldopa is started or when the dose is increased. When increasing
the
dosage, therefore, it may be desirable to increase the evening dose
first.
Withdrawal of Methyldopa is followed by return of hypertension,
usually
within 48 hours. This is not complicated generally by an overshoot of
blood
pressure.
_Patients with renal impairment_
Methyldopa is largely excreted by the kidney, and patients with
impaired renal
function may respond to smaller doses.
_Other antihypertensives _
Therapy with Methyldopa may be initiated in most patients already on
treatment with other antihypertensive agents by terminating these
antihypertensive medications gradually, as required. 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.
When Methyldopa is given to patients on other antihypertensives the
dose of
these agents may need to be adjusted to effect a smooth transition.
When 500mg of Methyldopa
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