Fenofibrate micronised 160mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Fenofibrate micronised

Доступна с:

Genus Pharmaceuticals Ltd

код АТС:

C10AB05

ИНН (Международная Имя):

Fenofibrate micronised

дозировка:

160mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02120000; GTIN: 5030451003812

тонкая брошюра

* Trademark
_Please read the back of this leaflet._
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENOFIBRATE 160MG TABLETS
(FENOFIBRATE)
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 Fenofibrate Tablets are and what they are used for
2.
Before you take Fenofibrate Tablets
3.
How to take Fenofibrate Tablets
4.
Possible side-effects
5.
How to store Fenofibrate Tablets
6.
Further information
1.
WHAT FENOFIBRATE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Fenofibrate 160mg Tablets (hereafter
referred to as Fenofibrate
Tablets).
Fenofibrate Tablets 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 Tablets 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 Tablets can be used in addition to other medicines
[statins] in some circumstances
when levels of fats in the blood are not controlled with a statin
alone.
2.
BEFORE YOU TAKE FENOFIBRATE TABLETS
DO NOT TAKE FENOFIBRATE TABLETS:
•
if you are allergic to fenofibrate or any of the other ingredients of
Fenofibrate Tablets (see
Section 6 'What Fenofibrate Tablets contain')
•
if you have a liver disorder
•
if you have a kidney disorder or severe kidney problems
•
if you have known allergic reactions to light during treatment with
fenofibrate or ketoprofen
(an anti-inflammatory drug)
•
if you have gallbladder disease
•
if you have inflammation of the pancre

Характеристики продукта

OBJECT 1
FENOFIBRATE 160MG TABLETS
Summary of Product Characteristics Updated 21-Nov-2016 | Genus
Pharmaceuticals
1. Name of the medicinal product
Fenofibrate 160 mg Tablets.
2. Qualitative and quantitative composition
Fenofibrate 160mg
Each Fenofibrate 160 mg tablet contains 238.45mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to off-white oblong 15mm x 7mm tablet.
4. Clinical particulars
4.1 Therapeutic indications
Fenofibrate 160 mg Tablets are 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
Posology:
Adults: The recommended dose is one tablet containing 160 mg
fenofibrate taken once daily. Patients
currently taking one fenofibrate 200mg capsule can be changed to one
fenofibrate 160 mg tablet without
further dose adjustment.
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/1.73 m2 (see
_Patients with renal impairment_
_ _
_ _)
_ _.
Patients with renal impairment: Fenofibrate should not be used if
severe renal impairment, defined as
eGFR <30 mL/min per 1.73 m2, is present.
If eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of
Fenofibrate should not exceed 100mg
standard or 67 mg micronized once daily.
If, during follow-up, the eGFR decreases persistently to <30 mL/min
per 1.73 m2, Fenofibrate should be
discontinued.
Paediatric population: The safety and efficacy of fenofibrate in
children and adolescents younger than 18
years has not been established. No data are available. There