Patient leaflet - Methyldopa tablets 250 mg

1. WHAT METHYLDOPA TABLETS ARE AND WHAT THEY ARE USED FOR

Methyldopa Tablets contain soy lecithin (E322)

Methyldopa Tablets contain the active ingredient methyldopa.

This medicine contains soy lecithin (E322), which may contain soya oil. If you are allergic to peanut or soya, do not take this medicine

Methyldopa belongs to a group of medicines called 'anti-hypertensive' agents.

These tablets are used to treat high blood pressure (hypertension).

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLDOPA TABLETS

3. HOW TO TAKE METHYLDOPA TABLETS

Do not take Methyldopa Tablets if:

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

! You are allergic to methyldopa or any of the other

ingredients of this medicine (listed in section 6) ! You have ever had liver disease

! You have pheochromocytoma or paraganglioma (a

The tablets should be swallowed with water.

rare tumour of the adrenal gland which causes high blood pressure)

Adults

! You suffer from depression

Usual dosage:

! You are taking monoamine oxidase inhibitors (MAOI)

The starting dose is 250mg twice a day for 2 days. This dose may be increased by your doctor by 250mg-500mg daily, at intervals of at least 2 days.

a type of antidepressant

! You have porphyria (a rare inherited blood disorder).

This increase may continue until satisfactory control of your blood pressure is achieved. Once control has been achieved, the daily dose will be in the region of 500mg-2000mg. You should not take more than 3000mg in a day.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Methyldopa Tablets if you have:

! Liver problems

! A blood disorder called haemolytic anaemia ! Jaundice (yellowing of the skin and eyes) ! Fever

Elderly

The starting dose may be lower. Your doctor will tell you exactly the dose to take and how often to take it.

! Any abnormal movements (involuntary).

Children

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

The doctor will work out the number of tablets. The dose is based on the weight of the child. The usual starting dose is 10mg for each kg of body weight each day. This dose should be taken in two to four divided doses during the day.

! Dialysis

! An operation

! A blood transfusion.

Tests you may have while taking Methyldopa Tablets

The doctor may change the dose depending on how the child responds.

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 this medicine.

A child will not usually take more than 65mg per kg of body weight or 3000mg a day, whichever is less.

Tell your doctor you are taking this medicine 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.

Patients with kidney problems

If you have problems with your kidneys, your starting dose may be lower than the adult dose above. Your doctor will tell you exactly the dose to take and how often to take it.

Rarely, in patients taking this medicine urine may darken when it is exposed to air after voiding.

If you are already taking other medicines for high blood pressure (diuretics):

Your starting dose may be lower. You doctor will tell you exactly the dose to take and how often to take it.

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

The medicine you are currently taking will be gradually withdrawn and the dose of Methyldopa Tablets will be gradually increased.

Other medicines and Methyldopa Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription as some drugs may affect each other's action. This includes herbal medicines.

This increase in dose of Methyldopa Tablets will be adjusted upwards by 250mg to 500mg at 2 to 7 day intervals to maintain control of your blood pressure.

If you take more Methyldopa Tablets than you should

Do not take Methyldopa Tablets if you are taking a type of medicine called a 'monoamine oxidase inhibitor' (MAOI) 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: ! Other medicines for high blood pressure

If you take an unintentional extra dose, this should not be a problem. If you (or someone else) swallow a lot of tablets altogether, or if you think a child has swallowed one of the tablets, contact your nearest accident and emergency department or doctor immediately.

(antihypertensives)

! Lithium – used to treat some types of depression ! Medicines called 'phenothiazines' such as

							Unvarnish area
	100523/6
	Ennogen
	Methyldopa Leaflet
	UK
	English
	160 x 360 mm
	9 pt
	1
	10-05-23

160 mm

This leaflet was last revised in May 2023. If you forget to take Methyldopa Tablets

ENV01 Psychiatric:

! Mental changes, including nightmares or

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 5 hours, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

depression

! Delusions and paranoia – which will stop when you stop taking this medicine.

