ADIZEM XL 200MG CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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1114-7

Package Leaflet: Information for the user

2. Before you take Adizem-XL capsules
Do not take Adizem-XL capsules if you:

Adizem® -XL 120 mg, 180 mg, 200 mg,
240 mg and 300 mg prolonged-release
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 or pharmacist.
• 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 of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Adizem-XL capsules are and what they
are used for
2. Before you take Adizem-XL capsules
3. How to take Adizem-XL capsules
4. Possible side effects
5. How to store Adizem-XL capsules
6. Further information

Adizem XL caps PIL UK 1114-7 V2.indd 2

1. What Adizem-XL capsules are and
what they are used for
These capsules have been prescribed for you to
treat angina (chest pain caused by a reduction
of oxygen to the heart muscle) or high blood
pressure (hypertension). They contain the active
ingredient diltiazem. Diltiazem belongs to a
group of medicines called calcium antagonists.
Calcium antagonists help more blood to reach
the heart and reduce blood pressure. The other
ingredients of Adizem-XL capsules are listed in
section 6 of this leaflet.
Adizem-XL capsules are designed to work
properly over 24 hours. If the capsules are
crushed or chewed, the entire 24-hour dose
may be absorbed rapidly into your body. This
can be dangerous, causing serious problems
such as an overdose.

• are allergic (hypersensitive) to diltiazem or
any of the other ingredients of the capsules
(see section 6 ‘Further Information’);
• have a slow or irregular heart beat;
• have heart failure (which can cause shortness
of breath or ankle swelling).
Children should not take these capsules.
Take special care with Adizem-XL capsules
Before treatment with Adizem-XL capsules tell
your doctor or pharmacist if you:
• have liver or kidney problems as your doctor
may monitor you more closely;
• have porphyria (a rare disease of the blood
pigments);
• have bowel problems.
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. If you take Adizem-XL
capsules with some other medicines, the effect
of Adizem-XL capsules or the other medicine
may be changed.

Tell your doctor or pharmacist if you are taking:
• any other medicines for high blood pressure,
such as beta blockers (for example atenolol),
diuretics (for example bendrofluazide) or
ACE inhibitors (examples include captopril
and enalapril);
• medicines known as alpha blockers, which
you may be taking to treat high blood
pressure or prostate disorders (for example
prazosin);
• any medicines which may cause low blood
pressure or slow heart beat (for example
aldesleukin to treat cancer of the kidneys,
or antipsychotics to treat mental and
behavioural disorders);
• ivabradine to treat angina;
• anti-arrhythmic medicines to treat an
irregular or rapid heart beat (for example
digoxin, amiodarone or beta-blockers);
• cilostazol to treat intermittent claudication
(a condition that causes leg pain due to a
restriction in blood supply to the muscles);
• medicines known as statins to reduce
cholesterol levels in your blood (examples
include simvastatin, atorvastatin or
lovastatin);
• medicines known as H2 antagonists to treat
stomach ulcers, indigestion or heartburn,
such as cimetidine or ranitidine;
• carbamazepine or phenytoin to treat seizures,
fits or convulsions;

• medicines known as benzodiazepines to treat
anxiety or help you sleep (examples include
midazolam or triazolam);
• medicines known as barbiturates to either
treat fits or to help you sleep (examples
include phenobarbital or primidone);
• antidepressants known as tricyclic
antidepressants (examples include
amitriptyline or imipramine) or lithium;
• rifampicin to treat tuberculosis;
• ciclosporin, sirolimus or tacrolimus to
prevent organ transplant rejection or treat
other immune system disorders;
• a specific type of medicine known as a
protease inhibitor to treat HIV (examples
include atazanavir or ritonavir);
• dantrolene (a muscle relaxant);
• theophylline to treat breathing problems such
as asthma;
• medicines known as nitrate derivatives to
treat angina or high blood pressure (examples
include glyceryl trinitrate or isosorbide
mononitrate);
• medicines for inflammation or allergies,
known as steroids (for example
methylprednisolone).

Anaesthetics and Adizem-XL capsules
If you are having a general anaesthetic, tell your
doctor that you are taking these capsules.
Taking Adizem-XL capsules with alcohol
Do not take Adizem-XL capsules at the same
time as an alcoholic drink.
Pregnancy and breastfeeding
Do not take Adizem-XL capsules if you are
pregnant, likely to become pregnant or are
breastfeeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
The capsules may cause a number of side effects
such as dizziness and a general feeling of being
unwell. These could affect your ability to drive
(see section 4 for a full list of side effects) and
are usually most noticeable when you start
taking the capsules, or when changing to higher
dose. If you are affected you should not drive or
operate machinery.

3. How to take Adizem-XL capsules
Always take Adizem-XL capsules exactly as
your doctor has told you. The label on your
medicine will tell you how many capsules to
take and how often.
The usual starting dose for adults is one 240 mg
capsule every 24 hours. However, if you are
elderly or have kidney problems then your
doctor will probably suggest a lower starting
dose of one 120 mg capsule every 24 hours.
Your doctor will decide how many capsules you
should take.
Children should not take these capsules.
Do not exceed the dose recommended by your
doctor. You should check with your doctor or
pharmacist if you are not sure.
Swallow your capsules whole with a glass of
water. Do not chew or crush the capsules.
You should take your capsules every 24 hours.
For instance, if you take a capsule at 8 o’clock in
the morning, you should take your next capsule
at 8 o’clock the next morning.

