Methyldopa Tablets Bp 500mg
PATIENT INFORMATION LEAFLET
Methyldopa 250mg Tablets & Methyldopa 500mg Tablets Read all of this leaflet carefully before you start taking your medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist (chemist).
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Methyldopa is an antihypertensive agent. It used for the treatment of high blood pressure (hypertension).
2. BEFORE YOU TAKE YOUR MEDICINE
Do NOT take this medicine and tell your doctor if you:
• Suffer from active hepatic disease (such as acute hepatitis and active cirrhosis)
• Ever had an allergic reaction (including hepatic disorders associated with previous Methyldopa therapy) to Methyldopa or any of the ingredients in the tablets
• Suffer from phaeochromocytoma (tumour of adrenal gland)
• Suffer from depression
• Are undertaking therapy with monoamine oxidase inhibitors (MAOIs) Warnings and precautions
Talk to your doctor or pharmacist before taking Methyldopa Tablets if you:
• Suffer from cerebrovascular disease (damaged or diseased blood vessels in your brain).
• Suffer from angina (a disease of the coronary arteries of the heart) or heart problems?
• You have ever had a stroke
• Suffer from blood problems (porphyria)
• Suffer from any kidney problems such as discolouration of the urine or you are receiving dialysis
• Suffer from Parkinson"s disease
• Are pregnant or trying to become pregnant
• Are breast feeding
Your doctor may prescribe other medicines, such as thiazide diuretics, (water tablets) to be taken with your medicine. Tell your doctor if your condition does not continue to improve or if your condition gets worse. Your doctor may prescribe another treatment for your condition.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
• Other drugs that are used to treat high blood pressure (anti-hypertensives, nitrates, calcium channel blockers, beta-blockers)
• Monoamine oxidase inhibitors (isocarboxazide, phenelzine, tranylcypromine) - used to treat depression.
• Water tablets (thiazide diuretics) such as bendrofluazide, benzthiazide, chlorothiazide,
• Cyclopenthiazide, hydrochlorothiazide, hydroflumethiazide, polythiazide.
• Lithium containing medicines- used to treat mental illness or 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
• Treatments for Parkinson"s disease, e.g. levodopa and entacapone.
• Patients on methyldopa may require reduced doses of anaesthetics. The anaesthetist
• Should be informed that you are taking methyldopa.
• Alcohol may enhance the hypotensive (blood pressure lowering) effects of Methyldopa and should therefore be avoided when taking this medicine.
• Iron preparations such as ferrous sulphate or ferrous gluconate
• Muscle relaxants used for pain relief (e.g. baclofen and tizanidine)
• Oral contraceptives, "the pill" or hormone replacement therapy (HRT)
• Medicines to treat asthma, e.g. Salbutamol or some cough and cold medicines (e.g. ephedrine containing medicines)
• Medicines in the treatment of ulcers, example carbenoxolone
• Alprostadil - a treatment for erectile dysfunction (impotence), moxisylyte -(to treat Raynauds phenomenon).
• Some analgesics used to relieve pain or inflammation (NSAIDs- Nonsteroidal anti-inflammatory drugs)
• Linezolid, used to treat some infections.
• Some medicines used to treat anxiety or insomnia, e.g. diazepam.
• Corticosteroids, used in the treatment of Crohn"s disease or an inflamed bowel.
• Medicines to treat mental illness (chlorpromazine or thioridazine)
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including any medicines that you can buy without prescription and herbal products.
Tests
Tell your doctor you are taking Methyldopa if you are due to have tests carried out, e.g. urine tests or blood tests. Your doctor may also decide to perform regular blood tests (at the start of treatment and 3 months later) to check your liver is working normally.
Surgery
If you are due to have an operation, including dental surgery, which requires an anaesthetic let the surgeons know what medicines you are taking.
Pregnancy and breast-feeding
Always talk to your doctor before taking any medicine if you are pregnant, planning to become pregnant or are breast-feeding. Methyldopa should only be used during pregnancy if there are no safe alternatives and if the mother and baby are at risk from the degree of high blood pressure.
Methyldopa is excreted in breast milk and should not be used by nursing mothers. Always check with your doctor if you are not sure.
Driving and using machines
You may experience drowsiness or dizziness when you take this medicine. If you are affected by these symptoms do not drive or operate machinery.
3. HOW TO TAKE YOUR MEDICINE
Take this medicine exactly how your doctor or pharmacist has told you to. Their directions may differ from the information contained in this leaflet. The pharmacist's label should tell you how much to take and how often. If it does not, or you are unsure, check with your doctor or pharmacist.
Take your medicine by mouth. Swallow tablets with water.
Adults and children over 12 years:
The usual starting dose is 250mg 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 until an adequate response is achieved. The maximum recommended daily dose should not exceed 3g.
