Methyldopa 125mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Methyldopa (anhydrous)

Disponibil de la:

Sovereign Medical Ltd

Codul ATC:

C02AB01

INN (nume internaţional):

Methyldopa (anhydrous)

Dozare:

125mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02050200; GTIN: 05021730031558

Prospect

_ _
450mm
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 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
The name of your medicine is Methyldopa
125 mg, 250 mg or 500 mg Tablets (referred to
as Methyldopa Tablets throughout this leaflet).
Methyldopa Tablets contain the active
ingredient methyldopa, which belongs to a
group of medicines called antihypertensives,
which lower blood pressure.
Methyldopa Tablets are used for the treatment
of hypertension (high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE METHYLDOPA TABLETS
DO NOT TAKE THIS MEDICINE
•
if you are allergic to methyldopa or any of
the other ingredients of this medicine
(listed in section 6)
•
if you have ever had liver disease
•
if you have ever had depression
•
if you have been taking a type of medicine
called a monoamine oxidase inhibitor
(MAOI)
•
if you have high blood pressure due to a
tumour near your kidney called
'phaeochromocytoma' or 'paraganglioma'
•
If you have porphyria (a rare, inherited
blood disorder).
If you are unsure if any of the above apply to
you, please talk to your doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Methyldopa Tablets
•
if you have a blood disorder called
haemolytic

Caracteristicilor produsului

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