DILZEM XL 120MG PROLONGED-RELEASE HARD CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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DIL XL PIL 1860-8 P3.indd

Iteration No.:

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

9.0 pt

Profile Key

TEV-DIL-PIL-V1

Component:

PIL

Style:

OFF-PACK PHARMACODE
Number: 614

Profile Name:

TBC

Dimensions:

W 200 x H 323 mm

Folded Size:

N/A
Dilzem

Markets:

1860/8
03

Teva Job No.:

N/A

TEXT SIZE

All Over Varnish Unless Marked

Product:

TINT VALUES

TBC

Version:

01

Date:

19 Dec 13

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-A
Teva Eastbourne
14 Jun 14
428704A02

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.

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.

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 beta-blockers
(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.

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

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.

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 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).

3. HOW TO TAKE 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.

Elderly patients and those with kidney or liver problems may be
started on a lower dose of 120 mg a day.

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.
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).

REG0076150

Version 1.4

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.

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.
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:
• 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.

Approved

Page 1 of 3

Perforation

DIL XL PIL 1860-8 P3.indd

1860/8
03

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-A
Teva Eastbourne
14 Jun 14
428704A02

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

Artwork Approval Signature Box

Schawk

Site Packaging

Regulatory 1

Legal
(Trademark check)
Packaging Ctrl.

•  listering or peeling of the skin around the lips, eyes, skin
b
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.

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.

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.

Keep out of the reach and sight of children.

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.

6. FURTHER INFORMATION

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

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.
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.
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
Alkermes Pharma Ireland Limited,
Monksland,
Athlone,
Co. Westmeath,
Ireland.
This leaflet was last revised in May 2014.

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 dizziness,
A
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
- 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
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
64045-A

1860/8

REG0076150

Version 1.4

Approved

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
m
-prolonged-release-hard-capsules

APPROVALS
Signed by
Jack Barnwell

REG0076150

Meaning of Signature
Regulatory Affairs Approval

Version 1.4

Approved

Server Date
20-Jun-2014 02:46:35 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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