Methyldopa 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methyldopa (anhydrous)

Available from:

DE Pharmaceuticals

ATC code:

C02AB01

INN (International Name):

Methyldopa (anhydrous)

Dosage:

250mg

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
MEDOMET 250 MG &
500 MG TABLETS
METHYLDOPA
1. WHAT MEDOMET IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEDOMET
3. HOW TO TAKE MEDOMET
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MEDOMET
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is Medomet. It contains the
active ingredient Methyldopa, which belongs to a group of
medicines
called
anti-hypertensives.
Methyldopa
is
changed inside your body to a natural substance that
lowers
blood
pressure.
It
is
used
to
treat
high
blood
pressure (hypertension).
DO NOT TAKE MEDOMET IF YOU:

have ever had a bad reaction, such as allergic
(hypersensitive) to Methyldopa or to any of the other
ingredients in this tablet (listed in section 6 of this
leaflet)
The signs of an allergic reaction include a rash, itching
or difficulty breathing

have active liver disease (such as hepatitis or cirrhosis)

are suffering from depression

have high blood pressure due to a tumour on the
adrenal gland, near the kidney (phaeochromocytoma or
paraganglioma)

have an inherited blood disorder of the red blood
pigment haemoglobin known as acute porphyria

are taking MAOIs (monoamine oxidase inhibitors) for
depression.
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Medomet.
WARNINGS AND PRECAUTIONS
Tell your doctor BEFORE you take this medicine if you:

have kidney disease

have jaundice (yellowing of the skin and eyes)

have fever

have any abnormal movements (involuntary)

have liver problems

suffer from an abnormal breakdown of red blood cells
which can make the skin pale or yellow and cause
weakness or breathlessness (haemolytic anaemia).
OPERATIONS AND TESTS
If you are going to have an operation, dialysis, a blood
transfusion or an anaesthetic, tell your doctor, dentist or
nurse that you are taking Medomet.
Tell your doctor you are taking Medomet if you have a
laboratory test where urine or blo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 283.00mg of methyldopa equivalent to 250mg
anhydrous methyldopa
Excipient with known effect: Each tablet contains sunset yellow (E110)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow biconvex film coated tablets with an approximate diameter of
10.5mm either plain or coded MYD 250 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clinical indications:
Methyldopa is indicated for hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
General considerations
_Patients with renal impairment _
Methyldopa is largely excreted by the kidney, and the patients with
impaired renal
function may respond to smaller doses.
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 on treatment with other hypertensive agents _
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 antihypertensive the
dose of these
agents may need to be adjusted to effect a smooth transition.
_Addition of a thiazide _
When 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide,
the two
agents may be given together once daily.
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.
_Adults_
_ _
_Initial dosage:_ Usually 250mg two or three times a day, for two
days, increased at
i