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MEDOMET 250MG TABLETS

Active substance(s): METHYLDOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MEDOMET 250 mg &
500 mg TABLETS
METHYLDOPA
Read all of this leaflet carefully before you
start taking this medicine.
- 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.
- If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist

THIS LEAFLET CONTAINS
1. What Medomet is for
2. Before you take Medomet
3. How to take Medomet
4. Possible side effects
5. How to store Medomet
6. Further information

1. WHAT MEDOMET IS FOR
The name of your medicine is Medomet. It contains the
active ingredient Methyldopa, which belongs to a group of
medicines called anti-hypertensives. It is used to lower
high blood pressure, (hypertension).
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

2. BEFORE YOU TAKE MEDOMET
Do not take Medomet and tell your doctor if you:
• are allergic (hypersensitive) to Methyldopa or any of the
other ingredients in these tablets (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)
• 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 Methyldopa.
Take special care with Medomet
Tell your doctor before you take this medicine if you:
• have kidney disease.
• have previously had liver disease.
• have a history of depression.
• suffer from an abnormal breakdown of red blood cells
which can make the skin pale or yellow and cause
weakness or breathlessness (haemolytic anaemia).
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Medomet.
Operations and tests
If you are going to have an operation or an anaesthetic, tell
your doctor, dentist or nurse that you are taking Medomet.
Medomet may affect the results of certain laboratory tests.
Regular checks, (before the start of treatment and for 6-12
weeks after), may be carried out on blood cells and liver
function.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
bought without a prescription. This is because Medomet
can affect the way some medicines work. Also some
medicines can affect the way Medomet works.

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• other medicines to treat high blood pressure such as
captopril, enalapril (ACE inhibitors), doxazosin, prazosin
(alpha-blockers), candesartan, losartan (angiotensin-II
receptor antagonists), clonidine, diazoxide, guanethidine,
hydralazine, minoxidil, moxonidine or sodium
nitroprusside
• medicines to treat high blood pressure or chest pain
(angina) such as propranolol, atenolol (beta-blockers),
amlodipine, felodipine (calcium-channel blockers),
bendroflumethiazide, furosemide (diuretics), glyceryl
trinitrate, isosorbide mononitrate (nitrates)
• medicines to treat anxiety or mental health problems
such as diazepam, lorazepam, temazepam,
chlorpromazine, haloperidol, pimozide or lithium
• medicines known as MAOIs, (monoamine oxidase
inhibitors), used to treat depression such as phenelzine,
moclobemide or tranylcypromine
• medicines known as NSAIDs, (non-steroidal
anti-inflammatory drugs), for pain and inflammation such
as aspirin, ibuprofen or indometacin
• steroids such as hydrocortisone or prednisolone to treat
swelling and allergies
• medicines to treat Parkinson’s disease such as levodopa
or entacapone
• muscle relaxants such as baclofen and tizanidine
• oestrogens used for contraception or hormone
replacement therapy (HRT)
• moxisylyte to treat blood circulation problems like
Raynaud’s disease
• salbutamol used to treat asthma and other airways
problems
• alprostadil for problems maintaining an erection
• aldeslukin to treat cancer
• iron supplements
AVOID ALCOHOL whilst taking Medomet tablets. This is
because alcohol can affect the way Medomet works.
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 Medomet or any other medicine.
Driving and using machines
Medomet tablets may make you feel drowsy. Make sure
you are not affected before you attempt to drive or operate
machinery.

3. HOW TO TAKE MEDOMET
Taking this medicine
Always take Medomet tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.
These tablets should only be taken by mouth. Swallow
them whole with water.
Adults
The usual starting dose is 250 mg, two times a day, for 2
days. After which your doctor may gradually increase the
dose at intervals of 2 or more days, until an adequate
response is achieved. The maximum dose is 3 g daily.
Children
The usual starting dose is 10 mg per kg of bodyweight
daily taken in 2 - 4 divided doses, increased as required up
to a maximum of 65 mg per kg of bodyweight or 3 g daily,
whichever is less.
Elderly
The usual starting dose is 250 mg a day (e.g. 125 mg twice
daily). Your doctor may gradually increase the dose if
necessary, up to a maximum of 2 g a day.
Medomet 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 Medomet than you should
If you (or someone else) take too many tablets, contact
your doctor or the nearest hospital casualty department
immediately. Take this leaflet and the container with you so
they know what has been taken.

