Simvastatin 80mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Simvastatin

Saadav alates:

Phoenix Healthcare Distribution Ltd

ATC kood:

C10AA01

INN (Rahvusvaheline Nimetus):

Simvastatin

Annus:

80mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02120000

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVADOR 10MG, 20MG, 40MG AND
80MG TABLETS
Simvastatin
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.
•
Simvador
is
used
to
lower
levels
of
cholesterol
and
triglycerides in your blood and can help reduce your risk
of developing coronary heart disease. (See Section 1
’What Simvador is and what it is used for’).
•
Simvador can cause serious muscle problems in a very
small
number of patients.
If you suf fer from unexplained
pain, tenderness or weakness in your muscles STOP
TAKING the medicine and talk to your doctor at once.
•
DO NOT TAKE this medicine if you are already taking
medicines for fungal infections (such as itraconazole,
ketoconazole,
voriconazole
or
posaconazole),
HIV
protease inhibitors (such as indinavir,
nelfinavir,
ritonavir
and saquinavir), medicines for Hepatitis C virus infection
(such as boceprevir or telaprevir), antibiotics (such as
erythromycin, clarithromycin, telithromycin), nefazodone
which is used to treat depression,
gemfibrozil used for
lowing cholesterol, ciclosporin a medicine often used in
organ transplant patients, danazol a man-made hormone
used to treat endometriosis, fusidic acid (if you are taking,
or in the last
7 days have taken) used to treat bacterial
infections. (See Section 2 ‘Taking other medicines’).
•
If you are pregnant or trying to get pregnant or breast
feeding you MUST NOT take Simvador (See Section 2
’Before you take Simvador’).
•
If you have high blood pressure, high levels of fats or sugars
in your blood o

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 80mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg of simvastatin.
Excipients with known effect
Each film-coated tablets contains 533.7 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Light green coated, oval, scored, convex tablet coded “SIM 80” on
one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypercholesterolaemia _
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to
diet, when response to diet and other non-pharmacological treatments
(e.g. exercise,
weight reduction) is inadequate.
Treatment of homozygous familial hypercholesterolaemia as an adjunct
to diet and
other lipid-lowering treatments (e.g. LDL apheresis) or if such
treatments are not
appropriate.
_Cardiovascular prevention _
Reduction of cardiovascular mortality and morbidity in patients with
manifest
atherosclerotic cardiovascular disease or diabetes mellitus, with
either normal or
increased cholesterol levels, as an adjunct to correction of other
risk factors and other
cardioprotective therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 5-80 mg/day of simvastatin given orally as a single
dose in the
evening. Adjustments of dose, if required, should be made at intervals
of not less than
4 weeks, to a maximum of 80 mg/day given as a single dose in the
evening. The 80
mg dose is only recommended in patients with severe
hypercholesterolaemia and at
high risk for cardiovascular complications, who have not achieved
their treatment
goals on lower doses and when the benefits are expected to outweigh
the potential
risks (see sections 4.4 and 5.1).
_Hypercholesterolaemia _
_ _
The patient should be placed on a standard cholesterol-lowering diet,
and should
continue on this diet during treatment with simvastatin. The u