METHYLDOPA TABLETS BP 500 MG - patient leaflet, side effects, dosage

2. what you need to know before you take methyldopa tablets

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

• 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’

Warnings and precautions

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

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

• dialysis
• an operation
• a blood transfusion.

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:

• 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
• MAOIs (mono-amine oxidase inhibitors) used to treat depression (e.g. phenelzine)
• medicines to treat mental illness (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 or iron supplements (e.g. ferrous sulphate and ferrous gluconate)
• diuretic medicines used to increase urine output.

Pregnancy and breast-feeding

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.

Driving and using machines

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

Important information about some of the ingredients of Methyldopa Tablets:

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.

Other precautions you should take

Methyldopa may affect the results of certain laboratory tests. If you see another doctor, go into hospital, or are to have dental treatment or other surgery that requires an anaesthetic, it is important to let them know what medicines you are taking.

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).

3. how to take methyldopa tablets

Always take Methyldopa Tablets as your doctor tells you to. They will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and body weight. Your doctor will find the lowest dose to control your symptoms.

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 more Methyldopa Tablets than you should:

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.

Continued overleaf…

If you forget to take Methyldopa Tablets:

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.

If you stop taking Methyldopa Tablets:

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

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

4. possible side effects

Like all medicines, Methyldopa Tablets can cause side effects, although not everybody gets them.If any of the following happens, stop taking Methyldopa Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

This is a very serious side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor as soon as possible, if you notice any of the following serious side effects such as:

• chest pain, slow heart rate, or existing angina made worse, problems with the electrical current in the heart (AV block)
• severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)
• liver problems, including jaundice and hepatitis – 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 of the bowel (colitis)
• severe pain in the gut and back caused by inflammation of the pancreas (pancreatitis).

The following reactions have also been reported:

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

Nervous system:

• feeling sleepy or tired – this may happen at the start of treatment or when the dose is increased, and usually goes away
• headache or feeling weak – this may happen at the start of treatment and usually goes away
• pins and needles
• being unable to move part of your face (paralysis)
• having movements you cannot control
• confusion
• 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:

• feeling sick
• being sick
• abdominal pain
• feeling bloated
• constipation
• excess wind
• diarrhoea
• dry mouth
• sore or black tongue

Skin and hair:

• skin rash or peeling skin

Joints and muscles:

• painful and/or swollen joints
• muscle pains

Infections:

• swelling of salivary glands

General:

• water retention causing swelling and weight gain
• fever

Sexual:

• breast enlargement
• breast development in men
• loss of periods in women
• abnormal production of milk
• changes in sexual function such as impotence and not being able to ejaculate
• decreased sex drive

Psychiatric:

• mental changes, including nightmares or depression

Laboratory tests:

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

Results could show:

• a decrease in blood cell production
• an increase in some white blood cells
• abnormal levels of prolactin

5. how to store methyldopa tablets

Do not store above 25°C. Store in the original package in order to protect from light.

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

This medicine must not be used after the expiry date on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

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. contents of the pack and other information

What Methyldopa Tablets contain

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).

What Methyldopa Tablets look like and contents of the pack

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‘ embossed 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.

Marketing Authorisation Holder and Manufacturer

Intrapharm Laboratories Limited,

The Courtyard Barns,

Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call Intrapharm on +44 (0)1628 771800.

PL 17509/0035 Methyldopa Tablets B.P. 250 mg

PL 17509/0036 Methyldopa Tablets B.P. 500 mg

This leaflet was last revised in January 2019.