CO-CAPS METHYDOPA 250 MG - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet

• 1. What Methyldopa is and what it is used for

• 2. What you need to know before you take Methyldopa

• 3. How to take Methyldopa

• 4. Possible side effects

• 5. How to store Methyldopa

• 6. Contents of the pack and other information

1. what methyldopa is and what it is used for

The name of your medicine is Methyldopa 250 mg Capsules. It contains a substance called Methyldopa.

Methyldopa belongs to the general class of medicines called anti-hypertensives which are used to treat high blood pressure (hypertension). This medicine works by controlling impulses along certain nerve pathways. As a result it relaxes blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

Your doctor has prescribed Methyldopa to treat high blood pressure (hypertension).

2. what you need to know before you take methyldopa

Do not take Methyldopa if you:

• are allergic to methyldopa or any of the other ingredients of this medicine (listed in section 6)
• have ever had a liver disease
• have ever had depression
• have high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma’ or ‘paraganglioma’
• have been taking a type of medicine called a ‘monoamine oxidase inhibitor’(MAO inhibitor)
• have porphyria ( a rare ,inherited blood disorder).

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

Warnings and precautions

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

• a blood disorder called haemolytic anaemia
• jaundice (yellowing of the skin and eyes)
• fever(This is particularly important during the first few weeks you take methyldopa since fever may be a sign of a reaction to this medicine)
• any abnormal movements (involuntary)
• liver problems.

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

• dialysis
• an operation.
• a blood transfusion

Tests you may have while taking Methyldopa

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. Tell your doctor you are taking Methyldopa 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.

Rarely, in patients taking Methyldopa 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.

Other medicines and Methyldopa

Tell your doctor or pharmacist if your are taking, have recently taken or might take any other medicines.

• over-the-counter (non-prescription) medicines for appetite control, asthma, cold, cough, hay fever, or sinus problems since they may tend to increase your blood pressure.
• monoamine oxidase inhibitors (MAOI) for depression.
• other medicines for high blood pressure (antihypertensives) such as diuretics, beta blockers, ACE inhibitors etc.
• medicines for psychological disorders ,depression including lithium
• medicines called ‘phenothiazine,’ such as chlorpromazine-used for mental illness and sometimes feeling and being sick
• medicines called ‘tricyclic antidepressants’- used to treat depression
• Iron and supplements containing iron, such as multivitamins with minerals.

Before you begin using any new medicine (either prescription , non-prescription or herbal), or if you develop any new medical problem while you are using this medicine, check with your doctor, nurse or pharmacist.

Surgery

Before having any kind of surgery (including dental surgery) or emergency treatment that requires an anaesthesia, make sure the medical doctor or dentist in charge knows that you are taking this medicine.

Methyldopa with food, drink and alcohol

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

Pregnancy and breast feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy or light-headed while taking Methyldopa. If this happens do not drive or use any tools or machines.

3. how to take methyldopa

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

Taking this medicine

Take this medicine by mouth and only in the doses prescribed by your doctor.

Dosages:

The amount you take each day will depend on 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 recommended dose is:

Adults: The normal starting dose is 250mg 2–3 times daily for 2 days, which may then be adjusted by your doctor up to a maximum of 3 g daily.

Elderly: The normal staring dose is 125mg, not more than 250 mg each day, slowly adjusted if necessary to a maximum of 2 g by your doctor.

Use in Children: The doctor will work out the numbers of tablets. The dose is based on weight of the child. The initial dosage is based upon 10mg/kg of body weight daily in 2–4 oral doses. 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.

If you take more Methyldopa than you should

If you think you may have taken an overdose of this medicine, obtain emergency help at once at your nearest casualty ward. Some signs of an overdose are weakness, dizziness, lightheadedness, constipation, diarrhoea, sickness and vomiting. Tell the doctor in charge, or the nurse or pharmacist, that you are taking this medicine.

If you forgot to take Methyldopa

If you do miss a dose, take it right away if you remember within a hour or so of the missed dose. However, if you do not remember until later then skip the missed dose and go back to your regular dosing schedule. Do not double the dose.

If you stop taking Methyldopa

Do not stop taking Methyldopa without talking to your doctor.

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

4. possible side effects

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

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

• an allergic reaction-symptoms such as shortness of breath , skin rash or itching ,hives, swelling of your lips, face or tongue, chills or
• fever or painful joints
• chest pain ,slow heart rate, existing angina made worse, problems with electrical current in the heart(AV block)
• severe skin reaction (such as painful reddening, followed by blistering and peeling of layers of skin)
• liver problems, including jaundice and hepatitis-signs including yellowing of your skin and eyes, sometimes with a fever ,pale stools and dark urine
• pain in the gut and diarrhoea causes by inflammation of the bowel (colitis)
• severs pain in the gut and back caused by inflammation of the pancreas (pancreatitis).

The following reactions have also been reported:

Blood:

• reduction in red blood cells (anaemia)-this can 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 your blood cells and cause a rise in urea in the blood.

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
• Parkinsonism-with symptoms such as tremor, a

decrease in body movements with an inability to move your muscles

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

Marketing Authorisation Holder.

Psychiat ric: This leaflet was revised in March 2017

• mental changes, including nightmares or depression
• delusion and paranoia-which will stop when you stop taking this medicine.

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 decreased in blood cells production
• An increase in some white blood cells
• Abnormal levels of prolactin.

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 Yellow Card

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

5. how to store methyldopa

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

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.

Keep your medicine in a dry place and store below 25°C. Keep container tightly closed and protect from light.

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 to protect the environment.

6. contents of the pack and other information what methyldopa contains

The active substance is Methyldopa. Each Methyldopa 250 mg

Capsules contains 250 mg Methyldopa.

The other ingredients are: Starch 1500, Sodium Starch Glycollate, Magnesium Stearate, Gelatin, Titanium Dioxide (E171), Tartrazine (E102).

What Methyldopa looks like and contents of the pack

Methyldopa 250 mg Capsules is a bright yellow opaque capsule engraved METHYLDOPA CO-CAPS 250 mg.

It is available in plastic containers of 100 and 500 capsules.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

11 Boumpoulinas, 3rd Floor, Nicosia, P.C. 1060, Cyprus.

Manufacturer

DDSA Pharmaceuticals Ltd.,

Chatfield Road, off York Road, London SW11 3SE.

For more information about this product, please contact the