P042053

Package leaflet: Information for the patient

Plendil 2.5 mg prolonged-release tablets Plendil 5 mg prolonged-release tablets Plendil 10 mg prolonged-release tablets

felodipine

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.    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 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 if 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 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 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. Very common: may affect more than 1 in 10 people

•    Ankle swelling

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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    ¹--— — — — — — —

•    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. Website: 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

This medicine does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after ‘EXP'. The expiry date refers to the last day of that month.

Do not use this medicine if you notice the packaging is torn or damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Plendil contains

•    The active substance is felodipine. Each tablet contains 2.5 mg (or 5 mg or 10 mg) of felodipine.

•    The other ingredients are:

Tablet core:

Hydroxypropylcellulose Hypromellose 50 mPa-s Hypromellose 10000 mPa-s Lactose anhydrous Macrogolglycerol hydroxystearate Microcrystalline cellulose Propyl gallate

Sodium aluminium silicate Sodium stearyl fumarate Tablet coating:

Carnauba wax

Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg)

Iron oxide yellow (E172)

Hypromellose 6 mPa-s Macrogol 6000 Titanium dioxide (E171)

What Plendil looks like and contents of the pack

Plendil 2.5 mg prolonged-release tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.

Plendil 5 mg prolonged-release tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm.

Plendil 10 mg prolonged-release tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9 mm.

Pack sizes prolonged-release tablets 2.5 mg 20 tablets (blister pack)

28 tablets (blister pack with days of the week printed)

30 tablets (blister pack and plastic bottle)

50 tablets (unit-dose pack)

98 tablets (blister pack with days of the week printed)

100 tablets (blister pack and plastic bottle)

500 tablets (plastic bottle for dose dispensing)

Pack sizes prolonged-release tablets 5 mg 14 tablets (blister pack with days of the week printed)

20 tablets (blister pack)

28 tablets (blister pack with days of the week printed)

30 tablets (blister pack and plastic bottle)

50 tablets (unit-dose pack)

90 tablets (blister pack)

98 tablets (blister pack with days of the week printed)

100 tablets (blister pack and plastic bottle)

500 tablets (plastic bottle for dose dispensing)

Pack sizes prolonged-release tablets 10 mg 14 tablets (blister pack with days of the week printed)

20 tablets (blister pack)

28 tablets (blister pack with days of the week printed)

30 tablets (blister pack and plastic bottle)

50 tablets (unit-dose pack)

90 tablets (blister pack)

98 tablets (blister pack with days of the week printed)

100 tablets (blister pack, plastic bottle and plastic bottle for dose dispensing)

500 tablets (plastic bottle for dose dispensing)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Plendil is held by:

AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UK

Plendil is manufactured by:

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK102NA

UK

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, United Kingdom: Plendil

France: Flodil Germany: Modip Portugal: Preslow

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name    Reference number

Plendil    2.5 mg tablets    17901/0156

Plendil    5 mg tablets    17901/0157

Plendil    10 mg tablets    17901/0155

This is a service provided by the Royal National Institute

of the Blind.

This leaflet was last revised in August 2016.

© AstraZeneca 2016

Plendil is a trade mark of the AstraZeneca group of companies.

CV 16 0045

AstraZeneca

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P042053