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PIL Adipine XL CP0007-3:INITIAL.QXD 10/04	/	2015 09:32 Page 1
		J

GChiesi

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adipine® XL 30 mg & 60 mg Prolonged Release Tablets

Nifedipine

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 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

1. What Adipine is and what it is used for

Adipine XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). Adipine has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called prolonged release tablets because they are manufactured in a way that allows the nifedipine to be released and slowly absorbed by your body over a period of several hours.

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.

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 (chest pains) occurring when extra strain is placed upon the heart.

2. What you need to know before you take Adipine

Do not take Adipine:

•    if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or any of the other ingredients in Adipine

•    if you are pregnant, likely to become pregnant or are breast-feeding

•    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)

•    if the severity or frequency of your angina has rapidly worsened over a matter of hours or days

•    to treat an angina attack as it occurs, but rather to reduce the frequency of the angina you experience overtime

•    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

•    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)

Take special care with Adipine and always tell your doctor if:

•    you suffer from low blood pressure

•    you experience chest pains when you first start taking Adipine, contact your doctor immediately

•    you are diabetic, the treatment for your diabetes may need to be adjusted

•    you are receiving kidney dialysis and have very high blood pressure with low blood volume

•    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

•    you have to give a urine sample, have an barium contrast x-ray or undergo surgery

•    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.

Your doctor may, under certain conditions, think it necessary to keep you on Adipine whilst you are pregnant. If this is the case particular care must be taken if you are also having magnesium sulfate injections.

Taking other medicines

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 anti-epileptic drug phenytoin

•    the antibiotic rifampicin

•    combination treatment quinupristin/dalfopristin

•    cisapride, a drug used to speed up the movement of food through the gullet and stomach

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

•    the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole

•    indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infection

•    the antidepressant drugs fluoxetine and nefazodone

•    tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs

•    carbamazepine and valproic acid, used for the treatment of epilepsy

•    the barbiturate phenobarbital, used primarily to treat insomnia and anxiety

Taking Adipine with food and drink

Do not drink grapefruit juice at the same time or soon after taking Adipine because grapefruit juice can increase the blood levels of nifedipine.

Pregnancy, breast-feeding and fertility

Do not take Adipine if you are pregnant, trying to become pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

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

Important information about some of the ingredients of Adipine

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.

Please read the back of this leaflet

3. How to take Adipine

Always take Adipine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adipine is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet must be swallowed whole with a glass of water and not with grapefruit juice. Do not break or chew your tablets.

Adults:

The usual adult dose for treating high blood pressure or preventing angina is 30 mg or 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 90 mg of Adipine once a day.

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

Do not stop taking your medicine until your doctor tells you.

Children:

Adipine 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 take more Adipine than you should

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.

If you forget to take Adipine

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adipine can cause side effects, although not everyone gets them.

Allergic reactions, although serious, have been reported in rare cases. If you experience any of the following, contact your doctor or casualty department immediately:

•    rash or skin redness affecting • wheezing or breathing    • yellowing of the skin and

your whole body    difficulties    whites of the eyes

•    swelling of the face, lips and • fever tongue

If you experience chest pains when you first start taking Adipine, contact your doctor immediately.

The following side effects have also been reported, if you do experience any of these side effects they will usually go away when treatment is stopped.

•    drowsiness

•    pins and needles

•    dizziness

•    difficulty in breathing

•    itching

•    rash

•    passing large volumes of urine

•    an increased need to urinate at night

trembling mood changes nose bleeds

lumpy, itchy red rash that appears on the body, lips, eyes, or tongue sweating

•    problems with the eyes that may be painful or cause blurred vision

pain, discomfort or burning sensation when passing urine

•    failure to achieve or maintain an erection

•    red or purple discolourations on the skin

•    blistering of the skin when exposed to sunlight

•    too much sugar in the blood, resulting in increased thirst, frequent urination, weight loss and tiredness.

•    blurred vision

The development of breast tissue in older men on long term therapy and heart attacks have also been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Adipine

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C. Keep the blister in the outer carton.

•    Do not use Adipine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adipine contains:

•    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).

What Adipine look like and the contents of the pack:

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.

Marketing Authorisation Holder and Manufacturer.

The Marketing Authorisation holder and manufacturer is Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK.

Is this leaflet hard to see or read? Phone 0161488 5555 for help.

This leaflet was last revised in 02/2015