Methyldopa 125mg Tablets
Patient Information Leaflet
797-9271
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.
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.
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:
• 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 Pic 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