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METHYLDOPA 125MG TABLETS

Active substance(s): METHYLDOPA

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Patient Information Leaflet
797-9271

Methyldopa 125 mg, 250 mg & 500 mg Tablets
Methyldopa
Read all of this leaflet carefully before you start taking this
medicine.
• Please keep this leaflet. You may need to read it again.
• If you have any further questions, please 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.
• If any of the side effects becomes severe, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Methyldopa 125 mg, 250 mg and 500 mg Tablets are
and what they are used for.
2. Before you take Methyldopa 125 mg, 250 mg and 500 mg
Tablets.
3. How to take Methyldopa 125 mg, 250 mg and 500 mg Tablets.
4. Possible side effects.
5. How to store Methyldopa 125 mg, 250 mg and 500 Tablets.
6. Further information.
1. WHAT METHYLDOPA 125 MG, 250 MG AND 500 MG
TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Methyldopa 125 mg, 250 mg or 500 mg
Tablets. The active ingredient is methyldopa. Methyldopa, belongs to a
group of medicines called “antihypertensives”. It is used for the treatment
of hypertension (high blood pressure).
Methyldopa 125 mg, 250 mg and 500 mg Tablets are used to help
control your blood pressure.
2. BEFORE YOU TAKE METHYLDOPA 125 MG, 250 MG AND
500 MG TABLETS
Do not take this medicine if:
• you have ever had an allergic reaction to methyldopa or any
of the other ingredients of this medicine (allergic reactions include
mild symptoms such as itching and/or rash. More severe symptoms
include swelling of the face, lips, tongue and/or throat with difficulty
in swallowing or breathing);
• you currently have any liver problems;
• you suffer from depression;
• you are being treated with a type of medicine called monoamine
oxidase inhibitors (MAOIs) for depression;
• You have a condition known as ‘phaeochromocytoma (a normally
benign growth of tissue in the adrenal gland).
Take special care with this medicine and tell your doctor
or pharmacist if:
• you have ever had any liver problems in the past;
• you have kidney problems;
• you are receiving dialysis treatment;
• you have severe bilateral cerebrovascular disease (which leads
to the disruption of the blood supply to either side of the brain);
• you have a genetic condition known as ‘porphyria’.

Taking other medicines:
Tell your doctor if you are taking any other medicines, especially the
following:
• other medicines to treat hypertension, including thiazides;
• if you have to undergo surgery with a general anaesthetic, you should
tell the medical doctor in charge that you are taking methyldopa,
before the operation;
• medicines used to treat depression (e.g. tricyclics, MAOIs or
lithium);
• medicines used to treat psychoses (e.g. phenothiazines);
• medicines used to mimic the effect of adrenaline
(e.g.sympathomimetics);
• medicines containing iron (e.g. ferrous sulphate or ferrous
gluconate).
It is important that you tell the doctor about ALL the medicines
you have taken recently, those you are taking or are likely to take,
including those you have bought without a prescription.
Your doctor will know more about these medicines and will alter your
treatment if considered necessary.
Other special warnings
• Be careful when drinking alcohol - it may affect you more than
usual.
• Whilst you are taking this medicine, your doctor may want to
give you a check-up from time to time.
• Tell your doctor that you are taking Methyldopa Tablets if you are
going to have an operation of any kind.
• Tell your doctor you are taking methyldopa if you are having a
blood or urine test.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or if you are breast-feeding.
Driving and operating machinery
Methyldopa may make you feel drowsy during the initial period of
taking your tablets, or if your doctor increases your dose, you may
feel drowsy for a short time after. Do not drive, operate machinery
or do anything that requires you to be alert until you know how the
tablets affect you.

