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METHYLDOPA TABLETS BP 500MG

Active substance(s): METHYLDOPA

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Methyldopa 125mg, 250mg
and 500mg tablets
Read all of this leaflet carefully before
you start to take your medicine.




Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• alprostadil used to treat erectile dysfunction
• NSAIDs (non-steroidal anti-inflammatory drugs)
which are used to relieve pain
• antihypertensive medicines used to treat high blood
pressure (e.g. propranolol, nifedipine, verapamil or
‘water tablets’)
• medicines used to treat anxiety or insomnia (e.g.
diazepam, temazepam)
• combined oral contraceptive (“the pill”) or hormone
replacement therapy (HRT)
• medicines to treat Parkinson’s disease such as
levodopa, entacapone
• linezolid (used to treat some infections)
• lithium (used to treat depression and mental illness)
• MAOIs (mono-amine oxidase inhibitors) used to treat
depression (e.g. phenelzine)
• medicines to treat mental illness (e.g.
chlorpromazine and thioridazine)
• moxisylyte used to treat Raynaud’s syndrome
• muscle relaxants such as baclofen, tizanidine
• nitrates (e.g. glycerol trinitrate “GTN”, isosorbide
dinitrate/mononitrate)
• steroids (e.g. prednisolone, hydrocortisone)
• sympathomimetics medicines used mainly for
coughs and colds (e.g. ephedrine or salbutamol)
• medicines used to treat ulcers such as carbenoxolone
• iron supplements.

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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

Index
1 What Methyldopa tablets are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Methyldopa tablets are and what



they are used for

Methyldopa belongs to a group of medicines called
antihypertensives, which lower blood pressure.
Methyldopa tablets are used to treat high blood
pressure (hypertension).

2 Before you take



Do not take Methyldopa tablets and tell your
doctor if you:

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are
breast-feeding ask your doctor or pharmacist for advice
before taking this medicine.

• are allergic (hypersensitive) to methyldopa or any of
the other ingredients. (see section 6).
• have liver disease
• have high blood pressure due to a tumour near the
kidney (phaeochromocytoma)
• suffer from depression
• are taking MAOIs (monoamine oxidase inhibitors) for
depression.

Driving and using machines

Methyldopa tablets may make you feel drowsy. Make
sure you are not affected before you drive or operate
machinery.

Colourants

Check with your doctor or pharmacist before
taking Methyldopa tablets if you:

Each tablet contains sunset yellow (E110) which may
cause allergic reactions.

• have had liver disease
• have kidney disease
• or a relative have a genetic/inherited disorder of the
red blood pigment haemoglobin (porphyria)
• have damaged or diseased blood vessels in your
brain.

Blood tests

Methyldopa may affect the results of certain laboratory
tests.
Regular checks (before the start of treatment and 6-12
weeks later) may be carried out on blood cells and liver
function (blood test to show your liver is working).

Surgery

If you have to have surgery, including dental, that
requires an anaesthetic let them know what medicines
you are taking.

Continued top of next column
AAAG9639 50809801

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Methyldopa 125, 250 & 500mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAG9639
2
18.06.14

originated by:

DR

revision date:

15.07.14

revised by:
supplier:

DR
Actavis UK

dimensions:

148x210

6.5pt

1. Black

JDE No.:

2.
4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6784

6.

Date Sent:
30/05/14
Technologist: R.Wrey

1. Profile

date sent:

50809801

5.
Non Printing Colours

Technical Approval

technically app. date:

Methyldopa Tablets
125, 250 & 500mg x 56’s

3.

pharmacode:
min pt size:

colours/plates:

Technically Approved

2.
30.05.14

3.

