patient information leaflet beta-adalat

PATIENT INFORMATION LEAFLET

PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING BETA-ADALAT

Beta-Adalat®

"What exactly is high blood pressure?"

Blood has to be pumped to all the organs in your body and this 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. Your blood pressure can be greater than the upper limit and not cause 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 partially blocked. 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. 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.

BETA-ADALAT

(nifedipine and atenolol)

What do my capsules contain?

Each brown-reddish capsule contains 20 mg of the active ingredient nifedipine and 50 mg of the active ingredient atenolol. Each capsule is marked "BETA-ADALAT" on one side with the Bayer symbol on the other side.

Beta-Adalat capsules also contain microcrystalline cellulose, polysorbate 80, hypromellose, lactose, maize starch, macrogol 4000, gelatin, magnesium carbonate, sodium lauryl sulphate, and magnesium stearate. Titanium dioxide (E171) and iron oxide (E172) are included as colouring agents.

Your medicine comes in packs of 28 capsules.

The active ingredient, nifedipine, is one of a group of medicines called calcium antagonists. These relax and expand blood vessels. The active ingredient, atenolol, is one of a group of medicines called beta-blockers. These affect the heart and circulation.

Why have I been prescribed Beta-Adalat by my doctor?

It 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. Atenolol reduces the workload of the heart. This reduces the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.

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. Atenolol reduces the workload of the heart which decreases the amount of oxygen the heart needs. This reduces the chances of angina occurring.

When should I not take Beta-Adalat?

Do not take Beta-Adalat if you have previously had an allergic reaction to the active ingredients, atenolol and nifedipine or to any other drugs similar to nifedipine (known as dihydropyridines). If you are unsure about this, ask your doctor.

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

Do not take this medicine if you have a history of wheezing or asthma. Consult your doctor or pharmacist first.

Do not take this medicine if you are taking the antibiotic, rifampicin.

Beta-Adalat must not be taken at the same time as monoamine oxidase inhibitors, e.g. phenelzine or isocarboxazid. Please consult with your doctor if you think you may be taking such medication.

If you have been told that you have an unusually slow heart rate (your heart’s electrical signals move more slowly through the heart than is normal (second or third degree heart block)), you should not take this medicine.

If you have been told that your heart fails to pump your blood properly around the body (heart failure), you should not take this medicine.

If you have been told that you have a narrowing (stenosis) of the aortic valve of the heart, sick sinus syndrome or sino-atrial block you should not take this medicine.

Do not take this medicine if you have experienced a collapse which was caused by a heart problem (cardiogenic shock), during which you would have become breathless, pale and had a cold sweat and dry mouth.

If the severity or frequency of your angina has rapidly worsened over a matter of hours or days, you must contact a doctor and tell him. You may be advised not to take Beta-Adalat.

Beta-Adalat should not be used for the treatment of a heart attack or within one month of a heart attack.

You should not take Beta-Adalat to treat an angina attack when it occurs, but rather to reduce the frequency of the angina you experience over time.

You should not take this medicine if your blood pressure is continuing to rise despite treatment. This is a condition known as malignant hypertension.

You should not take this medicine at the same time as other drugs which lower your heart’s workload, for example a drug called verapamil.

If you have severe problems with the circulation in your hands and feet you should not take this medicine.

Beta-Adalat must not be used if you have acidosis (a decline in blood pH value). Symptoms of acidosis may include a marked decline in conscious level with confusion and irritability. In addition your breathing may be deep, sighing and rapid (Kussmaul’s respiration).

In patients with phaeochromocytoma, a rare tumour found within the tissue of the adrenal gland, Beta-Adalat must only be administered after prior therapy with alpha-blockers.

Beta-Adalat must not be used if your kidneys do not work properly. Your doctor will have specific guidelines to determine how well your kidneys work. If you are unsure about this and require further information, please consult with your doctor.

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

What special precautions should I take?

