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DILZEM XL 120MG PROLONGED-RELEASE HARD CAPSULES

Active substance(s): DILTIAZEM HYDROCHLORIDE

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Other medicines and DILZEM XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Package leaflet: Information for the user

Regulatory Approved for
submission
Digitally signed by
kristina.mills@tevapharm.c
om
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cn=kristina.mills@tevaphar
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Date: 2015.12.14 15:35:29 Z

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 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. Do not pass it on
to others. It may harm them, even if their signs of illness 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.

Pantone Black - 15%

Pantone Black - 50%

What is in this leaflet
1. What DILZEM XL is and what it is used for.
2. What you need to know before you take DILZEM XL.
3. How to take DILZEM XL.
4. Possible side effects.
5. How to store DILZEM XL.
6. Contents of the pack and other information.
1. What DILZEM XL is and what it is used for
DILZEM XL contains the active ingredient, diltiazem
hydrochloride.
Diltiazem hydrochloride belongs to a group of medicines called
calcium channel blockers (which interfere with the movement of
calcium in heart muscle cells). 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 hydrochloride, in a controlled manner throughout the
whole day so that blood pressure and angina are treated for a
full 24 hour period.

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2. What you need to know before you take DILZEM XL
Do not take DILZEM XL:
- if you are allergic to diltiazem hydrochloride or any of the
other ingredients of this medicine (listed in section 6).
- if you are a woman able to have children and not using
contraception.
- if you are pregnant or think you may be pregnant or are
breast-feeding.
- if you are currently in shock (reduced blood flow to vital organs).
- if you suffer from any serious heart problems such as heart
failure with shortness of breath, a markedly slow heartbeat
abnormal heart rhythm which may result in palpitation and
do not have a pacemaker.
- if you have had a complicated heart attack.
- if you have a very low pulse rate or low blood pressure.
- if you are currently receiving an infusion of a muscle relaxant
called dantrolene (this is only given in hospitals).
- if you are taking a medicine containing ivabradine for the
treatment of certain heart diseases
Warnings and precautions
Talk to your doctor or pharmacist before taking DILZEM XL:
- if you have diabetes.
- if you have any liver or kidney problems or if you are 65 or over.
- if you have any heart problems, such as heart failure with
shortness of breath, low pulse rate, abnormal heart rhythm
which may result in palpitation.
- if you have a rare disease of the blood pigment called
“porphyria”, or anyone in your family has it.
- if you have myasthenia gravis (a nervous condition which
causes muscle weakness).
- if 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.

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DILZEM XL is used to treat and control mild to moderately high
blood pressure and to prevent and treat chest pain (angina
pectoris) due to the narrowing of blood vessels in the heart,
which is brought on by exercise.

Tell your doctor or pharmacist if you are taking any of the following:
- Statins e.g. Simvastatin, or atorvastatin (used to treat
high cholesterol)
- Lithium (used to treat mental health problems such as
depression and manic disorder)
- Warfarin (used to thin the blood)
- Nitrate derivatives (usually used to treat angina or heart
disease such as glyceryl trinitrate, isosorbide dinitrate)
- Theophylline (used to treat asthma or breathing problems)
- Alpha-blockers used to treat high blood pressure (such as
hytrin and doxazosin). If you are taking Alpha-blockers your
doctor should strictly monitor your blood pressure.
- Any medicine used to treat heart problems, including betablockers (such as propranolol), amiodarone or digoxin. If you
are taking beta-blockers your doctor will monitor your heart
rate at the beginning of treatment
- Methyldopa, nifedipine, diuretics ‘water tablets’ (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, fits
and stabilisation of mood) or rifampicin (used to treat bacterial
infections and tuberculosis) Blood levels of carbamazepine
may be raised in combination with DILZEM XL.
- Cimetidine or ranitidine (medicines used to treat stomach
problems)
- Ciclosporin (which works by suppressing the body’s immune
or defence system used to prevent your body from rejecting
skin grafts, transplanted organs or bone marrow)
- Benzodiazepines (midazolam, triazolam) used for the
treatment of mental illness
- Methylprednisolone (a corticosteroid-a hormone used to treat
different types of diseases.)
- Any medicine which affects contractility of your heart muscle
- Ivabradine (for the treatment of certain heart diseases).
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 and the effect of the anaesthetics on
the function of your heart may be increased by 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.
DILZEM XL contains sucrose
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 this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended 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. An overdose is likely to cause severe
low blood pressure, collapse, and slow heart rate. Take along
any capsules that are left, the container and this leaflet so that
the hospital staff can easily tell what medicine you have taken.

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

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.

Children

Do not take a double dose to make up for the forgotten one.

This medicine is not recommended for use in children.

If you stop taking DILZEM XL

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Do NOT stop taking your medicine without talking to your
doctor first even if you feel better.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 or go to the casualty
department at your nearest hospital:
• 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. This
is a very serious side effect. You may need urgent medical
attention or hospitalisation.
• 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.
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.

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Swollen, enlarged or bleeding gums
Increased sensitivity to sunlight
Red or brown lesions at sun exposed skin areas
Sweating
Swelling of the lymph nodes
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
Weight gain
Increase of something called Creatine-Kinase (CK) in your
blood, which may be a sign of muscle damage
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
Widespread red, itchy and scaly skin
Fever.
Serious illness with blistering of the skin, mouth, eyes and
genitals
Serious illness with skin cell death
Serious illness with detachment of top layer of skin from the
lower layer

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.

Other side effects include:

Keep out of the sight and reach of children.

Very common (affects more than 1 in 10 people);
- Swelling of the ankles, feet or fingers

Do not use this medicine after the expiry date which is stated
on the carton and on the blister strips after EXP. The expiry
date refers to the last day of that month.

Common (affects less than 1 in 10 people)
- Headache, dizziness
- A heart problem called “atrioventricular block”, palpitations
(feeling your heart beat)
- Flushing (Red face and redness of skin)
- Constipation, indigestion, chest pain due to stomach acidity,
stomach pain, feeling sick (nausea)
- Oedema (swelling due to excess fluids), feeling of weakness,
tiredness
- A heart problem called “atrioventricular block” (heart block),
palpitations (abnormal or irregular heart beat).
- Rapid and irregular heart beat (Palpitation)
- Abdominal pain
- Feeling general discomfort.
Uncommon (affects less than 1 in 100 people)
- Nervousness, difficulty in sleeping
- Bradycardia (abnormally slow heart beat)
- Low blood pressure
- 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

Side effects with frequency not known:
- An allergic skin reaction
- Mood changes (including depression), change in personality
- Seeing, feeling or hearing things that are not there
(hallucinations)
- Reduction in blood platelets, which increases risk of bleeding
or bruising, high levels of white blood cells called eosinophils
- Shortness of breath or chest pains (angina)
- 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. Other symptoms of
this may include: red face, headache, swollen lower limbs,
weight loss, fever, red spots on skin, aching joints, mouth
ulcer, abdominal pain, breathing difficulty.)
- Heart failure (Heart problems which can cause shortness of
breath or ankle swelling)
- Leukocytoclastic Vasculitis. Symptoms of this may include:
blisters on the skin, bleeding into the skin, small solid raised
hives on skin etc

Version 3.8

Do not throw away any medicines via wastewater. 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 DILZEM XL contains
- The active substance is diltiazem hydrochloride.
- 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.

Rare (affects less than 1 in 1000 people)
- Dry mouth, hives (lumpy, red, itchy skin)

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

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.
OR
TEVA UK LIMITED,
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG
United Kingdom
This leaflet was last revised in
November 2015.

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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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