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CORACTEN SR CAPSULES 20MG

Active substance(s): NIFEDIPINE

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03520140Y01760140L00N050UPIRM

Package leaflet: Information for the user
Coracten SR Capsules 10 mg and Coracten SR Capsules 20 mg
Nifedipine

1. What Coracten SR is and
what it is used for

Coracten SR contains nifedipine, which belongs
to a group of medicines called calcium-channel
blockers.
Used to treat:
• high blood pressure in adults
To prevent:
• chronic stable angina pectoris (heart/chest
pain) in adults.
For high blood pressure: Coracten SR works by
relaxing and expanding the blood vessels. This
makes the blood flow more easily and lowers
blood pressure. Lower blood pressure reduces the
strain on your heart.
For angina: Coracten SR works by relaxing and
expanding the arteries supplying the heart. This
allows more blood and oxygen to reach the
heart and decreases the strain on it. Your angina
attacks will be less severe and less frequent if
there is less strain on the heart.
PLEASE NOTE: These capsules are sustainedrelease capsules which release the active
ingredient slowly over 12 hours. Do not use to
treat attacks of angina or heart attacks when
they happen. See your doctor if you are unsure
why you have been prescribed these capsules.

2. What you need to know
before you take Coracten SR

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>> READ DIRECTION
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Do not take Coracten SR:
• if you are allergic to nifedipine or any of the
other ingredients of this medicine (listed in
section 6) or other dihydropyridines such
as amlodipine, felodipine, isradipine or
nisolidipine.
• if you have taken nifedipine before and found
your heart pain got worse
• if you get a sudden angina attack. Coracten
SR will not help relieve symptoms of angina
quickly
• if you are pregnant, or likely to become
pregnant and breast-feeding
• if you have Porphyria
• if you have narrowing (stenosis) of the aortic
valve (one of the valves of the heart)
• if you have unstable angina (heart pain)
• if you have suffered a heart attack less than
one month ago
• if you have collapse of the circulation
(cardiogenic shock)
• if you have very high blood pressure
(malignant hypertension)
• if you are taking rifampicin – a treatment for
tuberculosis
• if you have a “Kock pouch” (a surgically
constructed intestinal reservoir with an
opening through the abdominal wall) in your
gut
• This medicine is not recommended for use in
children.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Coracten SR
• if you have heart problems other than chronic
stable angina (heart failure)
• if you have low blood pressure
• if you have diabetes. The treatment for your
diabetes may need to be adjusted
• if you are on kidney dialysis. If you have a very
high blood pressure and a low blood volume,
you might experience a sudden drop in blood
pressure when you take Coracten SR
• if your liver is not working properly. Your
doctor may need to do some blood tests. You
may also be given a lower dose of Coracten SR.
Children
Coracten SR is not recommended for use in
children and adolescents below 18 years of age,
because there are only limited data on the safety
and efficacy in this population.

Tell your doctor if you are taking any of the
following medicines:
• Other medicines to treat high blood pressure.
• Rifampicin (an antibiotic).
• Cimetidine (to treat stomach ulcers).
• Digoxin, diltiazem, quinidine or beta-blockers
(to treat heart conditions).
• Quinupristin/dalfopristin (a combination
antibiotic).
• Phenytoin, carbamazepine or valproic acid (to
treat epilepsy).
• Cisapride (to treat reduced movements of the
gullet and stomach).
• Magnesium sulphate injections during
pregnancy (may cause a severe fall in blood
pressure).
• Erythromycin (an antibiotic).
• Ketoconazole, itraconazole or fluconazole
(anti-fungal medicines).
• Indinavir, nelfinavir, ritonavir, saquinavir or
amprenavir (to treat HIV).
• Fluoxetine or nefazodone (to treat
depression).
• Tacrolimus (to prevent the rejection of
transplanted organs).
• Phenobarbital (usually used to treat insomnia
or anxiety).
• St John’s Wort (herbal medicine).

>> READ DIRECTION

FRONT

What is in this leaflet:
1. What Coracten SR is and what it is used for
2. What you need to know before you take
Coracten SR
3. How to take Coracten SR
4. Possible side effects
5. How to store Coracten SR
6. Contents of the pack and other information

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

1ST BAR

Read all this leaflet carefully before you
start taking 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 or pharmacist.
- This medicine has been prescribed for you
only. 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