Laboratory tests:

If you stop taking Methyldopa Tablets

Your doctor may need to carry out simple blood tests during the first few months of therapy with Methyldopa Tablets. Results could show:

Do not stop taking these Tablets without talking to your doctor. The dose needs to be gradually reduced. If you stop taking these tablets you will experience a rise in blood pressure and your original symptoms will return.

! A decrease in blood cell production

! An increase in some white blood cells

! Abnormal prolactin levels

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

! A positive result for antinuclear antibodies, LE cells and rheumatoid factor.

4. POSSIBLE SIDE EFFECTS

Methyldopa may also interfere with the interpretation of certain blood and urine tests.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Reporting of side effects

Contact your doctor IMMEDIATELY if you have any of the following side effects as they are serious and require medical attention:

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 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.

! An allergic reaction – symptoms such as shortness of

breath, skin rash or itching, hives, swelling of your lips, face or tongue, chills, fever or painful joints ! Chest pain, slow heart rate, or existing angina made

worse, problems with the electrical current in the heart (AV block)

5. HOW TO STORE METHYLDOPA TABLETS

! Severe skin reactions (such as painful reddening,

followed by blistering and peeling of layers of skin) ! Liver problems including jaundice and hepatitis –

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

of the bowel (colitis)

! Severe pain in the gut and back caused by

Methyldopa 125mg Tablets: Store in a cool dry place and protect from light.

inflammation of the pancreas (pancreatitis).

Methyldopa 250mg and 500mg Tablets: Store below 25°C. protect from light.

The following reactions have also been reported. The frequency of these are not known (frequency cannot be estimated from the available data).

Do not use this medicine if you notice visible signs of deterioration.

Blood:

! Reduction in red blood cells (anaemia) – this can

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 ! Your medicine may alter the numbers and types of

6. CONTENTS OF THE PACK AND OTHER INFORMATION

your blood cells and cause a rise in urea in the blood.

Nervous system:

What Methyldopa Tablets contain

! Feeling sleepy or tired – this may happen at the start

The active substance is methyldopa.

of treatment or when the dose is increased, and usually goes away

! Headache or feeling weak – this may happen at the

Methyldopa 125mg Tablets contain 125mg of Methyldopa in each tablet.

start of treatment and usually goes away ! Pins and needles

Methyldopa 250mg Tablets contain 250mg of Methyldopa in each tablet.

! Being unable to move part of your face (paralysis) ! Having movements you cannot control

Methyldopa 500mg Tablets contain 500mg of Methyldopa in each tablet.

! Parkinsonism – with symptoms such as tremor, a

decrease in body movements with an inability to move your muscles

The other ingredients are:

! Confusion

Sodium calcium edetate, citric acid, sodium starch glycolate, microcrystalline cellulose, ethyl cellulose, polyvinyl alcohol (E1203), magnesium stearate, colloidal anhydrous silica, purified talc (E553b), iron oxide yellow (E172), titanium dioxide (E171), soy lecithin (E322) and xanthan gum (E415).

! 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:

What Methyldopa Tablets look like and contents of the pack

! Feeling sick (nausea)

! Being sick (vomiting)

Methyldopa 125mg Tablets are yellow coloured, round, biconvex, film coated tablets plain on both sides with an approximate diameter of 8.1mm.

! Abdominal pain

! Feeling bloated

! Constipation

! Excess wind

Methyldopa 250mg Tablets are yellow coloured, round, biconvex, film coated tablets plain on both sides with an approximate diameter of 11.6mm.

! Diarrhoea

! Dry mouth

! Sore or black tongue.

Methyldopa 500mg Tablets are yellow coloured, capsule shaped, biconvex, film coated tablets, plain on both sides with an approximate dimension of 19.10mm X 8.60mm.

Skin and hair:

! Skin rash or peeling skin.

Joints and muscles:

! Painful and/or swollen joints

Methyldopa Tablets are available in a pack size of 56 tablets.

! Muscle pains.

Infections:

Marketing Authorisation Holder

! Swelling of salivary glands.

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

General:

Riverside Way, Dartford, DA1 5BS, UK

! Fever

! Water retention causing swelling and weight gain.

Manufacturer

Ennogen Pharma Limited

Sexual:

! Breast enlargement