Beta-Adalat
1. What Beta-Adalat is
2. Before you take Beta-Adalat
3. How you take Beta-Adalat
PACKAGE LEAFLET: INFORMATION FOR THE USER Beta-Adalat® Capsules
(nifedipine 20 mg / atenolol 50 mg)
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 more 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 Beta-Adalat is
2. Before you take Beta-Adalat
3. How you take Beta-Adalat
4. Possible side effects
5. How to store Beta-Adalat
6. Further information
Beta-Adalat contains two active ingredients: nifedipine and atenolol. Nifedipine belongs to a group of medicines called calcium antagonists. Atenolol belongs to a group of medicines called beta-blockers. Beta-Adalat is used to treat high blood pressure or angina.
For high blood pressure: Beta-Adalat works by expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Beta-Adalat works by expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Do not take Beta-Adalat:
• If you have had a heart attack within the last month.
• To prevent another heart attack, if you have a history of previous heart attack. Beta-Adalat will not help to prevent another heart attack.
• If you get a sudden angina attack. Beta-Adalat will not help relieve symptoms of angina quickly
• If you are allergic to the active ingredients (atenolol and nifedipine), to any other similar medicines (known as beta-blockers and dihydropyridines) or to any of the other ingredients. The ingredients of Beta-Adalat are listed in section 6.
• If you are pregnant or breastfeeding. If you think that you may be
pregnant or are planning to have a family, consult your doctor and do not take Beta-Adalat.
• If you have a history of wheezing or asthma. Consult your doctor or pharmacist first.
• If you are taking rifampicin, an antibiotic.
• If you are taking monoamine oxidase inhibitors such as 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)).
• If you have been told that your heart fails to pump your blood properly around the body (heart failure).
• If you have been told that you have a narrowing (stenosis) of the aortic valve of the heart.
• If you have been told that you have sick sinus syndrome or sino-atrial block (an irregularly slow or fast heartbeat).
• 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 your blood pressure is continuing to rise despite treatment.
This is a condition known as malignant hypertension.
• If you are also taking 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.
• If you have metabolic 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).
• If you have a condition called phaeochromocytoma (a rare cancer of the adrenal gland). In these circumstances Beta-Adalat must only be used after you have been treated with drugs called alpha-blockers.
• If your kidneys do not work properly. If you are unsure about this and require further information, please consult with your doctor.
• If your liver does not work properly. If you are unsure about this and require further information, please consult your doctor.
^ Tell your doctor and do not take Beta-Adalat if any of these apply to you.
Your doctor will take special care:
• If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
• If you have a heart condition where there is a split-second delay in the time that it takes electrical impulses to move through a specific section of your heart muscle (first degree heart block).
• If you suffer from low blood pressure and he or she prescribes Beta-Adalat for your angina.
• If you suffer from Prinzmetal’s angina. Tell your doctor if you have this condition.
• 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).
• If your liver or kidneys do not work properly.
^ Tell your doctor before you take Beta-Adalat if any of these apply to you.
Tell your doctor:
• If you are allergic to any of the other ingredients of this medicine.
• If you get chest pain for the first time at the start of treatment.
Contact your doctor immediately and do not take the next dose. He or she will give you advice.
• If your angina pain gets rapidly worse at the start of treatment or the frequency of attacks increases. Contact your doctor immediately and do not take the next dose. He or she will give you advice.
• If you notice increased breathlessness or swelling of the ankles,
or if your heart condition gets worse whilst taking your medicine.
• If you notice you have an enlarged thyroid and problems with your eyes. Beta-Adalat may block the signs of an overactive thyroid. If you have any questions about this, ask your doctor.
Check with your doctor:
• If you are male and have been unsuccessful in fathering a child
by in vitro fertilisation. Drugs like Beta-Adalat that contain the active ingredient nifedipine have been shown in laboratory experiments to impair sperm function.
• If you are about to have an operation, tell the anaesthetist or medical staff that you are taking Beta-Adalat. This is particularly important if you are also taking strong painkillers (narcotics) or drugs that affect your heart rhythm (antiarrhythmics).
• Beta-Adalat may interfere with the results of certain urine tests. If you are giving a urine sample, inform the person responsible that you are taking this medicine.
• If you may be subjected to drug testing for any reason, since Beta -Adalat may lead to positive test results in doping tests.
• If you develop symptoms which your doctor thinks are due to a slow heart rate, he or she may ask you to stop taking this medicine.
Other medicines and Beta-Adalat:
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:
• digoxin (or any other type of cardiac glycoside), theophylline, verapamil, disopyramide, or quinidine which are used to treat heart conditions
• cimetidine to treat stomach ulcers
• clonidine (for hypertension or migraine). 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
• ibuprofen or indomethacin. Other drugs that may cause similar effects are: reserpine, alpha-methyldopa, guanethidine or guanfacine
• other blood pressure lowering drugs such as beta-blockers, verapamil or diltiazem
• drugs that correct an irregular heartbeat (antiarrhythmics) such as lidocaine, amiodarone or sotalol
• chloroform, lignocaine and procainamide or beta-adrenoceptor stimulants such as isoprenaline
• noradrenaline, adrenaline or monoamine oxidase inhibitors such as phenelzine or isocarboxazid
• cisapride, a drug used to treat reduced movements of the gullet and stomach
• baclofen, a type of muscle relaxant used to relieve muscle spasms
If you suffer with a hypoglycaemic metabolic disorder, tell your doctor if you are taking insulin or drugs called oral antidiabetics.
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.
You should also 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 phenobarbital, used primarily to treat insomnia and anxiety
If you are taking any of these drugs, your doctor may want to monitor your blood pressure and might reduce your dose of Beta-Adalat.
Food and drink with Beta-Adalat
Do not drink grapefruit juice or eat grapefruit while taking Beta-Adalat.
You should not start taking Beta-Adalat within three days of drinking grapefruit juice or eating grapefruit. If you have, speak to your doctor. In addition, you should not drink grapefruit juice or eat grapefruit whilst taking Beta-Adalat. This is because grapefruit and grapefruit juice are known to increase the blood levels of the active ingredient, nifedipine.
This effect can last for at least three days.
Pregnancy and breastfeeding
Do not take Beta-Adalat if you are pregnant or breastfeeding. If you
are taking it and think that you may be pregnant or are planning a family, consult your doctor.
Driving and using machines
Dizziness or tiredness may occasionally occur after taking Beta-Adalat. Beta-Adalat could affect your ability to drive and use machines. Do not drive or operate machinery if you are affected. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.
Beta-Adalat contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Beta-Adalat.
The following is a translation of the days of the week which appear on the blister strip:
MO DI MI DO FR SA SO
MON TUE WED THU FRI SAT SUN
Take the capsules as prescribed by your doctor.
• For high blood pressure: the usual dose is 1 capsule, once a day. Your doctor may increase this to 1 capsule every 12 hours depending on how well your blood pressure is being controlled.
• For angina: the usual dose is 1 capsule, every 12 hours.
• The maximum dose is 2 capsules every 24 hours. Do not exceed the prescribed dose.
Take your capsules with a glass of water. Do not take them with grapefruit or grapefruit juice.
