Neofel XL 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Felodipine

Available from:

Kent Pharma (UK) Ltd

ATC code:

C08CA02

INN (International Name):

Felodipine

Dosage:

10mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5060003784326

Patient Information leaflet

170mm
500mm
Neofel PIL
Size: 170 x 500mm
Package leaflet: Information for the patient
NEOFEL XL 2.5, 5 & 10 MG PROLONGED RELEASE TABLETS
(FELODIPINE)
The name of this medicine is Neofel XL Prolonged Release Tablets
(felodipine), which will be referred to as
Neofel XL throughout this leaflet.
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 further questions, please ask your doctor or your
pharmacist.
• 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 or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
1. WHAT NEOFEL XL ARE AND WHAT THEY ARE USED FOR
The active ingredient in Neofel XL is felodipine which is one of a
group of medicines called dihydropyridine
calcium antagonists. These work by blocking the entry of calcium into
muscle cells. Neofel XL (felodipine)
affects the muscle in blood vessels more than other muscles. It causes
a relaxation of the muscle and a
widening of the blood vessels. As the blood vessels get wider, blood
pressure falls and the heart does not
need to work so hard to pump blood around the body, reducing the risk
of angina.
Neofel XL is used to treat high blood pressure (hypertension) and
prevent attacks of angina (a painful
condition where there is a lack of blood and oxygen to the heart). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOFEL XL
DO NOT TAKE NEOFEL XL:
• If you are PREGNANT, planning to become pregnant or you suspect
you are pregnant
• 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 had a HEART ATTACK (myocardial infarction) within the
last 4 weeks
• If you SUFFER FROM SEVERE CHEST PAIN DUE TO A LACK OF BLOOD AND

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Neofel XL 10mg Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neofel XL 10 mg Prolonged Release Tablets contain 10mg of felodipine.
3
PHARMACEUTICAL FORM
Reddish brown, round, biconvex, film coated prolonged-release tablets
with
imprint 10.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In_ _the management of hypertension and prophylaxis of chronic stable
angina
pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken in the morning and be swallowed with
water. In
order to keep the prolonged release properties, the tablets must not
be divided,
crushed or chewed. The tablets can be administered without food or
following
a light meal not rich in fat or carbohydrate._ _
Hypertension
The dose should be adjusted individually. Treatment can be started
with 5 mg
once daily. Depending on the patient’s response, the dosage can,
where
applicable, be decreased to 2,5 mg or increased to 10 mg daily. If
necessary
another antihypertensive agent may be added. The standard maintenance
dose
is 5 mg once daily.
Angina pectoris
The dose should be adjusted individually. Treatment should be
initiated with 5
mg once daily and, if needed, increased to 10 mg once daily.
_ _
Elderly population
Initial treatment with lowest available dose should be considered.
Renal Impairment
Dose adjustment is not needed in patients with impaired renal
function.
Hepatic Impairment
Patients
with
impaired
hepatic
function
may
have
elevated
plasma
concentrations of felodipine and may respond to lower doses (see
section 4.4
Special warnings and precautions for use).
_ _
Paediatric Population
There
is
limited
clinical
trial
experience
of
the
use
of
felodipine
in
hypertensive paediatric patients, see sections 5.1 and 5.2.
Neofel XL 10 mg Prolonged Release Tablets can be used in combination
with
β
-blockers, ACE inhibitors or diuretics. The effects on blood pressure
are
likely
to
be
additive
and
combination
therapy
will
usually
enhance
the
ant