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DILTIAZEM HYDROCHLORIDE TABLETS 60MG

Active substance(s): DILTIAZEM HYDROCHLORIDE

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Diltiazem Hydrochloride 60mg tablets
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K eep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you
only. 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.

2
3
4
5
6

What is in this leaflet:
1 What Diltiazem Hydrochloride
tablets are and what they are
used for
What you need to know before you take
Diltiazem Hydrochloride tablets
How to take Diltiazem Hydrochloride
tablets
Possible side effects
How to store Diltiazem Hydrochloride
tablets
Contents of the pack and other information

1 What Diltiazem Hydrochloride tablets are
and what they are used for
Diltiazem Hydrochloride tablets belong to a group of
medicines called calcium channel blockers.
Diltiazem Hydrochloride tablets are used to:
• treat (long-term) and prevent angina pectoris
• treat mild to moderate high blood pressure.

2 What you need to know before you take
Diltiazem Hydrochloride tablets

Do not take Diltiazem Hydrochloride tablets if you

• are allergic (hypersensitive) to diltiazem hydrochloride or
any of the other ingredients in Diltiazem Hydrochloride
tablets (see section 6).
• are pregnant, are a woman of child bearing age or you
are breast-feeding.
• have severe low blood pressure.
• have a heart condition such as; a severe slow heart
beat (bradycardia), disturbances in heart rhythm causing
palpitations or fainting (sick sinus syndrome) not requiring
a pacemaker, heart failure with reduced blood flow,
congestive heart failure, second or third degree heart
block without a functioning pacemaker, narrowing of the
opening of the aortic valve in the heart (aortic stenosis),
shock caused by heart problems (cardiogenic shock),
• have an inherited disorder of the red blood pigment
haemoglobin, causing skin blisters, abdominal pain and
nervous system disorders (porphyria).
Continued top of next column

• are already taking a medicine containing ivabradine for
the treatment of certain heart diseases

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Diltiazem Hydrochloride tablets if you:
• have impaired liver function.
• have impaired kidney function
• have depression
• are likely to have surgery which requires a general
anaesthetic
• have problems with your stomach or intestines
• have heart problems including a slow heart beat, first
degree heart block, a change in the electrical activity of the
heart (prolonged PR interval).
• have diabetes. The treatment for your diabetes may need
to be adjusted, as Diltiazem Hydrochloride tablets may
impair glucose tolerance.

Other medicines and Diltiazem Hydrochloride
tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
Especially:
• dantrolene infusion (a muscle relaxant)
• antiarrhythmic drugs such as amiodarone (used to treat an
irregular heart beat)
• antihypertensives (used to lower blood pressure)
• lithium (used for mental health problems)
• nitrates such as glyceryl trinitrate or isosorbide trinitrate
(used to treat angina)
• midazolam or triazolam (used for sedation and anaesthesia)
• rifampicin (used to treat tuberculosis)
• imipramine and other tricyclic antidepressants (used for
depression)
• phenobarbital, phenytoin or carbamazepine (to treat
epilepsy)
• ciclosporin (used to suppress immune system e.g. after
organ transplantation)
• theophylline (used in breathing problems such as asthma)
• digitalis glycosides e.g. digoxin (used for some heart
conditions)
• beta blockers such as propranolol (used for some heart
problems)
• H2 antagonists e.g. cimetidine (used to treat conditions
caused by excess acid such as stomach ulcers)
• diuretics (water tablets)
• alpha blockers such as prazosin
• anaesthetics
• statins, e.g. simvastatin (used to treat high cholesterol)
• corticosteroids (used to treat inflammation).

Pregnancy, breast-feeding and fertility

Do not take Diltiazem Hydrochloride tablets if you are
pregnant, planning to become pregnant, are a woman of
child bearing age or if you are breast-feeding. Speak to your
doctor before taking any medicine.

Driving and using machines

Diltiazem tablets may cause dizziness or tiredness, therefore
make sure you are not affected before driving or operating
machinery.
Continued over page

130x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Diltiazem 60mg 84 Tablets PIL - UK

1.

item no: AAAI2999

dimensions: 130 x 210

print proof no: 2

pharmacode:

origination date: 15.09.15

min pt size: 7

revision date: 22.09.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

JDE No.:

50871234

4.

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

5.

Pharmacode: 4166

3.

