DILZEM XL 120MG PROLONGED-RELEASE HARD CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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1860-7 Dilzem XL P1.indd

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OFF-PACK PHARMACODE
Number: 606

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Profile Name: DIL-PIL-1LG-V1

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1860/7
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Product Name
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Component
No. of Colours
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Barcode
Pharmacode
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Date
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5%

Dilzem XL
UK
PIL (FRONT)
1 (One)
DIL-PIL-1LG-V1
W 364 x H 148 mm
W 34 x H 148 mm
N/A
N/A
606
6001985/05
Alkermes Pharma
29 Feb 12
326427A01

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

Site Packaging

Regulatory 1

Commercial

Medical

Packaging Ctrl.

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
-  heart problem called “atrioventricular block”, palpitations
A
(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)
-  fall in blood pressure on standing up which causes
A
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
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- 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 XL
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 XL after the last day of the month shown in the
expiry date printed on the carton and on the blister strips.

What DILZEM XL looks like and contents of the pack
DILZEM XL capsules are white coloured capsules printed with
e120, e180 or e240. They are supplied in blister packs of
28 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.

If your doctor tells you to stop your treatment, return any left over
capsules to the pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

DILZEM XL 120 mg, 180 mg, 240 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 XL is and what it is used for.
2. Before you take DILZEM XL.
3. How to take DILZEM XL.
4. Possible side effects.
5. How to store DILZEM XL.
6. Further information.

6. FURTHER INFORMATION

1. WHAT DILZEM XL IS AND WHAT IT IS USED FOR

What DILZEM XL contains
Each DILZEM XL capsule contains 120 mg, 180 mg or 240 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 gelatin, titanium dioxide (E171), black iron oxide
(E172), shellac and propylene glycol (E1520).

DILZEM XL contains
hydrochloride.

7

the

active

ingredient,

diltiazem

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.
DILZEM XL 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.
8

1

(CODE)
THIS WAY UP

Schawk

Bar prints 100mm @ 100%

Artwork Approval Signature Box

Perforation

W 364 x H 148 mm

Folded Size:

W 34 x H 148 mm
Dilzem
UK and Ireland

Version:

Black - 15%

Varnish Free
Area
100%

Dimensions:
Fold

TBC

Markets:

8.0 pt

Style:

First Bar

PIL

Product:

Cephalon Job No.:

Component:

01

Date:

08 Jul 10

1860-7 Dilzem XL 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: DIL-PIL-1LG-V1
Style:

8.0 pt

Non Print
Area

Dimensions:

Black

Varnish Free
Area
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 XL
UK
PIL (BACK)
1 (One)
DIL-PIL-1LG-V1
W 364 x H 148 mm
W 34 x H 148 mm
N/A
N/A
606
6001985/05
Alkermes Pharma
29 Feb 12
326427A01

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

Schawk

Site Packaging

Regulatory 1

Bar prints 100mm @ 100%

Artwork Approval Signature Box

DILZEM XL 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 XL

Commercial

Medical

Packaging Ctrl.

Do not take DILZEM XL if you:
- Are allergic to diltiazem hydrochloride or any of the other
ingredients of DILZEM XL.
- Are a woman able to have children and not using
contraception.
- Are pregnant or think you may be pregnant or are breastfeeding.
- 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).

If any of the above apply to you, please tell your doctor or
pharmacist before taking DILZEM XL.
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).

Pregnancy and breast-feeding
Do not take DILZEM XL if you are pregnant, think you may be
pregnant, or if you are breast-feeding.
Driving and using machines
DILZEM XL 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 XL
DILZEM XL contains sucrose. If you have been told that you have
an intolerance to some sugars, contact your doctor before taking
DILZEM XL.

Take special care with DILZEM XL:
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.

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 betablockers (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)

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 you are due to have surgery, or visit your dentist, tell the
doctor or dentist that you are taking DILZEM XL as it may interact
with anaesthetics.

If you take more DILZEM XL than you should
If you accidentally take too many DILZEM XL 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.

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3

4

3. HOW TO TAKE DILZEM XL
Always take DILZEM XL 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 180 mg capsule 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 XL, depending on
your response to the drug.
Elderly patients and those with kidney or liver problems may be
started on a lower dose of 120 mg a day.
DILZEM XL is not recommended for children.

If you forget to take DILZEM XL
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 XL can cause side effects, although not
everybody gets them.
If you notice any of the following, stop taking DILZEM XL and
contact your doctor immediately:
• Swelling of the face, throat, lips, tongue or glands,
•  kin rash, blistering affecting the skin, mouth, eyes, genitals
S
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 XL 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
- 
- 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.

5

Perforation

W 364 x H 148 mm

Folded Size:

W 34 x H 148 mm
Dilzem
UK and Ireland

Version:

Fold

TBC

Markets:

Iteration No.:

1860/7
01

PIL

Product:

Cephalon Job No.:

Component:

01

Date:

08 Jul 10

Expand view ⇕

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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