FELOTENS XL 2.5MG PROLONGED RELEASE TABLETS

Active substance: FELODIPINE

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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 XL Tablets 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 XL Tablets
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 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. 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 XL Tablets
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.
Please read the back of this leaflet.
*Trademark

24986401

GEN/FLT/PIL/253_04
25/02/2014

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:
Common:

Uncommon:

Rare:

Very rare:

Not known:

In more than 1 in 10 patients
treated
In less than 1 in 10, but
more than 1 in 100 patients
treated
In less than 1 in 100, but
more than 1 in 1,000
patients treated
In less than 1 in 1,000, but
more than 1 in 10,000
patients treated
In less than 1 in 10,000
patients treated, including
single reports
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.

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, filmcoated prolonged-release tablet with imprint 2.5.
Felotens XL 5mg: Light pink, round, biconvex, filmcoated 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
PL 06831/0226
PL 06831/0227

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

Marketing Authorisation Holder and
Manufacturer
MA holder:
Genus Pharmaceuticals,
Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.
Manufacturer:
STADA Arzneimittel AG,
Stadastraße 2-18,
D-61118 Bad Vilbel,
Germany.
This leaflet was last revised in February 2014

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: 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 Felotens XL Tablets
Keep out of the reach and sight 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.

*Trademark

24986401

GEN/FLT/PIL/253_04
25/02/2014

MHRA Header Box
Product
Title

Felotens XL 2.5mg,
5mg & 10mg Tablets Genus

Colours used

Component

Leaflet

Pack Size

28's

Helvetica Nar Bold

IG code

24986401

Optima

Dimensions

150 x 420mm

Proof No.

04

Black

Date

25/02/2014

Fonts used
Helvetica Nar Plain

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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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