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PLENDIL 2.5MG TABLETS

Active substance(s): FELODIPINE / FELODIPINE / FELODIPINE

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Plendil® 2.5mg Tablets
(felodipine)

Plendil Tablets are available in the following strengths:
2.5mg, 5mg and 10mg. Plendil 2.5mg Tablets will be referred
to as Plendil throughout the leaflet.

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.
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. This
includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Plendil is and what it is used for
What you need to know before you take Plendil
How to take Plendil
Possible side effects
How to store Plendil
Contents of the pack and other information

1. What Plendil is and what it is used for
Plendil contains the active substance felodipine. This belongs
to a group of medicines called calcium antagonists. It lowers
blood pressure by dilating small blood vessels. It does not
negatively affect the heart function.
Plendil is used in the treatment of high blood pressure
(hypertension) and heart and chest pain brought on by for
example exercise or stress (angina pectoris).

2. What you need to know before you take
Plendil
Do not take Plendil





if you are pregnant. You should tell your doctor as soon
as possible if you become pregnant while using this
medicine.
if you are allergic to felodipine or any of the other
ingredients of this medicine (listed in section 6).
if you suffer from uncompensated heart failure.






if you have acute myocardial infarction (heart attack).
if you have chest pain of recent onset, or angina
pectoris that is lasting for more than 15 minutes or
longer or is more severe than usual.
if you have disease of a heart valve or heart muscle,
until you have talked to your doctor.

Warnings and precautions

Plendil, like other blood-pressure lowering medicinal products,
may in rare cases lead to pronounced low blood pressure
which in some patients may result in an inadequate supply
of blood to the heart. Symptoms of excessive low blood
pressure and inadequate blood supply to the heart itself,
frequently include dizziness and chest pain. If you experience
these symptoms, seek emergency care immediately.
Talk to your doctor before taking Plendil, especially if you
have problems with your liver.
Taking Plendil may cause your gums to become swollen.
Practice good oral hygiene to help avoid your gums from
swelling (see section 4).

Pregnancy and breast-feeding
Pregnancy

Do not use Plendil if you are pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start
breast-feeding. Plendil is not recommended for mothers who
are breast-feeding, and your doctor may choose another
treatment for you if you wish to breast-feed.

Driving and using machines

Plendil can have minor or moderate influence on your ability
to drive and use machines. If you experience headache,
nausea, dizziness or fatigue your ability to react may be
impaired.
Caution is recommended especially at the start of treatment.

Plendil contains lactose and polyoxyl 40
hydrogenated castor oil

The use of Plendil is not recommended in children.

Plendil contains lactose that is a type of sugar. If you have
been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicine.
Plendil contains polyoxyl 40 hydrogenated castor oil, which
may cause stomach upset and diarrhoea.

Other medicines and Plendil

3. How to take Plendil

Children

Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Some medicines/herbal remedies can affect treatment with
Plendil.
Examples are:

cimetidine (medicine to treat gastric ulcers)

erythromycin (medicine to treat infections)

itraconazole (medicine to treat fungi)

ketoconazole (medicine to treat fungi)

medicines to treat HIV protease inhibitors (such as
ritonavir)

medicines to treat HIV infection (such as efavirenz,
nevirapine)

phenytoin (medicine to treat epilepsy)

carbamazepine (medicine to treat epilepsy)

rifampicin (medicine to treat infections)

barbiturates (medicine to treat anxiety, sleeping
problems and epilepsy)

tacrolimus (medicine used in organ transplantations)
Medicines containing St John’s wort (Hypericum perforatum)
(herbal product used to treat depression) may reduce the
effect of Plendil and should therefore be avoided.

Plendil with food and drink

Do not drink grapefruit juice if you are treated with Plendil, as
this may increase the effect of Plendil and the risk of side
effects.

Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Plendil extended release tablets should be taken in the
morning and be swallowed with water.
The tablet must not be divided, crushed or chewed. This
medicine can be taken without food or following a light meal
not high in fat or carbohydrates.

