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TILDIEM 60 MG MODIFIED-RELEASE TABLETS

Active substance(s): DILTIAZEM HYDROCHLORIDE

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Tildiem® 60 mg Modified-Release
Tablets

2619
18.03.16[7]

(diltiazem hydrochloride)
PATIENT INFORMATION 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.
Your medicine is available by using the above name but will be referred to
as Tildiem throughout the following leaflet
In this leaflet:
1. What Tildiem is and what it is used for
2. Before you take Tildiem
3. How to take Tildiem
4. Possible side effects
5. How to store Tildiem
6. 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.
Take special care with Tildiem
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 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.
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:
- 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 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
Tildiem may make the following medicine work less well:
- Rifampicin used for tuberculosis
The following medicines can increase the effect of Tildiem:
- 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 can not 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
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.
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
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.
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 day of that month.
Do not store above 25oC.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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
- Each modified release tablet contains 60mg of the active substance
diltiazem hydrochloride.
- The other ingredients are lactose monohydrate, macrogol 6000,
hydrogenated castor oil and magnesium stearate
What Tildiem looks like and contents of the pack
Tildiem are white, round, convex tablets engraved with ‘Tildiem 60’ on one
side and plain on the other side.
The tablets are provided in blister packs containing 90 or 100 tablets.
Manufacturer and Product Licence holder
Manufactured by Sanofi-Winthrop Industrie,
Zone Industrielle St. Symphorien, Tours F-37100, France.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2619

Leaflet revision and issue date (Ref.) 18.03.16[7]
Tildiem is a trademark of the Sanofi.

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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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