Simvastatin 40mg/5ml oral suspension sugar free

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Simvastatin

Disponible des:

Rosemont Pharmaceuticals Ltd

Codi ATC:

C10AA01

Designació comuna internacional (DCI):

Simvastatin

Dosis:

8mg/1ml

formulario farmacéutico:

Oral suspension

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02120000; GTIN: 5016119205897

Informació per a l'usuari

0
10
20
30
40
50
60
70
80
90
100
JOB INFORMATION
Product Name:
Strength:
Keyline Ref:
Font Type:
Font Size:
Pharmacode:
Dimensions:
EAN Code:
Folded Size:
No. of Colours:
Tabbed:
Pack Size:
Bottle Size:
Design Icon:
Print
Colours:
Non-print
Colours:
New Item Code:
Previous Item Code:
Supplier Code:
Page Number:
COLOURS
ARTWORK
VERSION:
Date:
Date:
Operator:
Operator:
PREFLIGHT
VERSION:
JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
40mg/5ml
BLACK
7474
PANTONE
PANTONE
265
CUTTER
BRAILLE
UKL412
402
210 x 300mm
N/A
30 x 150mm
1
7pt
No
150ml
150ml
N/A
F6FD1RBJ3
F6FD1RBJ2
N/A
1 of 2
Simvastatin Rosemont 40mg/5ml
Oral Suspension (UK & IRL)
14/02/18
-
DH
-
1
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
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.
n
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

Fitxa tècnica

OBJECT 1
SIMVASTATIN ROSEMONT 40MG/5ML ORAL
SUSPENSION
Summary of Product Characteristics Updated 26-Mar-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Simvastatin Rosemont 40mg/5ml Oral Suspension
Simvastatin
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 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 5.1).
This product should not