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.    What Calcicard® CR is and what it is used for

2.    What you need to know before you take Calcicard® CR

3.    How to take Calcicard® CR

4.    Possible side effects

5.    How to store Calcicard® CR

6.    Contents of the pack and other information

1.    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