If you are already being treated for hypertension, your doctor may
decide to change your medication to methyldopa.
You may need to take your current medicine differently when
changing your treatment to methyldopa. Your doctor will gradually
adjust the dose of your current medication.
Sometimes your doctor may give you another medicine (thiazide) to
help control your blood pressure whilst you are taking methyldopa.
Your dose will be adjusted by your doctor accordingly.
Children:- The dose in children, which is based upon their body
weight, will be determined by your doctor. This dose should not
exceed 3 g (e.g. six 500 mg tablets) per day, or 65 mg per kg of
body weight, whichever is lower.
Elderly:- Usually start on a dose of not more than 250 mg per
day, usually given as one 125 mg tablet twice a day. Your doctor
may increase this slowly, up to a maximum dose of 2 g (e.g. four
500 mg tablets) per day.
If you take more tablets than you should
If you take too much of your medicine, tell your doctor at once or
contact your nearest hospital casualty department. Take your medicine
and this leaflet with you.
If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual
time, DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methyldopa Tablets can cause unwanted side
effects in some people, although it is generally well-tolerated. You
are unlikely to get any of the following but if you do, tell your
doctor immediately:
• unexpected bruising or bleeding, increased infections
(e.g. colds and sore throats) or fever
• a serious skin rash, with symptoms of fever and blisters on the
skin and mouth (toxic epidermal necrolysis)
• a reduction in the number of red blood cells (anaemia), which
may make you feel more tired than usual
• a condition affecting your immune system (lupus-like syndrome)
• inflammation of the heart muscle or sac surrounding the heart
(myocarditis or pericarditis)
• feeling dizzy, faint or light-headed or experiencing chest pain
• abnormal liver function, jaundice (yellowing of the skin and/or
whites of the eyes)
• progressive swelling (oedema) and weight gain, which could
be symptoms of a worsening heart condition
Your doctor may decide to conduct tests on your blood and/or
liver or to stop methyldopa treatment.
Methyldopa Tablets may also cause the following side effects:

3. HOW TO TAKE METHYLDOPA 125 MG, 250 MG AND
500 MG TABLETS
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. He
or she will tell you how many to take and how often to take them.
The doses commonly prescribed are listed below. Your doctor may
prescribe different doses depending on your needs.
Adults:- 250 mg tablet two or three times per day for two days. Your
doctor may adjust this dose at intervals of two days or more, up to a
maximum dose of 3 g (e.g. six 500 mg tablets) per day.

• tiredness, weakness, headaches or sedation (particularly when
you start taking Methyldopa Tablets or when your dose is
increased);
• pins and needles or tingling feelings;

• tremor or involuntary movement in the limbs (these may be
symptoms similar to those experienced in Parkinson’s disease);
• weakness of the muscles in one side of the face (Bell’s Palsy);
• nightmares, impaired mental activity (e.g. vagueness), psychosis
with symptoms such as hallucinations, thought disturbances,
mood swings or depression;
• dizziness, light-headedness, confusion, reduced blood flow to
the brain;
• slow heart rate, worsening of existing angina, low blood pressure
causing dizziness on standing (a decrease in dose may be required);
• blocked or stuffy nose;
• stomach or bowel problems for example; feeling or being sick,
bloated stomach, constipation, wind, diarrhoea, colitis (inflammation
of the colon), mild dryness of the mouth, sore or ‘black’ tongue,
inflammation of the salivary glands in the cheek or throat,
inflammation of the pancreas (pancreatitis) which can cause pain
in the stomach and back;
• skin rash (this may be itchy, red and/or scaly or patches of dead
skin on the nose and cheeks);
• pain in the joints and muscles with or without swelling;
• irregular or absent periods, swelling of breasts in men and
women, production of breast milk, failure to maintain an
erection (impotence), decreased sex drive, failure to ejaculate.
If any of these side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist
immediately.
5. HOW TO STORE METHYLDOPA 125 MG, 250 MG AND
500 MG TABLETS
Do not store above 25°C. Keep the container tightly closed and store
in the original container. Do not use after the expiry date that is stated
on the carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
Methyldopa Tablets are available in three different strengths containing
either 125 mg, 250 mg or 500 mg of methyldopa (anhydrous).
The tablets also contain anhydrous citric acid, povidone, sodium starch
glycollate, stearic acid, magnesium stearate, microcrystalline cellulose,
hydroxypropylmethylcellulose, opaspray M-1F-6047B solids.
Methyldopa 125 mg Tablets, Methyldopa 250 mg Tablets and Methyldopa
500 mg Tablets are packed in containers of 56 tablets.
Methyldopa 250 mg Tablets and Methyldopa 500 mg Tablets are also
available as blister packs of 56 tablets.
Marketing Authorisation Holder and Manufacturer:
Waymade Plc trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex, SS14 3FR.
This leaflet does not contain all the available information about your
medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
The information in this leaflet applies only to
Methyldopa 125 mg Tablets, Methyldopa 250 mg Tablets and
Methyldopa 500 mg Tablets
Date of preparation of the leaflet: December 2007

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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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