PACKAGE LEAFLET: INFORMATION FOR THE USER

Nidef 30mg Prolonged Release Tablets

Nifedipine

Read all of this leaflet carefully before you start using this

medicine.

•    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 foryou. 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 Nidef Tablets are and what they are used for

2.    Before you take Nidef Tablets

3.    Howto take Nidef Tablets

4.    Possible side effects

5.    How to store Nidef Tablets

6.    Further information

1. WHAT NIDEF TABLETS ARE AND WHAT THEY ARE USED FOR

Nidef Tablets contain nifedipine, which belongs to a group of medicines called calcium antagonists. Nidef Tablets are used to treat high blood pressure or angina (chest pain). For high blood pressure: Nidef Tablets work 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: Nidef Tablets work 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.

2. BEFOREYOU TAKE NIDEF TABLETS

Do not take Nidef Tablets if you

•    are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Nidef Tablets are listed in section 6.

•    have inadequate blood circulation due to a poor heart.

•    are taking rifampicin, an antibiotic.

•    have an obstruction or narrowing in your intestines, or have had this in the past.

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

Tell your doctor and do not take Nidef Tablets if any of these apply to you.

Take special care with Nidef Tablets if you

•    have low blood pressure.

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

•    sufferfrom heart failure.

•    are breastfeeding.

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

Talk to your doctor before you take Nidef Tablets if any of these apply to you.

Tell your doctor if you:

•    are giving a urine sample. Nidef Tablets may interfere with the results of certain urine tests.

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

•    are a man who has been unable to father a child by in vitro fertilisation. Drugs like Nidef Tablets have been shown to impair sperm function.

Taking other medicines

Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.

Some medicines may affect the way Nidef Tablets work. Tell your doctor if you are taking:

•    Beta-blockers (to treat heart conditions or high blood pressure).

•    Other medicines to treat high blood pressure.

•    Rifampicin (an antibiotic).

•    Cimetidine (to treat stomach ulcers).

•    Digoxin (to treat heart conditions).

•    Quinupristin/dalfopristin (a combination antibiotic).

•    Phenytoin, carbamazepine, phenobarbital 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, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).

•    Fluoxetine or nefazodone (to treat depression).

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

Nidef Tablets with food and drink

You can take NidefTablets with or without food.

Do not drink grapefruit juice or eat grapefruit while taking Nidef Tablets.

Do not start taking NidefTablets within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time.

Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

Pregnancy

Do not take NidefTablets if you are pregnant. If you are pregnant, thinkyou might be pregnant or are planning afamily, tell yourdoctor before taking NidefTablets.

Breast-feeding

Do not take NidefTablets if you are breastfeeding as nifedipine is passed into the mother's milk.

Driving and using machines

Nidef Tablets 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.

3. HOWTO TAKE NIDEFTABLETS

NidefTablets are specially formulated so that you only have to take one dose each day.

NidefTablets are not recommended for use in children. Take the tablets as prescribed by yourdoctor.

•    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 grapefruitjuice.

You can take NidefTablets 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: Nidef tablets are 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 NidefTablets than you should

Get medical help immediately. If possible, take your tablets or the box with you to show the doctor. 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.

If you forget to take Nidef Tablets

Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next dose.

Do not take a double dose to make up forthe missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nidef Tablets can cause side effects, although not everybody gets them.

Serious side effects

Ifyou notice:

•    Severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway).

•    other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life-threatening outcome).

•    shortness of breath or difficulty breathing.

•    itching (possibly severe), a rash or hives.

Contact your doctor immediately and do not take the next dose as these may be the first signs of allergic reaction which may become severe.

Ifyou develop:

•    a skin reaction or blistering / peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina).

Contact your doctor immediately before you continue treatment as these may be signs of a severe reaction.

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 NidefTablets.

•    you have chest pains after taking your first dose of Nidef Tablets. Your doctor may wish to change yourtreatment.

•    you notice increased breathlessness.

•    you notice swelling of the ankles.

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

Less serious side effects

Apart from the side effects listed above, these are the other side effects of Nidef Tablets, starting with the more common ones:

Common side effects

(These may affect up to 1 in 10 people)

•    headache.

•    flushing.

•    general feeling of being unwell.

•    constipation.

•    swelling, particularly of the ankles and legs.

Uncommon side effects

(These may affect up to 1 in 100 people)

•    stomach pain (abdominal pain).

•    unspecific pain.

•    chills.

•    low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion).

•    fainting.

•    irregular heartbeat.

•    dry mouth.

•    indigestion or upset stomach.

•    wind.

•    feeling sick.

•    muscle cramps.

•    joint swelling.

•    sleep disorders.

•    anxiety or nervousness.

Rare side effects

(These may affect up to 1 in 1,000 people)

•    pins and needles.

•    inflammation of the gums, tender or swollen gums, bleeding gums.

Other side effects (Frequency unknown)

•    stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal.

•    difficulty swallowing.

•    abdominal pain, caused by obstruction of the gut or ulcers in the gut.

•    vomiting.

•    a reduction in the number of white blood cells.

•    a more severe decrease in a specific class of white blood cell.

•    increased blood sugar.

•    decreased skin sensitivity.

•    drowsiness.

•    eye pain.

•    chest pain.

•    yellowing of the whites of the eyes or skin.

•    sensitivity to light.

•    small, raised areas of bleeding in the skin.

•    joint pain.

•    muscle pain.

All of these symptoms usually go away when treatment with Nidef Tablets is stopped.

Ifyou get side effects

Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.

5. HOWTO STORE NIDEF 30MG TABLETS

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

Store in the original container.

Do not use after the expiry date which is marked on both the outer carton and on each blister strip of tablets.

Do not dispose of medicines in household rubbish. Any unused NidefTablets should be returned to a pharmacist who will dispose of them properly. This helps the environment.

6. FURTHER INFORMATION

What NidefTablets contain

NidefTablets contain the active ingredient, nifedipine

NidefTablets also contain: polyethylene oxide, hydroxypropyl methylcellulose (E464), sodium chloride, magnesium stearate (E572), ferric oxide (E172), magnesium stearate, cellulose acetate, polyethylene glycol (E1521), hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), talc (E553b), iron oxide red (E172).

What NidefTablets look like and contents of the pack

Each prolonged release tablet contains 30 mg of nifedipine.

Each tablet is pink coloured, film coated, circular and biconvex, having an orifice on one side and plain on the other side.

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road

Leicester

LE30PA

UK

Manufacturer

Morningside Pharmaceuticals Ltd.

5 Pavilion Way Loughborough LE11 5GW