Twicor 10mg/10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN, EZETIMIBE

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

C10BA06

INN (International Name):

ROSUVASTATIN 10 mg EZETIMIBE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROSUVASTATIN 10 mg EZETIMIBE 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2018-10-26

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

1
1.
NAME OF THE MEDICINAL PRODUCT
TWICOR 10 mg/10 mg film-coated tablets
TWICOR 20 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TWICOR 10 mg/10 mg film-coated tablets: Each film-coated tablet
contains 10 mg of rosuvastatin (as
calcium) and 10 mg of ezetimibe.
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 10 mg/10 mg film-coated tablets:
Pink coloured round shaped film-coated tablet with a diameter
of 10.1 mm embossed with “AL” on one side.
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 mono-
components and after setting the appropriate doses the switch to the
fixed dose combination of the ap-
propriate strength is possible.
Treatment should be individualised according to the target lipid
levels, the recommended goal of ther-
apy, 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 rosuvas-
tatin.
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