NYEFAX RETARD™

nifedipine 20 mg tablets

What is in this leaflet

This leaflet answers some common questions about NYEFAX tablets. It does not
contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking NYEFAX tablets against the benefits this medicine is expected to have
for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine

You may need to read it again.

What NYEFAX tablets are used for

NYEFAX is a calcium antagonist and acts particularly on the cells of the
heart muscle, the smooth muscle cells of the coronary arteries and the
peripheral resistance vessels. It does not change the amount of calcium in your
blood or bones.

NYEFAX dilates the coronary arteries, reduces the vascular smooth muscle tone
in the coronary arteries and prevents vasospasm. The final result is an
increased blood flow and increased oxygen supply.

NYEFAX is used to treat:

• coronary heart disease
• angina pectoris - exercise induced chest pain
• hypertension - high blood pressure

Your doctor may have prescribed NYEFAX tablets for another reason.

Ask your doctor if you have any questions about why NYEFAX tablets have been
prescribed for you.

NYEFAX tablets are a prescription only medicine.

Before you take NYEFAX

When you must not take it

Do not take NYEFAX tablets if you have had an allergy to:

• nifedipine
• other calcium channel blockers
• any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction to NYEFAX tablets may include:

• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives of the skin

Do not take NYEFAX tablets:

• if you are pregnant - nifidepine has been shown to cause birth defects in
  animals. There are limited studies on the effects of this medicine during
  pregnancy in humans
• if you are breast feeding - there is limited information on the possible
  effects of nifedipine on infants
• in cases of cardiovascular shock ( very low blood pressure due to a
  failing heart)
• if you are taking the medicine rifampicin (antibacterial) concurrently

Do not take NYEFAX tablets if the packaging is torn or shows signs of
tampering or if the tablets show visible signs of deterioration.

Do not take NYEFAX tablets after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as
well.

Before you start taking it

Tell your doctor or pharmacist if you are allergic to any other medicines,
foods, dyes or preservatives.

Tell your doctor if you have or have ever had any other health problems /
medical conditions, including:

• hypotension - low blood pressure
• heart failure
• severe narrowing of the aorta
• impaired liver fuction

Tell your doctor if you are pregnant or intend to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

If you planning to father a child by in vitro fertilisation, tell your
doctor you are taking NYEFAX.

NYEFAX may affect sperm function.

NYEFAX tablets may affect your ability to drive or use machinery. Care
should be taken until you know how this medicine affects you especially at the
start of treatment, on changing the medication and in combination with alcohol.

There is no evidence this medicine is addictive.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health
food shop. Some medicines may interfere with NYEFAX tablets. These include:

• other hypertensive medicines
• digoxin, quinidine - medicines used to treat arrhythmias
• phenytoin - a medicine used to treat epilepsy
• quinupristin/dalfopristin, rifampicin - an antibacterial medicine
• cimetidine - a medicine used to treat peptic ulcers
• diltiazem - a medicine used to enlarge blood vessels
• grapefruit juice - grapefruit and it's juice may increase the effects of
  NYEFAX
• cisapride - a medicine used to treat severe reflux oesophagitis

The following medicines may interact with NYEFAX even though studies have not
been carried out:

• erythromycin - a medicine used to treat bacterial infections
• fluoxetine - a medicine used to treat depression
• indinavir, ritonavir, saquinavir - antiviral medicines used to treat HIV
• ketoconazole, itraconazole, fluconazole - medicines used to treat fungal
  infections
• tacrolimus - an immunosuppressant
• carbamazepine, phenobarbitone, valproic acid - medicines used to treat
  epilepsy

Your doctor and pharmacist may have more information on medicines to be
careful with or avoid while taking this medicine

How NYEFAX tablets are taken

Carefully follow all directions given to you by your doctor. Their directions
may differ from the information contained in this leaflet. If you do not
understand the instructions on the label, ask your doctor or pharmacist for
help.

How many NYEFAX tablets to take

Your doctor will decide the dose depending on your medical condition and
response to treatment. If you have impaired liver function, it is important you
undergo monitoring.

How to take NYEFAX tablets

NYEFAX tablets should be taken with a little water, independently of meals or
as instructed by your doctor or pharmacist.

When to take

The usual dose is one NYEFAX tablet twice daily (2 X 20 mg/day). The
recommended dosage interval should be about 12 hours and should not be less than
4 hours.

How long to take NYEFAX tablets

Your doctor will determine the duration of treatment with NYEFAX.

Do not stop taking NYEFAX tablets unless advised to by your doctor.

Sudden withdrawal may cause severe adverse effects.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you remember
and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

While you are using NYEFAX

Things you must do

Be sure to keep all of your doctor's appointments so that your progress can
be checked.

If you become pregnant while you are taking NYEFAX tablets, tell your doctor.

Tell all the doctors, dentists and pharmacists who are treating you that you
are taking NYEFAX tablets.

Things you must not do

Do not stop taking NYEFAX tablets or lower the dosage without checking with
your doctor. Your doctor may want you to gradually reduce the amount of NYEFAX
tablets you are using before stopping completely.

Do not let yourself run out of tablets over the weekend or holidays.

Do not give NYEFAX tablets to anyone else, even if they have the same
condition as you.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking NYEFAX tablets.

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.

Tell your doctor immediately if you notice any of the following:

• weakness
• swelling
• headache
• nausea
• abdominal pain
• general feeling of being unwell
• constipation
• diarrhoea
• dry mouth
• heart burn
• vomiting
• painful joints
• muscle ache
• insomnia
• excessive or infrequent urination
• sensitivity to light
• increased gum size
• development of breasts in males
• burning pain in the feet or hands and redness

Seek medical treatment immediately if you notice any of the following:

• palpitations
• dizziness
• chest pain
• fainting
• tingling in fingers or toes
• sleepiness
• tremour
• shortness of breath
• sweating
• skin rash and discolourment or decreased sensitivity
• abnormal vision

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything else that is making you
unwell.

Overdose

Immediately telephone a doctor, or the Poisons Information Centre (telephone
0800 POISON or 0800 764 766) or go to the accident and Emergency Department at
your nearest hospital, if you think you or anyone else may have taken too many
NYEFAX tablets. Do this even if there are no signs of discomfort or poisoning.

Storage

Store NYEFAX tablets below 30°C.

Do not store NYEFAX tablets in the bathroom or near a sink. Do not leave it
in the car on hot days. Heat and dampness can destroy some medicines.

Keep your tablets in the original pack they are provided in until it is time
to take them. If you take the tablets out of the pack they may not keep well.

Keep it out of reach of children. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the tablets have
passed their expiry date, ask your pharmacist what to do with any that are left
over.

Product description

What it looks like

NYEFAX 20 mg Film-Coated Tablet: Pale pink, biconvex, film-coated
tablet of 7 mm diameter and comes in bottles of 100 or 30 tablets.

Other Ingredients

Microcrystalline cellulose, Maize cornflour, Lactose, Polysorbate 80 and
Magnesium stearate.