Simvastatin Rosemont 40mg/5ml Oral Suspension

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Simvastatin

Διαθέσιμο από:

Rosemont Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

C10AA; C10AA01

INN (Διεθνής Όνομα):

Simvastatin

Δοσολογία:

40 mg/5ml

Φαρμακοτεχνική μορφή:

Oral suspension

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

HMG CoA reductase inhibitors; simvastatin

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2013-08-23

Φύλλο οδηγιών χρήσης

SIMVASTATIN 40MG/5ML ORAL SUSPENSION
MODULE 1.3.1
LEAFLET
VERSION: APRIL 2018
PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Simvastatin Rosemont is and what it is used for
2. What you need to know before you take Simvastatin Rosemont
3. How to take Simvastatin Rosemont
4. Possible side effects
5. How to store Simvastatin Rosemont
6. Contents of the pack and other information
1. WHAT SIMVASTATIN ROSEMONT IS AND WHAT IT IS USED FOR
The name of your medicine is Simvastatin Rosemont 40mg/5ml Oral
Suspension
(called simvastatin in this leaflet). This belongs to a group of
medicines called
HMG-CoA reductase inhibitors (also known as statins).
This medicine works by lowering the amount of cholesterol and fatty
substances
called triglycerides in your blood.
Simvastatin can be used along with diet for:

lowering high cholesterol levels or fat levels in the blood when diet,
exercise
and weight loss are not enough

lowering high cholesterol levels that are hereditary (close members of
your
family also have high cholesterol levels). Simvastatin may be given at
the
same time as other medicines that lower your cholesterol

lowering risk of coronary heart disease (CHD) if you have diabetes,
have had
a stroke or you have other blood vessel diseases.
In most people, there are no immediate symptoms of high cholesterol.
Your
doctor can measure your cholesterol with a simple blood test. Visit
your doctor
regularly, keep track of your cholestero

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
14 September 2018
CRN008HH4
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin Rosemont 40mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 8mg simvastatin (40mg/5ml)
Excipients with known effect: 1ml contains methyl parahydroxybenzoate
(E218)
1.8mg, ethyl parahydroxybenzoate (E214) 0.4mg, and propyl
parahydroxybenzoate
(E216) 0.16mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
A white to off-white suspension with lime flavour and odour.
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 (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 - 80mg/day (0.625 – 10ml) given orally as a
single dose in the
evening. Adjustments of dosage, if required, should be made at
intervals of not less
Health Products Regulatory Authority
14 September 2018
CRN008HH4
Page 2 of 25
than 4 weeks, to a maximum of 80mg/day (10ml) given as a single dose
in the
evening. The 80mg (10ml) 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