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CALCICARD CR TABLETS 120 MG

Active substance(s): DILTIAZEM HYDROCHLORIDE

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Package leaflet: Information for the user
Calcicard® CR Tablets 90 mg or 120 mg
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 of the 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.
2.
3.
4.
5.
6.
1.

What Calcicard® CR is and what it is used for
What you need to know before you take Calcicard® CR
How to take Calcicard® CR
Possible side effects
How to store Calcicard® CR
Contents of the pack and other information
What Calcicard® CR is and what it is used for

Calcicard® CR is the brand name of your medicine. It is sometimes known as Diltiazem, which is
the name of the active ingredient. This medicine will be referred to as Calcicard® CR throughout
this leaflet.
Calcicard® CR belongs to a group of drugs known as calcium channel blockers which interfere with
the movement of calcium in heart muscle cells.
Calcicard® CR Tablets are used to treat:
 mild to moderate high blood pressure
 angina pectoris (chest pain which is brought on by exercise).
2.

Before you take Calcicard® CR

Do not take Calcicard® CR:
 if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine
(listed in section 6).
 if you are pregnant, are of child-bearing age or are breast-feeding
 if you have severe kidney or liver problems
 if you have a markedly slow heartbeat, a block in the transmission of electrical impulses in your
heart, heart failure (where the pumping action of the heart is poor leading to slowing of the rate
of blood flow through the heart), or have any heart condition which affects your heart rhythm
and do not have a pacemaker
 if you are given dantrolene by infusion. Dantrolene is a muscle relaxant. Calcicard® CR reacts
with dantrolene when this drug is injected into a vein. If you are likely to use dantrolene tell
your doctor as it could cause a heart attack in combination with Calcicard® CR.





if you have rare hereditary problems of fructose or galactose intolerance, glucose-galactose
malabsorption, the Lapp lactase deficiency, or sucrase-isomaltase insufficiency
if you had a complicated heart attack.
if you are already taking a medicine containing ivabradine for the treatment of certain heart
diseases.

Warnings and precautions
Talk to doctor or pharmacist before taking Calcicard® CR
 if you have mild to moderate kidney or liver problems
 if you are diabetic
 if you have a slightly slow heartbeat or a mild block in the transmission of electrical impulses of
your heart
 if you are elderly
 if you have obstruction in gut.
 if you need surgery requiring anaesthesia. This is because the effect of the anaesthetics on the
function of your heart may be increased by Calcicard® CR.
Children
This medicine is not recommended for use in children.
Other medicines and Calcicard® CR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Talk to your doctor if you are taking any of the following:
 beta-blockers, anti-hypertensives or diuretics ‘water tablets’, used to treat high blood pressure ..
If you are taking beta blockers your doctor will monitor your heart rate at the beginning of
treatment
 alpha-blockers used to treat high blood pressure. If you are taking alpha blocker your doctor
should strictly monitor your blood pressure.
 digoxin, used to treat heart failure
 any medicines used to treat abnormal heart rhythm
 nitrate derivative, used to treat heart disease
 rifampicin used to treat bacterial infection
 amiodarone, used to correct irregular heart beats
 cimetidine or ranitidine, used to treat stomach ulcers
 theophylline used to treat breathing problems
 carbamazepine, used for the treatment of fits and stabilisation of mood . Blood levels of
carbamazepine may be raised in combination with Calcicard® CR
 lithium used to treat depression and manic disorder
 any medicine which affects contractility of your heart muscle
 benzodiazepine (e.g. midazolam, triazolam) used for the treatment of mental illness
 corticosteroid (a hormone used to treat different types of diseases)
 statins , used to treat high cholesterol
 ciclosporin used to prevent your body from rejecting skin grafts, transplanted organs or bone
marrow.

Pregnancy and breast-feeding

Calcicard® CR is not recommended if you are pregnant, are of childbearing age or are breastfeeding. Ask your doctor for advice before taking any medicine.
Driving and using machines
Calcicard® CR may cause dizziness or tiredness. If you are affected, do NOT drive or operate
machinery.
Calcicard® CR contains sucrose, lactose and caster oil
 Patients who are intolerant to sucrose or lactose should note that Calcicard® CR tablets contain
a small amount of sucrose and lactose. If your doctor has told you that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
 Patients should also note that Calcicard® CR Tablets contain castor oil, which may cause
stomach upset and diarrhoea.
3.