6.

originated by: S.Anson
approved for print/date

2.

Diltiazem Hydrochloride Tablets
60mg x 84’s (UK)

Non Printing Colours
1. Profile
2.
3.

Date Sent:
03/09/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Diltiazem Hydrochloride tablets contain lactose

If a doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it
contains lactose.

Uncommon: may affect up to 1 in 100 people: nervousness,
difficulty sleeping, slow heart beat, feeling faint when getting up
due to low blood pressure, being sick, diarrhoea, increase in liver
enzymes (as seen in blood tests).

Diltiazem Hydrochloride tablets contain
hydrogenated castor oil

Rare: may affect up to 1 in 1,000 people: dry mouth, itchy skin rash
with pale or red irregular raised patches.

Hydrogenated castor oil may cause stomach upset and diarrhoea.

Tests

If you have impaired kidney or liver function, your doctor may
want to monitor you by carrying out tests.

3 How to take Diltiazem Hydrochloride tablets

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adult
The maintenance dose is one tablet (60mg) three times a day. Up
to 8 tablets (480mg) a day may be used. Your doctor will decide on
the best dose for you.
Elderly and those with impaired kidney function
Initially one tablet (60mg) twice a day. Your doctor may adjust the
dose according to your response.
Use in children
Not recommended.

Taking the tablets

• Swallow the tablets whole with a little water.
• After all the drug has been released from the tablet, the empty
shell may pass into the stools. This is normal and does not affect
the action of the product.

If you take more Diltiazem Hydrochloride tablets than
you should
Do not take more tablets than your doctor tells you to. If you
take too many go to the nearest hospital casualty department
or tell your doctor at once. Take the container and any remaining
tablets with you. An overdose may lead to severe low blood
pressure leading to collapse, and a slow heart beat which may be
accompanied by changes in heart rhythm and conduction.

If you forget to take Diltiazem Hydrochloride tablets

If you forget to take a dose, take one as soon as you remember.
Then go on as before. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

Not known: frequency cannot be estimated from the available
data: lowered number of platelets in the blood (as seen in blood
tests), changes in mood (including depression), inflammation of
the liver causing yellowing of the skin or eyes (hepatitis), heart
failure, inflammation of the blood vessels, enlargement of the
gums, sensitivity to light, sweating, enlarged breasts in men,
tremor, slurred speech, restlessness, muscle spasm of neck,
shoulders and body, anxiety, distress (extrapyramidal syndrome).
Rash and other severe skin reactions including - circular, severe
skin rash (toxic epidermal necrolysis), severe form of skin rash with
flushing, fever, blisters or ulcers (Steven-Johnson’s syndrome),
inflammation and scaling of skin (exfoliative dermatitis), irregular
red patches of the skin of the hands and arms (erythema
multiforme), boil-like inflammation of the skin (exanthematous
pustulosis).

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 Diltiazem Hydrochloride tablets

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original container.
Keep the container tightly closed.
Do not use Diltiazem Hydrochloride tablets after the expiry date
stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will
help protect the environment

6 Contents of the pack and other
information

What Diltiazem Hydrochloride tablets
contain

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

• the active substance (the ingredient that makes the
tablets work) is diltiazem hydrochloride. Each tablet
contains 60mg of the active substance.
• the other ingredients are castor oil, lactose,
magnesium stearate, polyethylene glycol.

Contact your doctor at once, if you have an allergic
reaction such as swelling of the face, lips, tongue, mouth

What Diltiazem Hydrochloride tablets look
like and contents of the pack

4 Possible side effects

or throat, which may cause shortness of breath or difficulty
swallowing.

Tell your doctor if you notice any of the following side
effects.
Very common: may affect more than 1 in 10 people: water
retention causing swelling.
Common: may affect up to 1 in 10 people: headache, dizziness,
heart block, palpitations, flushing, constipation, indigestion,
stomach pain, feeling sick, skin redness, feeling of general
discomfort or illness.
Continued top of next column
50871234 AAAI2999

Diltiazem Hydrochloride tablets are white, uncoated,
modified-release tablets.
Pack size is 84.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in September 2015

Actavis, Barnstaple, EX32 8NS, UK

130x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Diltiazem 60mg 84 Tablets PIL - UK

1.

item no: AAAI2999

dimensions: 130 x 210

print proof no: 2

pharmacode:

origination date: 15.09.15

min pt size: 7

revision date: 22.09.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

JDE No.:

50871234

4.

