PACKAGE LEAFLET: INFORMATION FOR THE USER

Felotens XL 2.5mg, 5mg and 10mg Prolonged-release Tablets

Active ingredient: Felodipine

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.

In this leaflet:

1.    What Felotens XL Tablets are and what they are used for

2.    Before you take Felotens XL Tablets

3.    How to take Felotens XL Tablets

4.    Possible side-effects

5.    How to store Felotens XL Tablets

6.    Further information

1.    What Felotens XL Tablets are and what they are used for

Felotens XL Tablets belong to a group of medicines called dihydropyridine-type calcium channel blockers. These work by relaxing the smooth muscle in the blood vessel walls and opening the blood vessels. This then lowers the blood pressure.

Felotens XL Tablets are used to:

-    treat patients with high blood pressure (essential hypertension).

2.    Before you take Felotens XL Tablets DO NOT take Felotens XL Tablets if you:

-    are allergic (hypersensitive) to felodipine, other similar compounds (dihydropyridine-type calcium channel blockers) or any of the other ingredients in the tablets (see section 6. "Further information" at the end of this leaflet)

-    have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

-    have a very low pulse and blood pressure (cardiogenic shock)

-    have severe narrowing (stenosis) of the heart valves (mitral or aortic valve)

-    suffer from an enlarged heart muscle (obstructive hypertrophic cardiomyopathy)

-    get chest pain (unstable angina pectoris)

-    have suffered a heart attack within the last two months

-    have untreated and/or decompensated heart failure, causing swelling of the extremities, weakness, and shortness of breath

-    have severely reduced liver function

-    are or may be pregnant

-    suffer from acute porphyria (a disease that causes stomach problems and discolouration of the urine).

Take special care with Felotens XL Tablets if you:

-    have severely reduced kidney function

- have mild to moderate reduced liver function

-    suffer with stable heart failure

-    suffer with fast heartbeat (tachycardia)

- suffer with narrowing (stenosis) of the heart valves (mitral or aortic valve)

-    have conduction disturbances in the heart (e.g. 2nd or 3rd degree atrioventricular block).

Felodipine could cause an extensive fall in blood pressure resulting in fast heartbeat (tachycardia). This may lead to a restriction in blood supply (myocardial ischaemia) and stroke in sensitive patients.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, or natural products.

Especially:

-    other medicines that lower blood pressure such as hydrochlorothiazide, beta blockers (to treat high blood pressure), nitrates (to control coronary heart disease and chest pain) or tricyclic antidepressants (to treat depression)

-    amiodarone, diltiazem or verapamil (to treat heart problems)

-    digoxin (to treat heart failure)

-    fluconazole, itraconazole, ketoconazole, miconazole, or voriconazole (to treat fungal or yeast infections)

-    erythromycin, clarithromycin, or telithromycin (macrolide antibiotics)

-    rifampicin (to treat tuberculosis)

-    ciclosporin, tacrolimus (to suppress immune system e.g. after organ transplantation)

-    phenobarbital, phenytoin, or carbamazepine (to treat epilepsy)

-    cimetidine (to treat heartburn and stomach ulcers)

-    nevirapine, ritonavir, sakinavir (to treat HIV infection)

-    herbal medicines containing St. John's wort (Hypericum perforatum).

Taking Felotens XLTablets with food and drink

Take Felotens XL Tablets on an empty stomach or with a light meal. The tablets should not be taken with a high fat meal.

Do not drink grapefruit juice during treatment with Felotens XL Tablets as this may make the tablets work too strongly. If you have any questions, please ask your doctor.

Pregnancy and breast-feeding

Felodipine must not be taken during the whole pregnancy. If you think you are pregnant, plan to get pregnant or become pregnant while using Felotens XL Tablets stop using the medicine immediately and consult your doctor as soon as possible.

Felodipine is excreted in breast milk, therefore the use of Felotens XL Tablets is not recommended whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Felotens XL Tablets can cause dizziness or tiredness. These effects are more likely to occur at the start of treatment, after dose increases, or after taking alcohol at the same time. If you are affected, do not drive or operate machinery.