You should not start taking Beta-Adalat within three days of drinking grapefruit juice. If you have, speak to your doctor. In addition, you should not drink grapefruit juice whilst taking Beta-Adalat. This is because grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least three days after the last ingestion of grapefruit juice.

If you are allergic to any of the other ingredients of this medicine, please tell your doctor before starting your course of treatment.

If you experience chest pains within 1-4 hours of taking your FIRST dose of Beta-Adalat, contact your doctor BEFORE YOU TAKE THE NEXT DOSE. He/she may wish to change your treatment.

Beta-Adalat should be used with caution if you have suffered in the past with controlled congestive heart failure. Should symptoms of this condition return you should stop taking Beta-Adalat.

If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve), you should tell your doctor.

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

If you suffer from a peripheral circulatory disorder, such as Raynaud’s disease, Raynaud’s syndrome or cramping pains, please inform your doctor.

Like all medicines containing beta-blockers, Beta-Adalat should be used with caution in patients with Prinzmetal’s angina. Remind your doctor if you suffer from this condition.

If you notice increased breathlessness or swelling of the ankles, or if your heart condition gets worse whilst taking your medicine, you should contact your doctor.

If you are a diabetic, the treatment for your diabetes may need to be adjusted. This medicine may alter the fast heart rate that can occur with a low blood sugar level (hypoglycaemia). Beta-Adalat may also block the signs of an overactive thyroid. Common symptoms for Graves’ disease are an enlarged thyroid and problems with your eyes, whilst symptoms for hypoglycaemia include nausea, tiredness and headache. If you have any questions about this, ask your doctor.

If your liver or kidneys do not work properly, you should tell your doctor before taking this medicine.

If you need an operation, you should tell the anaesthetist or medical staff that you are taking Beta-Adalat. This is particularly important if you are also taking narcotics or antiarrhythmics.

If you develop symptoms which your doctor thinks are due to a slow heart rate, he/she may ask you to stop taking this medicine.

Your doctor may, under certain conditions, think it necessary to keep you on Beta-Adalat whilst you are pregnant. If this is the case, particular care should be exercised if you are also having magnesium sulphate injections.

Drugs like Beta-Adalat that contain the active ingredient nifedipine have been shown in laboratory experiments to impair sperm function. If you are male and have been unsuccessful in fathering a child by in vitro fertilisation please consult your doctor.

Beta-Adalat 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.

Before taking Beta-Adalat tell your doctor if you are taking any other medicines, whether bought or prescribed, since some medicines can interfere with your treatment. In particular, tell your doctor if you are taking:

the medicines digoxin, theophylline, verapamil, disopyramide, or quinidine which are used to treat heart conditions
cimetidine to treat stomach ulcers
if you are taking clonidine (for hypertension or migraine) at the same time as Beta-Adalat, you must not stop taking clonidine unless your doctor tells you to. Your doctor will give you instructions should you need to stop taking clonidine
the antibiotics rifampicin and combination treatment quinupristin/dalfopristin
the anti-epileptic drug phenytoin
drugs such as ibuprofen or indomethacin. Other drugs that may cause similar effects are: reserpine, alpha-methyldopa, clonidine, guanethidine, guanfacine or digoxin
other blood pressure lowering drugs, e.g. beta-blockers, verapamil or diltiazem, or drugs that correct an irregular heartbeat (antiarrhythmics), e.g. lidocaine, amiodarone or sotalol
chloroform, lignocaine and procainamide or beta-adrenoceptor stimulants such as isoprenaline
noradrenaline, adrenaline or monoamine oxidase inhibitors, e.g. phenelzine or isocarboxazid
cisapride, a drug used to treat reduced movements of the gullet and stomach

If you suffer with a hypoglycaemic metabolic disorder, tell your doctor if are taking insulin or oral antidiabetics.

