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PLENDIL 5MG TABLETS

Active substance(s): FELODIPINE / FELODIPINE

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Plendil® 5 mg Tablets

2720
09.06.17[7]

(felodipine)
PATIENT INFORMATION 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.
The name of your medicine is Plendil 5 mg Tablets but will be referred to as
Plendil throughout this leaflet. Other strengths are also available.
What is in this leaflet
1. What Plendil is and what it is used for
2. What you need to know before you take Plendil
3. How to take Plendil
4. Possible side effects
5. How to store Plendil
6. Contents of the pack and other information
1. WHAT PLENDIL IS AND WHAT IT IS USED FOR
Plendil contains the active substance called 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).
Children
The use of Plendil is not recommended in children.
Other medicines and Plendil
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 while you are treated with Plendil, as this may
increase the effect of Plendil and the risk of side-effects.
Pregnancy and breast-feeding
Pregnancy
Do not take 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 castor oil
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 castor oil, which may cause stomach upset and diarrhoea.
3. HOW TO TAKE PLENDIL
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.
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.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by AstraZeneca AB., S-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 20636/2720

Leaflet revision and issue date (Ref) 09.06.17[7]

Very common: may affect up to 1 in 10 people
- Ankle swelling

Plendil is a trademark of the AstraZeneca AB.

Common: may affect less than 1 in 10 people
- Headaches
- Flushing

Blind or partially sighted?
Is this leaflet hard to see or read? Call
020 8423 2111 to obtain the leaflet in
a format suitable for you.

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. 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 this medicine after the expiry date shown on the label.
- Do not store above 30°C.
- 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Plendil contains
Each tablet contains 5 mg felodipine.
The other ingredients are:
Tablet core
Hyprolose, hypromellose 2506/50, hypromellose 2506/10000, lactose
anhydrous, macrogolglycerol hydroxystearate, microcrystalline cellulose,
propyl gallate, sodium aluminium silicate, sodium stearyl fumarate,
Tablet coating
carnauba wax, iron oxide reddish-brown (E172), iron oxide yellow (E172),
hypromellose 2910/6, macrogol 6000, titanium dioxide (E171).
What Plendil looks like and contents of the pack
Pink circular biconvex tablets marked with ‘A FM’ on one side and ‘5’ on the
other side.
Plendil is available in bottles of 30 tablets

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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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