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CONVERDIEM 60MG PROLONGED-RELEASE TABLETS

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tildiem® 60mg Modified Release Tablets
(diltiazem hydrochloride)

This medicine is available using the name Tildiem 60mg
Modified Release Tablets but will be referred to as Tildiem
throughout this leaflet.

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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tildiem is and what it is used for
Before you take Tildiem
How to take Tildiem
Possible side effects
How to store Tildiem
Further information

1. What Tildiem is and what it is used for
Tildiem contains a medicine called diltiazem hydrochloride.
This belongs to a group of medicines called ‘calcium-channel
blockers’.
It works by making your blood vessels wider, which makes it
easier for your heart to pump blood around the body. This
helps to prevent the chest pain caused by angina.

Tildiem is used for:




Angina (chest pain)
Stopping you getting angina in the future

2. Before you take Tildiem
Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to diltiazem
hydrochloride or any of the other ingredients of Tildiem
(listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue

You are breast-feeding or planning to breast-feed
(see Section below: ‘Pregnancy and breast-feeding’)

You are having a medicine called dantrolene used for
severe muscle spasms or severe fever (see Section
below: ‘Taking other medicines’)

You have a very slow heartbeat - less than 50 beats per
minute

You have heart failure and problems with blood flow to
your lungs. With these illnesses, you may feel out of
breath and have swollen ankles

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

You have any other serious problems with your heart.
This includes having an uneven heartbeat (unless you
have a pacemaker)
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Tildiem.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines.
This is because Tildiem can affect the way some other
medicines work. Also some medicines can affect the way
Tildiem works.

In particular, do not take this medicine and tell your
doctor if you are taking:



Tildiem may increase the effect of the following
medicines:



















You have any other problem with your heart, apart from
angina or those described in the previous section
You are going to have an operation
You are at risk of mood changes, including depression
You are at risk of gut problems

Your doctor will check you more closely particularly when you
first start taking the tablets if:

You are over 65 years old

You have liver or kidney problems

You have diabetes
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking Tildiem.

Medicines for high blood pressure such as doxazosin,
tamsulosin, atenolol, propranolol or acebutolol
Medicines used for an uneven heartbeat such as
amiodarone and digoxin
Medicines used for angina such as glyceryl trinitrate or
isosorbide trinitrate
Medicines used for high levels of cholesterol such as
simvastatin, fluvastatin and atorvastatin
Ciclosporin used to stop the rejection of organs after a
transplant
Phenytoin used for epilepsy
Aspirin used for relieving pain and reducing fever
Iodinated contrast media (used for tests involving
X-rays)
Carbamazepine used for epilepsy
Theophylline used for breathing problems
Lithium used for some types of mental illness
Medicines used for sleeplessness or anxiety, such as
triazolam or midazolam
Methylprednisolone used for inflammation and allergic
reactions

Tildiem may make the following medicine work less
well:


Rifampicin used for tuberculosis

The following medicines can increase the effect of
Tildiem:




Take special care with Tildiem
Check with your doctor or pharmacist before taking
your medicine if:

Dantrolene (an infusion) used for severe muscle spasms
or severe fever (called ‘malignant hyperthermia’)
Medicines containing ivabradine used for the treatment
of certain heart diseases

Medicines for stomach ulcers such as cimetidine and
ranitidine.

Tildiem with food and drink

It is advisable to limit the amount of grapefruit juice you
drink while taking Tildiem as it can increase the blood levels
of the active ingredient diltiazem and may increase your
chance of getting side effects. If you are concerned you
should stop drinking grapefruit juice and consult your doctor.

Pregnancy and breast-feeding




You should not take Tildiem if you are pregnant, might
become pregnant or think you may be pregnant. This is
because Tildiem can cause problems for your baby.
Talk to your doctor if you might be pregnant.
Do not breast-feed if you are taking Tildiem. This is
because small amounts may pass into mother’s milk. If
you are breast-feeding or planning to breast-feed, talk
to your doctor or pharmacist before taking any
medicine.

Driving and using machines

You may feel dizzy while taking this medicine. If this
happens, do not drive or use any tools or machines.

Important information about some of the
ingredients of Tildiem

Tildiem contains:

Lactose. If you have been told by your doctor that you
cannot tolerate some sugars, talk to your doctor before
taking this medicine.

3. How to take Tildiem
Always take Tildiem exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not
sure.

Taking this medicine



Take this medicine by mouth
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
doctor

Page 1 of 2

How much to take
Adults:


The usual dose is one tablet three times a day.
If necessary, your doctor may increase this to:

Two tablets three times a day or

Two tablets four times a day

Over 65 years or adults with liver or kidney
problems:


The usual dose is one tablet twice a day.

