diltiazem hydrochloride tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Diltiazem Sandoz.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT DILTIAZEM SANDOZ IS USED FOR
This medicine is used to prevent angina.
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms and neck, and sometimes the shoulders and back. This may be caused by too little blood and oxygen getting to the heart. Angina is usually brought on by exercise or stress.
It contains the active ingredient diltiazem hydrochloride.
Diltiazem belongs to a group of medicines called calcium channel blockers.
It works by opening up blood vessels, thereby increasing the blood flow and allowing more blood (and oxygen) to reach the heart.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE DILTIAZEM SANDOZ
When you must not take it
Do not take this medicine if you have an allergy to:
diltiazem hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you have or have had any of the following conditions:
sick sinus syndrome (unless you have a working pacemaker)
second or third degree AV block (unless you have a working pacemaker)
low blood pressure (hypotension)
severe congestive heart failure
severe bradycardia (slow heart rate)
pulmonary congestion (excessive amount of fluid in the lungs).
Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine. The active ingredient in Diltiazem Sandoz passes into breast milk and there is a possibility that your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
sick sinus syndrome
second or third degree AV block
hypotension (low blood pressure)
heart attack or other heart-related problems
kidney or liver problems
If you have not told your doctor about any of the above, tell him/her before you start taking Diltiazem Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Diltiazem Sandoz may interfere with each other. These include:
beta-blockers, such as propranolol or atenolol, medicines used to treat high blood pressure or other heart problems
other medicines used for angina such as glyceryl trinitrate or isosorbide dinitrate
medicines used to treat high blood pressure
digoxin, a medicine used to treat heart failure
medicines used to treat irregular heartbeats, such as amiodarone
medicines used to treat reflux and stomach ulcers, such as cimetidine or ranitidine
diazepam, a medicine used to treat anxiety, depression or alcohol withdrawal
alpha-blockers, such as prazosin or tamsulosin, medicines used to treat high blood pressure, other heart problems or benign prostastic hyperplasia
rifampicin, a medicine used to treat tuberculosis
carbamazepine, a medicine used for a variety of conditions (such as epilepsy, mania, bipolar mood disorder or trigeminal neuralgia)
rimonabant, an appetite-reducing medicine
lithium, a medicine used to treat some types of depression
theophylline, a medicine used to treat asthma
cyclosporin, a medicine used in patients who have received organ transplants or to treat certain problems with the immune system
medicines used to treat high cholesterol, such as simvastatin or atorvastatin
inhaled anaesthetics such as isoflurane, enflurane or halothane (for surgery)
dantrolene, a muscle-relaxant medicine.
These medicines may be affected by Diltiazem Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW TO TAKE DILTIAZEM SANDOZ
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Diltiazem Sandoz may not work as well and your problem may not improve.
The usual adult dosage is 180mg to 240mg per day.
The maximum recommended dose is 360mg per day.
Diltazem Sandoz is usually taken three or four times daily before meals and at bedtime.
A lower dose may be required in elderly patients (over 65 years of age).
How to take it
Swallow the tablets whole with a full glass of water.
When to take Diltiazem Sandoz
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take Diltiazem Sandoz
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
If you are taking this medicine for angina, do not suddenly stop taking it, as this can cause severe angina for one or two days.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Diltiazem Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include:
slow or irregular heartbeat
pain in the left arm and/or chest.
WHILE YOU ARE TAKING DILTIAZEM SANDOZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Diltiazem Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you must not do
Do not take Diltiazem Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor. Stopping your medicine suddenly may bring on an angina attack. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
Things to be careful of
Be careful driving or operating machinery until you know how Diltiazem Sandoz affects you. This medicine may cause dizziness or lightheadedness in some people, especially after the first dose. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or lightheadedness may be worse.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Be careful not to overdo physical activities when you first start taking this medicine. You may feel better when you start taking this medicine, but you will need time to improve your physical fitness.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Diltiazem Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
weakness or tiredness.
These are the more common side effects of the medicine. Mostly, these are mild.
Tell your doctor as soon as possible if you notice any of the following:
oedema (swelling), which may occur in the arms, legs, hands or feet
shortness of breath, which may occur together with swelling of the feet or legs due to fluid build-up
feeling continuously lightheaded or dizzy
mild itchy skin rash or increased sensitivity to the sun (such as symptoms of sunburn occurring more quickly than normal)
yellowing of the skin and/or eyes (jaundice)
light coloured bowel motions or dark coloured urine
signs of frequent or worrying infections, such as fever, severe chills, sore throat or mouth ulcers
signs of anaemia, such as tiredness, being short of breath and looking pale
unusual movements, such as trembling and shaking of the hands and fingers, shuffling walk and stiffness of the arms and legs
depression or personality changes.
The above list includes serious side effects that may require medical attention. Serious side effects are uncommon.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
serious skin reactions such as red, painful, or itchy spots, hives, blisters or peeling of the skin
pain, which may be severe, in your left arm or chest
slow, fast or irregular heartbeat
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
Some of these side effects (for example, liver problems) can only be found when your doctor does tests from time to time to check your progress.
AFTER TAKING DILTIAZEM SANDOZ
Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Diltiazem Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Diltiazem Sandoz 60mg - white, round, biconvex tablets with a score notch on one side.
Available in blisters and bottles of 90 tablets.
Diltiazem Sandoz 60mg - 60mg diltiazem hydrochloride.
hydrogenated castor oil
sodium starch glycollate
colloidal anhydrous silica
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Diltiazem Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
This leaflet was revised in September 2009.
Australian Register Number
60mg tablets: AUST R 60838 (blisters)
60mg tablets: AUST R 62646 (bottles)
Published by MIMS/myDr October 2010
Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from