Bezalip 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bezafibrate

Available from:

Dowelhurst Ltd

ATC code:

C10AB02

INN (International Name):

Bezafibrate

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000

Patient Information leaflet

pharmacode
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
WHAT BEZALIP IS AND WHAT IT IS USED FOR
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BEZALIP
HOW TO TAKE BEZALIP
POSSIBLE SIDE EFFECTS
HOW TO STORE BEZALIP
CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT BEZALIP IS AND WHAT IT IS USED FOR
Bezalip 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 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BEZALIP
DO NOT TAKE Bezalip:
•
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 are taking STATINS (e.g. atorvastatin) AND have any of
the following which may increase the risk of you DEVELOPING
MUSCLE DISEASE (weakness, wasting and pain):
- impaired KIDNEY function
- an underactive THYROID (hypothyroidism)
- severe INFECTION
- TRAUMA
- SURGERY
- a change in the levels of HORMONES or CHEMICALS in your
body (seen in a blood test)
- a high ALCOHOL intake.
•
if you are having DIALYSIS.
•
if you have LIVER disease.
•
if you have GALL BLADDER disease.
•
if you have NEPHROTIC SYNDROME (a kid

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bezalip
Bezafibrate 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of bezafibrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet for oral use.
Bezalip is a round film-coated tablet with a white core and is
imprinted G6.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bezalip 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 recommended dosage for Bezalip tablets is one tablet three times a
day,
equivalent to 600mg bezafibrate. Each tablet should be swallowed whole
with
sufficient fluid after a meal. Occasionally gastro-intestinal symptoms
may occur. In
susceptible patients a slowly increasing dosage over 5 to 7 days may
help to avoid
such symptoms.
ELDERLY
In elderly patients there is a physiological reduction of the renal
function with age.
Bezafibrate dosage should be adjusted based on serum creatinine
clearance values
(see _Renal impairment _below).
PAEDIATRIC POPULATION
At present there is inadequate information regarding an appropriate
dosage in
children.
RENAL IMPAIRMENT
In dialysis patients the use of bezafibrates is contraindicated.
In patients with renal insufficiency the dose should be adjusted
according to serum
creatinine levels or creatinine clearance as shown in the following
table;
_Serum _
_creatinine_
_(_
μ
_mol/l)_
_Creatinin_
_e _
_clearance_
_(ml/min)_
_Dosage _
_(tablets/d_
_ay) _
Up to 135
Over 60
3
136 – 225
60 – 40
2
226 – 530
40 – 15
1 every 1
or 2 days
Over 530
Less than
15
Contra-
indicated
The response to therapy is normally rapid, although a progressive
improvement may
occur over a number of weeks. Treatment should be withdrawn if an
adequate
respon