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CO-CAPS METHYDOPA 250MG

Active substance(s): METHYLDOPA / METHYLDOPA / METHYLDOPA

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PROPOSED
PATIENT INFORMATION LEAFLET
INFORMATION FOR THE USER
CO-CAPS Methyldopa 250 mg
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 a 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 CO-CAPS is and what it is used for
2. What you need to know before you take CO-CAPS
3. How to take CO-CAPS
4. Possible side effects
5. How to store CO-CAPS
6. Contents of the pack and other information
1. WHAT CO-CAPS IS AND WHAT IT IS USED FOR
The name of your medicine is CO-CAPS Methyldopa 250 mg
Capsules (referred to as Co-Caps throughout this leaflet). 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 Co-Caps to treat high blood pressure
(hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CO-CAPS
Do not take Co-Caps 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 Co-Caps if any of the above applies to you. If you
are not sure talk to your doctor or pharmacist before taking CoCaps.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Caps 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 Co-Caps
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 CoCaps. Tell your doctor you are taking Co-Caps if you have a
laboratory test where a urine or blood sample is taken. This is
because Co-Caps may affect the results of some types of tests.
Rarely, in patients taking Co-Caps 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 Co-Caps.
Other medicines and Co-Caps
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 chlorpromazineused 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.
Co-Caps with food, drink and alcohol
You are advised not to drink alcohol while taking co-Caps
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 Co-Caps. If
this happens do not drive or use any tools or machines.
3. HOW TO TAKE CO-CAPS
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

PROPOSED
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 Co-Caps 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 Co-Caps 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 Co-Caps
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 Co-Caps
Do not stop taking Co-Caps 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.

PROPOSED




Psychiatric:
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 Co-Caps .
Results could show:
 a decreased in blood cells production
 an increase in some white blood cells
 abnormal levels of prolactin.
Co-Caps 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 Yellow Card
Scheme [www.mhra.gov.uk/yellowcard]. By reporting side
effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE CO-CAPS
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 Co-Caps contains
The active substance is Methyldopa. Each Co-Caps Methyldopa
250 mg contains 250 mg Methyldopa.
The other ingredients are: Starch 1500, Sodium Starch
Glycollate, Magnesium Stearate, Gelatin, Titanium Dioxide
(E171), Tartrazine (E102).
What Co-Caps looks like and contents of the pack
CO-CAPS Methyldopa 250 mg 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
Marketing Authorisation Holder.

This leaflet was revised in March 2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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