Children under 12 years:
The usual starting dose for children is 10 mg per kg of body weight daily, taken in 2 to 4 doses. The dose is then increased or decreased until an adequate response is achieved.
Maximum dose is 65 mg per kg of body weight daily or 3.0 g daily, whichever is less.
Elderly:
If you are elderly your doctor may start you on a low dose, no more than 125 mg twice daily, which can be increased slowly as required, to a maximum of 2 g daily. An alternative tablet preparation may therefore be required initially for this age group.
If you take more of your medicine than you should
If you accidentally take too much medicine, contact your doctor or nearest hospital accident department immediately. Symptoms of overdose include low blood pressure, drowsiness, weakness, dizziness, light headedness and stomach problems.
If you forget to take your medicine
Take your medicine daily as your doctor has told you to. However, if you forget to take your medicine, or miss a dose, take it as soon as you remember, then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it even if you feel better. If you stop taking the medicine, your condition may re-occur or get worse.
If you have any questions on the use of your medicine contact your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methyldopa can cause side effects, although not everybody gets them. Tell your doctor as soon as possible, if you notice any of the following serious side effects such as:
• Chest pain, slow heart rate, or existing angina made worse
• Severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)
• Liver problems, including jaundice and hepatitis - signs include yellowing of your skin and eyes, sometimes with a fever, pale stools and dark urine
• Pain in the gut and diarrhoea caused by inflammation of the bowel (colitis)
• Severe pain in the gut and back caused by inflammation of the pancreas (pancreatitis).
The following reactions have also been reported:
Blood:
• Reduction in red blood cells (anaemia) - this can make your skin pale and make you weak or breathless
• Abnormal blood test causing symptoms such as pale skin, tiredness, fever and sore throat
• Bruising and prolonged bleeding after injury Nervous system:
• Feeling sleepy or tired - this may happen at the start of treatment or when the dose is increased, and usually goes away
• Headache or feeling weak - this may happen at the start of treatment and usually goes away
• Pins and needles
• Being unable to move part of your face (paralysis)
• Having movements you cannot control
• Confusion
• Frequent dizziness or fainting
• Dizziness due to low blood pressure and light-headedness (particularly when standing up quickly)
Nose and chest:
• Nasal stuffiness
Stomach and gut:
• Feeling sick
• Being sick
• Abdominal pain
• Feeling bloated
• Constipation
• Excess wind
• Diarrhoea
• Dry mouth
• Sore or black tongue
Skin and hair:
• Skin rash or peeling skin
Joints and muscles:
• Painful and/or swollen joints
• Muscle pains
Infections:
• Swelling of salivary glands General:
• Water retention causing swelling and weight gain
• Fever Sexual:
• Breast enlargement
• Breast development in men
• Loss of periods in women
• Abnormal production of milk
• Changes in sexual function such as impotence and not being able to ejaculate
• Decreased sex drive
Psychiatric:
• Mental changes, including nightmares or depression Laboratory tests:
• Your doctor may need to carry out simple blood tests during the first few months of therapy with Methyldopa. Results could show:
• A decrease in blood cell production
• An increase in some white blood cells
• Abnormal levels of prolactin
Methyldopa may also interfere with the interpretation of certain blood and urine tests. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 YOUR MEDICINE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use your medicine after the expiry date shown on the label.
Store this medicine in a dry place below 25oC and protect it from light. Keep it in the pack in which it was given to you. Do not transfer your medicine to another container.
If your doctor tells you to stop your treatment, return any left over to the pharmacist. Only keep it if your doctor tells you to.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Methyldopa Tablets contain
Active ingredient: 250 mg or 500 mg of Anhydrous Methyldopa as Methyldopa BP. Each tablet also contains Citric Acid , Disodium Calcium Edetate , Ethylcellulose , Guar Gum , Microcrystalline Cellulose PHIOI (Avicel) , Silicon Dioxide , Magnesium Stearate , Isopropyl Alcohol , Hydroxypropylmethylcellulose (2910) , Ethylcellulose , Diethylphthalate , Opaspray K-1-6039 Yellow, Quinoline Yellow Aluminium Lake (E104).
What Methyldopa Tablets look like and contents of the pack
Methyldopa Tablets BP are film coated yellow coloured tablets. These tablets are available in 250 mg and 500 mg strengths.
The 250mg strength tablets are available in packs of 100, 500, and 1000. The 500mg tablets are available in packs of 100 and 500.
The Marketing Authorisation holder is:
Relonchem Limited, Cheshire House, Gorsey Lane, Widens, Cheshire, WA8 0RP. Methyldopa Tablets BP 250mg: PL Number: PL20395/0110 Methyldopa Tablets BP 500mg: PL Number: PL20395/0111
Date of revision of leaflet: April 2016.