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DILCARDIA SR 60 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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Package Leaflet: Information For The Patient

Dilcardia SR 60 mg
Prolonged-release capsules, hard
Dilcardia SR 90 mg
Prolonged-release capsules, hard
Dilcardia SR 120 mg
Prolonged-release capsules, hard
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
only. 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Dilcardia SR is and what it is used for
2. Before you take Dilcardia SR
3. How to take Dilcardia SR
4. Possible side effects
5. How to store Dilcardia SR
6. Contents of the pack and other information

• ivabradine to treat angina;
• medicines used to treat a heart rhythm
condition e.g. digoxin, amiodarone;
• cilostazol to treat intermittent claudication
(a condition that causes leg pain due to a
restriction in blood supply to the muscles);
• beta-blockers, water tablets (diuretics)
or ACE inhibitors, used to treat high
blood pressure and heart conditions e.g.
propranolol, furosemide or lisinopril;
• rifampicin, used to treat an infection;
• ciclosporin, tacrolimus or sirolimus, usually
used after an organ or bone
marrow transplant;
• a specific type of medicine known as a
protease inhibitor to treat HIV (examples
include atazanavir or ritonavir);
• theophylline (to prevent shortness of breath
or difficulty breathing);
• barbiturates e.g. phenobarbital or
primidone, carbamazepine or phenytoin
(antiepileptics, to treat seizures, fits
or convulsions);
• cimetidine or ranitidine, for heartburn or
stomach ulcers;
• benzodiazepines, used to treat anxiety or
sleep disturbances e.g. midazolam
or triazolam;
• methylprednisolone, a corticosteroid
(normally used to treat inflammation
or allergy);
• statins, used to lower blood cholesterol
levels e.g. simvastatin.

1. What Dilcardia SR is and what it is
used for

If you need to have an operation and will
require an anaesthetic, tell your doctor or
dentist you are taking this medicine.

Dilcardia SR contains diltiazem hydrochloride
which belongs to a group of medicines called
calcium channel blockers. Diltiazem acts by
relaxing the muscles around the blood vessels
and so relaxes and widens the blood vessels.
This makes it easier for the heart to do its
work and allows more blood to flow to the
heart, relieving angina (chest pain due to an
inadequate blood supply to the heart) and
reducing blood pressure. Diltiazem also has
an effect on the heart muscle itself, helping
the heart to slow down and reduce the
amount of work it is doing.

Dilcardia SR with alcohol
Do not take Dilcardia SR at the same time as
an alcoholic drink.

Dilcardia SR can be used to treat:
• High blood pressure (hypertension)
• Chest pain (angina).

Dilcardia should not be taken if you are
breast-feeding.

2. What you need to know before you
take Dilcardia SR
Do not take Dilcardia SR if you:
• are allergic to diltiazem or any of the other
ingredients of this medicine (listed in
section 6)
• are pregnant or might become pregnant
• suffer from a very slow beating heart (less
than 40 beats per minute)
• have been told by your doctor that you
suffer from heart block or sick sinus
syndrome (disorders of the heart’s rhythm),
and do not have a pacemaker fitted
• have recently had a heart attack and are
suffering from heart failure
• have been given an infusion of a drug called
dantrolene (muscle relaxant)
• are already taking a medicine containing
ivabradine for the treatment of certain
heart diseases
Warnings and precautions
Talk to your doctor before taking this
medicine if you:
• suffer from a slow beating heart
• have heart disease or changes in the
electrical activity of the heart
• have liver or kidney problems as your doctor
may monitor you more closely
• are 65 or over
• have diabetes
• suffer from constipation or a history of
blockages in the bowel
• have porphyria (a rare disease of the
blood pigments)
Medicines like Dilcardia SR can cause mood
changes, including depression, especially in
patients prone to episodes of depression or
low mood. If you think you may be affected,
talk to your doctor or pharmacist.

