Wednesday, October 19, 2016

Cardene 20mg and 30mg capsules






UK



Cardene 20 mg and 30 mg capsules



Nicardipine hydrochloride




Please read this leaflet carefully before you start to take your medicine.



If you have any questions or are not sure about anything, ask your doctor or pharmacist.




What is Cardene?


Cardene contains 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.


Cardene capsules come in two strengths. Each capsule contains either 20 mg or 30 mg of nicardipine hydrochloride.


  • The 20 mg capsule is coloured blue and white.

  • The 30 mg capsule is coloured blue and pale blue.

They also contain the additional ingredients: starch, magnesium stearate, gelatin, indigotine E132, titanium dioxide El71.


Both strengths of capsules are available in packs of 56.


The Product Licence holder is



Astellas Pharma Limited

Lovett House

Lovett Road

Staines

Middx

TW18 3AZ

UK


This medicine is made by



Farmasierra, S.A.

Carretera de Irún

Km. 26,200

San Sebastián de los Reyes

28700 Madrid

Spain


The site where batch release takes place is



Astellas Pharma Europe BV

Hogemaat 2

Meppel

The Netherlands




What is Cardene 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.




When must Cardene not be used?


  • If you are allergic to nicardipine or other dihydropyridines, or any of the ingredients Cardene contains.

  • If you have had a recent heart attack (ie. within the last month), or a condition called advanced 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 occur without exertion, you should contact your doctor immediately.

  • If 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).

  • Cardene is not recommended for patients under the age of 18.


When should you be extra careful when using/while taking Cardene?


Make sure your doctor knows if you:


  • have a heart, liver or kidney condition, or have had a stroke.

  • are taking other medicines including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of either Cardene or other medicines. Examples of such effects have been reported for Cardene when also taking digoxin, cimetidine, cyclosporin and other blood pressure lowering drugs amongst other medicines. Rifampicin or grapefruit juice should not be taken with Cardene, since they could also interact and alter the effects of Cardene.

  • are about to undergo an operation. You must tell the doctors in the hospital that you are taking Cardene.

  • if you experience sudden dizziness, light-headedness or palpitations on treatment with Cardene, let your doctor know. Sometimes Cardene can cause too great a fall in blood pressure which, if not dealt with, could damage your heart or brain.



May Cardene be used during pregnancy or while breast feeding?


  • You should NOT take these 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 these capsules.




How should Cardene be taken?


  • Always take your medicine exactly as your doctor tells you to and do not stop treatment unless he/she tells you to do so:

  • The usual dose is 20-30 mg, every 8 hours. Your doctor may vary this according to your symptoms and blood pressure. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist.

  • Capsules should be swallowed with a glass of water, preferably at the same time each day. (NB. Do not use grapefruit juice).

  • If you forget to take a dose, take another dose as soon as you remember provided there are at least 3 hours between doses. If this is not possible, do not take the missed dose. Do not take two doses together.

  • 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

  • If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.



What are the possible unwanted effects of Cardene?


This medicine sometimes causes side-effects. These are usually mild and tend to pass with time, but if they trouble you consult your doctor.



Common side effects are:


Headache, ankle swelling (oedema), heat sensation, facial flushing, sensation of fast heart beats (palpitations), nausea, dizziness.


In some patients Cardene 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. If this happens to you, you must inform your doctor as soon as possible.


Other less frequent side-effects include heart complaints, drowsiness, sleeplessness, ringing in the ears, pins and needles, psychological upset, itching, rashes, diffculty in passing urine or an increase in passing urine, shortness of breath, stomach upsets, and rarely, depression, increase in bruising and impotence.


If you are concerned about these or any other unwanted effects talk to your doctor.





How should Cardene be stored?


  • 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 left over medicine to your pharmacist. Only keep it if your doctor tells you to.

  • REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.



Further information:


You can get more information on Cardene from your doctor or pharmacist.



Date of last review


July 2005


118143


14121/3






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