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DILZEM SR 60MG PROLONGED-RELEASE HARD CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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1853-7 Dilzem SR P1.indd

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OFF-PACK PHARMACODE
Number: 602

Profile Key
All Over Varnish Unless Marked

Profile Name: Dilzem PIL 8560 V6

Black - 40%

8.0 pt

Style:
Dimensions:
Fold

Black

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Perforation
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Product Name
Market
Component
No. of Colours
Profile
Dimensions
Stock Code
Barcode
Pharmacode
Material No.
Packaging supp.
Date
Schawk Job No.

5%

Dilzem SR
UK
PIL (FRONT)
1 (One)
Dilzem PIL 8560 V6
W 297 x H 148 mm
N/A
N/A
602
6001983/05
Alkermes Pharma
29 Feb 12
326501A01

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V1.08.2007

Artwork Approval Signature Box

Schawk

Regulatory 1

Commercial

Medical

Packaging Ctrl.

- Difficulty controlling movements and restlessness
- Irregular heart beat
- Low blood pressure
- Redness, itching or scaling of the skin
- Shortness of breath or chest pains (angina)
The frequency of these side effects is not known.
Other side effects include:
Very common (affects more than 1 in 10 people);
- Swelling of the ankles, feet or fingers
Common (affects less than 1 in 10 people)
- Headache, dizziness
- A heart problem called “atrioventricular block”,
palpitations (feeling your heart beat)
- Flushing
- Constipation, indigestion, stomach pain, feeling
sick (nausea)
- Oedema (swelling due to excess fluids), feeling of
weakness, tiredness
Uncommon (affects less than 1 in 100 people)
- Nervousness, difficulty in sleeping
- Bradycardia (slow heart beat)
- A fall in blood pressure on standing up which
causes dizziness, light-headedness or fainting)
- Vomiting (being sick), diarrhoea
- Blood tests which show changes in the way the
liver is working
Rare (affects less than 1 in 1000 people)
- Dry mouth, hives (lumpy, red, itchy skin)
Frequency not known:
- Reduction in blood platelets, which increases risk
of bleeding or bruising, high levels of white blood
cells called eosinophils
- Feeling unsteady on your feet, fainting, memory
loss, tingling or numbness, sleepiness, shaking
- Heart failure
- A disease of the blood vessels called vasculitis

- Swollen, enlarged or bleeding gums
- Increased sensitivity to sunlight, sweating
- Swelling of breast tissue in men, loss of ability to
have, or loss of interest in sex
- Lazy eye, eye irritation
- Increase of something called Creatine-Kinase (CK)
in your blood, which may be a sign of muscle
damage, weight gain
- Nose bleed, blocked nose
- Loss of appetite, increased blood sugar levels
- Increased need to pass urine or an increased
volume of urine, especially at night
- Muscle weakness or pain in muscles, bones or
joints
- Ringing or buzzing in the ears
If any of these side effects become serious or you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist
5. HOW TO STORE DILZEM SR
Do not store above 25°C. Store in the original package
in order to protect from light and moisture.
Keep out of the reach and sight of children.
Do not use DILZEM SR after the last day of the month
shown in the expiry date printed on the carton and on
the blister strips.
If your doctor tells you to stop your treatment, return
any left over capsules to the pharmacist.
6. FURTHER INFORMATION
What DILZEM SR contains
Each DILZEM SR capsule contains 60 mg, 90 mg or
120 mg of the active ingredient diltiazem hydrochloride.
The other ingredients are: fumaric acid, talc, povidone,
sugar spheres (containing sucrose and maize starch),
ammonio methacrylate copolymer Type A, ammonio
methacrylate copolymer Type B. The capsule shell

contains yellow iron oxide (E172), black iron oxide
(E172), erythrosine (E127), titanium dioxide (E171),
gelatin, shellac and propylene glycol (E1520).
What DILZEM SR looks like and contents of the
pack
DILZEM SR capsules are buff coloured capsules printed
with 60 mg, 90 mg or 120 mg. They are supplied in
blister packs of 56 capsules.
Marketing Authorisation Holder
Cephalon UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
UK
Manufacturer
Alkermes Pharma Ireland Limited,
Monksland,
Athlone,
Co. Westmeath,
Ireland.
This leaflet was last revised in March 2012.

