Lipantil Supra 215 mg, film-coated tablet

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Fenofibrate

Dostopno od:

Mylan IRE Healthcare Limited

Koda artikla:

C10AB; C10AB05

INN (mednarodno ime):

Fenofibrate

Odmerek:

215 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Fibrates; fenofibrate

Status dovoljenje:

Not marketed

Datum dovoljenje:

2005-03-18

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPANTIL
® SUPRA 215 MG FILM-COATED TABLETS
fenofibrate
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 or 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, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Lipantil® Supra is and what it is used for
2.
What you need to know before you take Lipantil® Supra
3.
How to take Lipantil® Supra
4.
Possible side effects
5.
How to store Lipantil® Supra
6.
Contents of the pack and other information
1.
WHAT LIPANTIL® SUPRA
IS AND WHAT IT IS USED FOR
Lipantil® Supra 215 mg contains the active substance fenofibrate and
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’.
Lipantil® Supra 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 LIPANTIL® SUPRA
DO NOT TAKE LIPANTIL® SUPRA
IF:

you are allergic to fenofibrate or any of the other ingredients of
this medicine (listed in Section
6: Further information)

you are allergic to peanut or arachis oil or soya lecithin or related
products

while taking other medicines, you have had an allergic reaction or
skin damage from sunlight or
UV light (these medicines include other fibrates and an
anti-inflammatory medicine called
‘ketoprofen’)

you have severe
_ _
liver, kidney or gallbladder problems

you have pancreatitis (an inflamed pancreas which causes ab

Lastnosti izdelka

Health Products Regulatory Authority
23 November 2020
CRN00C1PM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 215 mg, film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 215.0 mg fenofibrate.
Excipients with known effect: each tablet contains:
- 134.4 mg of lactose monohydrate
- 2.28 mg of Sunset yellow lake (E110)
- 5.31 mg of Allura red AC lake (E129)
- 0.6 mg of Soybean lecithin
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Orange-red, oblong, film-coatedtablet engraved “215” on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Supra 215mg 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
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 initial dose is 160 mg daily administered as one
Lipantil Supra 160mg tablet
The dose can be titrated up to 215 mg daily administered as one
Lipantil Supra 215 mg tablet.
Patients currently taking one 267mg capsule can be changed to one
Lipantil Supra 215 mg tablet without further dose
adjustment.
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/1.73 (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
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