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RETALZEM 60MG MR TABLETS

Active substance(s): DILTIAZEM HYDROCHLORIDE

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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

1.

WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR

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.

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

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.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR
MEDICINE

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

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.

3.

HOW TO TAKE YOUR MEDICINE

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.

4.

POSSIBLE SIDE EFFECTS

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

6.

CONTENTS OF PACK AND OTHER INFORMATION

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.

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
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.gov.uk/yellowcard.
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

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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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