Aldomet 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methyldopa (anhydrous)

Available from:

Sigma Pharmaceuticals Plc

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALDOMET
®
Film-coated Tablets 250 mg
ALDOMET
®
Film-coated Tablets 500 mg
(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 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, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See Section 4.
What is in this leaflet:
1.
What Aldomet is and what it is used for
2.
What you need to know before you take Aldomet
3.
How to take Aldomet
4.
Possible side effects
5.
How to store Aldomet
6.
Contents of the pack and other information
1.
What Aldomet is and what it is used for
Aldomet contains the active substance 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 Aldomet to
treat high blood pressure (hypertension).
2.
What you need to know before you take Aldomet
Do not take Aldomet 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 Aldomet if any of the above applies to you. If you are not
sure talk to your doctor or pharmacist before taking Aldomet.
Take special care with Aldomet
Talk to your doctor or pharmacist before tak

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ALDOMET® Tablets 500 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
‘Aldomet’ Tablets 500 mg, contain methyldopa equivalent to 500 mg
anhydrous
methyldopa.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow, film-coated tablets.
‘Aldomet’ Tablets 500 mg are marked ‘ALDOMET on one side and 500
on
the other side’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In 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
with ‘Aldomet’
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 ‘Aldomet’ 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 ‘Aldomet’ 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, ‘Aldomet’
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 ‘Aldomet’ is added to 50 mg of hydrochlorothiazide,
the two agents
may be given together once daily.
_ _
_P