Patient leaflet - Methyldopa 250 mg tablets
1. What Methyldopa tablets is and what it is used for
Methyldopa tablets contains the active substance called methyldopa. This belongs to a group of medicines called ‘antihypertensives’. Methyldopa is changed inside your body to a natural substance that lowers blood pressure. Your doctor has prescribed Methyldopa tablets to treat high blood pressure (hypertension).
2. What you need to know before you take Methyldopa tablets
Do not take Methyldopa tablets if you have:
- ever had a bad reaction, such as an allergy to methyldopa, or to any of the other ingredients (listed in section 6)
- ever had liver disease
- ever had depression
- high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma’ or ‘paraganglioma’.
- been taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor)
- porphyria (a rare, inherited blood disorder)
Do not take Methyldopa tablets if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Methyldopa tablets.
Take special care with Methyldopa tablets
Talk to your doctor or pharmacist before taking Methyldopa tablets if you have:
- a blood disorder called haemolytic anaemia
- liver problems
- jaundice (yellowing of the skin and eyes)
- fever
- any abnormal movements (involuntary)
Check with your doctor while taking this medicine if you are going to have:
- dialysis
- an operation
- a blood transfusion.
Tests you may have while taking Methyldopa tablets
Your doctor may do blood tests to check how your liver is working during the first 6 - 12 weeks. He or she may use similar tests if you have a fever at any time while you are taking Methyldopa tablets. Tell your doctor you are taking Methyldopa tablets if you have a laboratory test where a urine or blood sample is taken. This is because Methyldopa tablets may affect the results of some types of tests.
Rarely, in patients taking Methyldopa tablets urine may darken when it is exposed to air after voiding. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Methyldopa tablets. Other medicines and Methyldopa tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as some drugs may affect each other’s action. This includes herbal medicines.
Do not take Methyldopa tablets if you are taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used to treat depression.
It is particularly important that you tell your doctor or pharmacist if you are taking any of the following before taking Methyldopa tablets
- other medicines for high blood pressure (antihypertensives)
- lithium - used to treat some types of 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
- cough and cold remedies that contain a decongestant
- iron and supplements containing iron, such as multivitamins with minerals
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Methyldopa tablets. Surgery
If you have to have surgery, including dental, that requires an anaesthetic, you must inform the dentist or hospital that you are taking Methyldopa tablets.
Methyldopa tablets with alcohol
You are advised not to drink alcohol while taking Methyldopa tablets. Discuss this with your doctor if you have any questions. Pregnancy and breast-feeding
You should check with your doctor before taking Methyldopa tablets if you are or think you may be pregnant, if you are planning to become pregnant or if you are breast-feeding.
Driving and using machines
You may feel drowsy or light-headed while taking Methyldopa tablets. If this happens do not drive or use any tools or machines.
3. How to take Methyldopa tablets
Always take Methyldopa tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
You should take this 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 Methyldopa tablets for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.
The usual doses of Methyldopa tablets are:
Adults
- 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.
The 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.
Children
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.
If you take more Methyldopa tablets than you should
If you take too many tablets by mistake, contact your doctor immediately or seek medical attention. If you forget to take Methyldopa tablets
- If you forget to take a dose, just carry on with the next dose as normal.
- Do not take a double dose to make up for a forgotten dose.
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.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor IMMEDIATELY if you have any of the following side effects as they are serious and require medical attention:
- an allergic reaction - symptoms such as shortness of breath, skin rash or itching, hives, swelling of your lips, face or tongue, chills or
- fever or painful joints
- chest pain, slow heart rate, existing angina made worse, problems with the electrical current in the heart (AV block)
- 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
- your medicine may alter the numbers and types of your blood cells and cause a rise in urea in the blood 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
- Parkinsonism - with symptoms such as tremor, a decrease in body movements with an inability to move your muscles
- 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
- delusions and paranoia - which will stop when you stop taking this medicine
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.
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.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Methyldopa tablets
Keep out of the reach and sight of children.
Do not use the medicine past the expiry date which is stated on the side of the carton after 'Exp'. The expiry date refers to the last day of that month.
Do not store above 25°C.
Blisters: Store in the original package in order to protect from light.
Bottles: Keep the container tightly closed in order to protect from light.
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 contains
Active substances
The active ingredient in Methyldopa tablets is methyldopa.
Methyldopa tablets are available in two different strengths containing methyldopa equivalent to either 250 mg anhydrous methyldopa, or 500 mg anhydrous methyldopa.
Other ingredients
Cellulose powder, anhydrous citric acid, colloidal anhydrous silica, ethylcellulose, guar gum, magnesium stearate, sodium calcium edetate, hypromellose, propylene glycol, quinoline yellow aluminium lake E104, red iron oxide E172, talc, titanium dioxide, citric acid monohydrate. What Methyldopa tablets looks like and contents of the pack
Methyldopa is available as film-coated tablets which come in two different strengths. They are yellow-coloured, round tablets containing methyldopa equivalent to either 250 mg anhydrous methyldopa, or 500 mg anhydrous methyldopa. Methyldopa 250mg tablets are available in packs of 60.
Methyldopa 500mg tabletsare available in packs of 30.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Manufacturer
Aspen Bad Oldesloe GmbH,
Industriestraße 32 – 36,
23843 Bad Oldesloe,
Germany
The leaflet was last amended April 2022
Trademarks are owned by or licensed to the Aspen Group of companies. © 2022 Aspen Group of companies or its licensor. All rights reserved.
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