Children:

Tildiem should not be given to children.

If you take more Tildiem than you should

If you take more tablets than you should, tell a doctor or go
to a hospital casualty department straight away. Take the
medicine pack with you. This is so the doctor knows what you
have taken.
The following effects may happen: feeling dizzy or weak,
blurred vision, chest pain, shortness of breath, fainting, an
unusually fast or slow heartbeat, coma, slurred speech, and
confusion.

If you forget to take Tildiem

If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose. Do not take a double dose to make up for a
forgotten dose.

If you stop taking Tildiem

Keep taking Tildiem until your doctor tells you to stop. Do not
stop taking them just because you feel better. If you stop,
your illness may get worse.

Tests

Your doctor may do regular tests while you are taking this
medicine. These might include a check on your heart and
blood tests to check on your liver and kidneys.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Tildiem can cause side effects, although
not everyone gets them.

Stop taking and see a doctor or go to a hospital
straight away if:

Frequency unknown

You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue

You have a red or lumpy skin rash, swollen eyelids, face,
lips, throat, or tongue, difficulty in breathing or
swallowing

You get blistering or peeling of the skin around the lips,
eyes, mouth, nose and genitals, flu-like symptoms and
fever. This could be an illness called ‘Stevens-Johnson
syndrome’

You get a 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 and
have a fever, chills and aching muscles. This could be an
illness called ‘Toxic Epidermal Necrolysis’

You have a skin rash or skin lesions with a pink/red ring
and a pale centre which may be itchy, scaly or filled with
fluid. The rash may appear especially on the palms or
soles of your feet. These could be signs of a serious
allergy to the medicine called ‘erythema multiforme’

Tell your doctor straight away if you notice any of
the following serious side effects - you may need
urgent medical treatment:
Common (affects less than 1 in 10 people)

Slow or uneven heartbeat

Very fast, uneven or forceful heartbeat (palpitations)

Frequency unknown

Skin rash caused by narrow or blocked blood vessels
(called ‘vasculitis’)

Being short of breath, feeling tired along with swollen
ankles and legs. These could be signs of heart failure

Unusual movements of the tongue, muscle spasms in
your face, rolling eyes and trembling

High temperature, feeling tired, loss of appetite,
stomach pain, feeling sick.
These can be signs of inflammation of the liver (called
‘hepatitis’)







Passing large amounts of urine, excessive thirst and
having a dry mouth or skin. These may be signs of high
blood sugar (hyperglycemia)
Get sunburnt easier, and which may be more severe
than in someone not taking Tildiem. You should use sun
protection whilst taking this medicine
Breast enlargement in men

Tell your doctor as soon as possible if you have any
of the following side effects:
Very common (affects more than 1 in 10 people)

Swelling of the lower legs

Common (affects less than 1 in 10 people)

Indigestion, stomach pain, constipation, and diarrhoea
Uncommon (affects less than 1 in 100 people)

Feeling dizzy, light-headed or faint when you stand or sit
up quickly (low blood pressure)
Rare (affects less than 1 in 1000 people)

Dry mouth

Itchy, lumpy rash (called ‘urticaria’)

Manufacturer

Manufactured by: Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel - Tours, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0635

POM

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Tildiem® is a registered trademark of sanofi-aventis.
Leaflet revision and issue date (Ref): 05.05.16

Frequency unknown

Swollen gums

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days:
Common (affects less than 1 in 10 people)

Headache

Flushing (feeling of warmth)

Feeling sick (nausea) or being sick (vomiting)

General feeling of being unwell

Weakness or tiredness

Feeling dizzy

Skin redness
Uncommon (affects less than 1 in 100 people)

Difficulty sleeping
Frequency unknown

Mood changes, including depression

Bleeding or bruising under the skin

Blood tests

Tildiem can change the levels of liver enzymes shown up in
blood tests. This can mean that your liver is not working
properly.

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 Tildiem










Keep out of the sight and reach of children.
Do not use Tildiem after the expiry date which is stated
on the carton after ‘Exp’. The expiry date refers to the
last date of that month.
This medicinal product does not require any special
storage conditions.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Further information
What Tildiem contains

The active ingredient is diltiazem hydrochloride.
Each tablet contains 60mg diltiazem hydrochloride.
The other ingredients are lactose, macrogol 6000,
castor oil, hydrogenated and magnesium stearate.