LAST BAR

HEAD

If you are unsure about your other medication,
please talk to you doctor or pharmacist before
taking Coracten SR. They may need to alter your
treatment or give you some special advice.
Coracten SR with food, drink and alcohol
Coracten SR may be taken with or without food.
As a safety precaution, do not take with alcohol.
Do not drink grapefruit juice or eat grapefruit
while you are taking Coracten SR.
Do not start taking Coracten SR within 3 days of
drinking grapefruit juice or eating grapefruit.
Tell your doctor if you have had grapefruit
or grapefruit juice in this time. Also, do not
drink grapefruit juice or eat grapefruit whilst
taking Coracten SR. Grapefruit juice is known to
increase the blood levels of the active ingredient,
nifedipine. This effect can last for at least 3 days.
Pregnancy, breast-feeding and fertility
Do not take Coracten SR if you are pregnant or
breastfeeding.
Medicines like Coracten SR Capsules have been
shown in laboratory experiments to impair
sperm function. If you are male and have been
unsuccessful in fathering a child please consult
your doctor.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Driving and using machines
Coracten SR may make you feel dizzy, faint,
extremely tired or have visual disturbances.
Do not drive or operate machinery if you are
affected in this way.
This may be more likely when you first start
treatment, if you change medication, or if you
have drunk alcohol.
Coracten SR contains lactose monohydrate and
sucrose
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. How to take Coracten SR

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is one 10 mg or one
20 mg capsule (every 12 hours). Doses of up to
80 mg per day (40 mg every 12 hours) may be
prescribed by your doctor if considered necessary.
Coracten SR should be swallowed whole with
a drink of water. Do not break or chew the
capsules.
Do not take them with grapefruit juice.
Duration of treatment
Treatment for high blood pressure or angina is
usually for life. Your doctor will monitor your
treatment and check your blood pressure. Do not
stop taking the capsules unless your doctor tells
you to. DO NOT EXCEED THE STATED DOSE
Use in children and adolescents: Coracten SR
is not recommended for use in children and
adolescents below 18 years of age, because there
are only limited data on the safety and efficacy in
this population.

VERSION
Customer
Description

Item Code
PPN/2nd Code
Operator

Piramal
CORACTEN SR LFT UK
20160330A
161755
Kear, Andrew

Drawing

L00000079 1020-e

View/Backup

Flat Size

352 x 140

mm

Fold Size/Lip

176 x 140

mm / 0

050 gsm Uncoated

Material
Pharmacode/
2D Code
Type/Pages

tbc
Pre-Fold

2 pp

Title

Colours
FRONT
(or cover)

Black

Colours
BACK
(or inner)

Black

History

C on 14/04/2016 16:39:30

C

HEAD to HEAD

Submitted

Attention: The colours displayed in this proof are for electronic representational purposes only. Please refer to the PANTONE® colour guides for accurate colour matching. By approving this file, you are signifying full approval of design and text. To ensure
accurate viewing and printing of this PDF file, Overprint Preview must be activated for accurate colour representation. MPS Leaflets PDF files are designed to work with Adobe Acrobat 6 or higher and are PDF/X-01a-2001 compliant.

HEAD

03520160Y01760160L00N050UPIRM

If you take more Coracten SR than you should
If you take too many go straight to your casualty
department. Take the capsules, box and this
leaflet with you.
Taking too many capsules may cause your blood
pressure to become too low and your heartbeats
to speed up or slow down. It may also lead
to an increase in your blood sugar level or an
increase in the acidity of your blood, swelling
in the lungs, low blood oxygen levels and
disturbances in consciousness, possibly leading to
unconsciousness.
If you forget to take Coracten SR
Do not worry. Take the missed dose as soon as
you remember, waiting 12 hours before taking
your next dose. Do not take more than your
prescribed dose. Tell your doctor at your next visit
if you have missed a few doses.
Do not take a double dose to make up for a
forgotten dose.






















