Methyldopa 250mg tablets

Main information

  • Trade name:
  • Methyldopa 250mg tablets
  • Dosage:
  • 250mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Methyldopa 250mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02050200; GTIN: 5012617009494

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 0142/0093
  • Last update:
  • 30-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGE LEAFLET: INFORMATION FOR THE USER

MEDOMET 250 mg &

500 mg TABLETS

METHYLDOPA

1. What Medomet is and what it is used for

2. What you need to know before you take

Medomet

3. How to take Medomet

4. Possible side effects

5. How to store Medomet

6. Contents of the pack and other information

The name of your medicine is Medomet. It contains the

active ingredient Methyldopa, which belongs to a group of

medicines

called

anti-hypertensives.

Methyldopa

changed inside your body to a natural substance that

lowers

blood

pressure.

used

treat

high

blood

pressure (hypertension).

Do not take Medomet if you:

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)

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)

have an inherited blood disorder of the red blood

pigment haemoglobin known as acute porphyria

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 Medomet.

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)

have liver problems

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

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 Medomet.

Tell your doctor you are taking Medomet if you have a

laboratory test where urine or blood is taken. This is

because

Medomet

affect

results

certain

laboratory tests. Rarely, in patients taking Medomet 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 Medomet.

If you are not sure if any of the above applies to you, talk to

your doctor or pharmacist before taking Medomet.

Other medicines and Medomet

Tell your doctor or pharmacist if you are taking or have

recently taken any other medicines, including medicines

bought without a prescription. This is because Medomet

affect

some

medicines

work. Also

some

medicines

affect

Medomet

works.

This

includes herbal medicines.

Do not take Medomet if you are taking a type of medicine

called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used

to treat depression.

In particular, tell your doctor or pharmacist if you are taking

any of the following medicines:

other medicines to treat high blood pressure

(antihypertensives)

lithium-used to treat some types of depression

medicines called ‘phenothiazines’ such as

chlorpromazine-used for mental illness and sometimes

feeling and being sick

medicines called ‘tricyclic antidepressants’ – used to

treat depression

cough and cold remedies that contain a decongestant

iron and supplements containing iron, such as

multivitamins with minerals.

Medomet with alcohol

AVOID ALCOHOL whilst taking Medomet tablets. This is

because

alcohol

affect

Medomet

works.

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 planning to become pregnant, ask your doctor

or pharmacist for advice before taking Medomet.

Driving and using machines

Medomet

tablets

make

feel

drowsy

light-headed. Make sure you are not affected before you

attempt to drive or operate machinery.

Taking this medicine

Always take Medomet 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 Medomet 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 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.

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.

Elderly

The usual starting dose will not be more than 250 mg a day

(e.g.

twice

daily). Your

doctor

gradually

increase the dose if necessary, up to a maximum of 2 g a

day.

Medomet may be given with, or instead of, other medicines

to lower blood pressure and the doses may need to be

amended.

If you take more Medomet than you should

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.

Symptoms of an overdose include; excessive sedation,

weakness, slow heart rate, low blood pressure, dizziness,

light-headedness,

painful

infrequent

bowel

movements,

bloated feeling, wind, diarrhoea, feeling or being sick.

If you forget to take Medomet

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 Medomet

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.

Like

medicines,

Medomet

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:

inflammed salivary glands.

Effects on the skin:

eczema

hard skin rash (lichenoid).

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 Medomet. Results could

show:

a decrease in blood cell production

an increase in some white blood cells

abnormal levels of prolactin.

Medomet

also

interfere

with

interpretation

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. By

reporting

side

effects,

help

provide

more

information on the safety of this medicine.

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.

throw

away

medicines

wastewater

household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help

protect the environment.

What Medomet 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.

other

ingredients

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 Medomet tablets look like and contents of the

pack

tablets

yellow

film-coated

tablets,

engraved MEDOMET 250 on one side.

tablets

yellow,

bi-convex

film-coated

tablets, engraved MEDOMET 500 on one side.

Medomet 250 mg and 500 mg tablets both come in plastic

containers of 56, 100 and 500 tablets. Medomet 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 12/2017

CL0060-0061/O/PIL-Br/CL3

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 symptoms 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.

