1A, Ogunlana Drive, Surulerel Lagos, Nigeria.
Tel: 234-1-8988810, 234-8077717483
Aspen Port Elizabeth (Pty) Ltd, Cnr Fairclogh Road and Gibaud Road, Korsten, Port Elizabeth, 6020, Republic of South Africa.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: A4 - 5443): Methyldopa 250 mg.
Pack sizes: 60's and 100's.
This belongs to a group of medicines called alpha-adrenergic agonists.
Methyldopa is an aromatic-aminoacid decarboxylase inhibitor found in animals and in man. Although the mechanism of action has yet to be conclusively demonstrated, the antihypertensive effect of
Methyldopa probably is due to its metabolism to alpha-methylnorepinephrine, which then lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity.
Methyldopa has been shown to cause a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine, and epinephrine.
Aldomet is indicated for the treatment of hypertension or high blood pressure.
Do not take Aldomet if:
- you have or have had any liver disease
- you have had a bad reaction (including allergy) to this medicine, or to any of the 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. Talk to your doctor first and follow his advice.
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 if your liver is working properly during the first 6-12 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.
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.
Remeber: This medicine is for you. Do not share it with anyone else. It may not suit them.
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 or iron supplements.
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 earlier than usual.
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 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, pancreatitis (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 affect 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 (yellow skin and/or eyes), skin rash or peeling, severe skin reactions, nasal stuffiness, breast enlargement, breast development in men, abnormal production of milk, loss of periods 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 other unusual symptoms or feelings, seek medical attention immediately.
Dosage & Administration
You should take your medicine by mouth and exactly as advised by your doctor or pharmacist. The amount you take each day will depend upon your condition. It is very important to continue taking Aldomel 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:
The usual starting dose is 250 mg, taken two or three times a day, for the first two days. Your doctor may then change your dose at intervals of two days or longer. No more than 3 g should be taken in a day.
If you are elderly, your doctor will probably start you on a low dose (not exceeding 250 mg 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 the weight of the child. The usual initial 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 3 g daily, whichever 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.
This medicine must be kept out of the reach and sight of children.
Do not store above 25°C. Store in the original package to protect from light.
Do not transfer your medicine into 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.