Methyldopa Tablets Bp 250mg
PATIENT INFORMATION LEAFLET
METHYLDOPA TABLETS 250 MG & 500 MG
Read all of this leaflet carefully because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Methyldopa and what is it used for?
2. Before you take Methyldopa
3. How to take Methyldopa
4. Possible side effects
5. Storing Methyldopa
6. Further information
1. What is Methyldopa and what is it used for?
The name of this medicine is Methyldopa Tablets BP 250 mg or 500 mg. Methyldopa is one of a group of medicines called antihypertensives.
Methyldopa is indicated for the treatment of moderate to severe high blood pressure.
2. Before you take Methyldopa
Do not take Methyldopa if your doctor has told you that you:
• Are allergic to Methyldopa, or any other ingredient listed in section 6 of this leaflet,
• Have liver disease,
• Have a tumour near the kidney,
• Are depressed
• Are taking monoamine oxidase inhibitors (MAOIs)
• Have condition called porphyria
Special Precautions
Check with your doctor or pharmacist before taking your medicine if you have any kidney or liver impairment, or if there is a family history of a condition called liver porphyria.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
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. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Alprostadil
• Anaesthetics
• Linezolid
• Medicines to control high blood pressure such as levodopa
• Water tablets such as frusemide
• Medicines to treat depression such as lithium, imipramine or amitriptyline
• Medicines to treat anxiety such as diazepam
• Medicines to help sleep such as nitrazepam
• Beta-blockers such as propranolol
• Calcium-channel blockers such as nifedipine
• Sympathomimetics such as amphetamine, adrenaline, salbutamol or ephedrine
• Phenothiazines (used to treat mental illness) such as perphenazine
• Monoamine oxidase inhibitors (used to treat depression) such as pheneizine
• Dopaminergics (used to treat Parkinson disease) such as entacapone
• Muscle relaxant such as baclofen or tizanidine
• Moxisylyte used to treat Raynaud’s syndrome
• Nitrates (e.g. glycerol trinitrate “GTN”, isosorbide dinitrate / mononitrate)
• Corticosteroids such as prednisolone
• Contraceptive pills
• Carbenoxolone used to treat stomach ulcers
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Taking Methyldopa with food and drink Methyldopa tablets should not be taken with alcohol.
Pregnancy and breast feeding
Consult your doctor before taking this medicine if you are pregnant or breast feeding, as this medicine can be passed to the unborn child and into breast milk. This medicine will only be given to you if your doctor considers the benefits of treatment outweighs the risk to the foetus or new born baby.
Driving and using machines
This medicine may cause drowsiness, dizziness, light-headedness and involuntary muscular movements. Do not drive or operate machinery if the medicine has this effect on you.
In patients with cerebrovascular disease (deficient blood supply to the brain) the patient should speak to their doctor before driving.
3. How to take Methyldopa
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with them if you are not sure.
Methyldopa Tablets should be taken orally with water.
Adults:
The initial adult dose of Methyldopa Tablets is
250 mg, 2 to 3 times a day for two days. Your doctor may adjust this dose every two days until your condition is controlled. The maximum daily dose is 3 g.
Elderly:
The initial dose is 125 mg twice a day.
The maximum daily dose is 2 g.
Children:
10 mg/kg body weight daily in 2 to 4 divided doses. The maximum daily dose is 65 mg/kg body weight or 3 g, whichever is less.
If you take more Methyldopa than you should:
Do not take more tablets than stated on the label of your medicine. If you take too many tablets you should seek medical attention immediately, either by calling your doctor, or going to the nearest casualty department. Always take the labelled medicine container with you, even if there are no tablets left.
Symptoms of an overdose include excessive drowsiness, weakness, slow heart rate, low blood pressure, dizziness, light-headedness, painful infrequent bowel movements, bloated feeling, wind, diarrhoea and feeling or being sick.
If you forget to take Methyldopa:
If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, don't worry, skip the missed dose and just take your next tablet when it is due. Never take a double dose of tablets to make up for a forgotten dose.
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 can have side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking Methydopa. Although they are very rare, these symptoms can be serious.
• Severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (possible signs of a condition called toxic epidermal necrolysis)
• Severe abdominal and back pain accompanied with feeling very unwell (possible signs of pancreatitis)
• Increased bruising, nosebleeds, sore throat, infection or fever, unusual tiredness and weakness (possible signs of serious blood disorders)
Please tell your doctor or pharmacist if you notice any of the following other effects:
Common side effects (these can affect up to 1 in every 10 people):
• Central nervous system: Drowsiness - this will usually pass with time and may occur during the initial period of treatment when the dose is increased
Rare side effects (these can affect up to 1 in every 1000 people):
• Allergic reactions: inflammation of heart muscle or the sac surrounding the heart, skin rash which may be red and/or scaly, fever.
• Blood: rise in urea in the blood.
• Endocrine system: abnormal production of milk.
• Central nervous system: headache, loss of strength or weakness, tingling or pins and needles,
trembling and shuffling walk, partial paralysis of the face, involuntary jerky movements, mental changes including nightmares, confusion, mild depression, dizziness, light-headedness, reduced blood flow to the brain.
• Heart: slow heart rate and low blood pressure, worsening of existing angina, low blood pressure causing dizziness on standing, water retention causing swelling and weight gain.
• Respiratory system: blocked/stuffy nose.
• Stomach and intestines: feeling or being sick, bloated stomach, constipation, wind, diarrhoea, colitis, mild dryness of the mouth, sore or “black” tongue, inflamed salivary glands.
• Liver: abnormal liver function, hepatitis, jaundice (yellowing of the skin and/or whites of the eyes). These would be detected by a blood test.
• Skin: eczema, hard skin rash (lichenoid).
• Muscles and bones: mild joint pain with or without swelling. Muscle pain or cramps.
• Reproductive system and breasts: absence of periods, swelling of breasts in men and women, production of breast milk, failure to ejaculate, decreased sex drive, failure to maintain an erection (impotence).
If any of the above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. Storing Methyldopa
Keep all medicines out of the reach and sight of children.
Do not use Methyldopa Tablets after the expiry date on the carton, plastic container or blister. The expiry date refers to the last day of that month.
Keep the tablets in the container provided and protect from heat, light and moisture.
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. Further information What Methyldopa contains:
Each tablet contains either 250 mg or 500 mg of Methyldopa as the active ingredient.
The tablets also contain sodium starch glycollate, ethylcellulose, magnesium stearate, hypromellose, quinoline yellow aluminium lake (E104), erythrosine aluminium lake (E127), vegetable carbon black (E153), titanium dioxide (E171) and polyethylene glycol 6000.
What Methyldopa looks like and contents of the pack:
Methyldopa 250 mg tablets are round tablets with the ‘AM’ on one side and the marking 'A336' on the other.
Methyldopa 500 mg tablets are round tablets with the ‘AM’ on one side and the marking 'A337' on the other.
Methyldopa tablets are available in:
• Blister packs of 28, 30, 42, 56, 60, 84, 90 and 112 tablets.
• Plastic container packs of 28, 30, 42, 50, 56, 60, 84,
90, 100, 112, 250, 500, 1000 and bulk tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Crescent Pharma Limited, 3&4 Quidhampton Business Units, Polhampton Lane, Overton Hampshire, RG25 3ED, UK
Manufacturer: TioFarma B.V., Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijereland, The Netherlands