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ADIZEM-XL CAPSULES 180MG

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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1114-8

350x148mm (LSN-NAPP-02) (L) V1

V9-2012

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ADIZEM XL CAPS PIL UK 1114-8
4541
N/A
UK
1114-8
N/A
Datamatrix
1114-8
N/A
N/A
BARD
350x148mm (LSN-NAPP-02)(L) V1
N/A
N/A

ADIZEM XL CAPS PIL UK 1114-8 V2.indd 1

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PRD-PMS-005
LSN-NAPP-02
N/A
350x148mm
148x36,34mm
N/A
N/A
Adobe InDesign 7.5.0.142
hab04
rmm02
1
2
04-05-16
06-01-17

PMS 280
PMS 280 @ 20%

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PINK
BLUE
PURPLE
BUFF

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Package Leaflet: Information for the user
Adizem -XL 120 mg, 180 mg, 200 mg,
240 mg and 300 mg capsules
®

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 side effects, talk
to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet:
1. What Adizem-XL capsules are and
what they are used for
2. What you need to know 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. Contents of the pack and other
information

ADIZEM XL CAPS PIL UK 1114-8 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.

2. What you need to know before
you take Adizem-XL capsules
Do not take Adizem-XL capsules if
you:
• 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.
Warning and precautions
Talk to your doctor or pharmacist
before taking these capsules 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.
Other medicines and Adizem-XL
capsules
Please tell your doctor or pharmacist
if you are taking, have recently taken
or might take 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.
Adizem-XL capsules with alcohol
Do not take Adizem-XL capsules at
the same time as an alcoholic drink.
Pregnancy, breastfeeding and
fertility
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.
Adizem-XL capsules contain soya oil
If you are allergic to peanuts or soya
do not take these capsules.

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.
Adults (over 18 years of age)
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
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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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.

ADIZEM XL CAPS PIL UK 1114-8 V2.indd 3

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 (May affect
more than 1 in 10 people)
• Swelling of the hands, ankles or feet.
Common side effects (May affect
more than 1 in 100 people)
• Feeling sick, abdominal pain,
indigestion, constipation.
• Dizziness, headache.
• Flushing or redness of the skin,
itching.
• A fast, slow or irregular heartbeat.
• Generally feeling unwell.
• Tiredness.
Uncommon side effects (May affect
up to 1 in 100 people)
• 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 (May affect up to
1 in 1000 people)
• Dry mouth.
• Hives.
Frequency not known (Frequency
cannot be estimated from the
available data)
• 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).
• Sweating.
• Low blood pressure.
You may see the remains of the
capsules in your faeces. This
should not affect how the capsules
work.

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 Adizem-XL
capsules
Keep out of the sight and reach 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.
Do not store your capsules above 25ºC.
Do not take your capsules if they
are broken or crushed as this can
be dangerous and can cause serious
problems such as overdose.
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 Adizem-XL capsules contain
The active ingredient is diltiazem
hydrochloride. Each capsule contains
120 mg, 180 mg, 200 mg, 240 mg or
300 mg of diltiazem hydrochloride.
The other ingredients are:
• Microcrystalline cellulose
• Ethylcellulose
• Colloidal anhydrous silica
• Polysorbate 80
• Dibutyl sebacate
• Magnesium stearate
• Sodium dodecyl sulphate
• Gelatin
• Shellac
• Soya lecithin
• 2-ethoxyethanol
• Dimeticone
• Iron oxide (E172)
• Titanium dioxide (E171)
The capsules also contain the
following colourants:
120 mg, 180 mg and 240 mg –
Erythrosine (E127) and indigo
carmine (E132)
300 mg – Erythrosine (E127), indigo
carmine (E132) and patent blue V
(E131)

What Adizem-XL capsules look like
and the contents of the pack
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 packed in blister packs
and then placed in boxes. In each box
there are 28 capsules.

Marketing Authorisation Holder
Napp Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road, Cambridge
CB4 0GW, UK.
Manufacturer
Bard Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road, Cambridge
CB4 0GW, UK.

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 January 2017
® Adizem and the NAPP logo are registered trade marks.
© 2009-2016 Napp Pharmaceuticals Limited.

06/01/2017 15:51

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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