Skip to Content

UK Edition. Click here for US version.

CORACTEN XL 60MG

Active substance(s): NIFEDIPINE / NIFEDIPINE / NIFEDIPINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
CORACTEN XL 30 mg and 60 mg Capsules
Nifedipine
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.
What is in this leaflet
1. What Coracten XL is and what it is used for
2. What you need to know before you take Coracten XL
3. How to take Coracten XL
4. Possible side effects
5. How to store Coracten XL
6. Contents of the pack and other information
1. What Coracten XL is and what it is used for
Coracten XL 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 XL 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 XL 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 sustained-release 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 XL
Do not take Coracten XL:
• 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 XL 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 XL
• 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 XL
• 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 XL.
Children
Coracten XL 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.
Other medicines and Coracten XL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

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).
If you are unsure about your other medication, please talk to your doctor or
pharmacist before taking Coracten XL. They may need to alter your
treatment or give you some special advice.
Coracten XL with food, drink and alcohol
Coracten XL 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
XL.
Do not start taking Coracten XL 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 XL. 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 XL if you are pregnant or breastfeeding. Medicines like
Coracten XL 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 XL 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 XL contains lactose
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 XL
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 30 mg or one 60 mg capsule per day (every 24
hours). Doses of up to 90 mg per day may be prescribed by your
doctor if considered necessary.
Coracten XL 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 XL 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.
If you take more Coracten XL 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.






















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
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 XL
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 25°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 XL contains
The active substance is nifedipine. Each capsule contains either 30 mg or 60
mg Nifedipine, in sustained release form.
The other ingredients are: lactose monohydrate; microcrystalline cellulose;
hydroxylpropyl methlcellulose K100; povidone K30; magnesium
stearate; hydroxypropylcellulose; ammonio methacrylate copolymer type B;
polyethylene glycol 6000; dibutylphthalate; titanium dioxide E171; talc.
The capsule shells for Coracten XL 30 mg contain: yellow iron oxide E172; red
iron oxide E172; titanium dioxide E171; gelatin. The capsule shells for
Coracten XL 60 mg contain: red iron oxide E172; titanium dioxide E171;
gelatin; black printing ink.
What Coracten XL looks like and contents of the pack
The 30 mg capsules have an opaque caramel cap and body overprinted in
black with ‘COR 30’. The 60 mg capsules have an opaque orange cap and
body overprinted in black with ‘COR 60’.
Coracten XL is available in PVC/PVdC/aluminium blister strips packed in
cartons containing 10, 15, 30, 56, 60, 100, 150, 250, 500 and 600. 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 MA Holder:
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE.
This leaflet was last revised in May 2017.

11001629

If you forget to take Coracten XL
Do not worry. Take the missed dose as soon as you remember and take the
next dose 24 hours later. Do not take more than your prescribed dose
in 24 hours. 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
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
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 XL 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 XL 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 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)

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.

Hide