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Methyldopa Tablets Bp 250mg

Document: leaflet MAH GENERIC_PL 00142-0093 change

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Methyldopa 125mg, 250mg and 500mg tablets

Read all of this leaflet carefully before you start to take your medicine.

•    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.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

^ What Methyldopa tablets are and what they are used for

Before you take How to take Possible side effects T| How to store a Further information

T| What Methyldopa tablets are and what they are used for

Methyldopa belongs to a group of medicines called antihypertensives, which lower blood pressure. Methyldopa tablets are used to treat high blood pressure (hypertension).

^1 Before you take

Do not take Methyldopa tablets and tell your doctor if you:

•    are allergic (hypersensitive) to methyldopa or any of the other ingredients. (see section 6).

•    have liver disease

•    have high blood pressure due to a tumour near the

kidney (phaeochromocytoma)

•    suffer from depression

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

Check with your doctor or pharmacist before taking Methyldopa tablets if you:

•    have had liver disease

•    have kidney disease

•    or a relative have a genetic/inherited disorder of the red blood pigment haemoglobin (porphyria)

•    have damaged or diseased blood vessels in your brain.

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:

   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

   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 (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.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Methyldopa tablets may make you feel drowsy. Make sure you are not affected before you drive or operate machinery.

Colourants

Each tablet contains sunset yellow (E110) which may cause allergic reactions.

Blood tests

Methyldopa may affect the results of certain laboratory tests.

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).


Surgery

If you have to have surgery, including dental, that requires an anaesthetic let them know what medicines you are taking.

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|3| How to take

Always take Methyldopa tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. You are advised not to drink alcohol with this medicine. Discuss this with your doctor if you have any questions.

Swallow these tablets with water.

Doses:

Adults and children over 12 years:

Initially 250mg two or three times a day, for 2 days. Then increased every 2 or more days until an adequate response is achieved up to a maximum of 3g daily.

Children under 12 years:

Initially 10mg per kg of bodyweight daily in 2-4 divided doses adjusted as required up to 65mg/kg or 3g daily, whichever is less.

Elderly:

Initially no more than 250mg a day (e.g. 125mg twice daily), increasing up to a maximum of 2g a 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 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.

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

If you forget to take the 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 the 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.

14 Possible side effects

Like all medicines, Methyldopa tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

   Allergic reactions: inflammation of heart muscle or the sac surrounding the heart skin rash which may be red and/or scaly, fever.

   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.

   Endocrine system: abnormal production of milk.

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   Central nervous system: drowsiness (usually lasts a few days at start of treatment or after an increased dose), headache, loss of strength or weakness, tingling or pins and needles, trembling and shuffling walk, partial paralysis of the face, involuntary jerky movements, mental changes including nightmares, confusion, mild depression, dizziness, lightheadedness, reduced blood flow to the brain.

   Heart: slow heart rate and low blood pressure, worsening of existing angina, low blood pressure causing dizziness on standing, water retention causing swelling and weight gain.

   Respiratory system: blocked/stuffy nose.

   Stomach and intestines: feeling or being sick, bloated stomach, constipation, wind, diarrhoea, colitis, mild dryness of the mouth, sore or "black" tongue, inflamed salivary glands and inflammation of the pancreas (pancreatitis). Tell your doctor immediately if you get very severe abdominal pains.

   Liver: abnormal liver function, hepatitis, jaundice (yellowing of the skin and/or whites of the eyes). These would be detected by a blood test.

   Skin : eczema, hard skin rash (lichenoid), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis).

   Muscles and bones: mild joint pain with or without swelling. Muscle pain or cramps.

   Reproductive system and breasts: absence of periods, swelling of breasts in men and women, production of breast milk, failure to ejaculate, decreased sex drive, failure to maintain an erection (impotence).

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/Vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

~5| How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place. Protect from light.Do not use Methyldopa tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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.

a Further information

What Methyldopa tablets contain

•    The active substance (the ingredient that makes the tablet work) is anhydrous methyldopa. Each film-coated tablet contains either 125mg, 250mg or 500mg of the active substance.

•    The other ingredients are polyvidone, sodium edetate, magnesium stearate, crospovidone, precipitated silica, macrogol, talc, E104, E110 (sunset yellow), E132, E171, E172, E330, E460, E464.

What Methyldopa tablets look like and contents ofthe pack

Methyldopa tablets are yellow, circular, biconvex, film-coated tablets.

Pack size: 56

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in June 2014.

Actavis, Barnstaple, EX32 8NS, UK AAAG9639 50809801