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CORACTEN XL 30 mg and 60 mg CAPSULES Nifedipine PATIENT INFORMATION LEAFLET

In this leaflet:

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

2.    Before you take Coracten XL

3.    How to take Coracten XL

4.    Possible side effects

5.    How to store Coracten XL

6.    Further information

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

Coracten XL is an antihypertensive or anti-anginal medicine and belongs to a group of medicines called calcium-channel blockers.

Used to treat:

•    high blood pressure To prevent:

•    chronic stable angina pectoris (heart/chest pain).

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.    Before you take Coracten XL

Do not take this medicine if you have/are:

•    Allergic to any of the ingredients in Coracten XL or other dihydropyridines such as amlodipine, felodipine, isradipine or nisolidipine.

•    Taken nifedipine before and found your heart pain got worse

•    Pregnant, or likely to become pregnant and breast- feeding

•    Porphyria

•    Narrowing (stenosis) of the aortic valve (one of the valves of the heart)

A. .Unstable angina, (heart .pain).........................

•    Suffered a heart attack less than one month ago

•    Collapse of the circulation (cardiogenic shock)

•    Very high blood pressure (malignant hypertension)

•    Taking rifampicin - a treatment for tuburculosis

•    If you have liver disease

•    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

Do not drink grapefruit juice while you are on Coracten XL, as the absorption of the drug is increased and this will make your blood pressure drop too low and your heart beat faster.

Tell your doctor if the answer is yes to any of the following statements, as special care should then be taken.

Do you have:

•    Heart problems other than chronic stable angina (heart failure)

•    Low or high blood pressure

•    Diabetes

-• Kidney failure and require dialysis Are you taking any other medicines?

Tell your doctor if you are taking any other medicine, especially:

•    Beta-blockers for high blood pressure (If you are changing from beta-blockers to Coracten XL, you should gradually reduce your beta-blockers over 10 days, after discussion with your doctor).

•    Other calcium channel blockers such as diltiazem

•    Medicines to treat infections such as the antibiotics: erythromycin, dalfopristin and quinupristin, ritanovir (for HIV) and antifungal medicines

•    Anti-epilepsy drugs such as valproic acid, carbamazapine, phenytoin and phenobarbitone

•    Medicines used during an operation such as anaesthetics and the muscle relaxants tubocurarine or vecuronium

•    Anti-depressants such as fluoxetine and nefazodone

•    Antipsychotic medicines (used to treat mental illness) such as chlorpromazine, fluphenazine

•    Intravenous ionic X-ray contrast mediums (used to help show internal organs more clearly)

•    Medicines to treat various heart conditions such as digoxin, quinidine, prazosin, diuretics (water tablets)

•    Magnesium sulphate as injection

•    Aldesleukin to treat cancer of the kidneys

•    Alprostadil for erectile dysfunction

•    Medicines used following organ or tissue transplants such as ciclosporin and tacrolimus

•    Cisapride to treat disorders of the stomach and digestion

•    Cimetidine to treat stomach/gastric ulcers

•    Mizolastin to treat hayfever, theophylline to treat asthma

•    Herbal medicines such as St John's Wort, gingko biloba, ginseng.

If you are unsure about your other medication, please talk to you doctor or pharmacist before taking Coracten XL. They may need to alter your treatment or give you some special advice. 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.

Taking Coracten XL with food or drink

Coracten XL may be taken with or without food. As a safety precaution, do not take with alcohol.

Driving and using machines

Coracten XL may cause dizziness and tiredness.

A large drop in blood pressure may result in temporary loss of vision. If affected by any of these you should not drive or use machines.

This medicine 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

Coracten XL should be swallowed whole with a drink of water. Do not break or chew the capsules. The usual 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.

Please read the pharmacist's label for further instructions on how many to take and when to take the capsules. If the dosage is not clear to you, check with your doctor or pharmacist.

How long should I take them for?

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 What if I take too many?

If you take too many go straight to your casualty department. Take the capsules, box and this leaflet with you.

What if I forget a dose?

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. If you do not remember your missed dose until it is time for your next one then do not take the missed dose. Tell your doctor at your next visit if you have missed a few doses.

4.    Possible side-effects

Like all medicines Coracten can cause side effects although not everyone 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 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 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 - These 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 - These 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 an erection (impotence), blurred vision, temporary increase in certain liver enzymes.

Rare side effects - These may affect up to 1 in 1,000 people:

pins and needles, itchy skin, rash, hives, changes in mood, inflammation or the gums, tender or swollen gums, bleeding gums.

Other side effects - Frequency unknown: 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), sleepiness, lethargy, insufficient blood flow to the brain, eye pain, chest pain (angina pectoris), decreased blood flow to your heart, 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. The 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

Do not use after the expiry date shown on the pack and the blister foil. Keep the capsules in their original package.

Do not store above 25°C.

KEEP THIS AND ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Return all unused medicines to a pharmacy for disposal.

6. Further Information

Coracten XL is available in 30 mg and 60 mg capsules and comes in packs of 28 capsules containing 30 mg or 60 mg of the active ingredient nifedipine.

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'.

Other ingredients include: lactose monohydrate; microcrystalline cellulose; hydroxylpropyl methlcellulose K100; povidone K30; magnesium stearate; hydroxypropylcellulose; ammonio methacrylate copolymer type B; polyethylene glycol 6000; dibutylphthalate; titanium diocxie 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; gelatine; black printing ink.

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.

Date of preparation of the leaflet: May 2014.