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

5.

Pharmacode: 4166

3.

6.

originated by: S.Anson
approved for print/date

2.

Diltiazem Hydrochloride Tablets
60mg x 84’s (UK)

Non Printing Colours
1. Profile
2.
3.

Date Sent:
03/09/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Diltiazem Hydrochloride 60mg tablets
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, pharmacist or nurse.
• This medicine has been prescribed for you
only. 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.

2
3
4
5
6

What is in this leaflet:
1 What Diltiazem Hydrochloride
tablets are and what they are used
for
What you need to know before you take
Diltiazem Hydrochloride tablets
How to take Diltiazem Hydrochloride tablets
Possible side effects
H
 ow to store Diltiazem Hydrochloride
tablets
Contents of the pack and other information

1 What Diltiazem Hydrochloride tablets are
and what they are used for
Diltiazem Hydrochloride tablets belong to a group of
medicines called calcium channel blockers.
Diltiazem Hydrochloride tablets are used to:
• treat (long-term) and prevent angina pectoris
• treat mild to moderate high blood pressure.

2 What you need to know before you take
Diltiazem Hydrochloride tablets

Do not take Diltiazem Hydrochloride tablets if you
• are allergic (hypersensitive) to diltiazem hydrochloride or
any of the other ingredients in Diltiazem Hydrochloride
tablets (see section 6).
• are pregnant, are a woman of child bearing age or you are
breast-feeding.
• have severe low blood pressure.
• have a heart condition such as; a severe slow heart
beat (bradycardia), disturbances in heart rhythm causing
palpitations or fainting (sick sinus syndrome) not requiring
a pacemaker, heart failure with reduced blood flow,
congestive heart failure, second or third degree heart block
without a functioning pacemaker, narrowing of the opening
of the aortic valve in the heart (aortic stenosis), shock caused
by heart problems (cardiogenic shock),

• have an inherited disorder of the red blood pigment
haemoglobin, causing skin blisters, abdominal pain and
nervous system disorders (porphyria).
• are already taking a medicine containing ivabradine for the
treatment of certain heart diseases

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Diltiazem Hydrochloride tablets if you:
• have impaired liver function.
• have impaired kidney function
• have depression
• are likely to have surgery which requires a general
anaesthetic
• have problems with your stomach or intestines
• have heart problems including a slow heart beat, first
degree heart block, a change in the electrical activity of the
heart (prolonged PR interval).
• have diabetes. The treatment for your diabetes may need
to be adjusted, as Diltiazem Hydrochloride tablets may
impair glucose tolerance.

Other medicines and Diltiazem Hydrochloride
tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
Especially:
• dantrolene infusion (a muscle relaxant)
• antiarrhythmic drugs such as amiodarone (used to treat an
irregular heart beat)
• antihypertensives (used to lower blood pressure)
• lithium (used for mental health problems)
• midazolam or triazolam (used for sedation and anaesthesia)
• rifampicin (used to treat tuberculosis)
• imipramine and other tricyclic antidepressants (used for
depression)
• phenobarbital, phenytoin or carbamazepine (to treat
epilepsy)
• ciclosporin (used to suppress immune system e.g. after
organ transplantation)
• theophylline (used in breathing problems such as asthma)
• digitalis glycosides e.g. digoxin (used for some heart
conditions)
• beta blockers such as propranolol (used for some heart
problems)
• H2 antagonists e.g. cimetidine (used to treat conditions
caused by excess acid such as stomach ulcers)
• diuretics (water tablets)
• alpha blockers such as prazosin
• anaesthetics
• statins, e.g. simvastatin (used to treat high cholesterol)
• corticosteroids (used to treat inflammation).

Pregnancy, breast-feeding and fertility

Do not take Diltiazem Hydrochloride tablets if you are
pregnant, planning to become pregnant, are a woman of
child bearing age or if you are breast-feeding. Speak to your
doctor before taking any medicine.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Diltiazem 60mg Tablets PIL - UK

1.

item no: AAAI2984

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 15.09.15

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 22.09.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1. Profile
2.
3.

Diltiazem Hydrochloride Tablets
60mg x 84 & 100’s (UK)
JDE No.:

50871226

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 7295
Date Sent:
03/09/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Driving and using machines

Diltiazem tablets may cause dizziness or tiredness, therefore make
sure you are not affected before driving or operating machinery.

