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FELOGEN XL 5MG PROLONGED RELEASE TABLETS

Active substance(s): FELODIPINE

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Read all of this leaflet carefully before you start
taking using 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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In this leaflet:
1. What Felogen XL is and what it is used for.
2. Before you take Felogen XL.
3. How to take Felogen XL.
4. Possible side effects.
5. How to store Felogen XL.
6. Further information.
1. WHAT FELOGEN XL IS AND WHAT IT IS USED FOR

Taking other medicines
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other
medicines. This includes herbal medicines and
medicines that you buy without a prescription.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• Cimetidine (for ulcers)
• Erythromycin (for bacterial infections)
• Itraconazole or ketoconazole (for fungal
infections)
• HIV protease inhibitors (such as ritonavir)
• Phenytoin, carbamazepine or phenobarbital (for
epilepsy)
• Tracrolimus (used after kidney or liver transplant)
• Rifampicin (used for treatment of tuberculosis)
• St John's Wort (Hypericum perforatum) (used to
treat depression and anxiety)
• Barbiturates ( a sedative)
• Efavirenz or Nevirapine (used to treat HIV)
• Warfarin (used to thin the blood)
• Ciclosporin (mainly used by transplant patients
but also used to treat rheumatoid arthritis and
psoriasis).

Felogen XL is in the form of a 'prolonged release'
film-coated tablet. This means that the tablet has
an effect for a long time after taking it, so that it
only needs to be taken once a day. It contains
felodipine which belongs to a group of medicines
called calcium channel blockers. They allow the
blood vessels in the body and heart to relax and
widen, allowing more blood to flow to the heart
and around the body. Felogen XL is used to treat
high blood pressure (hypertension).

Taking Felogen XL with food and drink
Do not drink grapefruit juice when you are taking
this medicine. This can increase the effect of
Felogen XL. Do not take this medicine with fatty
foods. This can alter the effect of Felogen XL.

2. BEFORE YOU TAKE FELOGEN XL

If you are breast-feeding, talk to your doctor
before taking Felogen XL.

Do not take Felogen XL if:
• you are allergic (hypersensitive) to felodipine or
any of the ingredients in Felogen XL
(see Section 6: Further information)
• you are allergic to dihydropyridine medicines
(such as nifedipine or amlodipine)
• you have something called unstable angina
(angina that is not well controlled by medical
treatment)
• you have severe heart problems
• you have had a heart attack in the last month
• you have something called cardiogenic shock
(a serious condition where the heart is unable to
supply enough blood to the body)
• you are pregnant or trying to get pregnant (see
Pregnancy and breastfeeding below).
Do not take Felogen XL if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist.
Take special care with Felogen XL
Before you take Felogen XL, tell your doctor if:
• you have liver problems

Elderly (over 65 years)
Your doctor will give you the lowest possible dose
and monitor you closely.

Driving and using machines
Do not drive or operate machinery if you feel less
alert while taking this medicine. This is more likely
at the start of treatment, if your doctor increases
your dose or you have been drinking alcohol.
Important information about some of the
ingredients of Felogen XL
This medicine contains lactose, which is a type of
sugar. If you have been told by your doctor that
you are intolerant to some sugars, talk to your
doctor before taking this medicine.
3. HOW TO TAKE FELOGEN XL
Always take Felogen XL as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
Swallow the tablets whole with a full glass of
water. The tablets may be taken on an empty
stomach or with a light meal not high in fat or
carbohydrates (sugar).
Do not divide, chew or crush the tablets. LT1392AB

Rare (affects less than 1 in 1, 000 people)
• fainting
• being sick
• pain in joints
• pain in muscles
• being unable to get an erection (impotence)
• lumpy rash (hives).

Children (under 18 years)
There is limited experience with the use of Felogen
XL in children (below the age of 18 years). Therefore
Felogen XL should not be given to children.

Very rare (affects less than 1 in 10,000 people)
• enlarged gums (if you already have enlarged
gums they may get worse. You can prevent this
by careful dental hygiene)
• increased levels of liver enzymes
• skin inflammation
• sensitivity of sunlight
• passing water (urine) more often, normally
during the daytime
• allergic reaction (anaphylaxis i.e. swelling of your
face, lips, mouth, tongue or throat, fever).

If you take more Felogen XL than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the container and any
remaining tablets with you. Symptoms of overdose
include low blood pressure and slow heart beat.

You may get any of the following side effects at
the beginning of treatment or if your dose has
been increased:
• flushing, headaches, faster or pounding
heartbeat, feeling dizzy or tired.

If you forget to take Felogen XL
Take the next dose as soon as you remember
unless it is almost time for your next dose. Do not
take a double dose to make up for a forgotten dose.

Do not be alarmed by this list of possible side effects.
You may not get any of them. If any of the side
effects get serious, or you notice any side effects
not listed in this leaflet, please tell your doctor or
pharmacist.

If you stop taking Felogen XL
Do not stop taking your medicine as it may cause
serious changes in your blood pressure.

5. HOW TO STORE FELOGEN XL

Patients with liver problems
If you suffer from liver problems your doctor may
give you a lower dose of Felogen XL.

Pregnancy and breast-feeding
Do not take Felogen XL if you are pregnant or
trying to get pregnant. This is because Felogen XL
can harm your unborn baby.

• dizziness
• feeling tired.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Felogen XL can cause side
effects, although not everyone gets them.
If any of the following happen to you, stop taking
Felogen XL and tell your doctor straight away:
• Chest pain and dizziness at the same time.
• An allergic reaction. The signs may include raised
lumps on your skin (weals) or swelling on your
face, lips, mouth, tongue and throat.
Other possible side effects:
Very common (affect more than 1 in 10 people):
• swelling of the feet and ankles.
Common (affects less than 1 in 10 people)
• headaches
• flushing of your skin
Uncommon (affects less than 1 in 100 people)
• faster heartbeat
• pounding heartbeat (palpitations)
• pins and needles feeling in your toes and fingers
• stomach pain
• feeling sick (nausea)
• rash
• itching

Keep out of the reach and sight of children. Do not
store your tablets above 25˚C. Do not use Felogen XL
after the expiry date which is stated on the carton
after 'EXP'. 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 Felogen XL contains
The active substance is felodipine. Each tablet
contains 5 mg or 10 mg felodipine. The other
ingredients are lactose monohydrate,
microcrystalline cellulose, hypromellose, povidone,
propyl gallate, colloidal anhydrous silica, magnesium
stearate, iron oxide red (E172), iron oxide yellow
(E172), titanium dioxide (E171), talc, propylene glycol.
What Felogen XL looks like and the contents of
the pack
The 5 mg tablets are light pink, round, marked '5'.
The 10 mg tablets are reddish-brown, round,
marked '10'. Felogen XL is available in blister packs
of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Date of revision: November 2012

LT1392AB 10003619

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(Felodipine)

The usual dose is:
Adults
The usual starting dose is 5 mg once a day in the
morning. After 2 weeks or more, your doctor may
increase the dose to 10 mg once a day.
If necessary, your doctor may also prescribe you
other antihypertensive medicines to reduce your
blood pressure further (such as a beta-blocker or
diuretic). The maximum daily dose is 10 mg a day.

• you have heart problems (i.e. faster heart beats,
high and/or low blood pressure).

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FELOGEN XL 5 mg
PROLONGED-RELEASE
TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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