Fenofibrate micronised 200mg capsules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Fenofibrate micronised

Verfügbar ab:

Sun Pharma UK Ltd

ATC-Code:

C10AB05

INN (Internationale Bezeichnung):

Fenofibrate micronised

Dosierung:

200mg

Darreichungsform:

Oral capsule

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02120000; GTIN: 5015525063329

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENOFIBRATE 200 MG CAPSULES
FENOFIBRATE 267 MG CAPSULES
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 any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fenofibrate Capsules are and what they are used for
2.
What you need to know before you take Fenofibrate Capsules
3.
How to take Fenofibrate Capsules
4.
Possible side effects
5.
How to store Fenofibrate Capsules
6.
Contents of the pack and other information
1.
WHAT FENOFIBRATE CAPSULES ARE AND WHAT THEY ARE USED FOR
Fenofibrate
Capsules belong to a group of medicines, commonly known as
‘fibrates’. These medicines are
used to lower the level of fats (lipids) in the blood. For example the
fats known as ‘triglycerides’.
Fenofibrate Capsules are used, alongside a low fat diet and other
non-medical treatments such as exercise
and weight loss, to lower levels of fats in the blood.
Fenofibrate
Capsules can be used in addition to other medicines (called
‘statins’) in some circumstances
when levels of fats in the blood are not controlled with a statin
alone.
Fenofibrate Capsules can often also increase the amount of a
‘good’ type of cholesterol, called HDL or high
density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment
with Fenofibrate Capsules.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENOFIBRATE CAPSULES
DO NOT TAKE FENOFIBRATE CAPSULES IF:

You are allergic
to fenofibrate, or any of the other ingredients of this medicine
(listed in section 6). An
allergic reaction can include r

Fachinformation

OBJECT 1
FENOFIBRATE 200 MG CAPSULES
Summary of Product Characteristics Updated 11-May-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Fenofibrate 200 mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 200 mg micronised fenofibrate.
Excipients with known effect:
Each capsule contains 46.34 mg lactose monohydrate. This capsule also
contains sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Hard Capsule
Orange cap/orange body, self locked hard gelatin capsules of size '0'
imprinted with 'FB200' on cap and
body containing white to off white granular powder.
4. Clinical particulars
4.1 Therapeutic indications
Fenofibrate is indicated as an adjunct to diet and other
non-pharmacological treatment (e.g. exercise,
weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL
cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not
tolerated.
- Mixed hyperlipidaemia in patients at high cardiovascular risk in
addition to a statin when triglycerides
and HDL cholesterol are not adequately controlled.
4.2 Posology and method of administration
Dietary measures initiated before therapy should be continued.
Response to therapy should be monitored
by determination of serum lipid values. If an adequate response has
not been achieved after several
months (e.g. 3 months), complementary or different therapeutic
measures should be considered.
Posology
_Adults: _
The recommended dose is 200 mg daily administered as one capsule of
Fenofibrate 200 mg. The dose can
be titrated up to 267 mg daily administered as one capsule of
Fenofibrate 267 mg or 4 capsules of
Fenofibrate 67 mg, if required. This maximum dose is not recommended
in addition to a statin.
Special populations
_Elderly patients (≥ 65 years old):_
No dose adjustment is necessary. The usual dose is recommended, except
for decreased renal function
with estimated glomerular filtration rate < 60 mL/min