Hypertension

Treatment should be started with 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
considered.

Stable angina pectoris

Treatment should be started with 5 mg once a day and if
needed, your doctor may increase the dose to 10 mg once a
day.

If you have liver problems

The level of felodipine in your blood may be increased. Your
doctor may lower the dose.

Elderly people

Your doctor may initiate treatment with the lowest available
dose.

Page 1 of 2

If you take more Plendil than you should

If you take more than the recommended number of doses of
Plendil, you may suffer from very low blood pressure and
sometimes palpitations, high or, rarely, 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 immediately.

If you forget to take Plendil

If you forget to take a tablet, leave out that dose completely.
Take your next dose at the right time. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Plendil

If you stop taking this medicine your condition may return.
Please consult your doctor and seek advice before you stop
taking Plendil. Your doctor will advise you how long to take
your medicine.
If you have any further questions on the use of this medicine,
ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any of the following happen to you, stop taking Plendil and
tell a doctor straight away:

Hypersensitivity and allergic reactions: The signs may
include raised lumps on your skin (weals) or swelling of
your face, lips, mouth, tongue or throat.
The following undesirable effects have been identified. Most
of these reactions appear at start of treatment or after a dose
increase. Should such reactions occur, they are usually brief
and diminish in intensity with time. If you experience any of
the following symptoms and they persist, please tell your
doctor.
Mild enlargement of the gums has been reported in patients
with an inflammation in the mouth (gingivitis/periodontitis).
The enlargement can be avoided or reversed by careful oral
hygiene.

Very common: may affect more than 1 in 10 people


Ankle swelling

Common: may affect up to 1 in 10 people




Headache
Flushing

Uncommon: may affect up to 1 in 100 people






Abnormally rapid heart rate
Palpitations
Too low blood pressure (hypotension)
Nausea
Abdominal pain






Burning/prickling/numbness
Rash or itching
Fatigue
Dizziness

Rare: may affect up to 1 in 1,000 people







Fainting
Vomiting
Nettle rash
Pain in joints
Muscular pain
Impotence/sexual dysfunction

Very rare: may affect up to 1 in 10,000 people







Gingivitis (swollen gums)
Increased liver enzymes
Skin reactions due to increased sensitivity to sunlight
Inflammation of small blood vessels of the skin
A need to pass water frequently.
Hypersensitivity reactions such as fever or swelling of
the lips and tongue

Other undesirable effects may occur. If you have any
bothersome or unusual reaction while taking Plendil, check
with your doctor right away.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
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 Plendil










Keep out of the sight and reach of children.
Do not use Plendil after the expiry date shown on the
label. The expiry date refers to the last day of that
month.
Do not store above 25°C.
Store in the original package.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if
your doctor tells you to.
If the tablets appear discoloured or show any other
signs of deterioration, take them to your pharmacist
who will advise you.
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
to protect the environment.

Page 2 of 2

6. Contents of the pack and other
information
What Plendil contains




The active ingredient is felodipine. Each modifiedrelease tablet contains felodipine 2.5mg in an extended
release formulation.
The other ingredients are: carnauba wax,
hydroxypropyl cellulose, hydroxypropyl methylcellulose,
iron oxide (E172), lactose anhydrous,
microcrystalline cellulose, polyethylene glycol 6000,
polyoxyl 40 hydrogenated castor oil, propyl gallate,
aluminium sodium silicate, sodium stearyl fumarate,
titanium dioxide (E171) and water purified.

What Plendil looks like and contents of the pack

Plendil are yellow, circular, biconvex, film coated tablets
coded A/FL on one side and 2.5 on the reverse.
Plendil comes in a bottle containing 30 tablets.

Manufacturer

Plendil is manufactured by:
AstraZeneca AB, S-151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0553

POM

Leaflet revision and issue date (Ref): 05.12.16
Plendil® is a registered trademark of AstraZeneca group of
companies.
If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 365000 and ask for the
Regulatory Department.
Please be ready to give the following information:
Product name: Plendil 2.5mg Tablets
Reference number: 08929/0553

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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