drug-medicine : adalat la 60

PATIENT INFORMATION LEAFLET

PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING ADALAT LA 60

Adalat® LA 60

Nifedipine

"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.

ADALAT LA 60

Prolonged release film-coated tablet

What do my tablets contain?

Each pink prolonged release film-coated circular tablet contains 60 mg of the active ingredient nifedipine and is marked "Adalat 60" on one side.

The tablets also contain propylene glycol, cellulose acetate, hypromellose, hydroxypropylcellulose, polyethylene oxide, macrogol, magnesium stearate and shellac. Titanium dioxide (E171) and iron oxide (E172) are included as colouring agents. Each tablet also contains 48 mg of sodium chloride (salt).

Adalat LA 60 comes in calendar packs of 28 tablets. Each tablet has the day of the week printed next to it to remind you when to take it.

The active ingredient, nifedipine, is one of a group of medicines called calcium antagonists. These relax and expand blood vessels.

Why have I been prescribed Adalat LA 60 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.

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 60?

Do not take this medicine:

if you have previously had an allergic reaction to the active ingredient nifedipine or to any other similar drugs (known as dihydropyridines). If you are unsure about this, ask your doctor
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
if you are taking the antibiotic rifampicin
if you have a liver disease
if you suffer from inflammation of the bowel or intestines (such as Crohn's disease)
if you have, or have had in the past, an obstruction or narrowing of the intestine
if you have been told that you have a narrowing (stenosis) of the aortic valve of the heart
if you have ever experienced a collapse in the past 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 you have ever had an oesophageal obstruction
for treatment of a heart attack or within one month of a heart attack.

If the severity or frequency of your angina has rapidly worsened over a matter of hours or days, you must contact a doctor. You may be advised not to take this medicine.

You should not take this medicine 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.

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 60 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 should not start taking this medicine within three days of drinking grapefruit juice. If you have, speak to your doctor. In addition, you should not drink grapefruit juice whilst taking this medicine. 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.

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.

Other precautions that you should take:

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 after taking your FIRST dose of Adalat LA 60, 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 this medicine for your angina
if you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve), you should tell your doctor
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. 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 this medicine. If you are on kidney dialysis please consult your doctor before taking this medicine
Adalat LA 60 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
your doctor may, under certain conditions, think it necessary to keep you on this medicine whilst you are pregnant. If this is the case particular care should be exercised if you are also having magnesium sulphate injections
if you have Kock pouch please consult your doctor, as he/she may wish to change your treatment. (A Kock pouch is a surgically constructed intestinal reservoir – the surgical procedure creates an opening from the small gut (ileum) through the abdominal wall to function as an anus)
if you are to have a barium contrast x-ray please inform the consultant that you are taking Adalat LA 60. This is because these tablets may affect the results of the test.

Drugs like Adalat LA 60 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.

Before taking this medicine, 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:

other drugs to treat high blood pressure
cimetidine, to treat stomach ulcers
the medicines digoxin, diltiazem, quinidine or beta-blockers, which are used to treat heart conditions
the antibiotics rifampicin and combination treatment quinupristin/dalfopristin
the anti-epileptic drug phenytoin
cisapride, a drug used to treat reduced movements of the gullet and stomach.

The effect of the following drugs on Adalat LA 60 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.

Do not drive or operate machinery if affected by dizziness, fainting, extreme tiredness, visual disturbances or anything that may affect your alertness. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.

When and how do I take Adalat LA 60?

The 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. You should not take your tablet(s) with grapefruit juice.

Continue to take these tablets for as long as your doctor has told you to.

Your doctor will determine the dosage that is appropriate for you. This may be from 20mg a day up to 90mg a day.

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 heartbeats to become irregular. Also, it may lead to dizziness, confusion, low blood oxygen levels and possibly 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 my Adalat LA 60?

You should take your normal dose immediately and then continue taking your tablets at the usual time of day, waiting at least 12 hours before taking your next dose. Do not take a double dose to make up for a missed dose.

What side-effects may I experience?

If you experience chest pains after taking your FIRST dose of Adalat LA 60, contact your doctor BEFORE YOU TAKE THE NEXT DOSE. He/she may wish to change your treatment.

As with all medicines, Adalat LA 60 can occasionally cause side-effects in some people. The most commonly reported (less than 1 person in 10) are:

headache
an irregular heartbeat (palpitations)
flushing
general weakness or loss of strength and energy
constipation
dizziness
swelling particularly of the ankles and legs.

Other less commonly reported side-effects (in less than 1 person in 100) are:

pain particularly in the stomach area (abdomen)
pain in the chest or legs
general feeling of being unwell
a low blood pressure when rising to the standing position (symptoms of low blood pressure include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
fainting
a fast heart beat (tachycardia)
diarrhoea
a dry mouth
indigestion
wind (flatulence)
feeling sick
leg cramps
inability to sleep
nervousness
pins and needles or sensations such as burning or prickling
sleepiness
sensation of spinning or whirling motion (vertigo)
shortness of breath or difficulty in breathing
itching
rash
an increase in the need to pass water
needing to go to the toilet during the night.

The following rare side-effects have been reported (in less than 1 person in 1000):

allergic reactions which may appear as a yellowing of the skin and/or whites of the eyes (jaundice)
chest pain deep in the sternum
chills
swelling of the face
fever
loss of appetite
belching
inflammation of the gums
tender or swollen gums that may bleed
an increase in gamma glutamyl-transferase (an enzyme that occurs naturally in the body)
liver function abnormalities
vomiting
problems with your joints that may be painful
muscle pain
increased sensitivity particularly in the skin
trembling
mood changes
nose bleeds
hives that appear on the body, lips, eyes or tongue
a rash presenting as elevated, discoloured spots on the skin
a visible collection of pus within or beneath the skin surface
skin blisters containing clear liquid
sweating
problems with the eyes that may be painful or cause blurred vision
difficulty in passing water that may be painful
a failure to achieve or maintain an erection (impotence).

As with similar prolonged release drugs which act on blood vessels, exacerbated angina pain may occur at the start of treatment with Adalat LA 60. Particularly if you are switching from another formulation of the active substance, nifedipine.

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.

A number of very rare side-effects have also occurred in approximately 1 person in 10,000:

an allergic reaction that may become severe
a mass of foreign material found in the stomach which may require surgery for removal
difficulty in swallowing
inflammation of the gullet
problems with the gums
obstruction of the gut
ulcers in the gut
jaundice (yellowing of the skin and/or whites of the eyes)
an increase in serum glutamate pyruvate transaminase (an enzyme that occurs naturally in the body)
a reduction in the number of white blood cells
reddish/purple skin discolouration
weight loss
muscle cramps
flaking of the skin with scaling and redness
blistering of the skin when exposed to sunlight.

Too much glucose in the blood (hyperglycaemia) may also occur. Symptoms of hyperglycaemia include thirst, resulting in the need to pass water more frequently, weight loss and tiredness. A slight development in breast tissue has also been reported in older men.

All of the symptoms above usually go away when treatment with Adalat LA 60 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 tablets?

Store in the original container. The tablets should be protected from strong light, so only remove the tablet from the container or blister strip when you are about to take it.

Do not store above 30ºC.

Keep all medicines out of the reach and sight 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.

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

Medicine: adalat la 60