Methyldopa 125mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Methyldopa (anhydrous)

Tillgänglig från:

DE Pharmaceuticals

ATC-kod:

C02AB01

INN (International namn):

Methyldopa (anhydrous)

Dos:

125mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02050200

Bipacksedel

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
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ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
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FMD info
NA (not a carton)

No

Yes
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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

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa 125 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 125 mg of methyldopa (anhydrous).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Yellow, round, film coated tablets, embossed with “MT/125”
separated by a
breakline.
The breakline is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Use in Adults _
_Initial dosage: _Usually 250 mg 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
3
g.
Many patients experience sedation for two or three days when therapy
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: _
Methyldopa therapy may be initiated in most patients already on
treatment
with other antihypertensive agents by terminating these other
antihypertensive
medications gradually if required. Following such previous
antihypertensive
therapy, methyldopa should be limited to an initial dose of not more
than 500
mg 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 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide,
the
two agents may be given together once daily.
_Paediatric population:_
Initial dosage is based on 10