Simvastatin 20mg/5ml oral suspension sugar free

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Simvastatin

Pieejams no:

Rosemont Pharmaceuticals Ltd

ATĶ kods:

C10AA01

SNN (starptautisko nepatentēto nosaukumu):

Simvastatin

Deva:

4mg/1ml

Zāļu forma:

Oral suspension

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 02120000; GTIN: 5016119206894

Lietošanas instrukcija

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JOB INFORMATION
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PREFLIGHT
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
20mg/5ml
BLACK
7474
PANTONE
PANTONE
265
CUTTER
BRAILLE
UKL412
401
210 x 300mm
N/A
30 x 150mm
1
7pt
No
150ml
150ml
N/A
E3WD1RBJ3
E3WD1RBJ2
N/A
1 of 2
Simvastatin Rosemont 20mg/5ml
Oral Suspension (UK & IRL)
14/02/18
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DH
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1
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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 20mg/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

Produkta apraksts

OBJECT 1
SIMVASTATIN ROSEMONT 20MG/5ML ORAL
SUSPENSION
Summary of Product Characteristics Updated 26-Mar-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Simvastatin Rosemont 20mg/5ml Oral Suspension
Simvastatin
2. Qualitative and quantitative composition
One ml contains 4mg of Simvastatin (20mg/5ml)
Excipients with known effect: 1 ml contains methyl parahydroxybenzoate
(E218) 1.8mg, ethyl
parahydroxybenzoate (E214) 0.4mg and propyl parahydroxybenzoate (E216)
0.16mg. Propylene glycol
(E1520) 17.2mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Suspension
A white to off-white suspension with strawberry 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 (1.25 – 20ml) 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
(20ml) given as a single dose in the evening. The 80mg (20ml) 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 sect