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Package leaflet: Information for the user


Cardene 20mg and 30mg capsules
Nicardipine hydrochloride

Read all of this leaflet carefully before you start using this medicine because 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, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Cardene is and what it is used for
2. What you need to know before you take Cardene
3. How to take Cardene
4. Possible side effects
5. How to store Cardene
6. Contents of the pack and other 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.

Warnings and precautions
Talk to your doctor before taking Cardene 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
If you experience sudden dizziness, light-headedness
or palpitations during treatment with Cardene capsules,
speak to your doctor immediately.

1. What Cardene is and what it is used for

Children and adolescents
Do not give this medicine to children or adolescents
under 18 years of age.

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.

Other medicines and Cardene
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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.

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.

This is especially important when also taking the
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)
• o
 ther blood pressure lowering drugs
• r ifampicin (used to treat certain types of infectious
beta blockers (used to treat different disorders
including high blood pressure and heart problems)
• diuretics (water tablets)

2. What you need to know before you take Cardene
Do not take Cardene
if you are allergic to nicardipine, other
dihydropyridines, or any of the other ingredients
of this medicine (listed in section 6)
• 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)
• 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
if you are pregnant or breast-feeding (see
Pregnancy and breast-feeding section)

Cardene 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
Always take this medicine exactly as your doctor has told
you to and do not stop treatment unless they tell you to
do so. Check with your doctor, pharmacist or nurse if you
are not sure. 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,
pharmacist or nurse. 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 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
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 forgotten dose.

• rashes
• itching
• ringing in the ears
• difficulty in passing urine or passing more urine than
• 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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Cardene
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton (EXP). The expiry date refers to the
last day of that month.
Do not store above 25°C.

If you have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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 a stronger heart beat (palpitations)
• nausea
• dizziness
Other side effects include:
heart complaints, such as increased heart rate
• stomach upsets
• vomiting
• pins and needles
• drowsiness
• shortness of breath
• medically unexplained symptoms thought to be the
result of psychological factors
• sleeplessness

What Cardene capsules contain
The active substance is nicardipine hydrochloride. Each
capsule contains either 20 mg or 30 mg of nicardipine
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
Marketing authorisation holder:
Astellas Pharma Ltd.,
2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK.
Farmasierra Manufacturing S.L., Carretera de Irún,
Km. 26,200,
San Sebastián de los Reyes, 28700 Madrid, Spain.
This leaflet was last revised in September 2016.


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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.