PATIENT INFORMATION LEAFLET

PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING ADALAT LA 30

Adalat LA 30

What exactly is high blood pressure?

Blood has to be pumped to all the organs in your body. This job is done by the heart. As the blood is pumped around the body, it pushes against the walls of your blood vessels creating pressure. This is your "blood pressure". There are upper and lower limits of blood pressure which are generally accepted as normal. If your blood pressure is greater than the higher limit, it can be detected, even though it's not necessarily causing you any discomfort. The medical term for this is hypertension.

Although high blood pressure may not make you feel ill, it can in the long-term put a strain on your heart because of the extra pumping effort it causes and may lead to other problems such as heart disease or a stroke.

What exactly is angina?

"Angina" is a pain usually experienced by patients who are suffering from coronary artery disease. In this disease the arteries supplying blood to the heart become stiffer and their width may be decreased. This results in less blood getting to the muscle which makes up the largest part of the heart. The heart is a muscular pump which circulates the blood throughout the whole body. It needs oxygen to do this and this is supplied by the blood. If the arteries which supply the muscle of the heart cannot deliver enough oxygen for the heart muscle to work properly, then pain is experienced. This pain is known as angina. Usually, angina occurs upon physical exercise and the pain will stop when the exercise stops. Sometimes, however, it can occur at rest.

Treating angina will reduce the frequency of your anginal attacks. However, most medicines which successfully treat angina either improve the blood flow to the heart muscle or reduce the speed of the beating heart. Either effect may reduce the likelihood of long-term damage to the heart.

Adalat LA 30

What do my tablets contain?

Each tablet contains 30 mg of the active ingredient nifedipine and is marked "Adalat 30" on one side.

Adalat LA 30 tablets also contain propylene glycol, cellulose acetate, hydroxypropyl methylcellulose, hydroxypropylcellulose, polyethylene oxide, polyethylene glycol, magnesium stearate and shellac. Titanium dioxide (E 171) and iron oxide (E172) are included as colouring agents. Each tablet also contains 24 mg of sodium chloride (salt).

Adalat LA 30 comes in calendar packs of 14 tablets. Each tablet has the day of the week printed next to it to remind you when to take it.

The nifedipine contained in Adalat LA 30 is one of a group of medicines called calcium antagonists which are used to treat high blood pressure and to reduce the frequency of anginal attacks.

Product Licence/Authorisation holder: Bayer plc, Pharmaceutical Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA.

Manufacturer: Bayer AG, Leverkusen, Germany.

Why have I been prescribed Adalat LA 30 by my doctor?

Adalat LA 30 has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn

reduces the strain on your heart. A good comparison is to imagine the difference in pressure you feel when you blow hard through a straw compared with something larger like the cardboard tube in a kitchen roll. You will feel less pressure with the cardboard tube because the hole is larger. It creates less resistance in the same way as does a widened blood vessel .

In angina, nifedipine works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina occurring when extra strain is placed upon the heart.

When should I NOT take Adalat LA 30?

Do not take Adalat LA 30 if you have previously had an allergic reaction to the active ingredient nifedipine. If you are unsure about this, ask your doctor.

Do not take Adalat LA 30 if you are pregnant or breast-feeding. If you are taking Adalat LA and think that you may be pregnant or are planning a family, consult your doctor.

Do not take Adalat LA if you are taking the antibiotic rifampicin.

These tablets should not be taken if you have a liver disease. They should also not be taken if you suffer from inflammation of the bowel or intestines (such as Crohn's disease). Patients with this sort of disease may experience attacks of diarrhoea containing blood or mucus. Also, if you have, or have had in the past, an obstruction or narrowing of the intestine, you should not take Adalat LA tablets.

If you have been told that you have a narrowing (stenosis) of the aortic valve of the heart, you should not take Adalat LA.

Do not take Adalat LA 30 if you have experienced a collapse of your blood circulation system (cardiogenic shock), during which you would have become breathless, pale and had a cold sweat and dry mouth.

If you are unsure whether you might have any of these conditions, please ask your doctor.

What special precautions should I take?

IMPORTANT: Adalat LA tablets must be swallowed whole. They will not work properly if they are bitten, chewed or broken up. If you have difficulty in swallowing tablets, consult your doctor as he/she may wish to change your medicine.

You may see what appears to be the complete tablet in the toilet or associated with your stools. This is normal as the outer shell of the tablet is not digested by the body. It does not mean that your tablets are not working.

