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CARDENE SR 30MG

Active substance(s): NICARDIPINE HYDROCHLORIDE

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Patient Information Leaflet

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Cardene SR 30mg or 45mg 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:
1. What Cardene SR capsules are and what they are used for
2. Before you take Cardene SR capsules
3. How to take Cardene SR capsules
4. Possible side effects
5. How to store Cardene SR capsules
6. Further information
The name of your medicine is Cardene SR 30mg/45mg capsules.
However, it will be referred to as Cardene SR capsules throughout
the remainder of the leaflet

• 
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 SR capsules with food and drink
Cardene SR capsules must NOT be taken with grapefruit juice
since it could interact and alter the effects of Cardene SR capsules.

Pregnancy and breast-feeding
1. WHAT CARDENE SR CAPSULES ARE AND WHAT
THEY ARE USED FOR
What are Cardene SR capsules
Cardene SR 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 SR capsules are used for
Your medicine is used for the treatment of mild to moderate high
blood pressure (hypertension).

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. Ask your doctor or pharmacist for
advice before taking any medicine.

Driving and using machines
Cardene SR capsules may cause dizziness. If you suffer from this
do not drive or operate machinery.

Important information about some of the ingredients of
Cardene SR capsules
This product contains lactose. If you are lactose intolerant,
contact your doctor or pharmacist before taking this product.

2. BEFORE YOU TAKE CARDENE SR CAPSULES
Do not take Cardene SR capsules

3. HOW TO TAKE CARDENE SR CAPSULES

• if you are allergic (hypersensitive) to nicardipine, other
dihydropyridines, or any of the other ingredients of Cardene
SR 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
• t o 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

Dosage

Take special care with Cardene SR 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
on treatment with Cardene SR 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 SR 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)

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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) is 30 mg every 12 hours. The usual
effective dose is 45  mg every 12 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 SR 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 SR 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.

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4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE CARDENE SR CAPSULES

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

Keep this medicine out of the reach and sight of children.

In some patients, Cardene SR 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.

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.

In addition a few patients experience an increase in the severity
or frequency of chest pain during treatment with Cardene SR
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.

Protect from light and moisture and do not store above 25 °C.

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 SR capsules contain
Cardene SR capsules contain the active ingredient nicardipine
hydrochloride in a sustained release formulation. Cardene SR
capsules come in two strengths. Each capsule contains either
30mg or 45mg of nicardipine hydrochloride.
The other ingredients are pregelatinised starch, maize starch,
magnesium stearate, microcrystalline cellulose, lactose and
methacrylic acid copolymer. The capsule shell contains gelatin and
titanium dioxide E171 and the 45mg capsule shell also contains
indigo carmine E132. Printing Ink containing Shellac (E904),
Red Iron Oxide (E172), Propylene Glycol, Ammonia Solution,
Potassium Hydroxide.

What Cardene SR capsules look like and contents of
the pack
Cardene SR 30 mg capsules are coloured opaque white and are
printed in red ink with the strength and company logo.
Cardene SR 45  mg capsules are coloured opaque blue and are
printed in red ink with the strength and company logo.
Both strengths of capsules are available in packs of 56.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Cardene SR capsules 30mg and
45mg are held by Astellas Pharma Ltd., 2000 Hillswood Drive,
Chertsey, Surrey, KT16 0RS, UK.
Cardene SR capsules are made by 3M Healthcare Limited,
Morley Street, Loughborough, Leicestershire, LE11 1EP, UK.
The site where batch release takes place is Astellas Pharma
Europe BV, Sylviusweg 62, 2333 BE Leiden, The Netherlands.
This leaflet was last revised in October 2014.

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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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