Bezalip Mono 400mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bezafibrate

Available from:

Teva UK Ltd

ATC code:

C10AB02

INN (International Name):

Bezafibrate

Dosage:

400mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5012617017482

Patient Information leaflet

MOCK UP
ONLY
Bezafibrate 400 mg All Pack Sizes, PIL, United Kingdom
item no: AAAJ0781
print proof no: 04
origination date: 06/06/16
originated by: C.Grant
revision date: 28/06/16
revised by: C.Grant
dimensions: 148 x 297
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.
2.
3.
4.
5.
6.
1. Profile Info
2.
3.
date sent: 06/06/16
supplier: Cenexi SAS
technically app. date: 13/06/16
min pt size: 9pts
TECHNICAL APPROVAL
Black
148x297 (2 pages)
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 BEZALIP MONO IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BEZALIP MONO
3 HOW TO TAKE BEZALIP MONO
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE BEZALIP MONO
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT BEZALIP MONO IS AND WHAT IT IS
USED FOR
Bezalip Mono belongs 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.
Bezalip Mono is 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.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BEZALIP MONO
DO NOT TAKE Bezalip Mono:
• if you are ALLERGIC (hypersensitive) to bezafibrate
or any of the other ingredients in the tablets (see
section 6).
• if you are ALLERGIC (hypersensitive) to fibrates or
have developed a sensitivity to sunlight or artificial
light (e.g. sunbeds) when taking these medicines.
• if you ar

Summary of Product characteristics

BEZALIP MONO 400MG TABLETS
Summary of Product Characteristics Updated 13-Oct-2016 | Actavis UK
Ltd
1. Name of the medicinal product
Bezalip Mono
Calberzol XL 400mg Prolonged-release Tablets
2. Qualitative and quantitative composition
Each tablet contains 400mg of bezafibrate.
Excipients with known effect
Each 400mg tablet contains 51 mg lactose, as monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified release tablet for oral use.
Bezalip Mono is a round film-coated tablet with a white core and is
imprinted D9.
4. Clinical particulars
4.1 Therapeutic indications
Bezalip Mono 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.
4.2 Posology and method of administration
Posology
_ADULTS_
The dosage for Bezalip Mono is one tablet daily, equivalent to 400mg
bezafibrate. The tablets should be
swallowed whole with sufficient fluid after a meal either at night or
in the morning.
_PAEDIATRIC POPULATION_
At present there is inadequate information regarding an appropriate
dosage in children.
_ELDERLY_
Bezafibrate prolonged-release tablets should not be used in elderly as
the creatinine clearance after 70
years of age is normally lower than 60ml/min.
_RENAL IMPAIRMENT_
In dialysis patients the use of Bezafibrate 400mg prolonged release
tablets is contraindicated.
Bezalip Mono is contra-indicated in patients with renal impairment
with serum creatinine > 135
micromol/l or creatinine clearance < 60ml/min. Such patients may be
treated with conventional Bezalip
tablets (200mg bezafibrate) using an appropriately reduced daily
dosage.
For patients with a history of gastric sensitivity, the dosage may be
gradually increased over 5-7 days to
the maintenance level.
The response to therapy is normally rapid, although a progressive
improvement may occur over a number
of