Methyldopa Tablets Bp 500mg
PACKAGE LEAFLET: INFORMATION FOR THE USER Methyldopa Tablets B.P. 250 mg & 500 mg
(Referred to as Methyldopa Tablets in the remainder of the leaflet)
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 please ask your doctor or pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Methyldopa Tablets are and what they are used for
2. What you need to know before you take Methyldopa Tablets
3. How to take Methyldopa Tablets
4. Possible side effects
5. How to store Methyldopa Tablets
6. Contents of the pack and other information.
1. What Methyldopa Tablets are and what they are used for
The name of this medicine is Methyldopa Tablets. Methyldopa, the active ingredient in these tablets, belongs to a group of medicines called antihypertensives. These medicines work by lowering blood pressure. Methyldopa Tablets may be used for the treatment of severe hypertension (high blood pressure).
2. What you need to know before you take Methyldopa Tablets Do not take Methyldopa Tablets and tell your doctor if you:
are allergic to methyldopa or any of the other ingredients in the tablets (see section 6) have a history of depression
have been diagnosed as having a liver disorder such as acute hepatitis and active cirrhosis have been diagnosed as having phaeochromocytoma (a disorder of the adrenal glands)
are taking MAOIs (monoamine oxidase inhibitors) for depression.
Check with your doctor or pharmacist before taking Methyldopa tablets if you:
• have ever had liver disease
• have kidney disease
• or a relative have a genetic/inherited disorder of the red blood pigment haemoglobin (porphyria)
• have ever had a stroke.
If any of the above applies to you this medicine may not be suitable for you to use. Your doctor will advise you. Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• antihypertensive medicines used to treat high blood pressure (e.g. propranolol)
• medicines to treat Parkinson's disease (e.g. levodopa)
• lithium - used to treat depression and mental illness
• MAOIs (mono-amine oxidase inhibitors) used to treat depression (e.g. phenelzine)
• medicines to treat mental illness (e.g. chlorpromazine)
• medicines called 'tricyclic antidepressants' used to treat depression
• medicines used mainly for coughs and colds that contain a decongestant (e.g. ephedrine)
• iron or iron supplements
•diuretic medicines used to increase urine output.
Pregnancy and breast-feeding
You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take this medicine.
Methyldopa passes into breast milk, therefore, if you are breast-feeding, this medicine should be avoided.
Your doctor will be able to discuss this with you to determine whether the anticipated benefits are worth the possible risks.
Driving and using machines
Methyldopa Tablets may make you feel drowsy or light-headed. If this occurs, you should avoid driving or using machinery.
Important information about some of ingredients of Methyldopa Tablets:
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Other precautions you should take
Methyldopa may affect the results of certain laboratory tests. If you see another doctor, go into hospital, or are to have dental treatment or other surgery that requires an anaesthetic, it is important to let them know what medicines you are taking.
Regular checks (before the start of treatment and 6-12 weeks later) may be carried out on blood cells and liver function (blood test to show your liver is working).
3. How to take Methyldopa Tablets
Always take Methyldopa Tablets as your doctor tells you to. They will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and body weight. Your doctor will find the lowest dose to control your symptoms.
Adults and children over 12 years:
•The usual starting dose for the first two days is 250 mg two or three times a day.
• Your doctor may then change your dose depending on how you respond.
• You should not take more than 3000 mg in a day.
Children under 12 years:
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 for each kg of body-weight each day.
• This dose is taken in two to four doses during the day.
• Your doctor may then change the dose, depending on how the child responds.
• A child will not usually take more than 65 mg for each kg (or 3000 mg a day), whichever is less.
Elderly:
• The usual starting dose will not be more than 250 mg each day.
• Your doctor may then slowly increase the dose.
• You should not usually take more than 2000 mg in a day.
If you take more Methyldopa Tablets than you should:
If you take too much medicine or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take Methyldopa Tablets:
If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when it is due.
If you stop taking Methyldopa Tablets
Do not stop taking Methyldopa Tablets without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methyldopa Tablets can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Methyldopa Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
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:
• your medicine may alter the numbers and types of your blood cells and cause a rise in urea in the blood. If you notice increased bruising, nosebleeds, sore throats, infections or fever, you should tell your doctor who may want to give you a blood test
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 Tablets.
Results could show:
• a decrease in blood cell production
• an increase in some white blood cells
• abnormal levels of prolactin
Methyldopa Tablets 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, pharmacist or nurse. 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 Methyldopa Tablets
Do not store above 25°C. Store in the original package in order to protect from light.
Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date on the pack. Return any leftover medicine to your pharmacist.
Only keep it if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Methyldopa Tablets contain
The active substance is methyldopa. Each film-coated tablet contains either 250 mg or 500 mg of the active substance.
The tablets also contain, citric acid, lactose monohydrate, maize starch, talc, magnesium stearate, stearic acid, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) and silica colloidal anhydrous (500mg only).
What Methyldopa Tablets look like and contents of the pack Methyldopa Tablets B.P. 250 mg are round yellow film-coated biconvex tablets.
Methyldopa Tablets B.P. 500 mg are round yellow film-coated biconvex tablets, each having 'M500' embossed on one side.
Methyldopa Tablets BP 250 mg and 500 mg are packed in blister strips in cartons containing 28 or 56 tablets.
Note: not all strengths and / or pack sizes may be available in all markets.
Marketing Authorisation Holder and Manufacturer Intrapharm Laboratories Limited,
The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT.
Other formats
To request a copy of this leaflet in Braille, large print or audio please call Intrapharm on +44 (0)1628 771800.
PL 17509/0035 Methyldopa Tablets B.P.250mg PL 17509/0036 Methyldopa Tablets B.P. 500mg
Date leaflet revised: March 2016