Methyldopa 250mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHYLDOPA 250 mg & 500 mg TABLETS
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Read all of this leaflet carefully before you start taking this 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.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
THIS LEAFLET CONTAINS
1. What Methyldopa is for
2. Before you take Methyldopa
3. How to take Methldopa
4. Possible side effects
5. How to store Methyldopa
6. Further information
1. WHAT METHYLDOPA IS FOR
Methyldopa belongs to a group of medicines called anti-hypertensives. It is used to lower high blood pressure, (hypertension).
If you are not sure why you have been prescribed this medicine then please ask your doctor.
2. BEFORE YOU TAKE METHYLDOPA
Do not take Methyldopa and tell your doctor if you:
• are allergic (hypersensitive) to Methyldopa or any of the other ingredients in these tablets (listed in section 6 of this leaflet).
The signs of an allergic reaction include a rash, itching or difficulty breathing.
• have active liver disease (such as hepatitis or cirrhosis)
• are suffering from depression
• have high blood pressure due to a tumour on the adrenal gland, near the kidney (phaeochromocytoma)
• have an inherited blood disorder of the red blood pigment haemoglobin known as acute porphyria
• are taking MAOIs (monoamine oxidase inhibitors) for depression.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Methyldopa.
Take special care with Methyldopa
Tell your doctor before you take this medicine if you:
• have kidney disease.
• have previously had liver disease.
• have a history of depression.
• suffer from an abnormal breakdown of red blood cells which can make the skin pale or yellow and cause weakness or breathlessness (haemolytic anaemia).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Methyldopa.
Operations and tests
If you are going to have an operation or an anaesthetic, tell your doctor, dentist or nurse that you are taking Methyldopa.
Methyldopa may affect the results of certain laboratory tests.
Regular checks, (before the start of treatment and for 6-12 weeks after), may be carried out on blood cells and liver function.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription.
This is because Methyldopa can affect the way some medicines work. Also some medicines can affect the way Methyldopa works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• other medicines to treat high blood pressure such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), clonidine, diazoxide, guanethidine, hydralazine, minoxidil, moxonidine or sodium nitroprusside
• medicines to treat high blood pressure or chest pain (angina) such as propranolol, atenolol (beta-blockers), amlodipine, felodipine (calcium-channel blockers), bendroflumethiazide, furosemide (diuretics), glyceryl trinitrate, isosorbide mononitrate (nitrates)
• medicines to treat anxiety or mental health problems such as diazepam, lorazepam, temazepam, chlorpromazine, haloperidol, pimozide or lithium
• medicines known as MAOIs, (monoamine oxidase inhibitors), used to treat depression such as phenelzine, moclobemide or tranylcypromine
• medicines known as NSAIDs, (non-steroidal anti-inflammatory drugs), for pain and inflammation such as aspirin, ibuprofen or indometacin
• steroids such as hydrocortisone or prednisolone to treat swelling and allergies
• medicines to treat Parkinson's disease such as levodopa or entacapone
• muscle relaxants such as baclofen and tizanidine
• oestrogens used for contraception or hormone replacement therapy (HRT)
• moxisylyte to treat blood circulation problems like Raynaud's disease
• salbutamol used to treat asthma and other airways problems
• alprostadil for problems maintaining an erection
• aldeslukin to treat cancer
• iron supplements
AVOID ALCOHOL whilst taking Methyldopa tablets. This is because alcohol can affect the way Methyldopa works.
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 Methyldopa or any other medicine.
Driving and using machines
Methyldopa tablets may make you feel drowsy. Make sure you are not affected before you attempt to drive or operate machinery.
3. HOW TO TAKE METHYLDOPA
Taking this medicine
Always take Methyldopa tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
These tablets should only be taken by mouth. Swallow them whole with water.
Adults
The usual starting dose is 250 mg, two times a day, for 2 days. After which your doctor may gradually increase the dose at intervals of 2 or more days, until an adequate response is achieved. The maximum dose is 3 g daily.
Children
The usual starting dose is 10 mg per kg of bodyweight daily taken in 2 - 4 divided doses, increased as required up to a maximum of 65 mg per kg of bodyweight or 3 g daily, whichever is less.
Elderly
The usual starting dose is 250 mg a day (e.g. 125 mg twice daily). Your doctor may gradually increase the dose if necessary, up to a maximum of 2 g 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 Methyldopa than you should
If you (or someone else) take too many tablets, contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the container with you so they know what has been taken.
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 Methyldopa
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose skip the missed dose, do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you suddenly stop taking Methyldopa
Do not stop taking this medicine until your doctor tells you to. Your doctor will advise you on how best to do this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methyldopa can cause side effects, although not everybody gets them.
If you get any of the following side effects, STOP TAKING Methyldopa and tell your doctor immediately or go to the nearest hospital emergency department:
• an allergic reaction to Methyldopa which may cause any kind of rash, red and/or scaly skin, or swelling. You could also notice sudden wheezing, fluttering or tightness of the chest, collapse, inflammation of heart muscle or the sac surrounding the heart.
If you get any of the following side effects, see a doctor straight away:
• slow heart beats or heart failure (signs include breathlessness and swollen ankles)
• altered numbers and types of blood cells. If you notice increased bruising, bleeding, sore throats, infections or fever, you should tell your doctor who may want to give you a blood test
• severe stomach or back pain, this could be a sign of an inflammation of the pancreas (pancreatitis)
• severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis)
Tell your doctor or pharmacist if you get any of these side effects:
Effects on the blood: raised levels of urea in the blood
Effects on the brain and central nervous system:
mental changes including nightmares, confusion, mild depression, decreased sex drive, drowsiness (usually lasts a few days at start of treatment or after an increased dose), headache, tingling or pins and needles, trembling and shuffling walk, partial paralysis of the face, involuntary jerky movements, decreased mental sharpness, dizziness, light-headedness, reduced blood flow to the brain
Effects on the heart: worsening of existing angina, low blood pressure causing dizziness on standing
Effects on the respiratory system: blocked/stuffy nose
Effects on the 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
Effects on the liver: abnormal liver function, yellowing of the skin and/or whites of the eyes (jaundice), inflammation of the liver (hepatitis). These would be detected by a blood test.
Effects on the skin: eczema, hard skin rash (lichenoid)
Effects on the muscles and bones: mild joint pain with or without swelling, muscle pain
Effects on your reproductive system and breasts:
swelling of breasts in men and women, abnormal production of breast milk, absence of periods, failure to maintain an erection (impotence) and failure to ejaculate
General effects: Fever, water retention causing swelling and/or weight gain
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METHYLDOPA
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Store below 25°C in a dry place Protect from light and keep the container well closed.
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. FURTHER INFORMATION
What Methyldopa tablets contain
The active substance (the ingredient that makes the tablets work) is anhydrous Methyldopa. Each tablet contains either 250 mg or 500 mg of the active substance.
The other ingredients are citric acid, sodium calcium edetate, microcrystalline cellulose, magnesium stearate, ethylcellulose, colloidal anhydrous silica, guar gum, opaspray K-1-6039 (titanium dioxide E171, talc, iron oxide yellow E172, hydroxypropyl cellulose), hypromellose, diethyl phthalate, dispersed yellow 14650 E104
What Methyldopa tablets look like and contents of the pack
The 250 mg tablets are yellow film-coated tablets, engraved MEDOMET 250 on one side.
The 500 mg tablets are yellow, bi-convex film-coated tablets.
Methyldopa 250 mg and 500 mg tablets both come in plastic containers of 56, 100 and 500 tablets. Methyldopa 500 mg tablets also come in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited Boumpoulinas 11, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.