Cardene 30mg
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Patient Information Leaflet
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Read all of this leaflet carefully before you start using this medicine. 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 your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cardene capsules are and what they are used for
2. Before you take Cardene capsules
3. How to take Cardene capsules
4. Possible side effects
5. How to store Cardene capsules
6. Further information
The name of your medicine is Cardene 20mg/30mg capsules. However, it will be referred to as Cardene capsules throughout the remainder of the leaflet.
1. WHAT CARDENE CAPSULES ARE AND WHAT THEY ARE USED FOR
What are Cardene capsules
Cardene capsules contain the active ingredient nicardipine hydrochloride which belongs to the class of drugs called calcium channel blockers. These cause relaxation of the smooth muscle of the blood vessels causing these vessels to widen or dilate.
What Cardene capsules are used for
Your medicine is used for the treatment of mild to moderate high blood pressure (hypertension) and to help prevent attacks of chest pain diagnosed by your doctor as chronic stable angina. Chronic stable angina is a pattern of attacks of chest pain that are predictable and reproducible under certain conditions such as after exercise, stress or in cold weather. They are short in duration and can be relieved by rest or certain drugs.
2. BEFORE YOU TAKE CARDENE CAPSULES
Do not take Cardene capsules
• i f you are allergic (hypersensitive) to nicardipine, other dihydropyridines, or any of the other ingredients of Cardene capsules (see list in section 6 ‘Further information’)
• if you have had a recent heart attack (ie. within the last month)
• if you suffer from a condition called severe aortic stenosis which is narrowing of your aortic heart valve
• if your chest pain is diagnosed by your doctor as unstable angina (for example, if the pattern of attacks of chest pain changes and occurs without exertion, you should contact your doctor immediately)
• i f you need immediate relief of chest pain in a sudden or acute angina attack (this situation should be treated with a different class of medicine)
• to try to prevent the occurrence of future heart attacks (if you have already had at least one heart attack)
• if you are pregnant or breast-feeding (see Pregnancy and breast-feeding section)
• if you are under 18 years of age
Take special care with Cardene capsules (and speak to your doctor)
Make sure your doctor knows if you:
• have a heart, liver or kidney disorder. Your doctor may decide you need a lower dose.
• have had a stroke
• are about to undergo an operation
• experience sudden dizziness, light-headedness or palpitations during treatment with Cardene capsules (speak to your doctor immediately if this happens)
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of either Cardene capsules or other medicines. This is especially important when also taking the following:
• digoxin (used to treat heart problems)
• cimetidine (used to treat digestive problems)
• cyclosporine, tacrolimus or sirolimus (used to dampen down the body’s immune reactions)
• other blood pressure lowering drugs
• rifampicin (used to treat certain types of infectious disease)
• beta blockers (used to treat different disorders including high blood pressure and heart problems)
• diuretics (water tablets)
Taking Cardene capsules with food and drink
Cardene capsules must NOT be taken with grapefruit juice since it could interact and alter the effects of Cardene capsules.
Pregnancy and breast-feeding
You should NOT take Cardene capsules if you are pregnant. You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You should NOT breast-feed if you are taking Cardene capsules. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Cardene capsules may cause dizziness. If you suffer from this do not drive or operate machinery.
3. HOW TO TAKE CARDENE CAPSULES Dosage
Always take your medicine exactly as your doctor tells you to and do not stop treatment unless they tell you to do so. Do not change the prescribed dose of your medicine yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.
The usual starting dose for treating mild to moderate high blood pressure (hypertension) and to help prevent attacks of chest pain (chronic stable angina) is 20 mg every 8 hours. The usual effective dose is 30 mg every 8 hours. Your doctor may vary your dose according to your symptoms and blood pressure, taking particular care if you are elderly. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist. Do not take this medicine if you are under 18 years of age.
Capsules should be swallowed whole with a glass of water, preferably at the same time each day. Do not use grapefruit juice.
If you take more Cardene capsules than you should
If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take Cardene capsules
If you forget to take a dose, take another dose as soon as you remember, provided there are at least 3 hours until your next dose. If this is not possible, do not take the missed dose. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
This medicine sometimes causes side-effects. These are usually mild and tend to pass with time, but if they trouble you consult your doctor.
In some patients, Cardene capsules may cause an attack of angina (chest pain) shortly after first starting to take the capsules. If this happens to you, do not take any further doses and contact your doctor.
In addition a few patients experience an increase in the severity or frequency of chest pain during treatment with Cardene capsules. If this happens to you, you must inform your doctor as soon as possible.
Most frequent side effects
• headache
• ankle swelling (oedema)
• heat sensation
• facial flushing
• sensation of fast heart beats (palpitations)
• nausea
• dizziness
Other side effects include:
• heart complaints
• stomach upsets
• pins and needles
• drowsiness
• shortness of breath
• medically unexplained symptoms thought to be the result of psychological factors
• sleeplessness
• rashes
• itching
• ringing in the ears
• difficulty in passing urine or passing more urine than usual
• depression
• increased bleeding or bruising more easily than usual
• impotence (loss of libido)
• serious allergic reaction which causes difficulty in breathing or dizziness
• changes in blood tests of how your liver is working Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 you can help provide more information on the safety of this medicine.
5. HOW TO STORE CARDENE CAPSULES
Keep this medicine out of the reach and sight of children. Do not store above 25 °C.
This medicine must not be used after the date (EXP) printed on the pack. Return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cardene capsules contain
Cardene capsules contain the active ingredient nicardipine hydrochloride. Cardene capsules come in two strengths.
Each capsule contains either 20 mg or 30 mg of nicardipine hydrochloride.
The other ingredients are pregelatinised starch and magnesium stearate. The capsule shell contains gelatin, indigotine E132 and titanium dioxide E171.
What Cardene capsules look like and contents of the pack
Cardene 20mg capsules are coloured blue and white and are printed in red ink with the strength and company logo. Cardene 30mg capsules are coloured blue and pale blue and are printed in red ink with the strength and company logo.
Both strengths of capsules are supplied in blister packs of 56.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Cardene 20mg and 30mg capsules are held by Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK.
Cardene capsules are manufactured by Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26,200, San Sebastian de los Reyes, 28700 Madrid, Spain.
This leaflet was last revised in October 2014.
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