PLENDIL 2.5 MG TABLETS

Active substance: FELODIPINE

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Plendil® 2.5 mg Tablets

2417
13.09.12[2]

(felodipine)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking 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 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.
The name of your medicine is Plendil 2.5 mg Tablets but will be referred to
as Plendil throughout this leaflet.
Other strengths are also available.
In this leaflet:
1. What Plendil is and what it is used for
2. Before you take Plendil
3. How to take Plendil
4. Possible side effects
5. How to store Plendil
6. 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 tablets (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 breastfeeding" below).
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.
Take special care with Plendil
Before you take Plendil, tell your doctor if:
- You have liver problems.
- You have heart problems (i.e. faster heart beats, 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 tablets. 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 this medicine, do not drive or use any tools or
machines.
Important information about some of the ingredients of Plendil
Plendil tablets contain lactose, 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 this medicine.
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 5 mg tablet in the morning.
- However, your doctor may start you on one 2.5 mg tablet.
- Your doctor may increase the dose to 10 mg.
Adults with angina
- The usual dose is one 5 mg tablet in the morning.
- Your doctor may increase the dose up to 10 mg.
The Elderly (over 65 years)
- For high blood pressure (hypertension) - the usual dose is one 2.5 mg
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 Plendil
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 this product, 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 (affect 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.
Uncommon (affects less than 1 in 100 people)
- Faster heartbeat.
- Pounding heartbeat (palpitations)
- Pins and needles feeling in your toes or fingers.
- Stomach pain.
- Feeling sick (nausea).
- Rash.
- Itching.
- Dizziness.
- Feeling tired.

Rare (affects less than 1 in 1,000 people)
- 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.
- Allergic 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.
5. HOW TO STORE PLENDIL
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date shown on the label.
- Do not store above 25°C. Store in the original package.
- If your doctor stops treating you with this medicine, return any left over
tablets to a pharmacist. Only keep them if the doctor tells you to.
- If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Plendil contains
Each tablet contains 2.5 mg felodipine in an extended release formulation.
They also contain the following inactive ingredients: polyoxyl 40
hydrogenated castor oil, hydroxypropylcellulose LF, propyl gallate,
hypromellose 10000 mPa.s, hypromellose 6 mPa.s , hypromellose 50
mPa.s, sodium aluminium silicate, microcrystalline cellulose, lactose
anhydrous, sodium stearyl fumarate, macrogol 6000, yellow iron oxide
(E172), titanium dioxide (E171) and carnauba wax.
What Plendil looks like and contents of the pack
Yellow circular biconvex tablets marked ‘A FL’ on one side and ‘2.5’ on the
reverse.
Plendil is available in bottles of 30 tablets
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Corden Pharma GmbH., Otto-Hahn Strasse, 68273 Plankstadt, Germany.
AstraZeneca AB., Mariehemsvagen 8, SE-906 56, Umea, Sweden.
AstraZeneca AB., Gartunavagen, SE-151 85, Södertälje, Sweden.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.

POM

PL No: 20636/2417

Leaflet revision and issue date (Ref) 13.09.12[2]
Plendil is a trade mark of the AstraZeneca AB.

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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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