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DILCARDIA 180 XL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dilcardia XL 120 mg, 180 mg and 240 mg Capsules
(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 any further questions, ask your doctor.
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 side effect gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.

In this leaflet:
1.
What Dilcardia XL is and what it is used for
2.
Before you take Dilcardia XL
3.
How to take Dilcardia XL
4.
Possible side effects
5.
How to store Dilcardia XL
6.
Further information

1.

WHAT DILCARDIA XL IS AND WHAT IT IS USED FOR

Dilcardia XL contains diltiazem hydrochloride which belongs to a group of medicines called calcium
channel blockers. Diltiazem hydrochloride works by relaxing the blood vessels and increasing the
supply of blood and oxygen to the heart while reducing its workload. Dilcardia XL can be used to:
reduce chest pains caused by angina
lower high blood pressure (hypertension).

2.

BEFORE YOU TAKE DILCARDIA XL

Do not take Dilcardia XL if you
are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of
Dilcardia XL
are pregnant or might become pregnant
suffer from a very slow beating heart (less than 40 beats per minutes)
have been told by your doctor that you suffer from heart block or sick sinus syndrome
(disorders of the heart’s rhythm), not requiring a pacemaker
are suffering from heart failure
have been given an infusion of a drug called dantrolene (muscle relaxant)
Take special care with Dilcardia XL if you
have a slow heartbeat, an irregular heartbeat or other heart condition
are going to have a general anaesthetic for an operation
have liver or kidney problems
are 65 or over
suffer from constipation
Medicines like Dilcardia XL can cause mood changes, including depression. If you think you may be
affected, talk to your doctor or pharmacist.

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Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, or the following:
• dantrolene, a muscle relaxant (see section ‘Do not take’ above)
• lithium, to treat severe depression
• nitrate derivates, usually used to treat angina e.g. glycerol trinitrate
• theophylline, to treat asthma
• alpha-blockers, used to treat prostate problems or high blood pressure e.g. prazosin
• medicine to treat a heart condition e.g. digoxin, amiodarone
• beta-blockers or ACE inhibitors, used to treat high blood pressure and heart conditions e.g.
propranolol or lisinopril
• carbamazepine, antiepileptic medicine
• rifampicin, used to treat an infection
• medicine to treat of stomach ulcers or heartburn e.g. cimetidine, ranitidine
• ciclosporin, tacrolimus or sirolimus, usually used after an organ or bone marrow transplant
• benzodiazepines, used to treat anxiety or sleep disturbances e.g. midazolam or triazolam
• methylprednisolone, a corticosteroid
• statins used to lower blood cholesterol levels e.g. simvastatin
If you need to have an operation and will require an anaesthetic, tell your doctor you are taking this
medicine.
Pregnancy and breast-feeding
Do not take Dilcardia XL if you are pregnant or planning to become pregnant. Dilcardia XL should
not be taken if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Dilcardia XL may cause side effects such as dizziness or feeling generally unwell. If you are affected
you should not drive or use machines.
Important information about some of the ingredients of Dilcardia XL
Dilcardia XL contains sucrose. If your doctor has told you that you have an intolerance to some
sugars, such as sucrose, contact your doctor before taking this medicine.

3.

HOW TO TAKE DILCARDIA XL

Always take Dilcardia XL exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.


Swallow the capsules whole with a glass of water. Do not crush or chew them.

The usual dose is:
Adults
The usual dose is 240 mg Dilcardia XL once a day. If necessary this may be increased to a dose of
360 mg of Dilcardia XL daily.

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Elderly or patients with liver or kidney problems
Your doctor may prescribe a lower dose of 120 mg of Dilcardia XL.
Children
Dilcardia XL is not recommended.
If you take more Dilcardia XL than you should
If you take more Dilcardia XL then you should contact your doctor or nearest hospital emergency
department immediately. Take the container and any remaining capsules with you. Symptoms of
overdose include severe low blood pressure possibly leading to collapse, slowing of the heartbeat and
general heart problems.
If you forget to take Dilcardia XL
If you forget to take Dilcardia XL take the next dose as soon as you remember unless it is almost time
for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of your medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Dilcardia XL can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Dilcardia XL and tell your doctor immediately or go
to your nearest hospital emergency department:
• allergic reactions such as swollen skin or swelling of the face, lips, tongue and/or throat which
may cause difficulty breathing or swallowing
• liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes
• severe skin reactions including blistering of the skin, mouth, eyes and genitals, and swollen blood
vessels in the skin.
These side effects are serious. You may need medical attention.
Tell your doctor straight away if you notice any of the following side effects:
• mood changes, including depression
• uncontrollable movements, including trembling or shaking of the hands and fingers
• trembling, muscle stiffness or spasms, slowing of movement (Parkinsonian syndrome)
• shortness of breath, swelling of the feet or legs
Very common side effects (affecting more than 1 in 10 people):
• swelling of the ankles, feet and fingers
Common side effects (affecting fewer than 1 in 10 people):
• headache
• feeling dizzy
• abnormal heart rhythm (AV block)
• palpitations
• flushing
• constipation
• indigestion
• stomach pain
• feeling sick
• redness of the skin
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feeling generally unwell

Uncommon side effects (affecting fewer than 1 in 100 people)
• feeling nervous
• difficulty sleeping
• slower heart beat
• dizziness, light-headedness or fainting on standing up
• being sick
• diarrhoea
• increase in liver enzymes
Rare side effects (affecting fewer than 1 in 1,000 people)
• dry mouth
• a nettle-like rash or hives
Other side effects (frequency not known):
• reduction in blood platelets which increase risk of bleeding or bruising
• pins and needles or tingling
• bleeding, tender or enlarged gums
• skin problems such as an increased sensitivity to light, rash, dark areas, severe flaking or
peeling
• sweating
• breast enlargement in men
If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your
doctor or pharmacist.

5.

HOW TO STORE DILCARDIA XL

Keep out of the reach and sight of children.
Do not use Dilcardia XL after the expiry date, stated on the pack after EXP. The expiry date refers to
the last day of that month.
Store in a cool dry place. Protect from light.
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.

FURTHER INFORMATION

What Dilcardia XL capsules contains
-

The active substance is diltiazem hydrochloride 120 mg, 180 mg or 240 mg
The other ingredients are sugar spheres (sucrose and maize starch), povidone, shellac,
ethylcellulose, talc, ethanol 96%, acetate. The 180 mg and 240 mg also contain erythrosine
E127, indigo carmine E132 and titanium dioxide E171.

What Dilcardia XL capsules look like and contents of the pack
Your medicine comes as a hard gelatine capsule and is available in three strengths, 120 mg which has
a natural transparent cap and pink transparent body, 180 mg which has a natural transparent cap and
pink opaque body, and 240 mg which has a natural transparent cap and scarlet opaque body.

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Dilcardia XL is available in three pack sizes of 4, 28 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last approved in 03/2011

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Expand Transcript

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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