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Active substance(s): NIFEDIPINE

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Patient information leaflet

Cardilate MR 10mg Tablets
Please read this leaflet carefully before you start to take your tablets.
It contains important information. If you are not sure about anything, or you want to know more,
ask your doctor or a pharmacist.
Keep this leaflet safe, as you may want to read it again
About your tablets

Your tablets are called Cardilate MR Tablets. The common name for your tablets is nifedipine.
They are part of a group of drugs known as calcium channel blockers which interfere with the movement
of calcium in heart muscle cells.
What is in your tablets
Each tablet contains:

Nifedipine Ph Eur 10 milligrams (mg); and

Microcrystalline cellulose, carboxymethyl sodium starch,mannitol, colloidal anhydrous silica,
povidone, magnesium stearate, sodium lauryl sulphate, methyl hydroxyl propyl cellulose,
polyoxyethylene glycol 400 and 6000, talc and colours E171 and E172 (inactive ingredients).
Cardilate MR 10mg Tablets are pink modified release tablets.
Cardilate MR Tablets come in packs of 56 and 100.

Who makes your tablets
The marketing authorisation holder and company responsible for batch release is IVAX Pharmaceuticals
UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX 
What your tablets do
Cardilate MR Tablets are used to treat high blood pressure (hypertension) and to prevent the condition
called angina pectoris (pain in the centre of your chest which is brought on by exercise).
Before you take your tablets
Do not take Cardilate MR Tablets if you:
 are pregnant, may become pregnant or are breast-feeding;
 have ever had a bad reaction to any of the ingredients listed in the ‘What is in your tablets’ section or
to other drugs of this type (dihydropyridines);
 are taking rifampicin (for infection);
 have ever suffered from cardiogenic shock (where your blood pressure drops, your heart speeds
up, you sweat and are restless and you have breathing difficulties);
 suffer from very severe high blood pressure (hypertension);
 suffer from a hereditary metabolic disorder called porphyria;

suffer from a heart condition known as aortic stenosis (where the aortic valve becomes closed
off slightly causing a reduced flow of blood);
 have just had a heart attack or have had a heart attack within the last month, have regular angina
attacks which are difficult to control, or have severe unexpected angina attack
Do not drink grapefruit juice while you are taking Cardilate MR Tablets. It will affect the amount of drug in
your blood.

Please tell your doctor before you start to take your tablets if you:

suffer from low blood pressure (hypotension);
have low cardiac reserve (low ability of the heart to adjust to extra demands when required);
are diabetic (nifedipine may cause temporary high blood sugar levels, your doctor may need to
change your treatment for diabetes);
are already taking heart drugs especially beta-blockers, quinidine (to control heart rhythm), digoxin or
other drugs to lower your blood pressure;
are taking cimetidine (for stomach ulcers); or
are taking other medicines including ones that you have bought for yourself without a prescription.

Sometimes Cardilate MR Tablets may give you headaches or make you feel dizzy, sick and tired. If you
feel these effects after taking your tablets, do not drive or use machinery. You should not drink alcohol
while you are taking Cardilate MR Tablets as it may make these symptoms worse.

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.
How to take your tablets
You must take your tablets as your doctor has told you to. The label will tell you how many to take and
how often to take them. The number of tablets you take is called the ‘dose’. The usual starting dose
for adults and children over 16 years old is one Cardilate MR 10mg Tablet twice a day, every 12
hours(twice a day) .
Your doctor may change this dose when he sees how you respond to the tablets. You should not take
more than four 10mg tablets or two 20mg tablets every 12 hours. If you are elderly or you suffer from
liver problems, your doctor may wish to see you more regularly.

Cardilate MR Tablets is not recommended for use in children and adolescents below 18 years of age,
because there are only limited data on the safety and efficacy in this population.

Swallow the tablets whole with a little water. Do not take your tablets with grapefruit juice and do not
break or chew them.
If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses
together. If it is almost time to take the next dose, wait until then and then carry on as before.
It can be dangerous to stop taking your tablets without your doctor’s advice
What to do if you take too many tablets
It is important not to take too many tablets.

Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have
swallowed too many tablets or if you think a child has swallowed any.
Take this leaflet, and any tablets that you still have to show the doctor.
After taking your tablets
You may have some side effects while you are taking your tablets.
Tell your doctor or pharmacist if you suffer from any of the following for more than a few days:

headache, dizziness, feeling sick or tired, a red face, swollen ankles, a rash or a need to pass urine
more often

Occasionally Cardilate MR Tablets can cause:

chest pain .This may be worse when treatment with Cardilate MR Tablets is started

your gums to get thicker ; and

your skin and whites of your eyes to turn yellow (jaundice)

Rarely, your angina may get worse at the start of the treatment .Also heart attacks have been reported
rarely after taking nifedipine, but it is not known whether this would have occurred without treatment.
If you notice any of these side effects, tell your doctor or pharmacist at once.
If you feel unwell in any other way tell or doctor or pharmacist as soon as you can.
Looking after your tablets
Keep your tablets in a safe place where children cannot see or reach them. You should keep your tablets
in a dry place, below 25°C and away from light.
Keep them in the pack they came in. Do not put them into another container.
Do not take the tablets after the ‘use by’ date.
You should take any tablets that are out of date or which you no longer need back to your pharmacist.
These tablets are only for you. Only a doctor can prescribe them for you. Never give them to anyone else.
This information refers only to IVAX Pharmaceutical’s Cardilate MR 10mg Tablets.
PL 00530/0517
This leaflet was rewritten in July 2012

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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.