Cardilate Mr 20mg Tablets
Patient information leaflet
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.
Each tablet contains:
• Nifedipine 20 milligrams (mg) (active ingredient); and
• Microcrystalline cellulose, carboxymethyl sodium starch,mannitol, colloidal anhydrous silica, povidone, magnesium stearate, sodium lauryl sulphate, hypromellose (E464), polyoxyethylene glycol 400 and 6000, talc and colours E171 and E172 (inactive ingredients).
Cardilate MR 20mg Tablets are brownishred film-coated tablets embossed with a notch and ‘20'.
Cardilate MR Tablets come in packs of 56 and 100.
The marketing authorisation holder and company responsible for batch release is IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX
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 cardiac 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 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
If you experience anginal (chest pain) at the start of treatment with Cardilate MR Tablets within 1-4 hours
of taking the first dose, see your doctor before continuing with further doses.
Do not drink grapefruit juice while you are taking Cardilate MR Tablets. Do not start to take Cardilate MR
Tablets until 3 days after drinking grapefruit juice. 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 poor cardiac reserve (this is the extra energy the heart muscles have to allow them to work harder);
• 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), cisapride (for nightime heartburn), quinpristin/dalfopristin (for treatment of infection) or phenytoin (epilepsy treatment); or
• are a dialysis patient and suffer from a very high blood pressure and a low blood volume, you might experience a sudden drop in your blood pressure;
• are taking any of the following drugs, as they may interact with Cardilate MR Tablets;
• erythromycin, ketoconazole, itraconazole or fluconazole (antibiotic);
• indinavir, nelfinavir, ritonavir,saquinavir or amprenavir (HIV protease inhibitors);
• fluoxetine or nefazodone (for depression);
• tacrolimus (an immunosuppressant used to prevent the rejection of transplant organs);
• carbamazepine and valproic acid (for treatment of epilepsy);
• phenobarbitone (for insomnia and anxiety);
• are taking medication similar to Cardilate MR Tablets (calcium channel blocker) and you have been unsuccessful in fathering by in vitro fertilisation.
Laboratory experiments have shown that drugs similar to Cardilate MR Tablets weakened the sperm function;
• 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. The following drugs do not interact with Nifedipine; ajmaline, aspirin, benazepril,candesartan, cilexetil, debrisquine, irbesartan, omeprazole, orlistat,pantoprazole, ranitidine, rosiglitazone,talinolol, and triamterence hydrochlororthiazide.
If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.
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.
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 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.
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
You may have some side effects while you are taking your tablets.
You may suffer from any of the following common, less common, rare or very rare side-effects, for more than a few days.
Common side-effects (less than 1 person in 10)
• headache, dizziness, feeling sick or tired, a red face, swollen ankles, general swelling in the body, constipation and an irregular heartbeat.
Less common side-effects (less than 1 person in 100)
• general pain, abdominal pain, general sick feeling, low blood pressure when standing up to quickly, fainting, a fast heart beat, constipation, diarrhoea, dry mouth, indigestion, vomiting, pain in the joints and muscles, nervousness, pins and needles, trembling, sleeping disorders, difficulty in breathing, skin rashes, itching or sweating, bed wetting and an increase in the need to pass urine more often.
Anginal (chest pain) pain may occur at the start of treatment with Cardilate MR tablets. If this occurs
within 1-4 hours of taking the first dose see your doctor before continuing with further
Heart attacks have been reported after treatment with nifedipine. It has not been proven whether the reported heart attacks were due to the treatment of nifedipine or was a natural course of the patient's heart disease.
Rare side-effects (less than 1 person in 1000)
• enlarged abdomen, allergic reactions which may colour your skin yellowish, blistering on the skin caused by sunlight, low blood pressure, flatulence (wind) digestive problems, elevated patches and intense itching on the skin, mood changes ,increase in liver proteins( enzymes),problems with your eyes and failure to achieve or maintain an erection(impotence)
Very rare side-effects (less than 1 person in 10,000)
• a burning feeling in the skin and an allergic reaction that may become painful, tender or swollen gums that may bleed. Some patients have had a decrease in the number of blood cells. A few elderly men have had a slight development of their breast tissue which usually disappears when treatment with Cardilate MR Tablets is stopped.
If you notice any minor side effects, these should only be reported if they become troublesome. If you notice any major side effects like allergic reactions, stop taking the medicine and consult a doctor immediately.
If you feel unwell in any other way or your heart condition gets worse you should contact your doctor as soon as you can.
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 20mg Tablets. PL 00530/0488
This leaflet was rewritten in July 2012.