PLENDIL 2.5MG TABLETS

Active substance: FELODIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Plendil.

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

In this leaflet:
1.
2.
3.
4.
5.
6.

What Plendil is and what it is used for
Before you take Plendil
How to take Plendil
Possible side effects
How to store Plendil
Further information

1. What Plendil is and what it is used for
Plendil contains a medicine called felodipine. This belongs to a
group of medicines called “calcium channel blockers”. Plendil is
used to treat high blood pressure (hypertension) or to prevent a
painful heart condition called angina.
It works by making your blood vessels relax and widen. This helps
to lower your blood pressure and to prevent chest pain (angina).

2. Before you take Plendil
Do not take Plendil if:

You are allergic (hypersensitive) to felodipine or any of the
other ingredients in Plendil (see section 6 “Further
information”).
You are allergic to dihydropyridine medicines (such as
nifedipine or amlodipine).
You have something called unstable angina (angina that is
not well controlled by medical treatment).
You have severe heart problems.
You have had a heart attack in the last month.
You have something called cardiogenic shock (a serious
condition where the heart is unable to supply enough blood
to the body).
You are pregnant or trying to get pregnant (see “Pregnancy
and breast-feeding” below).

Take special care with Plendil

Before you take Plendil, tell your doctor if:
You have liver problems.
You have heart problems (i.e. faster heartbeats, high and/or
low blood pressure).

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines. This includes herbal
medicines and medicines that you buy without a prescription.
In particular, tell your doctor or pharmacist if you are taking any
of the following medicines:
Cimetidine (for ulcers)
Erythromycin (for bacterial infections)
Itraconazole or ketoconazole (for fungal infections)
HIV protease inhibitors (such as ritonavir)
Phenytoin, carbamazepine or phenobarbital (for epilepsy)
Tacrolimus (used after kidney or liver transplant)
Rifampicin (used for treatment of tuberculosis)
St John’s Wort (Hypericum perforatum) (used to treat
depression and anxiety)
Barbiturates (a sedative)
Efavirenz or Nevirapine (used to treat HIV)
Warfarin (used to thin the blood)
Ciclosporin (mainly used by transplant patients but also
used to treat rheumatoid arthritis and psoriasis)

Taking Plendil with food and drink

Do not drink grapefruit juice while you are taking Plendil. It
can affect the way the medicine works.

Pregnancy and breast-feeding

Do not take Plendil if you are pregnant or trying to get
pregnant. This is because Plendil can harm your unborn
baby.
If you are breast-feeding, talk to your doctor before taking
Plendil.

Driving and using machines

If you feel dizzy after taking Plendil, do not drive or use any tools
or machines.

Important information about some of the
ingredients of Plendil

Plendil contain lactose anhydrous, which is a type of sugar.
If you have been told by your doctor that you are intolerant to
some sugars, talk to your doctor before taking Plendil.

Do not take Plendil if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Plendil.
Page 1 of 2

3. How to take Plendil
Always take Plendil exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Swallow your tablet(s) whole with a drink of water. Do not
divide, crush or chew the tablets.
Tablet(s) can be taken without food or following a light meal
not high in fat or carbohydrates (sugar).
Your tablets are in a pack with the days of the week shown.
This will help you to remember when to take them.

Adults with high blood pressure (hypertension)

The usual dose is one 5mg tablet in the morning.
However, your doctor may start you on one 2.5mg tablet.
Your doctor may increase the dose to 10mg.

Adults with angina

The usual dose is one 5mg tablet in the morning.
Your doctor may increase the dose up to 10mg.

The Elderly (over 65 years)

For high blood pressure (hypertension) – the usual dose is
one 2.5mg tablet in the morning.
In the elderly, the lowest available dose should be used for
initial treatment.

Children (under 18 years)

There is limited experience with the use of Plendil in
children (below the age of 18 years). Therefore Plendil
should not be given to children.

People with liver problems

If you suffer from liver problems your doctor may give you a
lower dose of Plendil.

If you take more Plendil than you should

If you have taken more Plendil than prescribed by your doctor,
tell your doctor or go to the nearest hospital straight away. Take
the medicine with you.

If you forget to take Plendil

If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next dose,
skip the missed dose.
Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.

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

4. Possible side effects
Like all medicines, Plendil 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:

Chest pain and dizziness at the same time.
An allergic reaction. The signs may include raised lumps on
your skin (weals) or swelling of your face, lips, mouth,
tongue or throat.

Other possible side effects:
Very common (affects more than 1 in 10 people)
Swelling of the feet and ankles

Common (affects less than 1 in 10 people)
Headaches
Flushing of your skin

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.

6. Further information

Uncommon (affects less than 1 in 100 people)

What Plendil contains

Rare (affects less than 1 in 1,000 people)

What Plendil looks like and contents of the pack

Faster heartbeat
Pounding heartbeat (palpitations)
Pins and needles feeling in your toes or fingers
Stomach pain
Feeling sick (nausea)
Rash
Itching
Dizziness
Feeling tired

Fainting
Being sick
Pain in joints
Pain in muscles
Being unable to get an erection (impotence)
Lumpy rash (hives)

Very rare (affects less than 1 in 10,000 people)

Enlarged gums (if you already have enlarged gums they
may get worse. You can prevent this by careful dental
hygiene)
Increased levels of liver enzymes
Skin inflammation
Sensitivity to sunlight
Passing water (urine) more often, normally during the
daytime

llergic reaction (anaphylaxis, i.e. swelling of your face, lips,
mouth, tongue or throat, fever)
You may get any of the following side effects at the beginning of
treatment or if your dose has been increased:
Flushing, headaches, faster or pounding heartbeat, feeling
dizzy or tired.
Do not be alarmed by this list of possible side effects. You may
not get any of them. 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.

The active ingredient is felodipine. Each modified-release
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, polyoxy 40 hydrogenated castor oil, propyl
galate, aluminium sodium silicate, sodium stearyl fumarate,
titanium dioxide (E171) and water purified.

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

A
Leaflet revision and issue date (Ref): 19.12.12
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
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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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