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Tildiem La 300mg Capsules

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TILDIEM® LA 300MG CAPSULES (diltiazem hydrochloride)

PATIENT INFORMATION LEAFLET

Please read all of this leaflet carefully before you start using TILDIEM LA 300MG CAPSULES.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them, even if their symptoms are the same as yours.

What is in your Medicine?

Your medicine is called TILDIEM LA 300MG CAPSULES.

Each capsule is unmarked with a yellow cap and white body and contains 300mg of the active ingredient diltiazem hydrochloride. The capsules also contain the following inactive ingredients: microcrystalline cellulose, carmellose sodium, acrylic and methacrylic esters copolymer, ethylcellulose, diacetylated monoglycerides, magnesium stearate, gelatin, titanium dioxide (E171) and yellow iron oxide (E172).

TILDIEM LA 300MG 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 300MG CAPSULES are supplied in calendar blister packs of 28 capsules.

TILDIEM LA 300MG CAPSULES are calcium antagonists. All muscles, including heart muscle and the muscle in blood vessel walls, need calcium in order to contract (tighten). Diltiazem stops heart muscle contracting too much, so helping to lower high blood pressure and prevent angina (chest pain).

Manufacturer:

Your medicine is manufactured by Synthelabo Groupe, Tours, France.

Your medicine is procured from within the EU and repackaged on behalf of the Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0283

What is this medicine used for?

TILDIEM LA 300MG CAPSULES are antianginals, that is, they help prevent angina pectoris (chest pain). They are also antihypertensives, that is, they can bring down high blood pressure.

Before you use your medicine:

Make sure it is safe for you to take TILDIEM LA 300MG CAPSULES.

Do not take this medicine if you are pregnant, are likely to become pregnant, or are breastfeeding.

You should not take this medicine if you have any of the following:

(if you are not sure whether you have any of these conditions, do ask your doctor before starting to take this medicine).

-    severe bradycardia (a very slow heart rate i.e. less than 50 beats per minute)

-    sick sinus syndrome (a disorder of the heart beat)

-    left ventricular failure (heart failure). This is the condition which can make you feel out of breath and perhaps give you swollen ankles.

-    2nd or 3rd degree heart block (unless you have a working pacemaker fitted) Heart block is a general term used to cover both sino-atrial block and atrioventricular block. If you have heart block, certain parts of the heart may beat at the wrong time. The result is that your heart does not pump the blood round your body very well.

-    kidney or liver disease.

-    currently taking dantrolene (a muscle relaxant).

If you have a mild case of one or more of the above heart conditions, it may still be appropriate for you to take this medicine. Your doctor can decide whether it is suitable for you but you should discuss this with him/her first.

Do not take TILDIEM LA 300MG CAPSULES if you

know you are allergic to any of the ingredients of TILDIEM LA 300MG CAPSULES (listed above).

Are there any drug interactions?

It may be appropriate for you to take TILDIEM LA 300MG CAPSULES with other heart drugs or diuretics (water tablets) depending on the type of heart problem you have. Your doctor will be able to tell you which drugs you can take together.

TILDIEM LA 300MG CAPSULES could possibly increase the effect of:

-    any drug which causes bradycardia (slowing of the heart rate) eg amiodarone

-    an anti-arrhythmic (a drug which helps to steady an irregular heart beat)

-    another anti-hypertensive drug (i.e. one which lowers high blood pressure)

TILDIEM LA 300MG CAPSULES could also increase the effect of:

-    carbamazepine (for epilepsy)

-    ciclosporin, tacrolimus (immuno suppressants)

-    theophylline (for breathing problems)

-    digoxin (for heart problems)

-    rifampicin (an antibiotic)

-    lithium (for manic depression)

-    statins (for cholesterol - lowering)

-    buspirone (for anxiety)

-    prednisolone (corticosteroid)

Histamine antagonists (for stomach ulcers) may increase the effect of TILDIEM LA 300MG CAPSULES. If you are due to have an operation, tell the doctor attending you that you are taking TILDIEM

LA 300MG CAPSULES. However, treatment with diltiazem has been continued without problems in patients who have had general anaesthetics.

How to use your medicine:

Take the exact dose your doctor has told you to. Do not change it without talking to your doctor first.

Swallow the capsules whole with a small glass of water. Do not chew them.

It is best to take the capsules before or during a meal. Take your capsules at the same time each day.

Adults: The usual starting dose is one TILDIEM LA 200MG CAPSULE daily. Your doctor may increase the dose to one TILDIEM LA 300MG CAPSULE daily, or two TILDIEM LA 200MG CAPSULES daily if necessary. If you still need a higher dose your doctor may give you one TILDIEM LA 300MG CAPSULE and one TILDIEM LA 200MG CAPSULE daily.

Elderly patients and people with poor liver or

kidney function: The starting dose should be one TILDIEM LA 200MG CAPSULE daily. If a higher dose is needed, this may be increased to one TILDIEM LA 300MG CAPSULE daily.

Children: TILDIEM LA 300MG CAPSULES should not be given to children.

What to do if you take too many capsules:

CONTACT A DOCTOR IMMEDIATELY AND SAY HOW MANY CAPSULES HAVE BEEN TAKEN.

What to do if you miss one or more doses:

If you forget to take a capsule do not take a double dose the next day but continue taking the usual dose.

Do TILDIEM LA 300MG CAPSULES have side effects?

As with all medicines, TILDIEM LA 300MG CAPSULES can have a few side effects. However, not everyone gets side effects.

The side effects are usually mild and do not last for many days. The following are known side effects: swelling of the lower legs, feeling faint when standing up, headaches, hot flushes/flushing, weakness or tiredness, palpitations, dizziness, a general feeling of illness or discomfort, indigestion, stomach pain, nausea (feeling sick), constipation, dry mouth, skin rash.

Some of the above side effects, especially swelling of the lower legs, may be worse with higher doses and are more common in elderly people.

Skin rashes, if they appear, usually only cover a small area of skin and disappear when treatment is stopped. Fever may occur with a rash but this is not very common. However, severe skin rashes have occurred occasionally. Cases of sensitivity to light and swollen gums have also been reported, which returned to normal when treatment was stopped.

Rare side effects of TILDIEM LA 300MG CAPSULES treatment include slowing of the heart rate (bradycardia), or an irregular heart rate (due to sinoatrial block or atrio-ventricular block - see “Before you use your medicine” for an explanation of these conditions), effects on the liver including hepatitis; trembling, pronounced muscle stiffness or spasm, slowness of movement, excess saliva, restlessness and breast enlargement in men. When these have occurred, they all returned to normal when treatment was stopped.

If you have any of the rare side effects tell your doctor straight away. If you become breathless or have any side-effects which are not mentioned on this leaflet, tell your doctor or pharmacist as soon as possible.

Storage:

Do not store above 25°C. Store in a dry place.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

Expiry Date:

Do not use after the expiry date printed on the pack.

Important:

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 signs of deterioration, you should seek the advice of your pharmacist.

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information.

TILDIEM is a registered trademark of Sanofi-Synthelabo

Leaflet revision date: 31 May 2007 Ref: TIL0283-PILv1

TIL0283-PILv1