Methyldopa 125Mg, 250Mg and 500Mg Tablets

Home , Methyldopa

Package leaflet: Information for the patient Methyldopa 125mg, 250mg and 500mg tablets Read all of this leaflet carefully before you start to • start to show symptoms of reduced blood cells including take your medicine because it contains important pale skin, jaundice, infection, fever, weakness, unexpected information for you. bruising or bleeding, headaches (acquired haemolytic • Keep this leaflet. You may need to read it again. anaemia (indicated by a positive Coombs test), leucopenia • If you have any further questions, ask your doctor or and thrombocytopenia are all reversible on stopping pharmacist. methyldopa treatment). • This medicine has been prescribed for you only. Other medicines and Methyldopa tablets Do not pass it on to others. It may harm them, even Please tell your doctor or pharmacist if you are taking, have if their signs of illness are the same as yours. recently taken or might take any other medicines, including • If you get any side effects, talk to your doctor or medicines obtained without a prescription. Especially: pharmacist. This includes any possible side effects • alprostadil used to treat erectile dysfunction not listed in this leaflet. See section 4. • antihypertensive medicines used to treat high blood pressure (e.g. propranolol, nifedipine, verapamil or ‘water What is in this leaflet tablets’) 1 What Methyldopa tablets are and • medicines to treat Parkinson’s disease such as levodopa, what they are used for entacapone • lithium (used to treat depression and mental illness) 2 What you need to know before you • MAOIs (mono-amine oxidase inhibitors) used to treat take Methyldopa tablets depression (e.g. phenelzine) 3 • medicines to treat mental illness (e.g. chlorpromazine) How to take Methyldopa tablets • moxisylyte used to treat Raynaud’s syndrome 4 Possible side effects • muscle relaxants such as baclofen, tizanidine 5 • nitrates (e.g. glycerol trinitrate “GTN”, isosorbide dinitrate/ How to store Methyldopa tablets mononitrate) 6 Contents of the pack and other • iron supplements. information Methyldopa with alcohol You are advised not to drink alcohol with this medicine. Discuss 1 What Methyldopa tablets are and what they this with your doctor if you have any questions. are used for Pregnancy and breast-feeding Methyldopa belongs to a group of medicines called If you are pregnant or breast-feeding, think you may be antihypertensives, which lower blood pressure. pregnant or are planning to have a baby, ask your doctor or Methyldopa tablets are used to treat high blood pressure pharmacist for advice before taking this medicine. (hypertension). Driving and using machines 2 Methyldopa tablets may make you feel drowsy. Make sure you What you need to know before you take are not affected before you drive or operate machinery. Methyldopa tablets Do not take Methyldopa tablets and tell your doctor if you: Blood tests • are allergic (hypersensitive) to methyldopa or any of the Methyldopa may affect the results of certain laboratory tests. other ingredients (see section 6) Regular checks (before the start of treatment and 6-12 weeks • have liver disease later) may be carried out on blood cells and liver function • have high blood pressure due to a tumour near the (blood test to show your liver is working). kidney (phaeochromocytoma or paraganglioma) Surgery • suffer from depression If you have to have surgery, including dental, that requires an • are taking MAOIs (monoamine oxidase inhibitors) for anaesthetic let them know what medicines you are taking. depression Methyldopa tablets contain sunset yellow (E110) • or a relative have a genetic/inherited disorder of the red May cause allergic reactions. blood pigment haemoglobin (porphyria). This medicine contains less than 1 mmol sodium Warnings and precautions (23 mg) per tablet, that is to say essentially ‘sodium-free’. Check with your doctor or pharmacist before taking Methyldopa tablets if you: 3 How to take Methyldopa tablets • have had liver disease Always take Methyldopa tablets exactly as your doctor has told • have kidney disease (dialysis removes methyldopa so you. If you are not sure, check with your doctor or pharmacist. hypertension may recur) Swallow these tablets with water. • have damaged or diseased blood vessels in your brain Continued top of next column Continued over page

148x210 Leaflet Reel Fed Profile (BST) Methyldopa ,125, 250 & 500 mg, 56 Tablets - UK Methyldopa All strengths Tablets Joint PIL - United Kingdom JDE No.: 50991367 approved for print/date Item number: BBBA8282 Colours Non Printing Colours 1. Black 1. Profile Originator: NM Dimensions: 148x210 Dimensions: 148x210 (Reel Fed) Origination Date: 28/05/2020 Min Body Text Size: 7.5pts 2. 2. Component: Leaflet for Blisters Revision Date: 23/06/2020 Supplier: Accord Barnstaple 3. 3. Revised By: NM 4. Pharmacode: 2132 5. Proof Round Date sent: N/A Technical 6. Date Sent: 04 Approval Date received: 21-05-20 [email protected] Technologist: RH