Other medicines and Dilcardia SR
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, especially any of the following:
• dantrolene (a muscle relaxant) (See section
‘Do not take’ above);
• antidepressants known as tricyclic
antidepressants (e.g. amitriptyline or
imipramine) or lithium;
• nitrate derivatives, usually used to treat
angina e.g. glyceryl trinitrate;
• alpha-blockers, used to treat prostate
problems or high blood pressure e.g. prazosin;
• any medicines which may cause low blood
pressure or slow heart beat (for example
aldesleukin to treat cancer of the kidneys,
or antipsychotics to treat mental and
behavioural disorders);

Description Diltiazem Hydrochloride 60 mg,90 mg,120 mg 56
Component Type Leaflet
Affiliate Item Code 1243482
Superceded Affiliate Item Code 747905
TrackWise PR No. 1243482
MA No.

04569/0350-0352

Packing Site/Printer NA
Supplier Code LT1417AH

Pharma Code 215
SAP No. NA
Vendor Job No. 317160
Trackwise Proof No. 4
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Pregnancy and breast-feeding
Do not take Dilcardia SR if you are pregnant
or planning to become pregnant.
If you are a woman of child bearing age or
have not gone through the menopause,
and your doctor recommends you take this
medicine, you must use an effective form
of contraception

Driving and using machines
Dilcardia SR may cause side effects such as
dizziness or feeling generally unwell. If you
are affected you should not drive or
use machines.
Dilcardia SR contains sucrose
If you have been told by your doctor that you
have an intolerance to some sugars, such as
sucrose, contact your doctor before taking
this medicine.

3. How to take Dilcardia SR
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure:
• This medicine should not be sucked
or chewed
• Swallow the capsule whole with a glass
of water
• Allow 12 hours between each dose

Angina
Adults: the recommended dose is 90 mg twice
daily. If necessary, your doctor may be gradually
increased to a dose of 180 mg twice daily.
Hypertension
Adults: the recommended dose is 120 mg
once or twice daily. Your doctor may give
you a lower starting dose and gradually
increase the dosage.
Older people or patients with liver or
kidney problems
Angina
Your doctor may prescribe a lower dose of
60 mg twice daily which may be increased
as required.
Hypertension
Your doctor may prescribe a lower dose of
60 mg twice a day which may be increased
to up to a maximum of 90 mg twice a day
if required.
Use in children and adolescents
Dilcardia SR is not suitable for children
and adolescents.
If you take more Dilcardia SR than
you should
Contact your doctor or nearest hospital
emergency department immediately. Take
the container and any remaining capsules
with you. Signs of overdose include low blood
pressure possibly leading to collapse, slow
heart beat or changes in heart rhythm and/or
abnormal blood sugar levels.

Date: 28 JUL 2017
No. of colours
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1

Time: 13:31
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v2/Oct 2016

If you forget to take Dilcardia SR
If you have forgotten to take a dose at the
scheduled time, take it as soon as possible.
If it is less than 6 hours until you are due to
take your next dose, do not double the dose,
just carry on as before. Do not take a double
dose to make up for forgotten individual doses.
If you stop taking Dilcardia SR
Take the medicine for as long as the doctor
has prescribed it. Do not discontinue
treatment without prior discussion with your
doctor or pharmacist.
If you have any further questions on the use
of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody
gets them.

