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TILDIEM LA 300 MG PROLONGED RELEASE CAPSULES

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Tildiem® LA 300mg
Prolonged-Release Capsules
(diltiazem hydrochloride)
Your medicine is available using the above
name, but will be referred to as Tildiem LA
throughout the remainder of this leaflet.
Your medicine is available in a lower strength.
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. What Tildiem LA is and what it is used for
2. Before you take Tildiem LA
3. How to take Tildiem LA
4. Possible side effects
5. How to store Tildiem LA
6. Further information

1. What Tildiem LA is and what it is
used for
Tildiem LA 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.
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 LA is used for:
 High blood pressure
 Angina (chest pain)

2. Before you take Tildiem LA
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 LA (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 breastfeed (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 are already taking a medicine containing
ivabradine for the treatment of certain heart
diseases
 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 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 LA.
Take special care with Tildiem LA
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
Your doctor will check you more closely
particularly when you first start taking the
capsules 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 LA.

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 LA can affect the way some other
medicines work. Also some medicines can affect
the way Tildiem LA 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
Tildiem LA 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 and anxiety,
such as triazolam and midazolam
 Methylprednisolone used for inflammation and
allergic reactions
Tildiem LA may make the following medicine
work less well:
 Rifampicin used for tuberculosis
The following medicines can increase the
effect of Tildiem LA:
 Medicines for stomach ulcers such as cimetidine
and ranitidine
Tildiem LA with food and drink
It is advisable to limit the amount of grapefruit
juice you drink while taking Tildiem LA 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 LA if you are
pregnant, might become pregnant or think you
may be pregnant. This is because Tildiem LA
can cause problems for your baby. Talk to your
doctor if you might be pregnant.
 Do not breast-feed if you are taking Tildiem LA.
This is because small amounts may pass into
mothers’ 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.

3. How to take Tildiem LA
Always take Tildiem LA 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 capsules
 Swallow the capsules whole with a drink of
water
 Take before or during a meal
 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 starting dose is one Tildiem LA
200mg capsule a day.
If necessary, your doctor may increase
this to:
 One Tildiem LA 300mg capsule a day or
 Two Tildiem LA 200mg capsules a day.
 One Tildiem LA 300mg capsule and one
LA Tildiem 200mg capsule a day.
Over 65 years or adults with liver or
kidney problems:
Angina and high blood pressure
 The usual starting dose is one Tildiem LA
200mg capsule a day.
If necessary, your doctor may increase this
dose to:
 One Tildiem LA 300mg capsule a day.
Children:
Tildiem LA should not be given to children.
If you take more Tildiem LA than you should
If you take more capsules 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 LA
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 LA
Keep taking Tildiem LA 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 LA 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 or 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. 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 (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

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.

Tell your doctor as soon as possible if you
have any of the following side-effects:

Do not use Tildiem LA after the expiry date stated
on the blister and carton. The expiry date refers to
the last day of that month.

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
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.

5. How to store Tildiem LA
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.

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.
If your medicine becomes discoloured or shows
any signs of deterioration, you should seek the
advice of your pharmacist.

6. Further Information
What Tildiem LA contains
The active substance is diltiazem hydrochloride.
Each capsule contains 300 mg diltiazem
hydrochloride.
The other ingredients: microcrystalline cellulose,
acrylic and methacrylic esters co-polymer,
ethylcellulose, carmellose sodium, diacetylated
monoglycerides, magnesium stearate, gelatin,
titanium dioxide (E171) and yellow iron oxide
(E172).

What Tildiem LA looks like and contents of
the pack
Tildiem LA is available as opaque capsules with a
white body and yellow cap, containing white to offwhite pellets.
The capsules are packaged in clear
PVC/aluminium blisters.
Your medicine is contained in packs of 28
capsules.
Manufacturer:
Sanofi Winthrop Industrie, Tours, France.

Procured from within the EU and repackaged
by Product Licence Holder:
Kosei Pharma UK Limited,
956 Buckingham Avenue,
Slough, Sl1 4NL, UK.

Tildiem LA 300 mg
Prolonged-Release Capsules
PL No: 39352/0193
Leaflet date: 22/01/2016

POM

Tildiem® LA is a registered trademark of sanofiaventis.

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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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