Cartons and label leaflets only German GTIN 14 (incorporating PZN): Technically Approved (labels only when specified) * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 Doses: • Heart: slow heart rate and low blood pressure, low blood pressure Adults and children over 12 years: causing dizziness on standing, water retention causing swelling Initially 250mg two or three times a day, for 2 days. Then increased and weight gain. every 2 or more days until an adequate response is achieved up to a • Respiratory system: blocked/stuffy nose. maximum of 3g daily. • Stomach and intestines: feeling or being sick, bloated stomach, Children under 12 years: constipation, wind, diarrhoea, mild dryness of the mouth, sore or Initially 10mg per kg of bodyweight daily in 2-4 divided doses “black” tongue, inflamed salivary glands. adjusted as required up to 65mg/kg or 3g daily, whichever is less. • Skin: eczema, hard skin rash (lichenoid), swelling in the face, tongue, larynx, abdomen, or arms and legs, hives. Elderly: • Muscles and bones: mild joint pain with or without swelling. Initially no more than 250mg a day (e.g. 125mg twice daily), Muscle pain or cramps. increasing up to a maximum of 2g a day. • Reproductive system and breasts: absence of periods, swelling Methyldopa may be given with, or instead of, other medicines to of breasts in men and women, abnormal production of breast lower blood pressure and the doses may need to be amended. milk, failure to ejaculate, decreased sex drive, failure to maintain an If you take more Methyldopa tablets than you should erection (impotence). If you (or someone else) swallow a lot of the tablets at the same time, Reporting of side effects or if you think a child may have swallowed any, contact your nearest If you get any side effects, talk to your doctor, pharmacist or nurse. hospital casualty department or tell your doctor immediately. This includes any possible side effects not listed in this leaflet. You Symptoms of an overdose include excessive drowsiness, weakness, can also report side effects directly via the Yellow Card Scheme at: slow heart rate, low blood pressure, dizziness, light-headedness, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the painful infrequent bowel movements, bloated feeling, wind, Google Play or Apple App Store. diarrhoea, feeling or being sick. By reporting side effects you can help provide more information on If you forget to take Methyldopa tablets the safety of this medicine. Do not take a double dose to make up for a forgotten dose. If you 5 How to store Methyldopa tablets forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Keep out of the sight and reach of children. Store below 25°C in a dry place. Protect from light. If you stop taking Methyldopa tablets Do not use Methyldopa tablets after the expiry date stated on the Do not stop treatment early because an increase in blood pressure label/carton/bottle. The expiry date refers to the last day of that may occur. Talk to your doctor before you stop taking the tablets and month. follow their advice. Medicines should not be disposed of via wastewater or household 4 Possible side effects waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Like all medicines, this medicine can cause side effects, although not everybody gets them. 6 Contents of the pack and other information Tell your doctor immediately or go to the casualty department of What Methyldopa tablets contain your nearest hospital if you experience any of the following serious • The active substance (the ingredient that makes the side effects: tablet work) is anhydrous methyldopa. Each film- • Severe allergic reaction (rash, itching, swelling of the face, coated tablet contains either 125mg, 250mg or 500mg lips, mouth or throat that may cause difficulty in swallowing or of the active substance. breathing). This is a serious but rare side effect (may affect up to 1 • The other ingredients are polyvidone, sodium edetate, in 1, 000 people). magnesium stearate, crospovidone, precipitated silica, • Fever; severe rash involving reddening, peeling and swelling of the macrogol, talc, E104, E110 (sunset yellow), E132, E171, skin that resembles severe burns (toxic epidermal necrolysis); chest E172, E330, E460, E464. pain, worsening of existing angina, problems with the electrical current in the heart (AV block); abnormal liver function including What Methyldopa tablets look like and hepatitis and jaundice (yellowing of the skin and/or whites of the contents of the pack eyes). These would be detected by a blood test; inflammation of Methyldopa 125mg tablets are yellow, circular, biconvex the bowel (colitis); inflammation of the pancreas (pancreatitis). film-coated tablets, impressed ‘C’ on one face and the The following side effects have also been reported: identifying letters ‘MA’ on the reverse. Not known (frequency cannot be estimated from the available Methyldopa 250mg tablets are yellow, circular, biconvex data): film-coated tablets, impressed ‘C’ on one face and the • Blood: your medicine may alter the numbers and types of your identifying letters ‘MC’ on the reverse. blood cells and cause a rise in urea in the blood. If you notice Methyldopa 500mg tablets are yellow, circular, biconvex increased bruising, nosebleeds, sore throats, infections or fever, film-coated tablets, impressed ‘C’ on one face and the you should tell your doctor who may want to give you a blood test. identifying letters ‘MD’ on the reverse. • Central nervous system: drowsiness (usually lasts a few days Pack size: 56 at start of treatment or after an increased dose), headache, loss of strength or weakness, tingling or pins and needles, trembling Marketing Authorisation Holder and and shuffling walk, partial paralysis of the face, involuntary jerky Manufacturer movements, mental changes including nightmares, confusion, Accord, Barnstaple, EX32 8NS, UK. mild depression, dizziness, light-headedness, reduced blood flow This leaflet was last revised in June 2020 to the brain. Continued top of next column 50991367 BBBA8282