Twicor 20 mg/10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin calcium; Ezetimibe

Available from:

Mylan IRE Healthcare Limited

ATC code:

C10BA06

INN (International Name):

Rosuvastatin calcium; Ezetimibe

Dosage:

10/20 mg/mg

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

rosuvastatin and ezetimibe

Authorization status:

Not marketed

Authorization date:

2019-04-26

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
TWICOR 10 MG / 10 MG FILM-COATED TABLETS TWICOR 20 MG / 10 MG FILM-COATED TABLETS
rosuvastatin and ezetimibe
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.
–
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TWICOR is and what it is used for
2.
What you need to know before you take TWICOR
3.
How to take TWICOR
4.
Possible side effects
5.
How to store TWICOR
6.
Contents of the pack and other information
1.
WHAT TWICOR IS AND WHAT IT IS USED FOR
TWICOR contains two different active substances in one film-coated
tablet. One of the active
substances is rosuvastatin, belonging to the group of so called
statins, the other active substance is
ezetimibe.
TWICOR is a medicine used in adult patients to lower levels of total
cholesterol, “bad” cholesterol
(LDL cholesterol) and fatty substances called triglycerides in the
blood. In addition, it also raises
levels of “good” cholesterol (HDL cholesterol). This medicine
works to reduce your cholesterol in two
ways: it reduces the cholesterol absorbed in your digestive tract, as
well as the cholesterol your body
makes by itself.
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood
vessels causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to the
heart or brain leading to a heart attack or a stroke. By lowering your
cholesterol levels, you can red

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2021
CRN009Z1Q
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Twicor 20 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TWICOR 20 mg/10 mg film-coated tablets: Each film-coated tablet
contains 20 mg of rosuvastatin (as calcium) and 10 mg of
ezetimibe.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
TWICOR 20 mg/10 mg film-coated tablets: Pink coloured round shaped
film-coated tablet with a diameter of 10.7 mm, plain
on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
TWICOR is indicated as adjunct to diet for treatment of primary
hypercholesterolemia as substitution therapy in adult patients
adequately controlled with the individual substances given
concurrently at the same dose level as in the fixed dose
combination, but as separate products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with TWICOR.
TWICOR can be administered within the dose range of 10/10 mg to 20/10
mg. The recommended dose is one film-coated
tablet of the given strength per day, with or without food.
TWICOR is not suitable for initial therapy. Treatment initiation
should only be done with the monocomponents and after
setting the appropriate doses the switch to the fixed dose combination
of the appropriate strength is possible.
Treatment should be individualised according to the target lipid
levels, the recommended goal of therapy, and the patient's
response. A dose adjustment can be made after 4 weeks where necessary.
TWICOR 10 mg/10 mg is not suitable for the treatment of patients
requiring 20 mg dose of rosuvastatin.
TWICOR should be taken either ≥2 hours before or ≥4 hours after
administration of a bile acid sequestrant.
_Paediatric population_
The safety and efficacy of TWICOR in children below the age of 18
years has not yet been establis