2. WHAT YOU NEED TO KNOW

BEFORE YOU TAKE MEDOMET

1. WHAT MEDOMET IS AND WHAT IT

IS USED FOR

WHAT IS IN THIS LEAFLET

3. HOW TO TAKE MEDOMET

PACKAGE LEAFLET: INFORMATION FOR THE USER

MEDOMET 250 mg &

500 mg TABLETS

METHYLDOPA

1. What Medomet is and what it is used for

2. What you need to know before you take

Medomet

3. How to take Medomet

4. Possible side effects

5. How to store Medomet

6. Contents of the pack and other information

The name of your medicine is Medomet. It contains the

active ingredient Methyldopa, which belongs to a group of

medicines

called

anti-hypertensives.

Methyldopa

changed inside your body to a natural substance that

lowers

blood

pressure.

used

treat

high

blood

pressure (hypertension).

Do not take Medomet if you:

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)

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)

have an inherited blood disorder of the red blood

pigment haemoglobin known as acute porphyria

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 Medomet.

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)

have liver problems

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

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 Medomet.

Tell your doctor you are taking Medomet if you have a

laboratory test where urine or blood is taken. This is

because

Medomet

affect

results

certain

laboratory tests. Rarely, in patients taking Medomet 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 Medomet.

If you are not sure if any of the above applies to you, talk to

your doctor or pharmacist before taking Medomet.

Other medicines and Medomet

Tell your doctor or pharmacist if you are taking or have

recently taken any other medicines, including medicines

bought without a prescription. This is because Medomet

affect

some

medicines

work. Also

some

medicines

affect

Medomet

works.

This

includes herbal medicines.

Do not take Medomet if you are taking a type of medicine

called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used

to treat depression.

In particular, tell your doctor or pharmacist if you are taking

any of the following medicines:

other medicines to treat high blood pressure

(antihypertensives)

lithium-used to treat some types of depression

medicines called ‘phenothiazines’ such as

chlorpromazine-used for mental illness and sometimes

feeling and being sick

medicines called ‘tricyclic antidepressants’ – used to

treat depression

cough and cold remedies that contain a decongestant

iron and supplements containing iron, such as

multivitamins with minerals.

Medomet with alcohol

AVOID ALCOHOL whilst taking Medomet tablets. This is

because

alcohol

affect

Medomet

works.

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 planning to become pregnant, ask your doctor

or pharmacist for advice before taking Medomet.

Driving and using machines

Medomet

tablets

make

feel

drowsy

light-headed. Make sure you are not affected before you

attempt to drive or operate machinery.

Taking this medicine

Always take Medomet 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 Medomet 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 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.

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.

Elderly

The usual starting dose will not be more than 250 mg a day

(e.g.

twice

daily). Your

doctor

gradually

increase the dose if necessary, up to a maximum of 2 g a

day.

Medomet may be given with, or instead of, other medicines

to lower blood pressure and the doses may need to be

amended.

If you take more Medomet than you should

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.

Symptoms of an overdose include; excessive sedation,

weakness, slow heart rate, low blood pressure, dizziness,

light-headedness,

painful

infrequent

bowel

movements,

bloated feeling, wind, diarrhoea, feeling or being sick.

If you forget to take Medomet

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 Medomet

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.

Like

medicines,

Medomet

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:

inflammed salivary glands.

Effects on the skin:

eczema

hard skin rash (lichenoid).

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 Medomet. Results could

show:

a decrease in blood cell production

an increase in some white blood cells

abnormal levels of prolactin.

Medomet

also

interfere

with

interpretation

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. By

reporting

side

effects,

help

provide

more

information on the safety of this medicine.

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.

throw

away

medicines

wastewater

household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help

protect the environment.

What Medomet 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.

other

ingredients

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 Medomet tablets look like and contents of the

pack

tablets

yellow

film-coated

tablets,

engraved MEDOMET 250 on one side.

tablets

yellow,

bi-convex

film-coated

tablets, engraved MEDOMET 500 on one side.

Medomet 250 mg and 500 mg tablets both come in plastic

containers of 56, 100 and 500 tablets. Medomet 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 12/2017

CL0060-0061/O/PIL-Br/CL3

6. CONTENTS OF THE PACK AND

OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE MEDOMET