Methyldopa 250mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Methyldopa (anhydrous)

Dostępny od:

Esteve Pharmaceuticals Ltd

Kod ATC:

C02AB01

INN (International Nazwa):

Methyldopa (anhydrous)

Dawkowanie:

250mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02050200; GTIN: 5039021003559

Ulotka dla pacjenta

Sexual:
• breast enlargement
• breast development in men
• loss of periods in women
• abnormal production of milk
• changes in sexual function such as impotence and not being
able to ejaculate
• decreased sex drive
Psychiatric:
• mental changes, including nightmares or depression
Laboratory tests:
• Your doctor may need to carry out simple blood tests during
the first few months of therapy with Methyldopa Tablets.
Results could show:
• a decrease in blood cell production
• an increase in some white blood cells
• abnormal levels of prolactin
Methyldopa Tablets may also interfere with the interpretation of
certain blood and urine tests.
The frequency of all the possible side effects listed above is
classed as 'not known', which means that it cannot be estimated
from the available data.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store.
By reporting side effects, you can help provide more information
on the safety of this medicine.
5. HOW TO STORE METHYLDOPA TABLETS
Do not store above 25ºC. Store in the original package in order
to protect from light.
Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date on the
pack. Return any left over medicine to your pharmacist. Only
keep it if your doctor tells you to.
Medicines should not be disposed of via wastewater or house-
hold waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT METHYLDOPA TABLETS CONTAIN
The active substance is methyldopa. Each film-coated tablet
contains either 250 mg or 500 mg of the active substance.
The tablets also contain citric acid, lactose monohydrate, maize
starch, talc, m

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa Tablets BP 250mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active:
Per Tablet:
Methyldopa Ph.Eur
281.960 mg equivalent to methyldopa anhydrous 250mg
Excipient(s) with known effect
Each tablet contains 33 mg of lactose (as monohydrate).
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Round, yellow film coated biconvex tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
250mg 2-3 times daily for 2 days, adjusted at intervals of 2 days
until adequate
response is obtained. Maximum dose 3g daily (increase evening dose
first).
Usual effective dose 500mg to 2g daily.
ELDERLY:
Initial dose should be kept as low as possible not exceeding 250mg
daily. An
appropriate starting dose would be 125mg twice daily, increased slowly
as
required but not exceeding a maximum daily dosage of 2g.
CHILDREN:
10mg/kg bodyweight daily in 2-4 divided doses. The dosage is increased
or
decreased until adequate response is achieved. Maximum recommended
daily
dose is 65mg/kg bodyweight or 3g whichever is less.
4.3
CONTRAINDICATIONS
Methyldopa tablets are contraindicated in patients with:
•Hypersensitivity to methyldopa or to any of the excipients listed
in section
6 (including hepatic disorders associated with previous methyldopa
therapy)
•A history of depression
•Active hepatic disease such as acute hepatitis and active cirrhosis
•On therapy with monoamine oxidase inhibitors (MAOIs)
•Porphyria
•Methyldopa Tablets are not recommended for the treatment of
phaeochromocytoma or paraganglioma (see 4.4 'Special warnings and
precautions for use').
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acquired haemolytic anaemia has occurred rarely; should symptoms
suggest anaemia, haemoglobin and/or haematocrit determinations should
be
made. If anaemia is confirmed, tests should be done for haemolysis. If
haemolytic anaemia is present, Methyldop