CP.DIL.60MRT.IS.V3P3 PATIENT INFORMATION LEAFLET

RETALZEM® 60mg MR TABLETS 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 any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What your medicine is and what it is used for

2.    What you need to know before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Contents of the pack and other information

The name of your medicine is Retalzem® 60mg MR Tablets. It contains the active ingredient diltiazem hydrochloride. It is one of a group of medicines called “calcium channel blockers”. These relax the muscles around blood vessels and make it easier for the heart to do its work. Retalzem® 60mg MR Tablets are used for the treatment of:

• angina

DO NOT take this medicine and tell your doctor if you:

•    have had an allergic reaction (rash, itching, swallowing problems, shortness of breath) to a medicine containing diltiazem or any of the ingredients listed in section 6, Contents of 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) 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 or severe fever)

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

Taking other medicines

Check with your doctor or pharmacist if you are taking, or have recently taken 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)

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

•    digoxin (to treat palpitations or irregular heart beat)

•    nitrates such as glyceryl trinitrate or isosorbide trinitrate (used to treat angina)

•    carbamazepine (used to treat epilepsy)

•    theophylline (for asthma or breathing difficulties)

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

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

•    anaesthetic agents at the doctors or dentists

•    lithium (used to treat some types of mental illness)

•    rifampicin (used to treat bacterial infections including tuberculosis)

•    medicines known as statins to lower the amount of cholesterol in the blood, e.g. atorvastatin, fluvastatin and simvastatin

•    midazolam (used as a sedative before medical procedures)

•    triazolam (used to help you sleep)

•    methylprednisolone, a corticosteroid used to reduce inflammation

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.

Pregnancy and breast-feeding

DO NOT take this medicine if you are pregnant, planning to become pregnant, or if you are breast-feeding. Always speak to your doctor before taking any medicine.

Important information about some of the ingredients of your medicine

Retalzem® 60mg MR Tablets contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Retalzem® 60mg MR Tablets contain hydrogenated castor oil - this may cause stomach upset and diarrhoea.

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

DOSAGE

Adults

•    The usual starting dose is one tablet three times a day. Your doctor may increase this dose up to two tablets four times a day if necessary.

•    For people over 65 and those with poor liver or kidney function, the recommended starting dose is one tablet twice a day.

Children

Retalzem® 60mg MR Tablets are not recommended for use in children. How to take your tablets

Swallow the tablets whole with a small glass of water. Do not crush or chew the tablets. Try to take your tablets at the same time each day.

If you forget to take your medicine

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. Do not take a double dose to make up for the dose you have missed.

If you take more of you medicine than you should

If you take too many tablets, or you think a child has accidentally swallowed any, contact your nearest hospital casualty department or doctor immediately. Take this leaflet and any remaining tablets with you to show the doctor. Symptoms of an overdose include feeling dizzy or weak, blurred vision, chest pain, shortness of breath, fainting, an unusually fast or slow heartbeat, coma, slurred speech and confusion.

If you stop taking your medicine

Keep taking your medicine until your doctor tells you to stop. Do not stop taking it because you feel better. If you stop, your condition may get worse.

6 ■ CONTENTS OF PACK AND OTHER INFORMATION

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.

Tell your doctor straight away 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

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

What Retalzem® 60mg MR Tablets contain

Retalzem® 60mg MR Tablets contains 60mg of the active ingredient diltiazem hydrochloride.

Each tablet also contains lactose monohydrate, hydrogenated castor oil, macrogol 6000 and magnesium stearate.

What Retalzem® 60mg MR Tablets look like and contents of the pack

Retalzem® 60mg MR Tablets are white, round, scored tablets.

Retalzem® 60mg MR Tablets are available in blister packs of 84 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. Manufacturers responsible for batch release

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent TN24 0GR, U.K.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. PL 30464/0048

This leaflet was last revised in August 2013.

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

Blood tests

Retalzem 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.

5 ■ HOW TO STORE YOUR MEDICINE

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

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 30°C in a dry place. Keep your tablets in the packaging that they came in.

Return any leftover tablets 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.60MRT.IS.V3P3