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Tildiem La 300mg Prolonged-Release Capsules

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3. How to take Tildiem


PACKAGE LEAFLET: INFORMATION FOR THE USER Tildiem® LA 300mg Prolonged Release Capsules

(diltiazem hydrochloride)

Your medicine is known as the above but will be referred to as

Tildiem throughout the remainder of this leaflet.

This product is available in multiple strengths and all strengths will be

referred to throughout this 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.    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

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

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 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.

Always take Tildiem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

1. What Tildiem 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 is used for:

•    High blood pressure

•    Angina (chest pain)


Please find below a translation of the days of the week printed on the blister.

AEY

TPI

TET

nEM

nAP

TAB

KYP

MON

TUE

WED

THUR

FRI

SAT

SUN


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


2. Before you take Tildiem



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

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 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.


How much to take Adults:

Angina and high blood pressure:

•    The usual starting dose is one Tildiem 200mg capsule a day. If necessary, your doctor may increase this to:

•    One Tildiem 300mg capsule a day or

•    Two Tildiem 200mg capsules a day.

•    One Tildiem 300mg capsule and one 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 200mg capsule a day. If necessary, your doctor may increase this dose to:

•    One Tildiem 300mg capsule a day.

Children:

Tildiem should not be given to children



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


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

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.


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.


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.


Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.


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


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')

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

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'