Methyldopa Tablets BP 250mg

• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally and you should 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• are allergic to methyldopa or any of the other ingredients in the tablets (see section 6)
• have a history of depression
• have been diagnosed as having a liver disorder such as acute hepatitis, active cirrhosis
• are taking MAOIs (monoamine oxidase inhibitors) for depression.
• porphyria (a rare, inherited blood disorder)
• have high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma’ or ‘paraganglioma’

Do not take Methyldopa Tablets if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Methyldopa Tablets.

Talk to your doctor or pharmacist before taking this medicine if you have:

• a blood disorder called haemolytic anaemia
• liver problems
• jaundice (yellowing of the skin and eyes)
• fever
• ever had a stroke
• any abnormal movements (involuntary)

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

• dialysis
• an operation
• a blood transfusion.

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

Rarely, in patients taking Methyldopa tablets 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 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 as some drugs affect each other's action. This include herbal medicine

Do not take Methyldopa tablets 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 Methyldopa tablets

• antihypertensive medicines used to treat high blood pressure (e.g. verapamil)
• medicines to treat Parkinson’s disease (e.g. levodopa)
• lithium - used to treat depression and mental illness
• medicines to treat mental illness and sometimes feeling and being sick (e.g. phenothiazines, such as chlorpromazine and butyrophenones such as haloperidol)
• medicines called ‘tricyclic antidepressants’ used to treat depression
• sympathomimetics (medicines used mainly for coughs and colds that contain a decongestant (e.g. pseudoephedrine)
• iron and supplements containing iron, such as multivitamins with minerals
• diuretic medicines used to increase urine output.

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

If you have to have surgery, including dental, that requires an anaesthetic, you must inform the dentist or hospital that you are taking Methyldopa tablets.

You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant.

Your doctor will then decide whether you should take this medicine.

Methyldopa passes into breast milk, therefore, if you are breast-feeding, this medicine should be avoided. Your doctor will be able to discuss this with you to determine whether the anticipated benefits are worth the possible risks.

Methyldopa Tablets may make you feel drowsy or light-headed. If this occurs, you should avoid driving or using machinery.

You are advised not to drink alcohol while taking Methyldopa tablets. Discuss this with your doctor if you have any questions.

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 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 Methyldopa tablets for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.

The usual doses of Methyldopa tablets are:

Adults and children over 12 years:

• 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.

Children under 12 years:

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.

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.

If you take too much medicine or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. Symptoms of overdose may include lowered blood pressure, drowsiness, weakness, reduced heart rate, dizziness, light-headedness (i.e. feeling faint), gastrointestinal disturbances e.g. constipation, bloating, flatulence, diarrhoea, nausea and vomiting.

If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when it is due.

Do not stop taking Methyldopa Tablets without talking to your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active substance is methyldopa. Each film-coated tablet contains either 250 mg or 500 mg of the active substance.

The tablets also contain citric acid, lactose monohydrate, maize starch, talc, magnesium stearate, stearic acid, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) and silica colloidal anhydrous (500mg only).

Methyldopa Tablets B.P. 250 mg are round yellow film-coated biconvex tablets.

Methyldopa Tablets B.P. 500 mg are round yellow film-coated biconvex tablets, each having 'M500' debossed on one side.

Methyldopa Tablets BP 250 mg and 500 mg are packed in blister strips in cartons containing 28 or 56 tablets.

Note: not all strengths and / or pack sizes may be available in all markets.