If you experience chest pains within 4 hours of taking your FIRST dose of Adalat LA, contact your doctor BEFORE YOU TAKE THE NEXT DOSE. He/she may wish to change your treatment.

Remind your doctor if you suffer from low blood pressure and he/she prescribes Adalat LA for your angina.

If you notice increased breathlessness whilst taking Adalat LA, you should contact your doctor.

If you are a diabetic, the treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor. Patients who are receiving kidney dialysis and have a very high blood pressure and low blood volume might experience a sudden drop in their blood pressure when they take Adalat LA. If you are on kidney dialysis please consult your doctor before taking this medicine.

Adalat LA may interfere with the results of certain urine tests. If you have given a urine sample, inform the person responsible that you are taking this medicine.

Please inform your doctor if you are taking any of the following:

When and how do I take Adalat LA 30?

The Adalat LA tablet is specially formulated so that you only have to take your tablets once a day.

Take the tablet as prescribed by your doctor. Usually this will be one tablet taken at the same time each day, preferably during the morning. The tablet should be swallowed whole with a glass of water.

It is possible that you may have to take these tablets indefinitely. You may want to discuss this with your doctor.

DO NOT EXCEED THE PRESCRIBED DOSE.

Exceeding the correct dosage or taking an overdose may cause your blood pressure to become too low and your beats to become irregular. Also, it may lead to nausea (feeling sick) and vomiting, a lack of energy, drowsiness, dizziness, confusion, flushing and, possibly, even unconsciousness.

If you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately and, if possible, take your tablets or the box with you to show the doctor.

What should I do if I forget to take by Adalat LA?

You should take your normal dose immediately and then continue taking your tablets as prescribed. However, it is best to allow at least 12 hours before taking your next dose to restore your normal time of dosing.

What side-effects may I experience?

As with all medicines, a number of side-effects are known for Adalat LA. You may experience swelling of the ankles or legs, headache, flushing, a fast or irregular heartbeat (palpitations), feeling sick (nausea), loss of energy (fatigue), dizziness or numbness in the hands and feet. These side-effects should go away with time.

Bleeding, tender or swollen gums may occur some time after starting Adalat LA.

Skin reactions such as a rash, itching or hives may occur.

You may experience muscle pain, trembling or visual disturbances.

You may experience an increase in the need to pass water.

Occasionally, the treatment of high blood pressure may lead to slight breast swelling in older men. This side-effect goes away when treatment is stopped.

As with all medicines, some people may be allergic to Adalat LA. Usually, if you are allergic to Adalat LA, a reaction will occur when you start taking the tablets. Allergic reactions can affect the liver and appear as yellowing of the skin (jaundice) or they can cause symptoms such as a rash and fever.

Very rarely, some people experience a purple/brown discolouration of the skin or redness, flaking and itching of the skin. Also, it has been known for people to develop a rash or blistering of the skin when they are exposed to sunlight.

All of the symptoms above go away when treatment with Adalat LA is stopped.

IF YOU EXPERIENCE ANY OF THESE EFFECTS OR ANY OTHER UNDESIRABLE EFFECTS, TELL YOUR DOCTOR IMMEDIATELY. YOUR DOCTOR WILL GIVE YOU ADVICE.

How should I store my Adalat LA 30 tablets?

It is best if you keep your Adalat LA tablets in the original box supplied. The tablets should be protected from strong light, so only remove the tablet from the box or blister strip when you are about to take it.

The tablets should be kept in a cool, dry place where the temperature is not likely to be greater than 30ºC, eg your bedroom rather than your bathroom.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Do not use tablets after the expiry date which is marked on both the outer carton and on each blister strip of tablets. Wherever you see "EXP" this means "expiry date". For example, EXP 02/98 means that your tablets must not be used after February 1998.

If you find that you have tablets after the expiry date, return them to your local pharmacist (chemist} who will dispose of them properly.

Date of Preparation: March 1995

REMEMBER: This medicine has been prescribed for you. Do not give it to anyone else under any circumstances, even if they have the same conditions as you. If you have any doubts about taking Adalat LA 30 correctly, seek the advice of your doctor or pharmacist.

Product Licence Number: 0010/0174

Product Authorisation Number: 21/3/7

Distributed in the Republic of Ireland by: Bayer Limited, Dun Laoghaire, Co Dublin.