PACKAGE LEAFLET: INFORMATION FOR THE
USER

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1

DILZEM SR 60 mg, 90 mg, 120 mg
Prolonged-release
Hard 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 get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What DILZEM SR is and what it is used for.
2. Before you take DILZEM SR.
3. How to take DILZEM SR.
4. Possible side effects.
5. How to store DILZEM SR.
6. Further information.
1. WHAT DILZEM SR IS AND WHAT IT IS USED
FOR
DILZEM SR contains the active ingredient, diltiazem
hydrochloride.
Diltiazem belongs to a group of medicines called calcium
channel blockers. These medicines work to lower blood
pressure and ease anginal chest pain by preventing the
narrowing of blood vessels.

(CODE)
THIS WAY UP

Site Packaging

W 297 x H 148 mm

Folded Size:

TBC
Dilzem

Markets:

First Bar

TBC

TBC

Version:

Iteration No.:

1853/7
01

PIL

Product:

Cephalon Job No.:

Component:

06

Date:

16 Jul 08

1853-7 Dilzem SR P1.indd

TINT VALUES

TEXT SIZE

Profile Key

Black - 40%

The SMALLEST
BODY text on this
A/W is at:

All Over Varnish Unless Marked

Profile Name: Dilzem PIL 8560 V6
Style:
Dimensions:

Fold
Black

Perforation
100%

90%

50%

Product Name
Market
Component
No. of Colours
Profile
Dimensions
Stock Code
Barcode
Pharmacode
Material No.
Packaging supp.
Date
Schawk Job No.

5%

Dilzem SR
UK
PIL (BACK)
1 (One)
Dilzem PIL 8560 V6
W 297 x H 148 mm
N/A
N/A
602
6001983/05
Alkermes Pharma
29 Feb 12
326501A01

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V1.08.2007

Artwork Approval Signature Box

Schawk

Site Packaging

Regulatory 1

Commercial

Medical

Packaging Ctrl.

DILZEM SR is designed to release the active ingredient,
diltiazem, in a controlled manner throughout the whole
day so that blood pressure and angina are treated for a
full 24 hour period.
DILZEM SR is used to treat and control mild to moderately
high blood pressure and to prevent and treat chest pain
due to the narrowing of blood vessels in the heart.
2. BEFORE YOU TAKE DILZEM SR
Do not take DILZEM SR if you:
- Are allergic to diltiazem hydrochloride or any of the
other ingredients of DILZEM SR.
- Are a woman able to have children and not using
contraception.
- Are pregnant or think you may be pregnant or are
breast-feeding.
- Are currently in shock (reduced blood flow to vital
organs).
- Suffer from any serious heart problems such as
heart failure with shortness of breath and abnormal
heart rhythm which may result in palpitation.
- Have a very low pulse rate or low blood pressure.
- Are currently receiving an infusion of a muscle
relaxant called dantrolene (this is only given in
hospitals).
Take special care with DILZEM SR:
Check with your doctor or pharmacist before taking your
medicine if:
- You have diabetes.
- You have any liver or kidney problems or if you are
65 or over.
- You have any heart problems, such as heart failure
with shortness of breath, low pulse rate, abnormal
heart rhythm which may result in palpitation.
- You have a rare disease of the blood pigment
called “porphyria”, or anyone in your family has it.
- You have myasthenia gravis (a nervous condition
which causes muscle weakness).