If any of the following happen, stop
taking Dilcardia SR and tell your doctor
immediately or go to your nearest
hospital emergency department:
Not known (frequency cannot be
estimated from the available data):
• allergic reactions such as swollen skin or
swelling of the face, lips, tongue and/or
throat which may cause difficulty breathing
or swallowing
• liver problems which may cause dark urine,
pale stools, yellowing of the skin or whites
of the eyes
• severe skin reactions including blistering
of the skin, mouth, eyes and genitals, and
swollen blood vessels in the skin.
These side effects are serious. You may need
medical attention.
Tell your doctor straight away if you
notice any of the following side effects:
Not known (frequency cannot be
estimated from the available data):
• mood changes, including depression
• uncontrollable movements, including
trembling or shaking of the hands
and fingers
• trembling, muscle stiffness or spasms, slowing
of movement (Parkinsonian syndrome)
• shortness of breath, swelling of the feet or
legs (congestive heart failure)
• abnormal heart rhythm, slow or uneven
heartbeat (sinoatrial block).
Other side effects include:
Very common side effects (may affect
more than 1 in 10 people):
• swelling of the ankles, feet and fingers
Common side effects (may affect up to 1 in
10 people):
• abnormal heart rhythm (AV block)
• headache
• feeling dizzy
• palpitations
• flushing
• constipation
• indigestion
• stomach pain
• feeling sick
• redness of the skin
• itching
• feeling generally unwell
• tiredness
Uncommon side effects (may affect up to
1 in 100 people):
• allergic reaction
• feeling nervous
• difficulty sleeping
• slower heart beat
• dizziness, light-headedness or fainting on
standing up
• being sick
• diarrhoea
• increase in liver enzymes (these may show
up in blood tests)
Rare side effects (may affect up to 1 in
1,000 people):
• dry mouth
• a nettle-like rash or hives
Not known (frequency cannot be estimated
from the available data):
• reduction in blood platelets which increase
risk of bleeding or bruising
• loss of appetite
• pins and needles or tingling
• bleeding, tender or enlarged gums
• skin problems such as an increased
sensitivity to light, rash, dark areas, severe
flaking or peeling
• sweating
• breast enlargement in men
• inflammation of blood vessels (often with
skin rash)
• gastrointestinal disorders
(e.g. upset stomach)
• low blood pressure

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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 or
search for MHRA Yellow Card in the Google Play
or Apple App Store.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store Dilcardia SR
Keep out of the sight and reach of children.
Do not use this medicine after the expiry
date which is stated on the label after EXP.
The expiry date refers to the last day of
that month.
Store below 25oC. Store in the original
package in order to protect from moisture.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
information
What Dilcardia SR contains
The active substance is diltiazem hydrochloride.
Each prolonged-release capsule contains 60 mg,
90 mg or 120 mg diltiazem hydrochloride.
The other ingredients are sucrose (see section
2, ‘Dilcardia SR contains sucrose’), maize
starch, povidone, methacrylic acid - ethyl
acrylate copolymer, ethylcellulose, diethyl
phthalate, and talc. The capsule also contains
gelatin, titanium dioxide (E171), red iron
oxide (E172) and the 90 mg and 120 mg
capsules also contain yellow iron oxide (E172).
The printing ink contains shellac, black iron
oxide (E172), propylene glycol, ammonium
hydroxide/strong ammonia solution and may
also contain potassium hydroxide.
What Dilcardia SR looks like and
contents of the pack
Your medicine comes in the form of a capsule.
Dilcardia SR 60 mg Prolonged-release
Capsules, Hard
Hard gelatin capsules with pink cap and white
body, printed with “G” and “DT60 SR”.
They are supplied in blister packs containing
56 or 100 capsules or in plastic containers
containing 100 capsules.
Dilcardia SR 90 mg Prolonged-release
Capsules, Hard
Hard gelatin capsules with pink cap and
yellow body, printed with “G” and “DT90 SR”.
They are supplied in blister packs containing
56 capsules or in plastic containers containing
100 capsules.
Dilcardia SR 120 mg Prolonged-release
Capsules, Hard
Hard gelatin capsules with pink cap and
orange body, printed with “G” and “DT120 SR”.
They are supplied in blister packs containing
56 capsules or in plastic containers containing
100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturers
Generics (UK) Limited,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
McDermott Laboratories Ltd T/A Gerard
Laboratories,
Unit 35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland.

This leaflet was last revised in 08/2017.

1243482
LT1417AH

Description Diltiazem Hydrochloride 60 mg,90 mg,120 mg 56
Component Type Leaflet
Affiliate Item Code 1243482
Superceded Affiliate Item Code 747905
TrackWise PR No. 1243482
MA No.

04569/0350-0352

Packing Site/Printer NA
Supplier Code LT1417AH

Pharma Code 215
SAP No. NA
Vendor Job No. 317160
Trackwise Proof No. 4
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Date: 28 JUL 2017
No. of colours
Colours

1

Time: 13:31
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v2/Oct 2016

Expand Transcript

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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