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ADIZEM-SR TABLETS 120MG

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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2273-9

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

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

2. Before you take Adizem-SR tablets
Do not take Adizem-SR tablets if you:
• are allergic (hypersensitive) to diltiazem or
any of the other ingredients of the tablets
(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 tablets.

These tablets 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 tablets are listed in
section 6 of this leaflet.

Take special care with Adizem-SR tablets

Adizem-SR tablets are designed to work
properly over 12 hours. If the tablets 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
tablets with some other medicines, the effect of
Adizem-SR tablets or the other medicine may
be changed.

Before treatment with Adizem-SR tablets 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

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 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-SR tablets
If you are having a general anaesthetic, tell your
doctor that you are taking these tablets.

Taking Adizem-SR tablets with alcohol
Taking Adizem-SR tablets at the same time as an
alcoholic drink is not recommended.
Pregnancy and breastfeeding
Do not take Adizem-SR tablets 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 tablets 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 tablets, 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 tablets
These tablets contain sucrose and lactose which
are forms of sugar. If you have been told by
your doctor that you have an intolerance to
some sugars, contact your doctor before taking
these tablets.

3. How to take Adizem-SR tablets
Always take Adizem-SR tablets exactly as your
doctor has told you. The label on your medicine
will tell you how many tablets to take and how
often.
The usual dose is one tablet twice daily.
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
tablets you should take.
Children should not take these tablets.
Do not exceed the dose recommended by your
doctor. You should check with your doctor or
pharmacist if you are not sure.
Swallow your tablets whole with a glass of
water. Do not chew or crush the tablets.
You should take your tablets every 12 hours.
For instance, if you take a tablet at 8 o’clock in
the morning, you should take your next tablet at
8 o’clock in the evening.

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2273-9

If you take more Adizem-SR tablets than you
should or if someone accidentally swallows your
tablets
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
tablets with you to show to the doctor.
If you forget to take Adizem-SR tablets
If you remember within 4 hours of the time your
tablet was due, take your tablet straight away. Take
your next tablet 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 tablet.
If you stop taking Adizem-SR tablets
You should not stop taking these tablets unless your
doctor tells you to. If you want to stop taking your
tablets, discuss this with your doctor first.
If you have any further questions on the use of
Adizem-SR tablets ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines, Adizem-SR tablets 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 tablets)
• Swelling of the hands, ankles or feet.
Common side effects (probably affecting more than
1 in 100 people taking these tablets)







Feeling sick, abdominal pain, indigestion, constipation.
Dizziness, headache.
Flushing or redness of the skin.
A fast, slow or irregular heartbeat.
Generally feeling unwell.
Tiredness.

Rare side effects (probably affecting fewer than
1 in 1000 people taking these tablets)
• 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.

Uncommon side effects (probably affecting fewer than
1 in 100 people taking these tablets)

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

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).

5. How to store Adizem-SR tablets

6. Further information

Keep out of the reach and sight of children.

What Adizem-SR tablets contain

Do not use any tablets after the expiry date
which is stated on the carton. EXP 08 2020
means that you should not take the tablets
after the last day of that month i.e. August
2020.

The active ingredient is diltiazem
hydrochloride. Each tablet contains 120 mg of
diltiazem hydrochloride.

Do not store your tablets above 25ºC. Store in
the original package.
Do not take your tablets 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.

The other ingredients are:












Lactose
Hydrogenated castor oil
Colloidal aluminium hydroxide
Acrylic resin
Talc
Magnesium stearate
Hypromellose
Sucrose
Glycerol
Titanium dioxide (E171)
Polysorbate 80

What Adizem-SR tablets look like
and the contents of the pack

Marketing Authorisation Holder and
Manufacturer

Adizem-SR tablets are white, capsule
shaped, film-coated tablets marked
120/DL on one side and with a
scoreline on the other.

The tablets 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.

In each box there are 56 tablets.

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 tablets
Reference number: 16950/0009
This leaflet was last revised in September 2010
® Adizem, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2008-2010 Napp Pharmaceuticals Limited.

04/10/2010 11:16

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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