Document: leaflet MAH BRAND_PL 04425-0641 change

• leaflet MAH BRAND_PL 04425-0641
• leaflet MAH BRAND_PLPI 33902-0593

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tildiem Retard 90mg and 120mg Prolonged Release Tablets

Diltiazem hydrochloride

SANOFI

Is this leaflet hard to see or read? Phone 0845 372 7101 for help

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 Retard is and what it is used for

2.    Before you take Tildiem Retard

3.    How to take Tildiem Retard

4.    Possible side effects

5.    How to store Tildiem Retard

6.    Further information

I.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’.

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:

x 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 x You are breast-feeding or planning to breast-feed (see Section below: 'Pregnancy and breast-feeding’) x You have a very slow heartbeat - less than 50 beats per minute

x 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 x You are already taking a medicine containing ivabradine for the treatment of certain heart diseases x You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker) x 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.

H

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

AYou have any other problem with your heart, apart from angina or those described in the previous section

AYou are going to have an operation AYou are at risk of mood changes, including depression

AYou are at risk of gut problems

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

A You are over 65 years old A You have liver or kidney problems A 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.

! 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:

•    Dantrolene (an infusion) used for severe muscle spasms or severe fever (called ‘malignant hyperthermia¹)

•    Medicines containing ivabradine used for the treatment of certain heart diseases

Tildiem Retard may increase the effect of the following medicines:

•    Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol oracebutolol

•    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

•    Cidosporin used to stop the rejection of organs after a transplant

•    Phenytoin used for epilepsy

•    Aspirin used for relieving pain and reducing fever

•    lodinated 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 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 cimetidineand 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 takingTildiem 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.

Bll 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 (2xTildiem 120mgTablets).To betaken into consideration by patients on a controlled sodium diet.

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:

•    OneTildiem Retard 90mg tablet three times a day or

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

•    OneTildiem Retard 90mg tablet three times a day or

•    TwoTildiem 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

•    OneTildiem 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

•    OneTildiem 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, slurred speech, confusion, coma and sudden death. If, in an emergency situation, the patient is treated quickly sudden death is not only the potential outcome.

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 3

•    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’

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

Turn

Over

•    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 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 Retard 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 Retard

Keep out of the sight and reach of children.

Do not use Tildiem Retard after the expiry date which is stated on the carton after ‘EXP’.

The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

6. Further information

What Tildiem Retard contains

• Each Tildiem 90mg Retard tablet contains 90mg of the active substance diltiazem hydrochloride. EachTildiem120mg Retard tablet contains120mg of the active substance diltiazem hydrochloride 4

• The other ingredients are sodium dihydrogen citrate, sucrose, povidone, magnesium stearate macrogol 6000, coating polymer, tributyl acetylcitrate, sodium hydrogen carbonate, ethyl vanillin, titanium dioxide (E171)

What Tildiem Retard looks like and contents of the pack

Tildiem Retard tablets are almost white, convex tablets with no markings.

The tablets are provided in blister packs containing 14 or 56 tablets, securitainers containing 56 or 100 tablets or glass bottles containing 56 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel: 0845 372 7101 email:

uk-medicalinformation@sanofi.com Manufacturer Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37000 Tours - France

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.

This leaflet was last revised in June 2016

© Sanofi, 1991-2016

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