CARDENE 20MG

Active substance: NICARDIPINE HYDROCHLORIDE

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Patient Information Leaflet

142101

Cardene 20mg and 30mg capsules
Nicardipine hydrochloride

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:
W
1.  hat 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
•  you are allergic (hypersensitive) to nicardipine,
if
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
•  your chest pain is diagnosed by your doctor
if
as unstable angina (for example, if the pattern of
attacks of chest pain changes and occurs 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)
•  try to prevent the occurrence of future heart
to
attacks (if you have already had at least one heart
attack)

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•  you are pregnant or breast-feeding (see
if
Pregnancy and breast-feeding section)

•  you are under 18 years of age
if
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.

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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.

• 
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)
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.

Most frequent side effects
• 
headache
• 
ankle swelling (oedema)
• 
heat sensation
• 
facial flushing
• 
sensation of fast heart beats (palpitations)
• 
nausea
• 
dizziness

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.

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

This leaflet was last revised in December 2013.

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Cardene capsules are manufactured by Farmasierra
Manufacturing S.L., Carretera de Irún, Km. 26,200,
San Sebastián de los Reyes, 28700 Madrid, Spain.

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10-12-13 14:47

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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.

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