ALDOMET TABLETS 125MG

Active substance: METHYLDOPA

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PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE
YOUR MEDICINE, EVEN IF YOU HAVE HAD A REPEAT PRESCRIPTION, SOME OF THE
INFORMATION IN YOUR LEAFLET MAY HAVE CHANGED
Keep this leaflet. You may want to read it again.

Aldomet ® Tablets
(methyldopa)

WHAT IS IN YOUR MEDICINE?
Active ingredient
The active ingredient in ‘Aldomet’ Tablets is methyldopa.
‘Aldomet’ is available as film-coated tablets. They are yellow-coloured round tablets containing
methyldopa equivalent to 125 mg anhydrous methyldopa.
Other ingredients
‘Aldomet’ Tablets contain: cellulose powder, anhydrous citric acid, colloidal silicon dioxide,
ethylcellulose, guar gum, magnesium stearate, sodium calcium edentate, propylene glycol,
anhydrous citric acid, hypromellose, quinoline yellow aluminium lake E104, red iron oxide E172,
talc, titanium dioxide, carnauba wax.
‘Aldomet’ Tablets 125mg are available in packs of 60 and 90 and bottles of 100 and 500.

HOW DOES YOUR MEDICINE WORK?
The active ingredient in your medicine is methyldopa. This belongs to a group of medicines
called ‘alpha-andrenergic agonists’. Methyldopa is converted in to a natural chemical in the body
which acts to lower blood pressure.

3

WHO MAKES YOUR MEDICINE?

‘Aldomet’ Tablets are made by Frost Iberica Cntra. Nacional 11 KM 32.6 28805 Alcala de
Henares, Madrid, Spain and released on to the market by Custom Pharmaceuticals Ltd, Hove,
East Sussex, UK. The Marketing Authorisation is held by Aspen Pharma Trading Limited, 12/13
Exchange Place, Custom House Docks, International Financial Service Centre, Dublin, Ireland.

4

WHY DO YOU NEED TO TAKE THIS MEDICINE?

Your doctor has prescribed ‘Aldomet’ for you because you have a condition known as
hypertension or high blood pressure.

5

ARE THERE PATIENTS WHO SHOULD NOT BE GIVEN THIS MEDICINE?

Yes, do not take ‘Aldomet’ if:
 You have or have had liver disease
 You have had a bad reaction (including allergy) to this medicine or to any ingredients
in the past.
 You have, or have had, a depressive illness
 You are on treatment with monoamine oxidase inhibitors
 You are being treated for high blood pressure due to a tumour near the kidney
If you think any of these apply to you, do not take ‘Aldomet.’ Go and talk to your doctor

first and follow his advice.

6

WHAT ELSE SHOULD YOU KNOW BEFORE TAKING YOUR MEDICINE?

You should check with your doctor before taking ‘Aldomet’:
 If you are or think you may be pregnant
 If you are planning to become pregnant
 If you are breast-feeding
 If you, or one of your close relatives has a condition called hepatic porphyria
 If you have kidney problems
 If you have had a stroke.
You should also tell your doctor that you are being treated with ‘Aldomet’ if you are to have
dialysis, if you are to have laboratory tests, or if you are to have an operation, or a blood
transfusion, as ‘Aldomet’ may affect these.
Your doctor may carry out blood tests and check your liver is working properly during the first 612 weeks that you take ‘Aldomet.’ He may also perform these tests if, for no apparent reason,
you develop a fever at any time while you are taking ‘Aldomet.
If you are unsure or confused, talk to your doctor or pharmacist.

7

WHAT ABOUT DRIVING AND OPERATING MACHINERY?

When you start treatment with ‘Aldomet,’ or if the dose is increased, you may feel drowsy or
light-headed. If this occurs, you should avoid hazardous activities like driving, or operating
machinery.
If you are unsure or confused about whether you should drive, talk to your doctor or pharmacist.

8

CAN YOU TAKE ‘ALDOMET’ WITH OTHER MEDICINES?

