PLENDIL® ER

Felodipine, 2.5 mg Extended Release (ER) Tablets

What is in this leaflet

This leaflet answers some of the common questions people ask about Plendil
ER. It does not contain all the information that is known about Plendil
ER.

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

All medicines have risks and benefits. Your doctor will have weighed the
risks of you taking Plendil ER against the benefits they expect it will
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 Plendil ER is used for

Plendil ER is used to treat high blood pressure (hypertension) and
heart and chest pain brought on, for example, by exercise or stress (known as
angina pectoris).

How Plendil ER works

Plendil ER belongs to a family of medicines called calcium channel
blockers. These medicines do not change the way that the body takes in calcium
from food.

Plendil ER works by dilating (expanding) small blood vessels, so that
blood can be pumped around the body more easily. It has no negative affect on
heart function.

The ER in Plendil ER stands for Extended Release.
This means that the tablets are designed to work over a 24 hour period.

Your doctor may prescribe this medicine for another use. Ask your doctor if
you want more information.

Before you use Plendil ER

When you must not use it

If you are allergic to any of its ingredients (listed at the end of
this leaflet). Inform your doctor if you have had any unusual reactions to other
medicines

If you have an allergic reaction, you may get a skin rash, hayfever,
difficulty with breathing or feel faint.

If you have any of these medical conditions:

• heart problems (i.e.uncompensated heart failure, acute heart attack)
• angina which has lasted without interruption for 15 minutes or longer and
  is more severe than usual.

It may not be suitable for you to take Plendil ER if you have any of
these conditions

Do not use Plendil ER if you are pregnant or breastfeeding unless your
doctor says so. Ask your doctor about the risks and benefits involved.

You should tell your doctor as soon as possible if you become pregnant.

Your baby can take in very small amounts of Plendil ER from breast
milk if you are breastfeeding, but it is unlikely to affect the baby if the
mother is taking the recommended dose.

Do not give Plendil ER to children. Plendil is not recommended for use
in children.

Do not use after the use by (expiry) date printed on the pack. It may
have no effect at all, or worse, an entirely unexpected effect if you take it
after the expiry date.

Do not use Plendil ER if the packaging is torn or shows signs of
tampering.

Do not use it to treat any other complaints unless your doctor tells you
to.

Do not give this medicine to anyone else even if their symptoms seem
similar to yours.

Before you start to use it

Plendil ER, may in rare cases lead to pronounced low blood pressure.
In some patients this may result in an inadequate supply of blood to the heart.

Tell your doctor about any health problems you have had in the past including
any allergic, unpleasant or unusual reaction to Plendil ER or any other
medicine or substance.

If you have not told your doctor about any of these things or are unsure
about them, tell your doctor of pharmacist before you start taking Plendil ER.

Taking other medicines

Tell your doctor if you are taking any other medicines, as treatment with
Plendil ER may be influenced if taken at the same time as:

• certain anti-ulcer medicines (cimetidine)
• antibiotics (erythromycin)
• anti-fungals (itraconazole, ketoconazole)
• sleeping pills (barbiturates)
• medicine for tuberculosis (rifampicin)
• medicines used to prevent epilepsy (phenytoin, carbamazepine)
• medicines used to prevent the body from rejecting a transplanted organ
  (tacrolimus)

Also tell your doctor if you drink grapefruit juice.

Include all medicines that you buy at the chemist, super-market or health
food shop. These medicines may affect the way Plendil ER works.

Your doctor or pharmacist can tell you what to do if you are taking any of
these medicines.

If you have not told your doctor about any of these things, tell them
before you take any Plendil ER.

Using Plendil ER

How much to take

Hypertension

The usual starting dose is 5 mg once a day. If necessary your doctor may
increase the dose or add another blood-pressure lowering medicine. The usual
dose, when treating this disease for a long time, is 5-10 mg once a day. In
elderly patients, a starting dose of 2.5 mg daily may be used.

Angina

The usual starting dose is 5 mg once a day and, if needed, your doctor may
increase the dose to 10 mg once a day.

Plendil ER should be taken in the morning.

Swallow Plendil ER tablets whole and wash them down with a glass of water.
They must not be divided, crushed or chewed. If they are broken or crushed
they will not work over 24 hours as they are supposed to.

It doesn't matter if you take Plendil ER with food or not, but you must
not take it with grapefruit juice. Grapefruit juice, but not other fruit
juices, may increase the effect of Plendil ER.

Overdose

Telephone your doctor or the National Poisons and Hazardous Chemicals
Information Centre Ph: 0800 POISON (0800 764 766) or go to Accident and
Emergency at your nearest hospital immediately if you think that you or anyone
else may have taken too much Plendil ER. Even if there are no signs of
discomfort or poisoning.

If you take more than the recommended number of doses of Plendil ER,
you may suffer from very low blood pressure and sometimes a slow heart rate.
Therefore it is very important that you take the number of doses prescribed by
your doctor. If you experience symptoms such as feeling faint, light-headedness
or dizziness, contact your doctor or pharmacist immediately.

While you are using Plendil ER

If you forget to take it

If you forget a dose, take it as soon as you remember, as long as it is at
least 12 hours before the next dose is due.

Do not double the dose.

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

How long to take it

Treatment of high blood pressure is necessary in most people for the rest of
their lives. Ask your doctor to explain the reasons for this.

Things you must not do

Do not stop taking Plendil ER unless you have discussed it with your
doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Plendil ER
affects you. When you start taking Plendil ER, whether you are
changing from another medicine for high blood pressure or not, you may feel
dizzy or faint due to the drop in your blood pressure.

Be careful when drinking alcohol while you are using Plendil ER.

Side effects

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

Ask your doctor or pharmacist to answer any questions you may have.

Be sure to tell your doctor if any of the following side effects bother
you or continue:

• headache
• dizziness
• flushing
• palpitations (rapid heart beat)
• ankle swelling
• fatigue (tiredness)

They are more likely if you are taking a high dose. They usually go away or
get less with time. If they do occur, it mostly happens at the beginning of
treatment, or when the dose is increased. However if they persist tell your
doctor.

A mild enlargement of the gums has been reported in patients with an
inflammation in the mouth (gingivitis / periodontitis). This can be reversed or
avoided with careful dental hygiene.

Tell your doctor immediately if you experience:

• Skin rash or itching
• Hives, swelling of the face, tongue or throat, as this could indicate a
  serious allergic reaction.

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

Some people may get other side effects while taking Plendil ER.

Important: This leaflet alerts you to some of the situations when you
should call your doctor. Other situations, which cannot be predicted, may arise.
Nothing in this leaflet should stop you from calling your doctor or pharmacist
with any questions or concerns you have about using Plendil ER.

After using it

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take Plendil ER out of the blister pack it will not keep well.

Keep it in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least
one-and-a-half metres above the ground is a good place to store medicines.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any tablets you have left over if your
doctor tells you to stop taking them, or you find that the expiry date has
passed.

Product description

What Plendil ER looks like

Plendil ER 2.5 mg are yellow, circular tablets engraved A/FL on one
side and 2.5 on the other. They are 8.5 mm in diameter.

Plendil ER is available in blister packs of 30 tablets.

Ingredients

Plendil ER tablets contain felodipine 2.5 mg as the active ingredient,
plus

• Hydrogenated castor oil
• Propyl gallate
• Hypromellose
• Sodium aluminium silicate
• Microcrystalline cellulose
• Lactose anhydrous
• Sodium stearyl fumarate
• Hydroxypropyl cellulose

The coating on each tablet contains

• Macrogol 6000
• Titanium dioxide
• Iron oxide yellow
• Carnauba wax.