Patient leaflet - Methyldopa 250 mg tablets, Medomet 250 mg tablets
1. What Methyldopa is and what it is used for
- iron and supplements containing iron, such as multivitamins with minerals.
2. What you need to know before you take Methyldopa
3. How to take Methyldopa
Methyldopa with alcohol
4. Possible side effects
AVOID ALCOHOL whilst taking Methyldopa tablets. This is because alcohol can affect the way Methyldopa works. Discuss this with your doctor if you have any questions.
5. How to store Methyldopa
6. Contents of the pack and other information
- 1.
WHAT METHYLDOPA IS AND WHAT IT IS USED FOR
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking Methyldopa.
Methyldopa belongs to a group of medicines called anti-hypertensives. Methyldopa is changed inside your body to a natural substance that lowers blood pressure. It is used to treat high blood pressure (hypertension).
Driving and using machines
Methyldopa tablets may make you feel drowsy or light-headed. Make sure you are not affected before you attempt to drive or operate machinery.
- 2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE METHYLDOPA
Do not take Methyldopa if you:
Taking this medicine
have ever had a bad reaction, such as allergic (hypersensitive) to Methyldopa or to any of the other ingredients in this tablet (listed in section 6 of this leaflet)
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. The amount you take each day will depend upon your condition. It is very important to continue taking methyldopa for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.
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 or paraganglioma)
The recommended dose is:
have an inherited blood disorder of the red blood pigment haemoglobin known as acute porphyria
Adults
The usual starting dose is 250 mg, two or three 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.
- 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.
Children
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 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.
Warnings and precautions
Tell your doctor before you take this medicine if you:
- have kidney disease
- have jaundice (yellowing of the skin and eyes)
- have fever
have any abnormal movements (involuntary)
Elderly
have liver problems
The usual starting dose will not be more than 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.
- suffer from an abnormal breakdown of red blood cells which can make the skin pale or yellow and cause weakness or breathlessness (haemolytic anaemia).
Operations and tests
Methyldopa may be given with, or instead of, other medicines to lower blood pressure and the doses may need to be amended.
If you are going to have an operation, dialysis, a blood transfusion or an anaesthetic, tell your doctor, dentist or nurse that you are taking Methyldopa.
If you take more Methyldopa than you should
Tell your doctor you are taking Methyldopa if you have a laboratory test where urine or blood is taken. This is because methyldopa may affect the results of certain laboratory tests. Rarely, in patients taking methyldopa urine may darken when it is exposed to air after voiding. Regular checks, (before the start of treatment and for 6-12 weeks after), may be carried out on blood cells and liver function. Your doctor may use similar tests if you have a fever at any time while you are taking methyldopa.
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.
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 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, contact your doctor immediately or go to the nearest hospital emergency department as they are serious and require medical attention:
- an allergic reaction, which may cause any kind of rash, red and/or scaly skin, or swelling of your lips, face or tongue, chills. You could also notice sudden wheezing, fluttering or tightness of the chest, collapse, inflammation of heart muscle or the sac surrounding the heart
- fever or painful joints
- chest pain, slow heart beats, worsening of existing angina, problems with the electrical current in the heart (AV block) 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
- pain in the gut and diarrhoea caused by inflammation of the bowel (colitis)
- 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)
- 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.
Tell your doctor or pharmacist if you get any of these side effects:
Effects on the blood:
- raised levels of urea in the blood
- reduction in red blood cells (anaemia) - this can make your skin pale and make you weak or breathless. Effects on the brain and central nervous system:
- mental changes including nightmares or depression
- delusions and paranoia-which will stop when you stop taking the medicine
- decreased sex drive
- confusion
- feeling sleepy or tired (usually lasts a few days at start of treatment or after an increased dose)
- headache or feeling weak (this may happen at the start of treatment and usually goes away)
- tingling or pins and needles
- partial paralysis of the face
- involuntary jerky movements
- parkinsonism-with symptoms such as tremor, a decrease in body movements with an inability to move your muscles
- decreased mental sharpness
- frequent dizziness or fainting
dizziness due to low blood pressure and
light-headedness (particularly when standing up quickly)
- reduced blood flow to the brain.
Effects on the respiratory system:
- blocked/stuffy nose.
Effects on the stomach and intestines:
- feeling or being sick
- abdominal pain
- bloated stomach
- constipation
- wind
- diarrhoea
- mild dryness of the mouth
- sore or “black” tongue.
Infections:
- inflamed salivary glands.
Effects on the skin:
eczema
- hard skin rash (lichenoid)
- peeling of the skin
- hives (skin rash with red itchy bumps)
- swelling of the skin.
Effects on the muscles and bones:
- mild joint pain with or without swelling
- muscle pain.
Effects on your reproductive system and breasts:
- breast enlargement
- breast development in men
- 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. Laboratory tests:
Your doctor may need to carry out simple blood tests during the first few months of therapy with methyldopa. Results could show:
- a decrease in blood cell production
- an increase in some white blood cells
- abnormal levels of prolactin.
Methyldopa may also interfere with the interpretation of certain blood and urine tests.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. 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.
- 5. HOW TO STORE METHYLDOPA
Keep out of the sight and reach 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.
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.
- 6. CONTENTS OF THE PACK AND OTHER 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, engraved MEDOMET 500 on one side. 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,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 05/2020
CL0060-0061/O/PIL/CL4