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CP.DIL.JNT.SRC.CH.V4P1 PATIENT INFORMATION LEAFLET

KENZEM 60mg, 90mg AND 120mg SR CAPSULES

(diltiazem hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please 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 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

IN THIS LEAFLET

1.    What Kenzem is and what it is used for

2.    What you need to know before you take Kenzem

3.    How to take Kenzem

4.    Possible side effects

5.    How to store Kenzem

6.    Contents of the pack and other information

Kenzem 60mg, 90mg and 120mg SR Capsules are one of a group of medicines called “calcium channel blockers” which are used to treat high blood pressure or to help control angina (chest pain).

DO NOT take Kenzem and tell your doctor if you:

•    have had an allergic reaction (rash, itching, shortness of breath) to a medicine containing diltiazem or any of the ingredients listed in section 6, Contents of the pack and other information

•    are pregnant, trying to become pregnant or are breast-feeding

•    are suffering from serious problems with your heart rhythm (e.g. slow pulse rate, palpitations, slow heart beat - less than 50 beats per minute) or heart failure. This includes having an uneven heart beat (unless you have a pacemaker)

•    are being treated with dantrolene injection (for severe muscle spasm)

Take special care and tell your doctor if you:

•    are elderly

•    are diabetic

•    suffer from a kidney or liver disorder

•    are suffering from mild problems with your heart rhythm or reduced heart function

•    are going to have an operation

•    are predisposed to mood changes or are depressed

•    are at risk of developing intestinal obstruction

Other medicines and Kenzem

Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following:

•    Dantrolene infusion (used as a muscle relaxant)

•Anti-hypertensive agents (medicines used to reduce your blood

pressure), such as beta blockers (e.g. propranolol) or alpha blockers (e.g. prazosin), diuretics (water tablets) or ACE inhibitors (e.g. captopril, ramipril)

•    Carbamazepine (used to treat epilepsy)

•    Theophylline (for asthma or breathing difficulties)

•    Ciclosporin (used after organ transplant to prevent rejection or used to treat psoriasis)

•    Digoxin (to treat palpitations or irregular heart beat)

•    Cimetidine or ranitidine (used to treat stomach ulcers or acid reflux disorders)

•    Anaesthetic agents at the doctor’s or dentist’s

•    Antiarrhythmic drugs (medicines used to treat abnormal heart rhythms e.g. adenosine, amiodarone)

•    Lithium (used to treat depression)

•    Rifampicin (used to treat bacterial infections including tuberculosis)

•    Medicines for lowering cholesterol - statins (e.g. atorvastatin, fluvastatin or simvastatin)

•    Nitrate derivatives (used to treat heart problems e.g. glyceryl trinitrate)

•    Midazolam or triazolam (used as sedatives for conditions such as panic disorders, anxiety, insomnia, alcohol withdrawal and in some cases for epileptic seizures)

•    Methylprednisolone (used as an anti-inflammatory to relieve pain)

Taking Kenzem SR Capsules with food and drink

Do not take Kenzem SR Capsules at the same time as taking an alcoholic drink.

Pregnancy, breast-feeding and Fertility

DO NOT take this medicine if you:

•    are pregnant or planning to become pregnant

•    are breast-feeding or planning to start breast-feeding Always speak to your doctor before taking any medicine.

Driving and using machines

You may feel dizzy while taking this medicine. Do not drive or operate any tools or machines if you feel dizzy.

Important information about some of the ingredients in your medicine

This product contains 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.

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Kenzem 60mg, 90mg and 120mg SR Capsules are sustained release capsules, which means the drug is released over a longer period of time.

DOSAGE

Adults

Angina: The usual dose is one 90mg or one 120mg capsule twice a day. Your doctor may increase your dose up to two 120mg capsules twice a day.

High blood pressure: The usual dose is one 90mg or one 120mg capsule twice a day.

Your doctor may increase your dose to one 120mg capsule three times a day.

Adults with liver or kidney problems and elderly patients

Angina and high blood pressure: The usual dose is one 60mg capsule twice a day.

Your doctor may increase your dose to one 90mg or one 120mg capsule twice a day. This will depend on your heart rate.