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.
If you forget to take Medomet
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next dose
skip the missed dose, do not take a double dose (two
doses at the same time) to make up for a forgotten dose.
If you suddenly stop taking Medomet
Do not stop taking this medicine until your doctor tells you
to. Your doctor will advise you on how best to do this.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Medomet can cause side effects,
although not everybody gets them.
If you get any of the following side effects, STOP
TAKING Medomet and tell your doctor immediately or
go to the nearest hospital emergency department:
• an allergic reaction to Methyldopa which may cause any
kind of rash, red and/or scaly skin, or swelling. You could
also notice sudden wheezing, fluttering or tightness of
the chest, collapse, inflammation of heart muscle or the
sac surrounding the heart.
If you get any of the following side effects, see a
doctor straight away:
• slow heart beats or heart failure (signs include
breathlessness and swollen ankles)
• altered numbers and types of blood cells. If you notice
increased bruising, bleeding, sore throats, infections or
fever, you should tell your doctor who may want to give
you a blood test
• severe stomach or back pain, this could be a sign of an
inflammation of the pancreas (pancreatitis)
• severe rash involving reddening, peeling and swelling of
the skin that resembles severe burns (toxic epidermal
necrolysis)
Tell your doctor or pharmacist if you get any of
these side effects:
Effects on the blood: raised levels of urea in the blood
Effects on the brain and central nervous system:
mental changes including nightmares, confusion, mild
depression, decreased sex drive, drowsiness (usually lasts
a few days at start of treatment or after an increased
dose), headache, tingling or pins and needles, trembling
and shuffling walk, partial paralysis of the face, involuntary
jerky movements, decreased mental sharpness, dizziness,
light-headedness, reduced blood flow to the brain
Effects on the heart: worsening of existing angina, low
blood pressure causing dizziness on standing
Effects on the respiratory system: blocked/stuffy nose
Effects on the 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
Effects on the liver: abnormal liver function, yellowing of
the skin and/or whites of the eyes (jaundice), inflammation
of the liver (hepatitis). These would be detected by a blood
test.
Effects on the skin: eczema, hard skin rash (lichenoid)
Effects on the muscles and bones: mild joint pain with or
without swelling, muscle pain
Effects on your reproductive system and breasts:
swelling of breasts in men and women, abnormal
production of breast milk, absence of periods, failure to
maintain an erection (impotence) and failure to ejaculate
General effects: Fever, water retention causing swelling
and/or weight gain

If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE MEDOMET
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date stated on the
pack. The expiry date refers to the last day of that month.
Store below 25°C in a dry place Protect from light and
keep the container well closed.
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.

6. FURTHER INFORMATION
What Medomet tablets contain
The active substance (the ingredient that makes the tablets
work) is anhydrous Methyldopa. Each tablet contains either
250 mg or 500 mg of the active substance.
The other ingredients are citric acid, sodium calcium
edetate, microcrystalline cellulose, magnesium stearate,
ethylcellulose, colloidal anhydrous silica, guar gum,
opaspray K-1-6039 (titanium dioxide E171, talc, iron oxide
yellow E172, hydroxypropyl cellulose), hypromellose,
diethyl phthalate, dispersed yellow 14650 E104
What Medomet tablets look like and contents of
the pack
The 250 mg tablets are yellow film-coated tablets,
engraved MEDOMET 250 on one side.
The 500 mg tablets are yellow, bi-convex film-coated
tablets.
Medomet 250 mg and 500 mg tablets both come in plastic
containers of 56, 100 and 500 tablets. Medomet 500 mg
tablets also come in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited
Boumpoulinas 11, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 12/2011

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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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