Aldomet 500 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methyldopa

Available from:

Aspen Pharma Trading Limited

ATC code:

C02AB; C02AB01

INN (International Name):

Methyldopa

Dosage:

500  milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Methyldopa; methyldopa (levorotatory)

Authorization status:

Not marketed

Authorization date:

1979-04-01

Patient Information leaflet

ALDOMET® 250 MG FILM-COATED TABLETS
ALDOMET® 500 MG FILM-COATED 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 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 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’.
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)

liver disease

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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Aldomet if you have:

a blood disorder called haemolytic anaemia

liver problems

jaundice (yellowing of the skin and eyes)

fever

any abnormal movements (involuntary)

had a stroke

had a heart att

Summary of Product characteristics

Health Products Regulatory Authority
09 September 2022
CRN00D551
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldomet 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
‘Aldomet’ tablets 500mg, contain methyldopa equivalent to 500mg
anhydrous methyldopa.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow coloured, round, film-coated tablets marked ‘ALDOMET’ on
one side and ‘500’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of hypertension (mild, moderate or severe).
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.
_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 if required
(see manufacturer’s recommendations on stopping these
drugs). 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.
‘Aldomet’ may also be used concomitantly with the combination of
amiloride hydrochloride and hydrochlorothiazide (such