What Tildiem looks like and contents of the pack

Tildiem are white, round, biconvex tablets engraved with 'DTZ
60' on one side and scored on the other.
Tildiem is available in blister packs of 90 tablets.
Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Converdiem 60mg Prolonged-release Tablets
(diltiazem hydrochloride)

This medicine is available using the name Converdiem 60mg
Prolonged-release Tablets but will be referred to as
Converdiem throughout this leaflet.

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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

What Converdiem is and what it is used for
Before you take Converdiem
How to take Converdiem
Possible side effects
How to store Converdiem
Further information

1. What Converdiem is and what it is used
for
Converdiem contains a medicine called diltiazem
hydrochloride. This belongs to a group of medicines called
‘calcium-channel blockers’.
It works by making your blood vessels wider, which makes it
easier for your heart to pump blood around the body. This
helps to prevent the chest pain caused by angina.

Converdiem is used for:




Angina (chest pain)
Stopping you getting angina in the future

2. Before you take Converdiem
Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to diltiazem
hydrochloride or any of the other ingredients of
Converdiem (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue

You are breast-feeding or planning to breast-feed
(see Section below: ‘Pregnancy and breast-feeding’)

You are having a medicine called dantrolene used for
severe muscle spasms or severe fever (see Section
below: ‘Taking other medicines’)

You have a very slow heartbeat - less than 50 beats per
minute

You have heart failure and problems with blood flow to
your lungs. With these illnesses, you may feel out of
breath and have swollen ankles

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

You have any other serious problems with your heart.
This includes having an uneven heartbeat (unless you
have a pacemaker)
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Converdiem.


Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines.
This is because Converdiem can affect the way some other
medicines work. Also some medicines can affect the way
Converdiem works.

In particular, do not take this medicine and tell your
doctor if you are taking:



Dantrolene (an infusion) used for severe muscle spasms
or severe fever (called ‘malignant hyperthermia’)
Medicines containing ivabradine used for the treatment
of certain heart diseases

Converdiem may increase the effect of the following
medicines:














Medicines for high blood pressure such as doxazosin,
tamsulosin, atenolol, propranolol or acebutolol
Medicines used for an uneven heartbeat such as
amiodarone and digoxin
Medicines used for angina such as glyceryl trinitrate or
isosorbide trinitrate
Medicines used for high levels of cholesterol such as
simvastatin, fluvastatin and atorvastatin
Ciclosporin used to stop the rejection of organs after a
transplant
Phenytoin used for epilepsy
Aspirin used for relieving pain and reducing fever
Iodinated contrast media (used for tests involving
X-rays)
Carbamazepine used for epilepsy
Theophylline used for breathing problems
Lithium used for some types of mental illness
Medicines used for sleeplessness or anxiety, such as
triazolam or midazolam
Methylprednisolone used for inflammation and allergic
reactions

Converdiem may make the following medicine work
less well:


Rifampicin used for tuberculosis

The following medicines can increase the effect of
Converdiem:


Medicines for stomach ulcers such as cimetidine and
ranitidine.

Converdiem with food and drink

It is advisable to limit the amount of grapefruit juice you
drink while taking Converdiem as it can increase the blood
levels of the active ingredient diltiazem and may increase
your chance of getting side effects. If you are concerned you
should stop drinking grapefruit juice and consult your doctor.

Pregnancy and breast-feeding




You should not take Converdiem if you are pregnant,
might become pregnant or think you may be pregnant.
This is because Converdiem can cause problems for your
baby.
Talk to your doctor if you might be pregnant.
Do not breast-feed if you are taking Converdiem. This is
because small amounts may pass into mother’s milk. If
you are breast-feeding or planning to breast-feed, talk
to your doctor or pharmacist before taking any
medicine.

Driving and using machines

You may feel dizzy while taking this medicine. If this
happens, do not drive or use any tools or machines.

Important information about some of the
ingredients of Converdiem

Take special care with Converdiem
Check with your doctor or pharmacist before taking
your medicine if:

Converdiem contains:

Lactose. If you have been told by your doctor that you
cannot tolerate some sugars, talk to your doctor before
taking this medicine.





3. How to take Converdiem



You have any other problem with your heart, apart from
angina or those described in the previous section
You are going to have an operation
You are at risk of mood changes, including depression
You are at risk of gut problems

Your doctor will check you more closely particularly when you
first start taking the tablets if:

You are over 65 years old

You have liver or kidney problems

You have diabetes
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Converdiem.

Always take Converdiem exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.

Taking this medicine



Take this medicine by mouth
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
doctor

Page 1 of 2

How much to take
Adults:


The usual dose is one tablet three times a day.
If necessary, your doctor may increase this to:

Two tablets three times a day or

Two tablets four times a day

Over 65 years or adults with liver or kidney
problems:


The usual dose is one tablet twice a day.