Diltiazem Hydrochloride tablets contain lactose

If a doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it
contains lactose.

Diltiazem Hydrochloride tablets contain
hydrogenated castor oil

Hydrogenated castor oil may cause stomach upset and diarrhoea.

Tests

If you have impaired kidney or liver function, your doctor may
want to monitor you by carrying out tests.

3 How to take Diltiazem Hydrochloride tablets

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adult
The maintenance dose is one tablet (60mg) three times a day. Up
to 8 tablets (480mg) a day may be used. Your doctor will decide on
the best dose for you.
Elderly and those with impaired kidney function
Initially one tablet (60mg) twice a day. Your doctor may adjust the
dose according to your response.
Use in children
Not recommended.

Taking the tablets

• Swallow the tablets whole with a little water.
• After all the drug has been released from the tablet, the empty
shell may pass into the stools. This is normal and does not affect
the action of the product.

If you take more Diltiazem Hydrochloride tablets than
you should
Do not take more tablets than your doctor tells you to. If you
take too many go to the nearest hospital casualty department
or tell your doctor at once. Take the container and any remaining
tablets with you. An overdose may lead to severe low blood
pressure leading to collapse, and a slow heart beat which may be
accompanied by changes in heart rhythm and conduction.

If you forget to take Diltiazem Hydrochloride tablets

If you forget to take a dose, take one as soon as you remember.
Then go on as before. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Contact your doctor at once, if you have an allergic reaction
such as swelling of the face, lips, tongue, mouth or throat, which
may cause shortness of breath or difficulty swallowing.

Tell your doctor if you notice any of the following side
effects.
Very common: may affect more than 1 in 10 people: water
retention causing swelling.

stomach pain, feeling sick, skin redness, feeling of general
discomfort or illness.
Uncommon: may affect up to 1 in 100 people: nervousness,
difficulty sleeping, slow heart beat, feeling faint when getting up
due to low blood pressure, being sick, diarrhoea, increase in liver
enzymes (as seen in blood tests).
Rare: may affect up to 1 in 1,000 people: dry mouth, itchy skin rash
with pale or red irregular raised patches.
Not known: frequency cannot be estimated from the available
data: lowered number of platelets in the blood (as seen in blood
tests), changes in mood (including depression), inflammation of
the liver causing yellowing of the skin or eyes (hepatitis), heart
failure, inflammation of the blood vessels, enlargement of the
gums, sensitivity to light, sweating, enlarged breasts in men,
tremor, slurred speech, restlessness, muscle spasm of neck,
shoulders and body, anxiety, distress (extrapyramidal syndrome).
Rash and other severe skin reactions including - circular, severe
skin rash (toxic epidermal necrolysis), severe form of skin rash with
flushing, fever, blisters or ulcers (Steven-Johnson’s syndrome),
inflammation and scaling of skin (exfoliative dermatitis), irregular
red patches of the skin of the hands and arms (erythema
multiforme), boil-like inflammation of the skin (exanthematous
pustulosis).
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 Diltiazem Hydrochloride tablets

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original container.
Keep the container tightly closed.
Do not use Diltiazem Hydrochloride tablets after the expiry date
stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment

6 Contents of the pack and other
information

What Diltiazem Hydrochloride tablets
contain

• the active substance (the ingredient that makes the
tablets work) is diltiazem hydrochloride. Each tablet
contains 60mg of the active substance.
• the other ingredients are castor oil, lactose,
magnesium stearate, polyethylene glycol.

What Diltiazem Hydrochloride tablets look
like and contents of the pack

Diltiazem Hydrochloride tablets are white, uncoated,
modified-release tablets.
Pack size is 100.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in September 2015

Common: may affect up to 1 in 10 people: headache, dizziness,
heart block, palpitations, flushing, constipation, indigestion,
Continued top of next column
50871226 AAAI2984

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Diltiazem 60mg Tablets PIL - UK

1.

item no: AAAI2984

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 15.09.15

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 22.09.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1. Profile
2.
3.

Diltiazem Hydrochloride Tablets
60mg x 84 & 100’s (UK)
JDE No.:

50871226

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 7295
Date Sent:
03/09/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Expand view ⇕

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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