Simvastatin 20mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Simvastatin

Disponible des:

Crescent Pharma Ltd

Codi ATC:

C10AA01

Designació comuna internacional (DCI):

Simvastatin

Dosis:

20mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02120000; GTIN: 5017123300233

Informació per a l'usuari

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

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 20 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of the active ingredient
simvastatin.
Excipient with known effect
Lactose monohydrate (tablet core and tablet coat)
144.06_ _mg per film-coated tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
Simvastatin 20 mg film-coated tablets are presented as dark tan
coloured, oval
shaped, film-coated tablets with “G” on one side and “SM”
breakline“20” on the
other 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 hypercholaesterolemia (HoFH) 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 dosage range is 5-80 mg/day of simvastatin given orally as a
single dose in the
evening. Adjustments of dosage, 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 p