- You suffer from constipation.
In some patients this medicine has caused mood
changes, including depression. If you think you are
affected in this way talk to you doctor.
If any of the above apply to you, please tell your doctor
or pharmacist before taking DILZEM SR.
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 or herbal
medicines. This is especially important if you are taking
any of the following medicines:
Do not take this medicine and talk to your doctor or
pharmacist if you are currently receiving an infusion of
a muscle relaxant called dantrolene (this is only given
in hospitals).
Also tell your doctor or pharmacist if you are taking any
of the following:
- Simvastatin, or atorvastatin (used to treat high
cholesterol)
- Lithium (used to treat mental problems)
- Warfarin (used to thin the blood)
- Nitrate derivatives (usually used to treat angina,
such as glyceryl trinitrate, isosorbide dinitrate)
- Theophilline (used to treat asthma)
- Alpha-blockers (such as hytrin and doxazosin)
- Any medicine used to treat heart problems, including
beta-blockers (such as propanolol), amiodarone or
digoxin
- Methyldopa, nifedipine, diuretics (such as
bendrofluazide), ACE inhibitors (such as enalapril),
or any other medicines used to treat high blood
pressure
- Phenobarbital or carbamazepine (used to treat
epilepsy) or rifampicin (used to treat tuberculosis)
- Cimetidine or ranitidine (medicines used to treat
stomach problems)

- Ciclosporin (which works by suppressing the body's
immune or defence system)
- Benzodiazepines (midazolam, triazolam)
- Methylprednisolone (a corticosteroid)
If you are due to have surgery, or visit your dentist,
tell the doctor or dentist that you are taking DILZEM SR
as it may interact with anaesthetics.
Pregnancy and breast-feeding
Do not take DILZEM SR if you are pregnant, think you
may be pregnant, or if you are breast-feeding.
Driving and using machines
DILZEM SR should not affect your ability to drive or use
machines. However, if you feel faint or dizzy, do not drive
or operate any machines.
Important information about some of the ingredients
of DILZEM SR
DILZEM SR contains sucrose. If you have been told that
you have an intolerance to some sugars, contact your
doctor before taking DILZEM SR.
3. HOW TO TAKE DILZEM SR
Always take DILZEM SR exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
The usual dose for adults is one 90 mg capsule twice
a day.
Always swallow the capsules whole with water.
Do not suck or chew the capsule or remove the contents
as this will affect the special release properties of the
product.
Your doctor may increase the dose of DILZEM SR,
depending on your response to the drug.
Elderly patients and those with kidney or liver problems
may be started on a lower dose of 60 mg twice a day.
DILZEM SR is not recommended for children.

If you take more DILZEM SR than you should
If you accidentally take too many DILZEM SR capsules,
tell your doctor immediately or go to the nearest hospital
accident and emergency department. Take along any
capsules that are left, the container and the label so
that the hospital staff can easily tell what medicine you
have taken.
If you forget to take DILZEM SR
If you forget to take a dose, take it as soon as you
remember. If it is almost time for your next dose (up to
eight hours before), do not take the missed dose but
take your next dose at your normal time. Do not take a
double dose to make up for the forgotten one.
4. POSSIBLE SIDE EFFECTS
Like all medicines, DILZEM SR can cause side effects,
although not everybody gets them.
If you notice any of the following, stop taking DILZEM SR
and contact your doctor immediately:
• Swelling of the face, throat, lips, tongue or glands,
• Skin rash, blistering affecting the skin, mouth,
eyes, genitals or anus.
• Sore throat and fever.
As these may be signs of an allergic reaction.
If you notice any of the following, stop taking DILZEM SR
and contact your doctor immediately:
• Darkening of your urine.
• Pale stools.
• Yellowing of your skin or eyes.
As these may be signs of liver problems.
Talk to your doctor straight away, if you notice any
of the following:
- Seeing, feeling or hearing things that are not there
(hallucinations)
- Mood changes (including depression), change in
personality

2

3

4

5

W 297 x H 148 mm

Folded Size:

TBC
Dilzem
TBC

Version:

8.0 pt

TBC

Markets:

Iteration No.:

1853/7
01

PIL

Product:

Cephalon Job No.:

Component:

06

Date:

16 Jul 08

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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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