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MEDOMET 250MG TABLETS

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

weeks after), may be carried out on blood cells and liver
function. Your doctor may use similar tests if you have a
fever at any time while you are taking Medomet.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Medomet.

METHYLDOPA

Other medicines and Medomet
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. This
includes herbal medicines.
Do not take Medomet if you are taking a type of medicine
called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used
to treat depression.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
 other medicines to treat high blood pressure
(antihypertensives)
 lithium-used to treat some types of depression
 medicines called ‘phenothiazines’ such as
chlorpromazine-used for mental illness and sometimes
feeling and being sick
 medicines called ‘tricyclic antidepressants’ – used to
treat depression
 cough and cold remedies that contain a decongestant
 iron and supplements containing iron, such as
multivitamins with minerals.

MEDOMET 250 mg &
500 mg TABLETS

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- 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
only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
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

1. WHAT MEDOMET IS AND WHAT IT
IS USED FOR
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).

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MEDOMET
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 blood is taken. This is
because Medomet may affect the results of certain
laboratory tests. Rarely, in patients taking Medomet urine
may darken when it is exposed to air after voiding.
Regular checks, (before the start of treatment and for 6-12

Medomet with alcohol
AVOID ALCOHOL whilst taking Medomet tablets. This is
because alcohol can affect the way Medomet works.
Discuss this with your doctor if you have any questions.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or planning to become pregnant, ask your doctor
or pharmacist for advice before taking Medomet.
Driving and using machines
Medomet tablets may make you feel drowsy or
light-headed. 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. The amount you take each day will
depend upon your condition. It is very important to continue
taking Medomet for as long as your doctor has prescribed.
Do not take more or less than your doctor has prescribed.
The recommended dose is:
Adults
The usual starting dose is 250 mg, two or three 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 doctor will work out the number of tablets. The dose is
based on the weight of the child. 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 will not be more than 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 sedation,
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 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, contact your
doctor immediately or go to the nearest hospital
emergency department as they are serious and require
medical attention:
 an allergic reaction, which may cause any kind of rash,
red and/or scaly skin, or swelling of your lips, face or
tongue, chills. You could also notice sudden wheezing,
fluttering or tightness of the chest, collapse, inflammation
of heart muscle or the sac surrounding the heart
 fever or painful joints
 chest pain, slow heart beats, worsening of existing
angina, problems with the electrical current in the heart
(AV block) 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
 pain in the gut and diarrhoea caused by inflammation of
the bowel (colitis)
 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)
 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.
Tell your doctor or pharmacist if you get any of these
side effects:
Effects on the blood:
 raised levels of urea in the blood
 reduction in red blood cells (anaemia) - this can make
your skin pale and make you weak or breathless.
Effects on the brain and central nervous system:
 mental changes including nightmares or depression
 delusions and paranoia-which will stop when you stop
taking the medicine
 decreased sex drive
 confusion
 feeling sleepy or tired (usually lasts a few days at start
of treatment or after an increased dose)
 headache or feeling weak (this may happen at the start
of treatment and usually goes away)
 tingling or pins and needles
 partial paralysis of the face
 involuntary jerky movements
 parkinsonism-with symptoms such as tremor, a
decrease in body movements with an inability to move
your muscles
 decreased mental sharpness
 frequent dizziness or fainting
 dizziness due to low blood pressure and
light-headedness (particularly when standing up quickly)
 reduced blood flow to the brain.
Effects on the respiratory system:
 blocked/stuffy nose.
Effects on the stomach and intestines:
 feeling or being sick
 abdominal pain
 bloated stomach
 constipation
 wind
 diarrhoea
 mild dryness of the mouth
 sore or “black” tongue.
Infections:
 inflammed salivary glands.

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:
 breast enlargement
 breast development in men
 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.
Laboratory tests:
Your doctor may need to carry out simple blood tests during
the first few months of therapy with Medomet. Results could
show:
 a decrease in blood cell production
 an increase in some white blood cells
 abnormal levels of prolactin.
Medomet may also interfere with the interpretation of
certain blood and urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 MEDOMET
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER 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, engraved MEDOMET 500 on one side.
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 11/2016
CL0060-0061/O/PIL-Br/CL2

Expand Transcript

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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