Tildiem Retard 120mg Tablets

Document: m1-3-1-leaflet MAH BRAND_PLPI 04423-0520 change

To change the name of the Manufacturer to 'Sanofi Winthrop Industrie' from 'Synthelabo Groupe' consequential to variation PLPI 04423/0520-0006.

No other changes assessed/approved.

TILDIEM® RETARD 120MG TABLETS (diltiazem hydrochloride)

PATIENT INFORMATION LEAFLET

Please read this leaflet before you start to take your medicine. This information is not designed to replace your doctor’s instructions but to guide you in the safe use of this medicine. If you would like to know more about Tildiem Retard, please ask your doctor or pharmacist.

About Tildiem Retard

Each tablet contains 120mg of the active ingredient diltiazem hydrochloride in a modified release formulation.

Tildiem Retard are plain off-white biconvex shaped tablets.

The tablets are designed to release the diltiazem slowly so that they work for 12 hours (a controlled release formulation).

The tablets are coated with a special membrane which enables the diltiazem to be released from the tablet at a gradual rate. This membrane may pass through your body unchanged.

This does not affect the way the product works.

The tablets also contain sodium dihydrogen citrate, sucrose, povidone, magnesium stearate, macrogol 6000, modified polyvinylchloride polymer, acetate tributyl citrate, castor oil polymerised, sodium bicarbonate, ethyl vanillin and titanium dioxide (E 171).

The medicine is available in blister packs of 30 and 60 tablets.

Your medicine is called a calcium antagonist.

All muscles, including heart muscle and the muscle in blood vessel walls need calcium in order to contract (tighten).

Your medicine stops the heart muscle from contracting too much, which helps to lower high blood pressure and prevent angina (chest pain).

Your medicine is manufactured by: Sanofi Winthrop Industrie (Tours), France. Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR. Product Licence holder: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

|POM| PL No: 04423/0520

What is this medicine used for?

There are two medical conditions which Tildiem Retard can be used to treat:

1. Angina (chest pain)

2. Hypertension (high blood pressure)

Warning: Tildiem Retard contains Sucrose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Before taking your tablets

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

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

• 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 a condition which can make you feel out of breath and perhaps give you swollen ankles

• second or third degree heart block (unless you have a working pacemaker fitted). Heart block is a general term used to cover both sinoatrial block and atrio-ventricular 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.

• if you are being treated with dantrolene infusion (for severe muscle spasm)

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

If you have a mild case of one or more of the above heart conditions, it may still be all right for you to take this medicine. Your doctor can decide whether it is suitable for you.

Do not take Tildiem Retard if you know you are allergic to any of the ingredients in the tablets (listed above).

Are there any drug interactions?

It may be all right for you to take Tildiem Retard 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.

Your medicine could possibly increase the effect of:

• any drug which causes bradycardia (slowing of the heart beat) 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)

Your medicine could also increase the effect of:

• carbamazepine (for epilepsy)

• cyclosporin, 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 Retard. If you are about to have an operation tell the doctor at the hospital that you are taking this medicine. Treatment with Tildiem Retard has been continued without any problems in patients who have had a general anaesthetic.

How to take your medicine

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

• Swallow your tablets whole with a small glass of water. Do not chew them.

Treatment of Angina

Adults:

The usual starting dose is one tablet (90mg or 120mg) twice daily. Your doctor may increase this dose to 2 tablets twice a day if necessary.

For people over 65 years and those with poorly functioning liver or kidneys:

The starting dose should be a lower strength Tildiem tablet (60mg) and not Tildiem Retard. Your doctor may increase the dose to one 90mg tablet or one Tildiem Retard 120mg tablet twice daily.

Treatment of Hypertension

Adults:

The usual starting dose is one tablet (90mg or 120mg) twice daily. Your doctor may increase this dose to 2 tablets twice a day if necessary.

For people over 65 years and those with poorly functioning liver or kidneys:

The starting dose should be one Tildiem Retard 120mg tablet once daily. Your doctor may increase the dose to one 90mg or one 120mg tablet twice daily if you need it.

Children:

Tildiem Retard should not be given to children.

What to do if you take too many tablets

If you or anyone you know accidentally takes too many tablets (an overdose) contact your doctor or your nearest hospital casualty department and say how many tablets have been taken.

What to do if you miss one or more doses

If you forget to take a tablet, do not take a double dose the next time but continue taking the usual dose.

Does Tildiem Retard have side effects?

As with all medicines, Tildiem Retard 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 treatment include slowing of the heart rate (bradycardia), or an irregular heart rate (due to sinoatrial block or atrio-ventricular block - see “Before taking your tablets” 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.

How to store this medicine

Store in a dry place below 30°C.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Tablets stored correctly can be used up to their expiry date printed on the edge of the blister strip and on the box or on the container label. Do not take this medicine after the month shown on the pack.

If you have any left over tablets, please return these to your pharmacist for safe disposal.

If your tablets appear to be discoloured or show any other signs of deterioration, please return these to your pharmacist who will advise you.

Leaflet revision and issue date: 14.07.09

Tildiem® is a trademark of Sanofi - Synthelabo, France.

To change the name of the Manufacturer to 'Sanofi Winthrop Industrie' from 'Synthelabo Groupe' consequential to variation PLPI 04423/0520-0006.

No other changes assessed/approved.