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ADIZEM-SR CAPSULES 180MG

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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1109-6

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

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

2. What you need to know 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets 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-SR 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-SR capsules with some other
medicines, the effect of Adizem-SR 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 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).
If you are having a general anaesthetic, tell your doctor
that you are taking these capsules.
Adizem-SR capsules with alcohol
Do not take Adizem-SR capsules at the same time as an
alcoholic drink.
Pregnancy, breastfeeding and fertility
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.
Adizem-SR capsules contain sucrose.
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.
Adults (over 18 years of age)
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
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.

1109-6

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Swallow your capsules whole with a glass of water. Do
not chew or crush the capsules.
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.
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.
If you forget to take Adizem-SR 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.

ADIZEM SR CAPS PIL UK 1109-6 V1.indd 3

4. Possible side effects
Like all medicines, Adizem-SR 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 can not 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.

5. How to store Adizem-SR 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-SR capsules contain

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

The active ingredient is diltiazem hydrochloride. Each capsule
contains 90 mg, 120 mg or 180 mg of diltiazem hydrochloride.

Reporting of side effects

The other ingredients are:

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











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

The capsules also contain the following colourants:

Marketing Authorisation Holder

120 mg – Iron oxide (E172) and indigo carmine (E132)
180 mg – Iron oxide (E172)

Napp Pharmaceuticals Limited,
Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.

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.

Manufacturer
Bard Pharmaceuticals Limited,
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 January 2017
® Adizem and the NAPP logo are registered trade marks.
© 2008-2016 Napp Pharmaceuticals Limited.

07/03/2017 13:24

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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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