Methyldopa 125mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Methyldopa (anhydrous)

Διαθέσιμο από:

Bristol Laboratories Ltd

Φαρμακολογική κατηγορία (ATC):

C02AB01

INN (Διεθνής Όνομα):

Methyldopa (anhydrous)

Δοσολογία:

125mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02050200; GTIN: 5060013945007

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFOMATION FOR THE PATIENT
METHYLDOPA 125 MG TABLETS
(Methyldopa)
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 your 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
24 mm
420 mm
180 mm
IXXXXXX
1. WHAT METHYLDOPA TABLETS ARE AND WHAT
THEY ARE USED FOR
This medicine contains Methyldopa which 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 IF YOU HAVE:
•
ever had a bad reaction, such as an allergy to
methyldopa, or to any of the other ingredients
(listed in section 6)
•
ever had liver disease
•
ever had depression
•
high blood pressure due to a tumour near your
kidney
called
‘phaeochromocytoma’
or
‘paraganglioma’
•
been taking a type of medicine called a
‘monoamine oxidase inhibitor’ (MAO inhibitor)
•
porphyria (a rare, inherited blood disorder)
Do not take Methyldopa if any of the above applies to
you. If you are not sure talk to your doctor or
pharmacist before taking Methyldopa.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Methyldopa if you have:
•
a

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa 125 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Methyldopa equivalent to anhydrous methyldopa 125
mg.
Excipient with known effect: Also contains 25 mg of lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet.
Yellow, circular, bi-convex, film coated tablets embossed with
‘125’ on one side and
‘BL’ on the reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of 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.
_ _
_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.
_ _
_Pa