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1114-7

If you take more Adizem-XL capsules than
you should or if someone accidentally
swallows your capsules
Call your doctor or hospital straight away.
People who have taken an overdose may become
very unwell, feel faint, have a slow heart
beat and lose consciousness. They may need
emergency treatment in hospital. When seeking
medical attention make sure that you take this
leaflet and any remaining capsules with you to
show to the doctor.
If you forget to take Adizem-XL capsules
If you remember within 4 hours of the time
your capsule was due, take your capsule straight
away. Take your next capsule at your normal
time. If you are more than 4 hours late, please
call your doctor or pharmacist for advice. Do not
take a double dose to make up for a forgotten
capsule.
If you stop taking Adizem-XL capsules
You should not stop taking these capsules unless
your doctor tells you to. If you want to stop
taking your capsules, discuss this with your
doctor first.
If you have any further questions on the use
of Adizem-XL capsules ask your doctor or
pharmacist.

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4. Possible side effects
Like all medicines, Adizem-XL capsules can
cause side effects, although not everybody gets
them.
Look out for the following severe allergic
reactions. They have occurred in a small number
of people, although their exact frequency cannot
be estimated:
• swelling of the face or throat;
• skin rash or itching especially those covering
your whole body, severe flaking, blistering or
peeling of the skin, with or without a fever.
Tell your doctor immediately if you get any of
these.
Very common side effects (probably affecting
more than 1 in 10 people taking these capsules)
• Swelling of the hands, ankles or feet.
Common side effects (probably affecting more
than 1 in 100 people taking these capsules)
• Feeling sick, abdominal pain, indigestion,
constipation.
• Dizziness, headache.
• Flushing or redness of the skin.
• A fast, slow or irregular heartbeat.
• Generally feeling unwell.
• Tiredness.

Uncommon side effects (probably affecting
fewer than 1 in 100 people taking these
capsules)
• Diarrhoea, being sick.
• A feeling of faintness, especially on standing
up.
• Nervousness.
• Difficulty in sleeping.
• A worsening in liver function tests (seen in a
blood test).
Rare side effects (probably affecting fewer than
1 in 1000 people taking these capsules)
• Dry mouth.
• Hives.
Other side effects
Other side effects have occurred in a small
number of people, but their exact frequency
cannot be estimated:
• Heart failure which can cause shortness of
breath or ankle swelling.
• Inflammation of the liver.
• Changes in muscle tone and/or abnormalities
of movement.
• Mood changes, including depression.
• Skin problems such as an increased
sensitivity to sunlight.
• A reduction in blood platelets which
increases the risk of bleeding or bruising.
• Breast enlargement in men.
• Bleeding, tender or enlarged gums.

• Inflammation of blood vessels (often with
skin rash).
• Gastrointestinal disorders (e.g. upset
stomach).
• Sweating.
• Low blood pressure.

What Adizem-XL capsules contain

You may see the remains of the capsules in your
faeces. This should not affect how the capsules
work.

The other ingredients are:

If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Adizem-XL capsules
Keep out of the reach and sight of children.
Do not use any capsules after the expiry date
which is stated on the carton. EXP 08 2020
means that you should not take the capsules after
the last day of that month i.e. August 2020.

6. Further information

The active ingredient is diltiazem hydrochloride.
Each capsule contains 120 mg, 180 mg, 200 mg,
240 mg or 300 mg of diltiazem hydrochloride.














Microcrystalline cellulose
Ethylcellulose
Colloidal anhydrous silica
Polysorbate 80
Dibutyl sebacate
Magnesium stearate
Sodium laurilsulfate
Gelatin
Shellac
Propylene glycol
Simeticone
Iron oxide (E172)
Titanium dioxide (E171)

Do not store your capsules above 25ºC.

The capsules also contain the following
colourants:

Do not take your capsules if they are broken or
crushed as this can be dangerous and can cause
serious problems such as overdose.

120 mg, 180 mg and 240 mg – Erythrosine (E127)
and indigo carmine (E132)

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.

300 mg – Erythrosine (E127), indigo carmine
(E132) and patent blue V (E131)

What Adizem-XL capsules look like and the
contents of the pack

Marketing Authorisation Holder and
Manufacturer

Adizem-XL capsules are marked DCR followed
by the strength (e.g. 120, 180 etc.) and are
coloured as follows:
120 mg – pale pink/navy blue,
180 mg – dark pink/royal blue,
200 mg – brown,
240 mg – dark red/blue,
300 mg – dark maroon/pale blue.

The capsules are made by
Bard Pharmaceuticals Limited for
the marketing authorisation holder
Napp Pharmaceuticals Limited, both at
Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.

The capsules are packed in blister packs and
then placed in boxes. In each box there are
28 capsules.

This leaflet is also available in large print, Braille or as
an audio CD. To request a copy, please call the RNIB
Medicine Information line (free of charge) on:

0800 198 5000
You will need to give details of the product name and
reference number.
These are as follows:
Product name: Adizem-XL prolonged-release capsules
Reference number: 16950/0010
This leaflet was last revised in July 2011
Adizem®-XL capsules are protected by UK Patent No. 2258613.
® Adizem and the NAPP device (logo) are Registered Trade Marks.
© 2009-2011 Napp Pharmaceuticals Limited.

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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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