The effect of the following drugs on Beta-Adalat is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:

the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole
the HIV protease inhibitors indinavir, nelfinavir, ritonavir, saquinavir or amprenavir
the antidepressant drugs fluoxetine and nefazodone
tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs
carbamazepine and valproic acid, which are both used for the treatment of epilepsy
the barbiturate phenobarbitone, used primarily to treat insomnia and anxiety

It is possible that you may react to Beta-Adalat. Reactions can vary in intensity from individual to individual and may impair your ability to drive or operate machinery. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.

When and how do I take Beta-Adalat?

Take the capsules as prescribed by your doctor. Usually this will be one capsule taken once-daily for hypertension and one capsule every 12 hours for angina. For hypertension, your doctor may increase this dose to one capsule every 12 hours depending on how well your blood pressure is being controlled. The maximum dose you should take is two capsules every 24 hours. The capsules should be swallowed with a little water. You should not take your capsule(s) with grapefruit juice.

If you suffer from a liver disorder, your doctor may want to start your treatment on a low dose and increase it with careful monitoring of your blood pressure.

If you are elderly, lower doses of this medicine may be prescribed by your doctor.

This medicine is not recommended for use in children.

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 heart beats to become irregular.

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

What should I do if I forget to take my Beta-Adalat?

You should take your normal dose immediately and then continue taking your capsules as prescribed, waiting at least 12 hours before taking your next dose.

What side-effects may I experience?

A number of side-effects are known for Beta-Adalat. You may experience swelling of the ankles or legs, headache, flushing, loss of energy (fatigue), dizziness or intestinal symptoms.

As with all medicines, some people may be allergic to Beta-Adalat. Usually, if you are allergic to Beta-Adalat, a reaction will occur when you start taking the capsules. Allergic reactions can affect the liver and appear as yellowing of the skin (jaundice).

As with similar drugs which act on blood vessels, anginal pain may occur rarely at the start of treatment with Beta-Adalat.

In addition, a number of side-effects are known to occur with atenolol therapy alone and include disturbances in your heart beat that may lead to a slowing of the heart rate, increased risk of heart failure, low blood pressure that may be associated with fainting and an inadequate amount of oxygen in the blood that may result in a bluish discolouration of the skin. More susceptible patients may also experience muscle cramps caused by the lack of blood supply to the muscles, spasms in the fingers (Raynaud’s phenomenon) and a reduction in the number of blood clotting agents, that may result in bleeding into the skin and cause a skin rash.

Patients have also reported the occurrence of a dry mouth, confusion, mood changes, nightmares, mental disorders including hallucinations, sleep disturbances, too much sugar in the blood (hyperglycaemia), hair loss, skin reactions such as a rash, problems with their joints, pins and needles, muscle weakness, narrowing of the air passage in patients with asthma, eye problems including dry eyes and the failure to achieve or maintain an erection (impotence).

A number of additional side-effects are also known to occur with nifedipine therapy alone and include an irregular heart beat (palpitations), a fast heart beat (tachycardia), fainting, weakness or loss of strength and energy, drowsiness, vertigo, nervousness, trembling, feeling sick (nausea), feeling full and disturbances in the way the liver functions. There have also been reports of swollen gums that may bleed and a slight development of breast tissue in older men.

Skin reactions such as itching or hives, blistering of the skin particularly when exposed to light, muscle pain, breathing difficulties, an increase in the need to pass water and a decrease in the number of blood cells have also been known to occur.

Because of the nature of coronary artery disease, heart attacks have occurred in patients treated with the active ingredient, nifedipine. It has not been shown that these heart attacks were due to treatment with nifedipine.

All of the symptoms above usually go away when treatment with Beta-Adalat is stopped.

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

How should I store my Beta-Adalat capsules?

This medicinal product does not require any special storage conditions.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

Do not use capsules after the expiry date which is marked on both the outer carton and on each blister strip of capsules.

If you find that you have capsules after their expiry date, return them to your local pharmacist (chemist) who will dispose of them properly.

Medicine: beta-adalat