How to take Calcicard® CR

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water. The tablets have been formulated
so that the medicine is released at a slower rate. Do not chew the tablets. The usual dose is:


Adults:
The usual starting dose is one tablet (90 mg or 120 mg) twice a day. Your doctor may change
this dose depending on your response to the treatment.
The maximum dose for the treatment of high blood pressure is 360 mg a day.
The maximum dose for the treatment of angina pectoris is 480 mg a day.



Elderly patients or patients with kidney or liver problems:
Your doctor may start you on a lower dose and monitor your heart rate. Your dose will be
reduced if your heart rate slows down.
A starting dose of 60 mg twice a day may be used to treat angina pectoris, and one 120 mg
tablet each day may be used to lower blood pressure. Your doctor may change this dose
depending on your response to the treatment.

If you take more Calcicard® CR than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately.
An overdose is likely to cause severe low blood pressure, collapse, and slow heart rate.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor
so that they know which tablets were consumed.
If you forget to take Calcicard® CR
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Calcicard® CR
Do not stop taking your medicine without talking to your doctor first even if you feel better.
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.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital:
 an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing;
chest pain, rapid or irregular heartbeat palpitations or painful joints and muscles, skin rash,
hives or blisters, which may be severe).
This is a very serious side effect. You may need urgent medical attention or hospitalisation.
The following side effects have been reported.
Very Common: may affect more than 1 in 10 people
 swollen fingers, feet ,ankles.
Common: may affect up to 1 in 100 people
 headache
 dizziness (a feeling that you are about to fall)
 heart block and sudden attack of unconsciousness
 rapid and irregular heart beat (Palpitation)
 red face
 constipation
 indigestion and chest pain due to stomach acidity
 abdominal pain
 feeling unwell
 redness of skin
 feeling general discomfort.
Uncommon: may affect up to 1 in 1000 people
 nervousness
 inability to sleep
 abnormally slow heart beat
 rapid drop of blood pressure when standing up
 vomiting
 loose stools
 abnormal liver function test.
Rare: may affect up to 1 in 10,000 people
 dry mouth
 rash and itchy skin.
Not known: frequency cannot be estimated from the available data
 small number of platelets in blood (This can be identified from a blood test)
 mood change including depression





















difficulty in controlling movement
heart block
heart failure
Vasculitis. Symptoms of this may include: red face, headache, swollen lower limbs, weight
loss, fever, red spots on skin, aching joints, mouth ulcer, abdominal pain, breathing
difficulty.
Leukocytoclastic Vasculitis. Symptoms of this may include: blisters on the skin, bleeding into
the skin, small solid raised hives on skin etc
overgrowth of gum tissue
inflammation of liver
skin sensitivity to light
red or brown lesions at sun exposed skin areas
swelling and hives on skin
red rash
serious illness with blistering of the skin, mouth, eyes and genitals
serious illness with skin cell death
serious illness with detachment of top layer of skin from the lower layer
widespread red, itchy and scaly skin
excessive development of the breasts in males
sweating
general tiredness
fever.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Calcicard® CR

Keep out of the sight and reach of children.
You should keep your tablets at room temperature, away from light. Keep them in the pack they
came in. Do not transfer them to another container.
Do not use this medicine after the expiry date that is stated on the outer packaging. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Calcicard® CR tablets contain
 The active substance is diltiazem hydrochloride 90 mg or 120 mg



The other ingredients are lactose, hydrogenated castor oil, colloidal aluminium hydroxide,
acrylic resin, talc, magnesium stearate, methyl hydroxypropylcellulose, sucrose, glycerol 85%,
titanium dioxide (E171), polysorbate 80, purified water, ethanol 96%.

What Calcicard® CR tablets look like and contents of the pack
 The Calcicard® CR Tablets 90 mg are white, film-coated, round, biconvex, slow-release tablets
with ‘DIL/90’ on one side and twin triangle logo on reverse.
 The Calcicard® CR Tablets 120 mg are white, film-coated, round, biconvex, slow-release tablets
with ‘DIL/120’ on one side and twin triangle logo on reverse.
 The product comes in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
The marketing authorisation holder is Norton Healthcare Ltd T/A IVAX Pharmaceuticals UK,
Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX.
The company responsible for manufacture is TEVA UK Limited, Eastbourne BN22 9AG
This leaflet was last revised: September 2015
PL 00530/0482-3

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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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