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

• Central nervous system: drowsiness (usually lasts a few days
at start of treatment or after an increased dose), headache,
loss of strength or weakness, tingling or pins and needles,
trembling and shuffling walk, partial paralysis of the face,
involuntary jerky movements, mental changes including
nightmares, confusion, mild depression, dizziness, lightheadedness, reduced blood flow to the brain.
• Heart: slow heart rate and low blood pressure, worsening
of existing angina, low blood pressure causing dizziness on
standing, water retention causing swelling and weight gain.
• Respiratory system: blocked/stuffy nose.
• Stomach and intestines: feeling or being sick, bloated
stomach, constipation, wind, diarrhoea, colitis, mild dryness
of the mouth, sore or “black” tongue, inflamed salivary glands
and inflammation of the pancreas (pancreatitis). Tell your
doctor immediately if you get very severe abdominal pains.
• Liver: abnormal liver function, hepatitis, jaundice (yellowing of
the skin and/or whites of the eyes). These would be detected
by a blood test.
• Skin: eczema, hard skin rash (lichenoid), severe rash involving
reddening, peeling and swelling of the skin that resembles
severe burns (toxic epidermal necrolysis).
• Muscles and bones: mild joint pain with or without swelling.
Muscle pain or cramps.
• Reproductive system and breasts: absence of periods,
swelling of breasts in men and women, production of breast
milk, failure to ejaculate, decreased sex drive, failure to
maintain an erection (impotence).

3 How to take

Always take Methyldopa tablets exactly as your doctor has told
you. If you are not sure, check with your doctor or pharmacist.
You are advised not to drink alcohol with this medicine. Discuss
this with your doctor if you have any questions.
Swallow these tablets with water.

Doses:
Adults and children over 12 years:
Initially 250mg two or three times a day, for 2 days. Then
increased every 2 or more days until an adequate response is
achieved up to a maximum of 3g daily.
Children under 12 years:
Initially 10mg per kg of bodyweight daily in 2-4 divided doses
adjusted as required up to 65mg/kg or 3g daily, whichever is
less.
Elderly:
Initially no more than 250mg a day (e.g. 125mg twice daily),
increasing up to a maximum of 2g a day.
Methyldopa may be given with, or instead of, other medicines to
lower blood pressure and the doses may need to be amended.

If you take more than you should

If you (or someone else) swallow a lot of the tablets at the same
time, or if you think a child may have swallowed any, contact
your nearest hospital casualty department or tell your doctor
immediately.
Symptoms of an overdose include excessive drowsiness,
weakness, slow heart rate, low blood pressure, dizziness,
light-headedness, painful infrequent bowel movements,
bloated feeling, wind, diarrhoea, feeling or being sick.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.

5 How to store

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If
you forget to take a dose take it as soon as you remember it and
then take the next dose at the right time.

Keep out of the reach and sight of children.
Store below 25°C in a dry place. Protect from light.Do not use
Methyldopa tablets after the expiry date stated on
the label/carton/bottle. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

If you stop taking the tablets

Do not stop treatment early because an increase in blood
pressure may occur. Talk to your doctor before you stop taking
the tablets and follow their advice.

4 Possible side effects

6 Further information

Like all medicines, Methyldopa tablets can cause side effects,
although not everybody gets them. Please tell your doctor
or pharmacist if you notice any of the following effects or any
effects not listed.

What Methyldopa tablets contain

• The active substance (the ingredient that makes
the tablet work) is anhydrous methyldopa. Each
film-coated tablet contains either 125mg, 250mg or
500mg of the active substance.
• The other ingredients are polyvidone, sodium
edetate, magnesium stearate, crospovidone,
precipitated silica, macrogol, talc, E104, E110
(sunset yellow), E132, E171, E172, E330, E460, E464.

Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
• Allergic reactions: inflammation of heart muscle or the sac
surrounding the heart, skin rash which may be red and/or
scaly, fever.
• Blood: your medicine may alter the numbers and types of
your blood cells and cause a rise in urea in the blood. If you
notice increased bruising, nosebleeds, sore throats, infections
or fever, you should tell your doctor who may want to give you
a blood test.
• Endocrine system: abnormal production of milk.

What Methyldopa tablets look like and
contents of the pack

Methyldopa tablets are yellow, circular, biconvex,
film-coated tablets.
Pack size: 56
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised
in June 2014.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column

AAAG9639 50809801

148x210 Leaflet Reel Fed Profile (BST)

Methyldopa 125, 250 & 500mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAG9639
2
18.06.14

originated by:

DR

revision date:

15.07.14

revised by:
supplier:

DR
Actavis UK

dimensions:

148x210

6.5pt

1. Black

JDE No.:

2.
4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6784

6.

Date Sent:
30/05/14
Technologist: R.Wrey

1. Profile

date sent:

50809801

5.
Non Printing Colours

Technical Approval

technically app. date:

Methyldopa Tablets
125, 250 & 500mg x 56’s

3.

pharmacode:
min pt size:

colours/plates:

Technically Approved

2.
30.05.14

3.

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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