Methyldopa 500mg Tablets

Document: leaflet MAH GENERIC_PL 17907-0351 change

180 mm

30 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

METHYLDOPA 250MG AND 500MG TABLETS

Read all of this leaflet 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 signs of illness are the same as yours.

• If you get any side effects, talk to 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 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 your medicine is Methyldopa 250mg or 500mg Tablets.

It contains the active ingredient called methyldopa.

Methyldopa belongs to a group of medicines called antihypertensives, which lower blood pressure. Methyldopa tablets are used to treat high blood pressure (hypertension). It works by relaxing the blood vessels so that blood can flow more easily through the body.

2. What you need to know before you take Methyldopa Tablets

Do not take Methyldopa Tablets if you:

• are allergic to methyldopa or any of the other ingredients of Methyldopa Tablets. See section 6.

• have liver disease

• suffer from depression

• are taking MAOIs (monoamine oxidase inhibitors) for depression.

• have high blood pressure due to a tumour near the kidney

(phaeochromocytoma)

Warnings and precautions:

Check with your doctor or pharmacist before taking methyldopa tablets if you

• or anyone in your family has an illness called 'hepatic porphyria'

• kidney problems

• had a stroke

Check with your doctor while taking this medicine if you are going to have

• dialysis

• an operation

• a blood transfusion

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. Especially:

• alprostadil used to treat erectile dysfunction

• NSAIDs (non-steroidal anti-inflammatory drugs) which are used to relieve pain

• antihypertensive medicines used to treat high blood pressure (e.g. propranolol, nifedipine, verapamil or 'water tablets')

• medicines used to treat anxiety or insomnia (e.g. diazepam, temazepam)

• combined oral contraceptive ("the pill”) or hormone replacement therapy (HRT)

• medicines to treat Parkinson's disease such as levodopa, entacapone, Amantadine

• linezolid (used to treat some infections)

• 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 and sometimes feeling ill and being sick (e.g. chlorpromazine and thioridazine)

• moxisylyte used to treat Raynaud's syndrome

• muscle relaxants such as baclofen, tizanidine

• nitrates (e.g. glycerol trinitrate "GTN”, isosorbide dinitrate/ mononitrate)

• steroids (e.g. prednisolone, hydrocortisone)

• sympathomimetics medicines used mainly for coughs and colds (e.g. ephedrine or salbutamol)

• medicines used to treat ulcers such as carbenoxolone

• iron supplements containing iron, such as multivitamins with minerals

• medicines called 'tricyclic antidepressants' - used to treat depression

Pregnancy, Breast-feeding and Fertility

Tell your doctor if you are pregnant, planning to become pregnant or if you are breast-feeding. If you become pregnant while taking methyldopa, call your doctor immediately. Ask your doctor or pharmacist for advice before taking any medicine.

Tests you may have while taking Methyldopa

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. Tell your doctor you are taking Methyldopa if you have a laboratory test where a urine or blood sample is taken. This is because Methyldopa may affect the results of some types of tests.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Methyldopa.

Methyldopa with food, drink and alcohol

Avoid drinking alcohol while taking this medicine. Methyldopa can add to the effects of alcohol. Your doctor may prescribe a low-salt or low-sodium diet. Follow these directions carefully.

Driving and using machines

You may feel drowsy or light-headed while taking Methyldopa. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Methyldopa Tablets

This medicinal product contains:

• lactose - if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• sunset yellow E110, which may cause allergic reactions.

3. How to take Methyldopa Tablets

• 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Swallow these tablets with water.

Doses:

Adults and children over 12 years:

The recommended initial dose is 250mg two or three times each day, for two days. This dose may be increased at intervals of 2 days until an adequate response is achieved upto 3g each day.

Children under 12 years:

The recommended initial dose is 10mg/kg of bodyweight daily in 2-4 divided doses adjusted as required up to 65mg/kg or 3g each day, whichever is less.

Elderly:

If you are elderly, the recommended dose initially is not exceeding 250mg each day (e.g. 125mg twice daily), increasing as required, up to 2g each day.

Methyldopa may be given with, or instead of, other medicines to lower blood pressure and the doses may need to be amended.

If you take more Methyldopa Tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. ^ixxxxxx

420 mm

Methyldopa Insert

SAME SIZE ARTWORK 180 x 420 mm Front

30 mm

Symptoms of an overdose include excessive drowsiness, weakness, slow heart rate, low blood pressure, dizziness, lightheadedness, painful infrequent bowel movements, bloated feeling, wind, diarrhoea, feeling or being sick.

If you forget to take Methyldopa Tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Methyldopa Tablets Do not stop treatment early because an increase in blood pressure may occur. Talk to your doctor before you stop taking the tablets and follow their advice.

4. Possible side effects

Like all medicines, this medicine 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 or 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, 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

• Keep out of the sight and reach 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.

• 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.

6. Contents of the pack and other information

What Methyldopa Tablets contain

The active ingredient in your tablets is methyldopa.

• Each Methyldopa 250mg Tablet contains methyldopa equivalent to 250mg of anhydrous methyldopa.

• Each Methyldopa 500mg Tablet contains methyldopa equivalent to 500mg of anhydrous methyldopa.

The other ingredients are lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, propylene glycol, polyethylene glycol, colours: titanium dioxide (E171), quinoline yellow aluminium lake (E104), iron oxide yellow (E172) and sunset yellow aluminium lake (E110).

What Methyldopa tablets look like and contents of the pack

• Methyldopa 250mg Tablets are yellow, circular, normal convex film-coated tablets embossed with '250' on one side and 'BL' on the reverse

• Methyldopa 500mg Tablets are yellow, circular, normal convex film-coated tablets embossed with '500' on one side and 'BL' on the reverse

Sodium content per tablet:

• 250 mg tablet - 158 micrograms

• 500 mg tablet - 315 micrograms

Pack sizes:

• 250mg tablets: Containers of 56, 84, 100, 500 and 1000 tablets and blister pack of 56 tablets

• 500mg tablets: Containers of 56, 84, 100 and 500 and blister pack of 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and Address: Bristol Laboratories Limited

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email: info@bristol-labs.co.uk

Methyldopa 250mg Tablets; PL 17907/0350 Methyldopa 500mg Tablets; PL 17907/0351

This leaflet was last revised in May 2016

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

420 mm

V4 11-05-2016 D0

Methyldopa Insert

SAME SIZE ARTWORK

180 x 420 mm

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