Methyldopa 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methyldopa (anhydrous)

Available from:

Kent Pharma (UK) Ltd

ATC code:

C02AB01

INN (International Name):

Methyldopa (anhydrous)

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050200

Patient Information leaflet

PATIENT INFORMATION LEAFLET
METHYLDOPA TABLETS BP 250MG & METHYLDOPA TABLETS BP 500MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist
(chemist).

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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. This includes any possible side
effects not listed in this
leaflet. See section 4.
In the entire leaflet Methyldopa Tablets BP 250mg & Methyldopa Tablets
BP 250mg will be referred as
Methyldopa tablets.
WHAT IS IN THIS LEAFLET
1.
What your Methyldopa tablets are and what it is 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 YOUR
METHYLDOPA TABLETS ARE
AND WHAT IT IS USED FOR
The active substance is called methyldopa. This belongs to a group of
medicines called
‘antihypertensives’.
Methyldopa is changed inside your body to a natural substance that
lowers blood pressure. Your doctor
has prescribed Methyldopa to treat high blood pressure (hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METHYLDOPA TABLETS
DO NOT TAKE METHYLDOPA TABLETSIF YOU HAVE:

ever had liver disease

ever had a bad reaction, such as an allergy to Methyldopa or any of
the ingredients in the tablets
(listed in section 6)

ever had depression

been taking a type of medicine called a monoamine oxidase inhibitors
(MAOIs)

high blood pressure due to a tumour near your kidney called
phaeochromocytoma or
paraganglioma

porphyria (a rare, inherited blood disorder)
Do not take Methyldopa tablets if any of the above applies to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa Tablets 500mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains methyldopa BP 500mg.
Excipient with known effect
FD&C Yellow 5 [Tartrazine (E 102)]
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Yellow coloured , capsule shaped , biconvex, film coated tablets ,
plain on
both sides
with an approximate dimensions of 19.10mm X 8.60mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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
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 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_
Ini