4. Possible side effects

It is important that you are aware of what these
side effects may be. They are usually mild and
disappear after a short time.
Stop taking Coracten SR and seek urgent medical
help immediately if you suffer from:
• An increase in chest pain at the start of
treatment
• An allergic reaction and experience difficulty
breathing, with or without swelling of the
face, lips, tongue, and/or throat which may
cause difficulty in swallowing.
Also stop taking Coracten SR and talk to your
doctor immediately if you:
• Start shaking or experience a loss of eyesight
caused by a sudden drop in blood pressure
• Notice a yellowing of the skin and eyes caused
by liver problems such as allergic hepatitis,
intra-hepatic cholestasis
• Notice flaking or purple blotching of the skin
caused by exfoliative dermatitis, erythema
multiform or pemphigoid reactions.
Other side effects
If any of the following side-effects become
troublesome, continue taking Coracten SR but
talk to your doctor immediately:
Common Side Effects: may affect up to 1 in 10
people
• headache
• general feeling of being unwell
• constipation
• swelling, particularly of the ankles and legs
Uncommon Side Effects: may affect up to 1 in
100 people
• stomach pain
• unspecific pain
• low blood pressure when standing up
(symptoms include fainting, dizziness, light
headedness, occasional palpitations, blurred
vision and sometimes confusion)
• fainting
• faster or irregular heartbeat (palpitations)
• dry mouth
• indigestion or upset stomach
• wind (flatulence)
• feeling sick (nausea)
• muscle cramps
• joint swelling
• sleep disorders
• anxiety or nervousness
• reddening of the skin
• nosebleeds
• nasal congestion
• a feeling of dizziness or “spinning” (vertigo)
• migraine
• trembling
• increase in the need to pass water (urinate)
• painful or difficult urination
• inability to achieve or maintain an erection
(impotence)
• blurred vision
• temporary increase in certain liver enzymes
• chills
Rare side effects: may affect up to 1 in 1,000
people
• pins and needles
• itchy skin
• rash, hives
• changes in mood
• inflammation of the gums
• tender or swollen gums
• bleeding gums
Not known: frequency cannot be estimated from
the available data
• a reduction in the number of white blood cells
(leucopenia)
• a more severe decrease in the number of white
blood cells (agranulocytosis)
• depression
• increased blood sugar (hyperglycaemia)
• decreased skin sensitivity (hypoaesthesia)

Because of the nature of coronary heart disease,
heart attacks have occurred in patients treated
with the active ingredient, nifedipine. It has not
been shown that these heart attacks were due to
treatment with nifedipine.
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 Coracten SR

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 and the blister foil
after EXP. The expiry date refers to the last day of
that month.
Store in the original package.
Do not store above 30°C.
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 protect the environment.

6. Contents of the pack and other
information
What Coracten SR contains
The active substance is nifedipine. Each capsule
contains either 10 mg or 20 mg nifedipine, in
sustained release form.
The other ingredients are: sucrose, maize starch,
lactose monohydrate, povidone K30, methacrylic
acid copolymer type A (Eudragit L100), talc.

The capsule shell contains: gelatin, red iron oxide
(E172), yellow iron oxide (E172), titanium dioxide
(E171), black iron oxide (E172, 10 mg only).
What Coracten SR looks like and contents of the
pack
The 10 mg capsules have an opaque brownishpink cap and opaque grey body, printed in white
with ‘coracten’ on the body and ’10 mg’ on the
cap, containing yellow spherical granules.
The 20 mg capsules have an orange opaque cap
and caramel opaque body, printed in white with
‘Coracten 20 mg’, and filled with yellow granules.
Coracten SR are available in PVC/PVdC/aluminium
blister strips packed in cartons containing 10, 15,
30, 56, 60, 100, 150, 250, 500 and 600 capsules.
Not all pack sizes may be marketed.
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor
or pharmacist, who will have access to further
information.
High blood pressure and heart disease are very
common. It is important to help yourself by
losing weight if you need to and taking regular
exercise. Your doctor can put you in touch
with organisations that offer information and
advice to people in your situation. One such
organisation is The British Heart Foundation.
Marketing Authorisation Holder and
Manufacturer:
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE.
This leaflet was last revised in April 2016.

20160330A

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

sleepiness
lethargy
insufficient blood flow to the brain
eye pain
chest pain (angina pectoris)
decreased blood flow to your heart
shortness of breath (dyspnea)
flushing
vomiting
heartburn or indigestion (gastroesophageal
sphincter insufficiency)
diarrhoea
sensitivity to light (photosensitivity allergic
reaction)
small raised areas of bleeding in the skin
(palpable purpura)
spider veins
joint pain
muscle pain
muscle weakness
fever
worsening of myasthenia gravis
development of breast tissue in older men on
long term therapy has been reported

VERSION
Customer
Description

Item Code
PPN/2nd Code
Operator

Piramal
CORACTEN SR LFT UK
20160330A
161755
Kear, Andrew

Drawing

L00000079 1020-e

View/Backup

Flat Size

352 x 140

mm

Fold Size/Lip

176 x 140

mm / 0

050 gsm Uncoated

Material
Pharmacode/
2D Code
Type/Pages

tbc
Pre-Fold

2 pp

Title

Colours
FRONT
(or cover)

Black

Colours
BACK
(or inner)

Black

History

C on 14/04/2016 16:39:30

C

HEAD to HEAD

Submitted

Attention: The colours displayed in this proof are for electronic representational purposes only. Please refer to the PANTONE® colour guides for accurate colour matching. By approving this file, you are signifying full approval of design and text. To ensure
accurate viewing and printing of this PDF file, Overprint Preview must be activated for accurate colour representation. MPS Leaflets PDF files are designed to work with Adobe Acrobat 6 or higher and are PDF/X-01a-2001 compliant.

Expand view ⇕

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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