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CARDENE SR 45MG

Active substance(s): NICARDIPINE HYDROCHLORIDE / NICARDIPINE HYDROCHLORIDE / NICARDIPINE HYDROCHLORIDE

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152008
Cardene SR
Cap
Great Britain
LFT 173 x 270 mm
LFT_272
Project 40341
Eq. to: N/A

Patient Information Leaflet

Cardene SR 30mg or 45mg capsules
Nicardipine hydrochloride

152008

20.04.2017

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

• a
 re 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 and Cardene SR

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.

Tell your doctor, pharmacist or nurse if you are using,
have recently used or might use 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. Especially tell
your doctor if you are using any of the following medicines:
• digoxin (used to treat heart problems)
• cimetidine (used to treat digestive problems)
cyclosporine, tacrolimus or sirolimus (used to control
• 
the body’s immune system)
• 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)

What Cardene SR capsules are used for

Taking Cardene SR capsules with food and drink

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

1. WHAT CARDENE SR CAPSULES ARE AND
WHAT THEY ARE USED FOR
What are Cardene SR capsules

Your medicine is used for the treatment of mild to moderate
high blood pressure (hypertension).

2. BEFORE YOU TAKE CARDENE SR CAPSULES
Do not 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
• 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 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

152008-LFT-Cardene SR Cap GB.indd 1

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
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
ingredients of Cardene SR capsules

of

the

This product contains lactose. If you are lactose
intolerant, contact your doctor or pharmacist before taking
this product.

3. HOW TO TAKE CARDENE SR CAPSULES
Dosage
Always take your medicine exactly as your doctor tells
you to and do not stop treatment unless they tell you to do

20-04-17 15:30

ms

Black

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






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 SR CAPSULES

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

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

If you forget to take Cardene SR capsules

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.

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 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.
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 a stronger heart beat (palpitations)
nausea
dizziness

Other side effects include:
• h
 eart complaints, such as increased heart rate
(tachycardia)
• stomach upsets
• vomiting
• 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

152008-LFT-Cardene SR Cap GB.indd 2

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 March 2017.
152008
14121/11

20-04-17 15:30

Expand Transcript

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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