Methyldopa 500mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER ALDOMET® 250mg TABLETS/ METHYLDOPA 250mg TABLETS ALDOMET® 500mg TABLETS/ METHYLDOPA 500mg TABLETS
(methyldopa)
This medicine is available as any of the above names but will be referred to as Aldomet throughout the following 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.
What is in this leaflet:
1. What Aldomet is and what it is used for
2. What you need to know before you take Aldomet
3. How to take Aldomet
4. Possible side effects
5. How to store Aldomet
6. Contents of the pack and other information
|1. WHAT ALDOMET IS AND WHAT IT IS USED FOI
Aldomet 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 Aldomet to treat high blood pressure (hypertension).
|2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALDOME'
Do not take Aldomet 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 Aldomet if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Aldomet.
Take special care with Aldomet
Talk to your doctor or pharmacist before taking Aldomet 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 Aldomet
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 Aldomet. Tell your doctor you are taking Aldomet if you have a laboratory test where a urine or blood sample is taken. This is because Aldomet may affect the results of some types of tests.
Rarely, in patients taking Aldomet 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 Aldomet.
Other medicines and Aldomet
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 Aldomet 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 Aldomet
• 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 Aldomet. Surgery
If you have to have surgery, including dental, that requires an anaesthetic, you must inform the dentist or hospital that you are taking Aldomet tablets.
Aldomet with alcohol
You are advised not to drink alcohol while taking Aldomet tablets. Discuss this with your doctor if you have any questions.
Pregnancy and breast-feeding
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 or if you are breast-feeding.
Driving and using machines
You may feel drowsy or light-headed while taking Aldomet. If this happens do not drive or use any tools or machines.
|3. HOW TO TAKE ALDOME'
Always take Aldomet 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 Aldomet for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.
The usual doses of Aldomet 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 Aldomet than you should
If you take too many tablets by mistake, contact your doctor immediately or seek medical attention.
If you forget to take Aldomet
• 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 Aldomet
Do not stop taking Aldomet without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
. POSSIBLE SIDE EFFECTSl
Like all medicines, Aldomet 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 Aldomet. Results could show:
- a decrease in blood cell production
- an increase in some white blood cells
- abnormal levels of prolactin
Aldomet 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 ALDOME'
• Keep out of the sight and reach 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.
• Do not use the medicine past the expiry date, which is clearly marked on the pack. The expiry date refers to the last day of that month.
• If you have any medicine left over when your doctor tells you to stop using it, return it to the pharmacist.
• 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.
• If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist who will advise you what to do.
|6. CONTENTS OF THE PACK AND OTHER INFORMATION!
What is in your medicine?
The active ingredient in Aldomet is methyldopa.
Aldomet are available as film-coated tablets, which come in two different strengths.
Each Aldomet 250mg Tablets contains methyldopa equivalent to 250mg anhydrous methyldopa. They are yellow-coloured, circular, biconvex tablets and are debossed with ‘ALDOMET' on one side and ‘250' on the reverse.
Each Aldomet 500mg Tablets contains methyldopa equivalent to 500mg anhydrous methyldopa. They are yellow -coloured, circular, biconvex tablets and are debossed with 'ALDOMET' on one side and '500' on the reverse.
Aldomet contains: 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 (E171).
Aldomet 250mg Tablets are available in blister packs of 60.
Aldomet 500mg Tablets are available in blister packs of 30 and 60.
|POM| PL No 15814/0897 Aldomet 250mg Tablets/ Methyldopa 250mg Tablets
PL No 15814/0898 Aldomet 500mg Tablets/ Methyldopa 500mg Tablets
Who makes your medicine?
Aldomet are made by Iroko Products Limited, One Silk Street, London, EC2Y 8HQ and procured from within the EU and repackaged by the Product Licence Holder O.P.D. Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 10.03.2016.
Aldomet is a registered trademark of Iroko Pharmaceuticals, LLC.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.