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DILZEM XL 120MG PROLONGED-RELEASE HARD CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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DIL XL PIL 1860-9 P4.indd

Iteration No.:

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

9.0 pt

Profile Key

Profile Name:

TEV-DIL-PIL-V1

Component:

PIL

Style:

TBC

Dimensions:

W 200 x H 323 mm

Folded Size:

N/A
Dilzem

Markets:

1860/9
04

Teva Job No.:

N/A

TEXT SIZE

All Over Varnish Unless Marked

Product:

TINT VALUES

TBC

Version:

01

Date:

19 Dec 13

OFF-PACK PHARMACODE
Number: 614

First Bar

Non Print
Area

Fold

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 (FRONT)
1 (One)
TEV-DIL-PIL-V1
H 323 x W 200 mm
N/A
N/A
614
64045-B
Teva Eastbourne
05 Jun 15
475859A05

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V2.04.2014

Artwork Approval Signature Box

Schawk

PACKAGE LEAFLET: INFORMATION FOR THE USER
Site Packaging

Regulatory 1

Legal
(Trademark check)
Packaging Ctrl.

Teva UK Ref:
64045-B Version 4
TW 333856

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:

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 you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
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.
1. WHAT DILZEM XL IS AND WHAT IT IS USED FOR
DILZEM XL 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.
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.
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
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).
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.
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 XL.

REG0076150

Version 2.12

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)
- Theophylline (used to treat asthma)
- Alpha-blockers (such as hytrin and doxazosin)
- Any medicine used to treat heart problems, including betablockers (such as propranolol), 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 XL as it may interact
with anaesthetics.
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.
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 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.
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.

Approved

Page 1 of 3

Perforation

DIL XL PIL 1860-9 P4.indd

1860/9
04

Teva Job No.:
Iteration No.:

Black - 15%

Profile Key

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

9.0 pt

TEV-DIL-PIL-V1

Component:

PIL

Style:

TEXT SIZE

Profile Name:

TBC

Dimensions:

W 200 x H 323 mm

Folded Size:

N/A
Dilzem

Markets:

Black - 50%

All Over Varnish Unless Marked

Product:

TINT VALUES

TBC

Version:

01

Date:

19 Dec 13

Non Print
Area

Fold

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)
TEV-DIL-PIL-V1
H 323 x W 200 mm
N/A
N/A
614
64045-B
Teva Eastbourne
05 Jun 15
475859A05

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V2.04.2014

Artwork Approval Signature Box

Schawk

4. POSSIBLE SIDE EFFECTS
Site Packaging

Like all medicines, DILZEM XL can cause side effects, although
not everybody gets them.

Regulatory 1

If you notice any of the following, stop taking DILZEM XL and
contact your doctor immediately:
• an allergic reaction. The signs include: a red or lumpy rash,
swallowing or breathing problems, swelling of the face,
throat, lips, tongue or glands, sore throat and fever.
• blistering or peeling of the skin around the lips, eyes, skin
rash, blistering affecting the skin, mouth, eyes, genitals or
anus, flu-like symptoms of fever. This could be an illness
called “Stevens-Johnson syndrome”.
• severe blistering rash in which layers of the skin may peel
off to leave large areas of raw exposed skin over the body.
You may feel generally unwell, have a fever, chills or aching
muscles. This could be an illness called “Toxic Epidermal
Necrolysis”.
• difficulty controlling movements and restlessness. This could
be an illness called “Extrapyramidal syndrome”.
It is not known how often these side effects happen.

Legal
(Trademark check)
Packaging Ctrl.

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
- Irregular heart beat
- Low blood pressure
- Shortness of breath or chest pains (angina)
- Reduction in blood platelets, which increases risk of bleeding
or bruising, high levels of white blood cells called eosinophils
- A heart problem called “atrioventricular block” (heart block),
palpitations (abnormal or irregular heart beat).
- Heart failure (Heart problems which can cause shortness of
breath or ankle swelling)
- Increase of something called Creatine-Kinase (CK) in your
blood, which may be a sign of muscle damage
- Weight gain
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

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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
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

Reporting of side effects
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.
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.
If your doctor tells you to stop your treatment, return any left
over capsules to the pharmacist.
6. FURTHER INFORMATION
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).
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
TEVA UK LIMITED,
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG
United Kingdom
This leaflet was last revised in June 2015.

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:
- Feeling unsteady on your feet, fainting, memory loss, tingling
or numbness, sleepiness, shaking
- A disease of the blood vessels called vasculitis (inflammation
of the blood vessels, often with skin rash)
- Swollen, enlarged or bleeding gums

REG0076150

Version 2.12

Approved

64045-B

1860/9

Page 2 of 3

Perforation

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-16260-0020-0021-0022-dilzem-xl-120mg-180mg-240mg-pro
longed-release-hard-capsules

APPROVALS
Signed by
Michael Silvester

REG0076150

Meaning of Signature
Regulatory Affairs Approval

Version 2.12

Approved

Server Date
15-Jun-2015 12:38:22 PM

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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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