• 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.

1. What Adipine is and what it is used for
2. What you need to know before you take Adipine
3. How to take Adipine
4. Possible side effects
5. How to store Adipine
6. Contents of the pack and other information

• if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or any of the other ingredients in Adipine (listed in section 6)
• if you have been told that you have a narrowing (stenosis) of the aortic valve in your heart
• if you have experienced a collapse which was caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth
• if you get a sudden angina attack. Adipine will not help relieve symptoms of angina quickly
• if you have unstable angina
• if you suffer from inflammation of the bowel or intestines (such as Crohn’s disease), oesophageal (gullet) obstruction or have in the past had an obstruction or narrowing of the intestine
• if you have a liver disease that prevents your liver from working properly
• if you have had a heart attack during the last month or to treat a heart attack
• if you are taking the antibiotic rifampicin (used to treat tuberculosis)
• if your blood pressure continues to rise despite treatment (malignant hypertension)
• if you have a Kock pouch (a type of ileostomy - a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut

• if you suffer from low blood pressure and you were prescribed Adipine for your angina. Your blood pressure may be decreased further by this treatment
• if you experience chest pains when you first start taking Adipine, contact your doctor immediately. Your doctor may wish to change your 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 Adipine, you should stop breast-feeding before you start to take this medicine
• if you are diabetic, the treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor
• if you are receiving kidney dialysis and have very high blood pressure with low blood volume, you might experience a sudden drop in blood pressure when you take Adipine
• 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 Adipine
• if you are taking other drugs to treat high blood pressure (e.g. beta-blockers). If you are changing from a beta-blocker to nifedipine, you should gradually reduce your beta-blocker after discussion with your doctor
• if you are giving a urine sample. Adipine 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 notice increased breathlessness
• if you notice swelling of the ankles
• 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 Adipine
• if you are male and have been unsuccessful in fathering a child by in vitro fertilisation. Medicines like Adipine have been shown to impair sperm function.

Before starting treatment, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Adipine. This is especially important if you are likely to have an anaesthetic or an operation.

In particular, tell your doctor if you are taking:

• other drugs to treat high blood pressure
• cimetidine, to treat stomach ulcers
• digoxin, diltiazem, quinidine, or beta-blockers, used to treat heart conditions
• the antibiotic rifampicin
• combination treatment quinupristin/dalfopristin
• cisapride, a drug used to speed up the movement of food through the gullet and stomach
• magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure)
• the antibiotics erythromycin, or anti-fungal medicines ketoconazole, itraconazole or fluconazole
• indinavir, nelfinavir, ritonavir, amprenavir or saquinavir, used to treat HIV infection
• the antidepressant drugs fluoxetine and nefazodone
• tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs
• phenytoin, carbamazepine and valproic acid, used for the treatment of epilepsy
• the barbiturate phenobarbital, used primarily to treat insomnia and anxiety

You can take Adipine with or without food.

Do not drink grapefruit juice or eat grapefruit while taking Adipine.

Do not start taking Adipine 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 Adipine. 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 Adipine 30 contains 24 mg salt (sodium chloride). Tell your doctor if you are on a low-salt diet.

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 Adipine but only after special consideration and agreement by your doctor.

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

If you feel dizzy, faint, extremely tired or have visual disturbances after taking Adipine, then do not drive or operate machinery.

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

Adipine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• Dose for high blood pressure: the recommended 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 Adipine XL 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: Adipine XL 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.

If you accidentally take more Adipine than you should, contact your nearest casualty department immediately. Remember to take the pack and any remaining tablets with you.

Taking too many tablets may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.

• The active substance is nifedipine.
• The other ingredients are povidone K30, lactose monohydrate, talc, hypromellose (E464), magnesium stearate, carbomer 974P, colloidal anhydrous silica, macrogol 4000, dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer, red iron oxide (E172) and titanium dioixide (E171).

Adipine XL 30 mg and 60 mg Prolonged Release Tablets are pale red with a round and biconvex shape, marked on one side with “30” or “60” respectively. They are available in calendar blister packs of 28 tablets.

The Marketing Authorisation holder and manufacturer is