FELOTENS XL 5 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

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 XLTablets 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 XLTablets are used to:

• – treat patients with high blood pressure (essential hypertension).

• 2. Before you take Felotens XLTablets
  
  DO NOT take Felotens XLTablets 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, contactyour 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 twomonths

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

• – have severely reduced liver function

• – areormaybepregnant

• – suffer from acute porphyria (a disease that causes stomach problems and discolouration of theurine).

Take special care with Felotens XLTablets 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 XLTablets 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 breastmilk, 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). Ifyou 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.Thema­ximumdaily dose is 10mg felodipine.

Elderly The doctor will decide your starting dose.

Children Notrecommended.

Taking the tablets

• Swallow these tablets whole at the same time of the day (e.g. in the morning) with a glass of water. Donotcrushorchew­them.
• Do NOT take the tabletswith 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 withoutyour doctor's advice.

If you take more Felotens XLTablets 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 XLTablets

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.

Please read the back of ths leaflet.

S'

Very common:	In more than 1 in 10 patients treated
Common:	In less than 1 in 10, but more than 1 in 100 patients treated
Uncommon:	In less than 1 in 100, but more than 1 in 1,000 patients treated
Rare:	In less than 1 in 1,000, but more than 1 in 10,000 patients treated
Very rare:	In less than 1 in 10,000 patients treated, including single reports
Not known:	frequency cannot be estimated from the available data

Stop taking Felotens XL Tablets and contact your doctor if you have an allergic reaction such as swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing.

Tell your doctor if you notice any of the following side-effects.

Very common:

• – headache

• – tinnitus (ringing or buzzing in the ears)

• – flushing.

These effects are more likely to occur at the start of treatment or after dose increases and may settle with continued use.

Common:

• – chest pain (angina pectoris) or worsening (increase in frequency, duration and severity) of chest pain in patients with pre-existing angina pectoris. This is more likely at the beginning of treatment

• – swelling of extremities (in particular the ankles, the degree of ankle swelling is dose related).

Uncommon:

• – pins and needles (paraesthesia)

• – dizziness

• – fatigue

• – restlessness

• – palpitations

• – fast heartbeat (tachycardia)

• – very low blood pressure (hypotension)

• – fainting (syncope)

• – shortness of breath (dyspnoea)

• – gastrointestinal complaints (e.g. feeling sick (nausea) or being sick (vomiting), diarrhoea, constipation, stomach pain)

• – skin and hypersensitivity reactions such as itching skin (pruritus), hives (urticaria), rash (exanthema)

• – sensitivity to light (photosensiti­zation)

• – increased sweating

• – joint or muscle pain (myalgia and arthralgia)

• – tremors

• – weight gain.

Rare:

• – palpable, normally painful purple colouration of the skin (cutaneous vasculitis, very rarely leucocytoclastic vasculitis).

• – rash and/or itching skin

• – erection disorders or impotence

• – inflammation or swelling of the gums (gum hyperplasia and gingivitis)

• – increased need to pass urine (pollakiuria)

• – fever.

Very rare:

• – heart attack (myocardial infarction)

• – liver function problems seen as raised transaminase levels in blood tests

• – scaling skin reactions (exfoliative dermatitis)

• – erection disorders

• – enlargement of breast tissue in males (gynecomastia)

• – heavy menstruation (menorrhagia)

• – angio-oedema (serious allergic reaction which causes swelling of the face or throat).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide more information on safety of this medicine.

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 how to 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

PL 06831/0226 Felotens XL 5mg

Prolonged-release Tablets

PL 06831/0227 Felotens XL 10mg

Prolonged-release Tablets

Marketing Authorisation Holder and Manufacturer

MA holder:

Genus Pharmaceuticals,

Linthwaite,

Huddersfield, HD7 5QH, UK.

Manufacturer:

STADA Arzneimittel AG,

StadastraBe 2–18,

D-61118 Bad Vilbel,

Germany.

This leaflet was last revised in

November 2016

£

GENUS PHMMACBJTKAiS

MHRA Header Box

Product Title	Felotens XL 2.5mg, 5mg and 10mg Prolonged-release Tablets			i
Component	Leaflet			c
Pack Size	28s
IG Code	20020201
Dimensions	150mm x 420mm
Proof No.	2	Date	22.12.2016

			cn
Colours Used		Fonts Used	vavu
■	Process Black	Helvetica
2	Keyline (non-printing)	Helvetica Neue
		Optima

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 XLTablets

• 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 XLTablets are used to:

• – treat patients with high blood pressure (essential hypertension).