There are a few other medicines which may not mix with ‘Aldomet.’ Your doctor knows about
these and will alter your treatment as needed. However, it is important that you tell your doctor
about all the medicines you are taking, including those obtained without a doctor’s prescription.
If you are taking any of the following medicines, you should talk to your doctor before taking
‘Aldomet’:
 Other medicines for high blood pressure
 A medicine called lithium.
 Sympathomimetics (such as adrenaline. Other adrenaline-like medicines are
included in most cough/cold remedies.)
 A group of medicines called ‘tricyclic antidepressants’ used to treat depression
 Monoamine oxidase inhibitors, used to treat depression
 A group of medicines called ‘phenothiazines’, such as chlorpromazine
 Iron and iron supplements

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HOW SHOULD YOU TAKE YOUR MEDICINE?

You should take your medicine by mouth and exactly as advised by your doctor or pharmacist.
The amount you take each day will depend on your condition. It is very important to continue
taking ‘Aldomet’ for as long as your doctor prescribes. Do not take more or less than your doctor
has prescribed.
The following is a guide to the usual doses of ‘Aldomet’:
Adult:
The usual starting does is 250 mg, taken two or three times a day, for the first
two days. Your doctor may change your dose at intervals of two days or longer.

Elderly:
Children:

No more than 3 g should be taken in a day.
If you are elderly, your doctor will probably start you on 125mg twice a day. Your
dose may then be slowly increased, but it should not be more than 2 g per day.
The doctor will work out the number of tablets to be taken, based on weight of
the child. The usual dose for children is 10 mg per kg of body-weight per day,
taken in two to four doses. The number of tablets may be increased or lowered at
intervals. The maximum dosage is 65 mg/kg or 3mg daily, which ever is less.

The number of tablets to be taken will be on the label of your medicine. If you are unsure about
the dose you should take, you must talk to your doctor or pharmacist.

10 WHAT IF YOU FORGET TO TAKE A DOSE OR TAKE TOO MUCH?
Try to take ‘Aldomet’ daily as prescribed. However, if you miss a dose, just carry on with the
next dose as normal. Do not take an extra dose to make up.
If you take too many tablets by mistake, contact your doctor immediately or seek medical
attention.

11 WHAT UNWANTED EFFECTS COULD YOUR MEDICINE HAVE?
Like all medicines, ‘Aldomet’ may occasionally cause side effects in some patients. Sedation,
usually temporary, may occur at the start of treatment or whenever the dose is increased.
Fatigue, headache or weakness may be experienced as early and temporary side effects of
‘Aldomet.’
The following side effects have been reported less frequently: Nervous system effects such as
pins and needles, trembling and shuffling walk, partial paralysis of the face, involuntary
movements, mental changes including nightmares, confusion depression, dizziness, low blood
pressure and light-headedness (particularly when standing up too quickly.) Heart and blood
circulation effects such as slow heart rate, worsening of pre-existing angina, water retention
causing swelling and weight gain. Digestive system problems such as nausea, vomiting,
abdominal pain and bloatedness, constipation, excess wind, diarrhoea, colitis, pancreatic
symptoms (such as severe abdominal and back pain, nausea and vomiting may be present), dry
mouth and sore or black tongue or inflammation of salivary glands.
Other side effects that have occurred include fever, blood disorders such as anaemia, which
affects the components of the blood and can only be detected through blood tests (symptoms
such as pallor, tiredness, fever, sore throat and mouth, bruising and prolonged bleeding after
injury may be present), chest pain, muscle pains, painful and/or swollen joints, liver problems,
jaundice (yellowish skin and/or eyes), skin rash or peeling, severe skin reactions in women, and
changes in sexual function such as impotence, decreased sex drive and failure to ejaculate.
If you notice any of the above effects or you have any unusual symptoms or feelings, seek
medical attention immediately.

12 HOW SHOULD YOUR MEDICINE BE KEPT?
Your medicine must be kept out of reach and sight of children.
Do not store above 25ºC. Store in the original package to protect form light,
Do not transfer your medicine in to another container, as it might get mixed up.
If you have any medicine left over when your doctor tells you to stop using it, return it to the
pharmacist.
Do not use the medicine past the expiry date which is clearly marked on the pack.
REMEMBER: This medicine is for you. Do not share it with anyone else. It may not suit them.

This leaflet was revised May 2011.

13 HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘ALDOMET’?
This leaflet gives you some of the most important patient information about ‘Aldomet’. If you
have any questions after you have read it, ask your doctor or pharmacist, who will give you
further information.

PL39699/0011

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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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