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DILZEM SR 60MG PROLONGED-RELEASE HARD CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 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.

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.

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.
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).

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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)

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:
• 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”.

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• 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 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
- 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

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
TEVA UK LIMITED,
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG
United Kingdom

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
- Flushing
- Constipation, indigestion, stomach pain, feeling sick (nausea)
- Oedema (swelling due to excess fluids), feeling of weakness,
tiredness

This leaflet was last revised in April 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
- Heart failure
- 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
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.
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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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