Medication Guide App

TILDIEM LA 200MG CAPSULES

Active substance: DILTIAZEM HYDROCHLORIDE

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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
overleaf). 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-feeding (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 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.

DATE:

CUSTOMER
APPROVED:

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

09/01/13
DATE OF PROOF:

UK PIL DATED MAY 2012

Tildiem LA may make the following medicine work less well:
• Rifampicin used for tuberculosis

6464/1016 1017F

DT

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
• 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

CODE:

04-1957

tildiem La 200mg 300mg caps
PRODUCT:

CUSTOMER: Waymade

ARTWORKER:

DATE:

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’)

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

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

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

PROOF HISTORY:
v.2 - waymade - 09/01/13

Leaflet Flat Size = 180 x 429

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as the above names but will be referred to as Tildiem LA throughout this leaflet.

WARNING!

27mm

TILDIEM® LA 200mg CAPSULES
TILDIEM® LA 300mg CAPSULES
(diltiazem hydrochloride)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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)

PROOF HISTORY:
v.2 - waymade - 09/01/13

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’)
• 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

Common (affects less than 1 in 10 people)
• Indigestion, stomach pain, constipation, and diarrhoea
DATE:

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’)

DATE:
09/01/13
DATE OF PROOF:

Uncommon (affects less than 1 in 100 people)
• Difficulty sleeping
Frequency unknown
• Mood changes, including depression
• Bleeding or bruising under the skin

UK PIL DATED MAY 2012

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

6464/1016 1017F

DT

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

CODE:

Q.A.
APPROVED:
04-1957

ARTWORKER:
tildiem La 200mg 300mg caps
PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

Frequency unknown
• Swollen gums

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.







5. How to store Tildiem LA
Tildiem LA 200mg capsules/Tildiem LA 300mg capsules should be stored in a dry place below 25°C.
Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep
the capsules if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist before taking them.
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
Your medicine is called Tildiem LA 200mg capsules/Tildiem LA 300mg capsules.
Each Tildiem LA 200mg capsule contains 200mg of the active ingredient, diltiazem hydrochloride in a modified release hard gelatin
capsule which has a pink cap marked with the Synthelabo logo and a grey body marked ‘200’.
Each Tildiem LA 300mg capsule contains 300mg of the active ingredient, diltiazem hydrochloride in a modified release hard gelatin
capsule which has a yellow cap and a white body.
Tildiem LA 200mg capsules/Tildiem LA 300mg capsules also contain the following inactive ingredients:
magnesium stearate, microcrystalline cellulose, acrylic and methacrylic esters co-polymers, ethyl cellulose, diacetylate
monoglyceride, titanium dioxide (E171), sodium carboxymethylcellulose and gelatin
Tildiem LA 200mg capsules also contain red iron oxide (E172), black iron oxide (E172) and black printing ink
Tildiem LA 300mg capsules also contain yellow iron oxide (E172).
The capsules are made in a ‘sustained release’ form. This means they release the active ingredient slowly and therefore they only
have to be taken once a day.
Tildiem LA 200mg capsules/Tildiem LA 300mg capsules are available as blister packs of 28 capsules.
POM

PL No: 6464/1016 Tildiem LA 200mg capsules
PL No: 6464/1017 Tildiem LA 300mg capsules

These products are manufactured by Synthelabo Groupe, Z.I. St. Symphorien, F-37100 Tours, France and are procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 7.1.2013
TILDIEM is a registered trademark of Sanofi-aventis

WARNING!

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 180 x 429

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

WARNING!

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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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