Children:

Converdiem should not be given to children.

If you take more Converdiem than you should

If you take more tablets than you should, tell a doctor or go
to a hospital casualty department straight away. Take the
medicine pack with you. This is so the doctor knows what you
have taken.
The following effects may happen: feeling dizzy or weak,
blurred vision, chest pain, shortness of breath, fainting, an
unusually fast or slow heartbeat, coma, slurred speech, and
confusion.

If you forget to take Converdiem

If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose. Do not take a double dose to make up for a
forgotten dose.

If you stop taking Converdiem

Keep taking Converdiem until your doctor tells you to stop.
Do not stop taking them just because you feel better. If you
stop, your illness may get worse.

Tests

Your doctor may do regular tests while you are taking this
medicine. These might include a check on your heart and
blood tests to check on your liver and kidneys.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Converdiem can cause side effects,
although not everyone gets them.

Stop taking and see a doctor or go to a hospital
straight away if:

Frequency unknown

You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue

You have a red or lumpy skin rash, swollen eyelids, face,
lips, throat, or tongue, difficulty in breathing or
swallowing

You get blistering or peeling of the skin around the lips,
eyes, mouth, nose and genitals, flu-like symptoms and
fever. This could be an illness called ‘Stevens-Johnson
syndrome’

You get a 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 and
have a fever, chills and aching muscles. This could be an
illness called ‘Toxic Epidermal Necrolysis’

You have a skin rash or skin lesions with a pink/red ring
and a pale centre which may be itchy, scaly or filled with
fluid. The rash may appear especially on the palms or
soles of your feet. These could be signs of a serious
allergy to the medicine called ‘erythema multiforme’

Tell your doctor straight away if you notice any of
the following serious side effects - you may need
urgent medical treatment:
Common (affects less than 1 in 10 people)

Slow or uneven heartbeat

Very fast, uneven or forceful heartbeat (palpitations)

Frequency unknown

Skin rash caused by narrow or blocked blood vessels
(called ‘vasculitis’)

Being short of breath, feeling tired along with swollen
ankles and legs. These could be signs of heart failure

Unusual movements of the tongue, muscle spasms in
your face, rolling eyes and trembling

High temperature, feeling tired, loss of appetite,
stomach pain, feeling sick.
These can be signs of inflammation of the liver (called
‘hepatitis’)







Passing large amounts of urine, excessive thirst and
having a dry mouth or skin. These may be signs of high
blood sugar (hyperglycemia)
Get sunburnt easier, and which may be more severe
than in someone not taking Converdiem. You should use
sun protection whilst taking this medicine
Breast enlargement in men

Tell your doctor as soon as possible if you have any
of the following side effects:
Very common (affects more than 1 in 10 people)

Swelling of the lower legs

Common (affects less than 1 in 10 people)

Indigestion, stomach pain, constipation, and diarrhoea
Uncommon (affects less than 1 in 100 people)

Feeling dizzy, light-headed or faint when you stand or sit
up quickly (low blood pressure)
Rare (affects less than 1 in 1000 people)

Dry mouth

Itchy, lumpy rash (called ‘urticaria’)
Frequency unknown

Swollen gums

What Converdiem looks like and contents of the
pack

Converdiem are white, round, biconvex tablets engraved with
'DTZ 60' on one side and scored on the other.
Converdiem is available in blister packs of 90 tablets.

Manufacturer

Manufactured by: Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel - Tours, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0635

POM

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Leaflet revision and issue date (Ref): 05.05.16

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days:
Common (affects less than 1 in 10 people)

Headache

Flushing (feeling of warmth)

Feeling sick (nausea) or being sick (vomiting)

General feeling of being unwell

Weakness or tiredness

Feeling dizzy

Skin redness
Uncommon (affects less than 1 in 100 people)

Difficulty sleeping
Frequency unknown

Mood changes, including depression

Bleeding or bruising under the skin

Blood tests

Converdiem can change the levels of liver enzymes shown up
in blood tests. This can mean that your liver is not working
properly.

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 Converdiem










Keep out of the sight and reach of children.
Do not use Converdiem after the expiry date which is
stated on the carton after ‘Exp’. The expiry date refers
to the last date of that month.
This medicinal product does not require any special
storage conditions.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Further information
What Converdiem contains

The active ingredient is diltiazem hydrochloride.
Each tablet contains 60mg diltiazem hydrochloride.
The other ingredients are lactose, macrogol 6000,
castor oil, hydrogenated and magnesium stearate.

Page 2 of 2

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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