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ADIZEM-SR CAPSULES 180MG

Active substance(s): DILTIAZEM HYDROCHLORIDE

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1109-5

Package leaflet: Information for the user
Adizem®-SR 90 mg, 120 mg and 180 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 becomes 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-SR capsules are and what they are used
for
2. Before you take Adizem-SR capsules
3. How to take Adizem-SR capsules
4. Possible side effects
5. How to store Adizem-SR capsules
6. Further information

1. What Adizem-SR capsules are and what they
are used for

2. Before you take Adizem-SR capsules
Do not take Adizem-SR 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.
Take special care with Adizem-SR capsules

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-SR capsules are listed in section 6 of this leaflet.

Before treatment with Adizem-SR capsules tell your
doctor or pharmacist if you:

Adizem-SR capsules are designed to work properly
over 12 hours. If the capsules are crushed or chewed,
the entire 12‑hour dose may be absorbed rapidly into
your body. This can be dangerous, causing serious
problems such as an overdose.

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-SR capsules with some other medicines, the
effect of Adizem-SR capsules or the other medicine may
be changed.

• 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

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 enalopril);

• 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 betablockers);
• 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-SR capsules
If you are having a general anaesthetic, tell your doctor
that you are taking these capsules.
Taking Adizem-SR capsules with alcohol
Do not take Adizem-SR capsules at the same time as an
alcoholic drink.
Pregnancy and breastfeeding
Do not take Adizem-SR 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.
Important information about some of the ingredients
of Adizem-SR capsules
These capsules contain sucrose which is a form of sugar.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking these capsules.
3. How to take Adizem-SR capsules
Always take Adizem-SR capsules exactly as your doctor
has told you. The label on your medicine will tell you
how many capsules to take and how often.
If you are taking these capsules to treat angina the usual
starting dose is one 90 mg capsule every 12 hours. If you
are taking these capsules to lower your blood pressure
then the usual dose is one 120 mg capsule every 12 hours.
However, if you are elderly or have kidney or liver
problems then you may need to start on a lower dose.
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.

Adizem SR caps PIL UK 1109-5 V2.indd 2

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1109-5

You should check with your doctor or pharmacist if you
are not sure.

4. Possible side effects

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

Like all medicines, Adizem-SR capsules can cause side
effects, although not everybody gets them.

You should take your capsules every 12 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
in the evening.

Look out for the following severe allergic reactions. They
have occurred in a small number of people, although their
exact frequency cannot be estimated:

If you take more Adizem-SR 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.

• 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.

If you forget to take Adizem-SR capsules

Common side effects (probably affecting more than
1 in  100 people taking these 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-SR 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-SR capsules ask your doctor or pharmacist.

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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 is unknown:
• 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.
You may see the remains of the capsules in your
faeces. This should not affect how the capsules work.
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-SR 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.
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.
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 Adizem-SR capsules contain
The active ingredient is diltiazem hydrochloride. Each capsule
contains 90 mg, 120 mg or 180 mg of diltiazem hydrochloride.
The other ingredients are:










Sucrose
Maize starch
Povidone
Ethylcellulose
Talc
Aquacoat ECD 30
Dibutyl sebacate
Gelatin
Titanium dioxide (E171)

The capsules also contain the following colourants:
120 mg – Iron oxide (E172) and indigo carmine (E132)
180 mg – Iron oxide (E172)
What Adizem-SR capsules look like and the contents of
the pack
Adizem-SR capsules are marked with the strength
(e.g.90 mg, 120 mg etc.) and coloured as follows:
90 mg – white, 120 mg – white/brown,
180 mg –white/pale brown.

Marketing Authorisation Holder and
Manufacturer
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 boxed in
cardboard cartons. In each carton there are 56 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-SR prolonged-release capsules
Reference number: 16950/0006
This leaflet was last revised in September 2010
® Adizem and the NAPP device (logo) are Registered Trade Marks.
© 2008-2010 Napp Pharmaceuticals Limited.

04/10/2010 11:09

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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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