Important information about some of the ingredients of Felotens XLTablets

This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Felotens XLTablets

Always take Felotens XL Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

The usual doses are described below.

Adults Initially, 5mg once daily. If needed, the doctor may increase the dose to 10mg daily or may prescribe an additional medicine to lower blood pressure. The maximum daily dose is 10mg felodipine.

Elderly The doctor will decide your starting dose.

Children Not recommended.

Taking the tablets

•    Swallow these tablets whole at the same time of the day (e.g. in the morning) with a glass of water. Do not crush or chew them.

•    Do NOT take the tablets with grapefruit juice, as this may make Felotens XL Tablets work too strongly.

•    Take the tablets on an empty stomach or with a light meal. The tablets should not be taken with a high fat meal.

•    Take this medicine for as long as your doctor tells you to. It may be dangerous to stop without your doctor's advice.

If you take more Felotens XL Tablets than you should

Do not take more tablets than your doctor tells you to. If you ever take too many, go to the nearest hospital casualty department or tell your doctor immediately. Take the container and any remaining tablets with you to show to the doctor. An overdose may lead to light-headedness, fainting and dizziness caused by very low blood pressure and in rare cases slowed heartbeat (bradycardia).

If you forget to take Felotens XL Tablets

If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take two doses at the same time to make up for a forgotten dose. If you are worried, ask your pharmacist or doctor for advice.

If you stop taking Felotens XLTablets

Do not stop treatment early because felodipine can be associated with withdrawal symptoms.

Please read the back of this leaflet.

trademark    24986402    GENUS PHARMACEUTICALS

GEN/FLT/PIL/331_02

5.    How to store Felotens XLTablets

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not take Felotens XL after the expiry ("use before") date, which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Felotens XL contains

-    The active substance is felodipine.

-    Each 2.5mg prolonged-release tablet contains 2.5mg of felodipine.

-    Each 5mg prolonged-release tablet contains 5mg of felodipine.

-    Each 10mg prolonged-release tablet contains 10mg of felodipine.

-    The other ingredients in the tablet core are:

•    lactose monohydrate

(2.5mg tablet contains 25.2mg lactose;

5mg tablet contains 22.75mg lactose;

10mg tablet contains 20.38mg lactose)

•    microcrystalline cellulose

•    hypromellose

•    povidone

•    propyl gallate

•    colloidal anhydrous silica

•    magnesium stearate.

-    The other ingredients in the film coating are:

•    hypromellose

•    titanium dioxide (E171)

•    red and yellow iron oxide (E172)

•    talc

•    propylene glycol

What Felotens XL 2.5mg, 5mg and 10mg Prolonged-release Tablets look like and the contents of the pack

Felotens XL 2.5mg: Yellow, round, biconvex, film-coated prolonged-release tablet with imprint 2.5. Felotens XL 5mg: Light pink, round, biconvex, film-coated prolonged-release tablet with imprint 5. Felotens XL 10mg: Reddish brown, round, biconvex, film-coated prolonged-release tablet with imprint 10.

Blister packs with pack sizes of: 10,14,20, 28, 30, 50, 56, 60, 90, 98,100, 250, 500 and 1000 prolonged-release tablets.

Not all pack sizes may be marketed.

POM

PL 06831/0225    Felotens XL 2.5mg

Prolonged-release Tablets P L 06831 /0226    Felotens XL 5mg

Prolonged-release Tablets PL 06831/0227    Felotens XL 10mg

Prolonged-releaseTablets

Marketing Authorisation Holder and

Manufacturer

MA holder:

Genus Pharmaceuticals,

Linthwaite,

Huddersfield, HD7 5QH,

UK.

Manufacturer:

STADA Arzneimittel AG,

StadastraGe 2-18,

D-61118 Bad Vilbel,

Germany.

Centrafarm Services B.V.,

Nieuwe Donk 9,

4879 AC Etten-Leur,

Netherlands.

This leaflet was last revised in April 2015

GENUS PHARMACEUTICALS * Trademark    24986402

GEN/FLT/PIL/331_02 23/04/2015