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TILDIEM RETARD 120MG TABLETS

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TILDIEM® RETARD 120MG TABLETS
(diltiazem hydrochloride)

Your medicine is available using the above name but will be
referred to as Tildiem Retard throughout the 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 Retard is and what it is used for
Before you take Tildiem Retard
How to take Tildiem Retard
Possible side effects
How to store Tildiem Retard
Further information

1. What Tildiem Retard is and what it is used
for
Tildiem Retard contains a medicine called diltiazem
hydrochloride. This belongs to a group of medicines called
'calcium-channel blockers'.

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 Retard
can affect the way some other medicines work. Also some
medicines can affect the way Tildiem Retard works.

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



Tildiem Retard may increase the effect of the
following medicines:













It works by making your blood vessels wider.
This helps to lower your blood pressure. It also makes it
easier for your heart to pump blood around the body. This
helps to prevent the chest pain caused by angina.



Tildiem Retard is used for:

High blood pressure

Angina (chest pain)



2. Before you take Tildiem Retard



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
Retard (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 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)
You are having a medicine called dantrolene used for
severe muscle spasms or severe fever (see section
below: 'Taking other medicines')

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 Retard.

Take special care with Tildiem Retard

Check with your doctor or pharmacist before taking
your medicine if:

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

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 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 Xrays)
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 Retard may make the following medicine
work less well:
Rifampicin used for tuberculosis

The following medicines can increase the effect of
Tildiem Retard:
Medicines for stomach ulcers such as cimetidine and
ranitidine

Tildiem Retard with food and drink

It is advisable to limit the amount of grapefruit juice you
drink while taking Tildiem Retard 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 Retard if you are pregnant,
might become pregnant or think you may be pregnant.
This is because Tildiem Retard can cause problems for
your baby. Talk to your doctor if you might be pregnant.
Do not breast-feed if you are taking Tildiem Retard. 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 Retard

Tildiem Retard contains:

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

Sodium. This product contains 26.9mg sodium per dose
(2 x Tildiem 90mg Tablets) or 35.94mg (2 x Tildiem
120mg Tablets). To be taken into consideration by
patients on a controlled sodium diet.

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
Retard.
Page 1 of 2

3. How to take Tildiem Retard
Always take Tildiem Retard 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
Do not break, crush or chew your tablets
Swallow the tablets whole with a drink of water
Tildiem Retard tablets are coated with a special
membrane which allows the medicine to be released
slowly throughout the day.
This membrane may pass through the body unchanged.
If this happens, do not worry, it does not affect the way
your medicine works.
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
doctor

How much to take

Adults:
Angina and high blood pressure:

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

One Tildiem Retard 90mg tablet three times a day
or

Two Tildiem Retard 120mg tablets twice a day
If necessary, your doctor may increase this to:

One Tildiem Retard 90mg tablet three times a day
or

Two Tildiem Retard 120mg tablets twice a day
Over 65 years or adults with liver or kidney
problems:
Angina

Your doctor will usually start you on another
strength - Tildiem 60mg tablet
If necessary, your doctor may increase this to:

One Tildiem Retard 90mg tablet twice a day or

One Tildiem Retard 120mg tablet twice a day
High blood pressure

The usual starting dose is one Tildiem 120mg
Retard tablet a day
If necessary, your doctor may increase this dose
to:

One Tildiem Retard 90mg tablet twice a day or

One Tildiem Retard 120mg tablet twice a day
Children:
Tildiem Retard should not be given to children.

If you take more Tildiem Retard 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 Retard

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 Retard

Keep taking Tildiem Retard 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 Retard 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 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'

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 Retard
Store in a dry place below 30°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Tablets stored correctly can be used up to their expiry date
printed on the edge of the blister strip and on the box or on
the container label. Do not take this medicine after the month
shown on the pack.
If you have any left over tablets, please return these to your
pharmacist for safe disposal.
If your tablets appear to be discoloured or show any other
signs of deterioration, please return these to your pharmacist
who will advise you.

6. Further information
What Tildiem Retard contains

Each tablet contains 120mg of the active ingredient diltiazem
hydrochloride in a modified release formulation.

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)

The tablets also contain sodium dihydrogen citrate, sucrose,
povidone, magnesium stearate, macrogol 6000, modified
polyvinylchloride polymer, acetate tributyl citrate, castor oil
polymerised, sodium bicarbonate, ethyl vanillin and titanium
dioxide (E 171).

Frequency unknown

What Tildiem Retard looks like and contents of the
pack




Slow or uneven heartbeat
Very fast, uneven or forceful heartbeat (palpitations)



Skin rash caused by narrow or blocked blood vessels
(called 'vasculitis')
Being short of breath, feeling tired along with swollen
ankles and legs. This 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 (hyperglycaemia)
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



Indigestion, stomach pain, constipation, and diarrhoea



Feeling dizzy, light-headed or faint when you stand or sit
up quickly (low blood pressure)

Tildiem Retard are plain off-white biconvex shaped tablets.
The medicine is available in blister packs of 30 and 60 tablets.

Manufacturer

Your medicine is manufactured by:
Sanofi Winthrop Industrie (Tours), France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 04423/0520

POM

Leaflet revision and issue date: 27.04.16
Tildiem® is a trademark of Sanofi - Synthelabo, France.

Common (affects less than 1 in 10 people)

Uncommon (affects less than 1 in 100 people)
Rare (affects less than 1 in 1000 people)



Dry mouth
Itchy, lumpy rash (called ‘urticaria’)



Swollen gums

Frequency unknown

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



Difficulty sleeping




Mood changes, including depression
Bleeding or bruising under the skin

Uncommon (affects less than 1 in 100 people)
Frequency unknown

Blood tests

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

Page 2 of 2

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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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