Use in children

Kenzem 60mg, 90mg and 120mg SR Capsules are not recommended for use in children.

Swallow the capsule whole with a drink of water. Do not suck or chew the capsule. Try to take your capsules at the same time each day.

If you forget to take Kenzem

If you forget to take a dose, take it as soon as you remember, unless it is more than six hours since your last dose was due. Do not take a double dose to make up for the dose you have missed.

If you take more Kenzem than you should

If you take too many capsules, or you think a child has accidentally swallowed any, contact your nearest hospital casualty department or doctor immediately. Take this leaflet and any remaining capsules with you to show the doctor.

If you stop taking Kenzem

Take this medicine for as long as your doctor tells you to, as you may become unwell if you stop.

If you have any further questions on the use of Kenzem, ask your doctor or pharmacist.

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

STOP taking your medicine and tell your doctor immediately, or go to your nearest hospital casualty department if you experience:

•    an allergic reaction. The symptoms may include a rash, problems with swallowing or breathing, swelling of the lips, face, throat or tongue

•    severe blistering rash where layers of skin peel off leaving scalded skin. You may also have a fever. This could be an illness called ‘toxic epidermal necrolysis’.

•    a skin rash with dark circles and pale centres, red patches, blistering or peeling. You may also have a fever. This could be an illness called ‘erythema multiforme’ or ‘Stevens-Johnson syndrome’.

•    heart problems or heart failure. The signs could be shortness of breath, flushing, feeling of tiredness along with swollen ankles and legs

•    a severe slowing of the heart (which may cause either fainting or dizziness)

•    hepatitis (symptoms include high temperature, nausea, muscle aches, tiredness, loss of appetite and diarrhoea). A disturbance in liver enzyme level is often detectable by a blood test.

What Kenzem SR Capsules contain

Kenzem 60mg, 90mg or 120mg SR Capsules contain the active ingredient diltiazem hydrochloride.

The other inactive ingredients include sugar spheres (sucrose and maize starch), povidone, methacrylic acid copolymer, ethylcellulose, talc and diethyl phthalate. The capsule is made of gelatin and contains titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

What Kenzem SR Capsules look like and contents of the pack

Kenzem 60mg SR Capsules are opaque pink and white capsules. Kenzem 90mg SR Capsules are opaque pink and yellow capsules. Kenzem 120mg SR Capsules are opaque pink and orange capsules.

Each pack contains 56 capsules.

Manufacturer

Ethypharm, Z.l. Saint Arnoult, 28170 Chateunauf-en-Thymerais, France. Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Tell your doctor if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

•    Swelling of the lower legs

Common: may affect up to 1 in 10 people

•    Headache, dizziness

•    Very fast, uneven or forceful heartbeat (palpitations)

•    Flushing (feeling of warmth)

•    Constipation, stomach pain, feeling sick, indigestion

•    Skin redness

•    Feeling unwell

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. PL 30464/0143, PL 30464/0144 and PL 30464/0145 This leaflet was last revised August 2014.

Uncommon: may affect up to 1 in 100 people

•    Nervousness

•    Difficulty sleeping

•    Slow or uneven heartbeat

•    Sudden increase in blood pressure

•    Vomiting (getting sick)

•    Diarrhoea

Rare: may affect 1 in 1,000 people

•    Dry mouth

•    Itchy, lumpy rash (called urticaria)

Not known: frequency cannot be estimated from the available data

•    Bruising or bleeding under the skin, which may be caused by a reduction in blood platelets

•    Mood changes, depression •Abnormal or jerky movements

•    Skin rash caused by narrow or blocked blood vessels (called vasculitis)

•    Swollen gums

•    Sensitivity of skin to light. You may get sunburnt easier than someone not taking this medicine. It is advisable to use sun protection while taking this medicine.

•    Breast enlargement in men

•    High blood sugar levels

Blood tests

Kenzem can change the levels of liver enzymes, which may show up in blood tests. This can mean that your liver is not working properly.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Do not use after the expiry date stated on the pack. The expiry date refers to the last day of that month.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 25°C in a dry place away from heat and moisture.

Return any leftover capsules to your pharmacist. Only keep them if your doctor tells you to. 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.

CP.DIL.JNT.SRC.CH.V4P1