LIPANTIL SUPRA 145 Milligram Coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
FENOFIBRATE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
FENOFIBRATE
Dosage:
145 Milligram
Pharmaceutical form:
Coated Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lipantil Supra 145 mg Film-coated tablet
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.
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
7.
1.
WHAT LIPANTIL SUPRA IS AND WHAT IT IS USED FOR
Lipantil Supra 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.
Lipantil Supra 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.
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 145mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 145.0 mg fenofibrate (nanoparticles).
Excipients with known effect: each tablet contains:
-
132.00 mg of Lactose monohydrate
-
145.00 mg of Sucrose
-
0.50 mg of Soybean lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Supra 145mg 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 one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200
mg capsule or one 160 mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment.
Special populations
Geriatric population:
In elderly patients, without renal impairment, the usual adult dose is recommended.
Renal impairment:
Dosage reduction is re
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