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Adalat La 30mg Prolonged-Release Tablets

Informations for option: Adalat La 30mg Prolonged-Release Tablets, show other option
Document: leaflet MAH BRAND_PLPI 16369-1694 change

1. What Adalat LA is and what it is used for


2. What you need to know before you take Adalat LA



3. How to take Adalat LA


Package leaflet: Information for the user Adalat® LA 30mg prolonged-release tablets

(nifedipine)

Your medicine is known as the above but will be referred to as Adalat LA throughout the remainder of this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only.

•    Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Adalat LA is and what it is used for

2.    What you need to know before you take Adalat LA

3.    How to take Adalat LA

4.    Possible side effects

5.    How to store Adalat LA

6.    Contents of the pack and other information

Adalat LA contains nifedipine, which belongs to a group of medicines called calcium antagonists.

Adalat LA is used to treat high blood pressure or angina (chest pain).

For high blood pressure: Adalat LA works by relaxing and 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: Adalat LA works by relaxing and 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 Adalat LA:

•    If you have had a heart attack within the last month.

•    If you get a sudden angina attack. Adalat LA will not help relieve symptoms of angina quickly.

•    If you have unstable angina.

•    If you are allergic to nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).

•    If you are taking rifampicin, an antibiotic.

•    If you have a liver disease that prevents your liver from working properly.

•    If you have inflammation of the bowel or intestines, such as Crohn's disease.

•    If you have an obstruction or narrowing in your intestines, or

have had this in the past.

•    If you have ever had an obstruction in the gullet (the oesophagus - the tube connecting the throat to the stomach).

•    If you have been told that you have a narrowing of the aortic heart valve (stenosis).

•    If you have ever had a collapse caused by a heart problem

(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.

•    If you have a “Kock pouch” (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut.

•    If your blood pressure continues to rise despite treatment (malignant hypertension).

Tell your doctor and do not take Adalat LA if any of these apply to you.

Warnings and precautions

Talk to your doctor before taking Adalat LA

•    If you have low blood pressure and you were prescribed Adalat LA for your angina. Your blood pressure may be decreased further by this treatment.

•    If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).

•    If you are pregnant.

•    If you are breast-feeding. If you need to take Adalat LA, you should stop breast-feeding before you start to take this medicine.

•    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.

•    If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Adalat lA.

•    If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Adalat LA.

Talk to your doctor before you take Adalat LA if any of these apply to you.

Tell your doctor:

•    If your chest pain (angina) gets worse (comes on more often or more severely) over a matter of hours or days. You may be advised not to take Adalat LA.

•    If you have chest pains after taking your first dose of Adalat LA. Your doctor may wish to change your treatment.

•    If you notice increased breathlessness.

•    If you notice swelling of the ankles.

Tell your doctor before you take the next dose if any of these apply to you.

Also tell your doctor:

•    If you are giving a urine sample. Adalat LA may interfere with the results of certain urine tests.

•    If you are to have a barium contrast x-ray (barium meal). These tablets may affect the results of the test.

•    If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat LA have been shown to impair sperm function.

Other medicines and Adalat LA

Tell your doctor if you are taking, have recently taken or might

take any other medicines.

Some medicines may affect the way Adalat LA works. Tell your

doctor if you are taking:

•    Other medicines to treat high blood pressure.

•    Rifampicin (an antibiotic).

•    Cimetidine (to treat stomach ulcers).

•    Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).

•    Quinupristin/dalfopristin (a combination antibiotic).

•    Phenytoin, carbamazepine or valproic acid (to treat epilepsy).

•    Cisapride (to treat reduced movements of the gullet and stomach).

•    Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).

•    Erythromycin (an antibiotic).

•    Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).

•    Indinavir, nelfifinavir, ritonavir, saquinavir or amprenavir (to treat HIV).

•    Fluoxetine or nefazodone (to treat depression).

•    Tacrolimus (to prevent the rejection of transplanted organs).

•    Phenobarbital (usually used to treat insomnia or anxiety).

Adalat LA with food and drink

You can take Adalat LA with or without food.

Do not drink grapefruit juice or eat grapefruit while taking Adalat LA.

Do not start taking Adalat LA within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Adalat LA. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

One tablet of Adalat LA 30 mg contains 24 mg salt (sodium chloride). Tell your doctor if you are on a low-salt diet.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You may be able to use Adalat LA but only after special consideration and agreement by your doctor.

Do not take Adalat LA if you are breast-feeding. If you need to take Adalat LA, you should stop breast-feeding before you start taking this medicine.

Driving and using machines

Adalat LA may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.

This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.

Adalat LA is specially formulated so that you only have to take one dose each day.

Always take this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

•    Dose for high blood pressure: the usual dose is 1 tablet, once a day.

•    Dose for angina: the dose depends on your individual requirements. Your doctor will decide how much you should take.

•    Swallow the tablets whole. Do not bite, chew or break them - if you do they will not work properly. If you have difficulty swallowing tablets, consult your doctor as he or she may wish to change your medicine.

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

Take your dose at the same time each day, preferably in the morning.

Take your tablets with a glass of water. Do not take them with grapefruit juice.

You can take Adalat LA with or without food.

You may see what looks like a complete tablet in the toilet or in your stools. This is normal - it's the outer shell of the tablet which is not digested by the body.

Use in children and adolescents: Adalat LA is not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.