Methyldopa 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methyldopa (anhydrous)

Available from:

A A H Pharmaceuticals 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: 5025903004431

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
300519/1
Ennogen
Methyldopa Leaflet
UK
English
160 x 360 mm
9 pt
1 of 1
17
21-01-20
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
METHYLDOPA 125MG, 250MG AND 500MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
!
Liver problems
DO NOT TAKE METHYLDOPA TABLETS IF:
!
You have pheochromocytoma or paraganglioma (a rare
tumour of the adrenal gland which causes high blood
pressure)
!
You are allergic to methyldopa or any of the other
ingredients of this medicine (listed in section 6)
!
You have ever had liver disease
!
You are taking monoamine oxidase inhibitors (MAOI) – a
type of antidepressant
!
You have porphyria (a rare inherited blood disorder).
OTHER MEDICINES AND METHYLDOPA TABLETS
!
Other medicines for high blood pressure
(antihypertensives)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking
Methyldopa Tablets if you have:
!
Fever
!
Dialysis
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METHYLDOPA TABLETS
!
Any abnormal movements (involuntary).
!
You suffer from depression
!
A blood disorder called haemolytic anaemia
!
An operation
!
A blood transfusion.
Your doctor may do blood tests to check how your liver is
working during the first 6-12 weeks. He or she may use similar
tests if you have a fever at any time while you are taking this
medicine.
Check with your doctor while taking this medicine if you are
going to have:
Tell your doctor you are taking this medicine if you have a
laboratory test where a urine or blood sample is taken. This is
because methyldopa may affect the results of some types of
tests.
Rarely, in patients taking this medicine urine may darken
when it is exposed to air after voiding.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Methyldopa Tablets.
TESTS YOU MAY HAVE WHILE TAKING METHY

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 283.00mg of methyldopa equivalent to 250mg
anhydrous methyldopa
Excipient with known effect: Each tablet contains sunset yellow (E110)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow biconvex film coated tablets with an approximate diameter of
10.5mm either plain or coded MYD 250 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clinical indications:
Methyldopa is indicated for hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
General considerations
_Patients with renal impairment _
Methyldopa is largely excreted by the kidney, and the patients with
impaired renal
function may respond to smaller doses.
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 on treatment with other hypertensive agents _
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 500 mg daily and
increased as
required at intervals of not less than two days.
When methyldopa is given to patients on other antihypertensive the
dose of these
agents may need to be adjusted to effect a smooth transition.
_Addition of a thiazide _
When 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide,
the two
agents may be given together once daily.
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.
_Adults_
_ _
_Initial dosage:_ Usually 250mg two or three times a day, for two
days, increased at
i