• 2. Before you take Felotens XLTablets

DO NOT take Felotens XLTablets ifyou:

• – 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 ofbreath

• – 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).

Takespecial carewith Felotens XLTablets ifyou:

• – 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 XLTablets 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). Ifyou 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 xl tablets

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.Thema­ximumdaily 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. Donotcrushorchew­them.
• 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 XLTablets 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).

Ifyou forget to take Felotens XLTablets

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.

Please read the back of this leaflet.

Trademark 24986402 GENUS PHAHMACEUnCAlS

06–05–13 09:07

Ifyou stop taking Felotens XLTablets

Do not stop treatment early because felodipine can be associated with withdrawal symptoms. If you stop taking the tablets too quickly you may develop high blood pressure again. Talk to your doctor before you stop taking the tablets and follow the advice.

• 4. Possible side-effects

Like all medicines, Felotens XL Tablets may cause side-effects, although not everyone gets them. Evaluation of the side-effects is based on the following frequencies:

Very common:	In more than 1 in 10patients treated
Common:	In less than 1 in10, but more than 1 in100 patients treated
Uncommon:	In less than 1 in 100, but more than 1 in 1,000 patients treated
Rare:	In less than 1 in 1,000, but more than 1 in 10,000 patients treated
Very rare:	In less than 1 in 10,000 patients treated, including single reports
Not known:	frequency cannot be estimated from the available data

Stop taking Felotens XL Tablets and contact your doctor if you have an allergic reaction such as swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing.

Tell your doctor if you notice any of the following side-effects.

Very common:

• – headache

• – tinnitus (ringing or buzzing in the ears)

• – flushing.

These effects are more likely to occur at the start of treatment or after dose increases and may settle with continued use.

Common:

• – chest pain (angina pectoris) or worsening (increase in frequency, duration and severity) of chest pain in patients with pre-existing angina pectoris. This is more likely at the beginning of treatment

• – swelling of extremities (in particular the ankles, the degree of ankle swelling is dose related).

Uncommon:

• – pins and needles (paraesthesia)

• – dizziness

• – fatigue

• – restlessness

• – palpitations

• – fast heartbeat (tachycardia)

• – very low blood pressure (hypotension)

• – fainting (syncope)

• – shortness of breath (dyspnoea)

• – gastrointestinal complaints (e.g. feeling sick (nausea) or being sick (vomiting), diarrhoea, constipation, stomach pain)

• – skin and hypersensitivity reactions such as itching skin (pruritus), hives (urticaria), rash (exanthema)

• – sensitivity to light (photosensiti­zation)

• – increased sweating

• – joint or muscle pain (myalgia and arthralgia) – tremors

• – weight gain.

Rare:

• – palpable, normally painful purple colouration of the skin (cutaneous vasculitis, very rarely leucocytoclastic vasculitis).

• – rash and/or itching skin

• – erection disorders or impotence

• – inflammation or swelling of the gums (gum hyperplasia and gingivitis)

• – increased need to pass urine (pollakiuria) – fever.

Very rare:

• – heart attack (myocardial infarction) – liver function problems seen as raised transaminase levels in blood tests

• – scaling skin reactions (exfoliative dermatitis)

• – erection disorders

• – enlargement of breast tissue in males (gynecomastia)

• – heavy menstruation (menorrhagia)

• – angio-oedema (serious allergic reaction which causes swelling of the face or throat).

Reporting of side effects

Ifyou get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: By reporting side effects you can help provide more information on safety of this medicine.

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 how to 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 offelodipine.

• – 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
• titaniumdioxi­de(E171)
• redandyellowi­ronoxide(E172)
• talc
• propylene glycol

What Felotens XL 2.5mg, 5mg and 10mg Prolonged-releaseTablets 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-releaseTablets

PL 06831/0226 Felotens XL 5mg

Prolonged-releaseTablets

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,

StadastraBe 2–18,

D-61118Bad Vilbel, Germany.

Centrafarm Services B.V.,

Nieuwe Donk 9,

4879AC Etten-Leur, Netherlands.

This leaflet was last revised in

May 2015

GENUS FHAHMACEUnatS

24986402

06–05–13 09:07

Centrafarm

MHRA Header Box

Product Title	Felotens XL 2.5mg, 5mg & 10mg prolonged release tablets
Component	Leaflet			■
Pack Size	28's
IG code	24986402
Dimensions	148mm x 420mm
Proof No.	04	Date	27/05/2015

Colours used	Fonts used
| Black	Helvetica 55 Roman
	Helvetica 75 Bold
	Optima