What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL30464/0048 .


Retalzem 60mg MR Tablets

PATIENT INFORMATION LEAFLET

RETALZEM® 60mg MR Tablets

diltiazem hydrochloride

Read all of 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 Retalzem is and what it is used for
2. What you need to know before you take Retalzem
3. How to take Retalzem
4. Possible side effects
5. How to store Retalzem
6. Contents of the pack and other information

1. WHAT RETALZEM IS AND WHAT IT IS USED FOR

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RETALZEM

DO NOT take Retalzem and tell your doctor:

  • if you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Retalzem (listed in Section 6)
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • if you are pregnant, trying to become pregnant or are breast-feeding (see Section 2: 'Pregnancy and breast-feeding')
  • if you 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)
  • if you have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles
  • if you are already taking a medicine containing ivabradine for the treatment of certain heart diseases
  • if you are being treated with dantrolene infusion (for severe muscle spasm or severe fever) (see Section 2: 'Other medicines and Retalzem')

Take special care and tell your doctor:

  • if you are elderly
  • if you are diabetic
  • if you suffer from a kidney or liver disorder
  • if you are suffering from mild problems with your heart rhythm or reduced heart function
  • if you are going to have an operation
  • if you are predisposed to mood changes or are depressed
  • if you have or have ever had asthma or easily triggered bronchospasm
  • if you are at risk of developing intestinal obstruction

Other medicines and Retalzem

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular tell your doctor if you are taking any of the following:

  • dantrolene infusion (used as a muscle relaxant)
  • ivabradine
  • 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)
  • phenytoin
  • antiplatelet medicines (used to reduce the chance of blood clots forming, such as aspirin or clopidogrel)
  • x-ray contrast media
  • 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
  • cilostazol (used for cramp like pains in your legs when you walk caused by shortage of blood supply in your legs)

Retalzem with food and drink

It is advisable to limit the amount of grapefruit juice you drink while taking Retalzem as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor

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.

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 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 RETALZEM

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 Retalzem

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 Retalzem

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 Retalzem 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 Retalzem

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.

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

4. POSSIBLE SIDE EFFECTS

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 centers, 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
  • Vomiting (getting sick)
  • Diarrhoea
  • Feeling dizzy, light-headed or faint when you stand up quickly

Rare: may affect up to 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
  • Heart failure
  • Skin rash caused by narrow or blocked blood vessels (called vasculitis)
  • Swollen gums
  • Hepatitis
  • 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
  • Aggravation of Asthma
  • Difficulty breathing, wheezing, tightness in the chest (called 'bronchospasm')
  • High blood sugar level

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RETALZEM

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.

Do not store above 25°C. Store in original package in order to protect from moisture.

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.

6. CONTENTS OF THE 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 April 2019

CP.DIL.60MRT.IS.V6P2