Simvastatin 20mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
01-03-2020
Prenos Lastnosti izdelka (SPC)
10-03-2020
Prenos Javno poročilo o oceni (PAR)
20-04-2020

Aktivna sestavina:

Simvastatin

Dostopno od:

Tillomed Laboratories Ltd

Koda artikla:

C10AA01

INN (mednarodno ime):

Simvastatin

Odmerek:

20mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02120000; GTIN: 5024655001958

Navodilo za uporabo

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10MG TABLETS
SIMVASTATIN 20MG TABLETS
SIMVASTATIN 40MG TABLETS
(Simvastatin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What Simvastatin Tablets are and what they are used for
2.
What you need to know before you take Simvastatin Tablets
3.
How to take Simvastatin Tablets
4.
Possible side effects
5.
How to store Simvastatin Tablets
6. Contents of the pack and other information
1.
WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Simvastatin belongs to a group of medicines called ‘HMG-CoA
reductase inhibitors’ which
reduce the amount of cholesterol and fatty substances called
triglycerides in the blood.
Cholesterol is vital to the normal functioning of the body but if
levels in the bloodstream are too
high, it can be deposited on the walls of the arteries and build up to
form plaques which can
eventually block the blood vessel.
Simvastatin Tablets are used to:
lower levels of cholesterol (and triglycerides) in the blood, thereby
reducing the risk of heart
disease
slow or reduce the progression of :

atherosclerosis (clogging of blood vessels by cholesterol) which can
lead to angina (chest
pain) and heart attack.

coronary heart disease (CHD) - Simvastatin Tablets can help to lessen
the risk of a heart
attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT TAKE SIMVASTATIN TABLETS
If you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of this medicine
(listed in Section 6: Contents of the pack and other information)

if you currently have liver problems

if you 
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 20mg Tablets
Simvador 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of simvastatin.
Excipient(s) with known effect: 140.96 mg lactose monohydrate per
tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-Coated Tablet
Simvastatin 20 mg tablets are tan coloured, oval shaped, biconvex,
film-coated
tablets, debossed with ‘20’ on one side and breakline on the other
side, containing
Simvastatin 20 mg.
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
The dosage range is 5-80mg/day 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 given as a single dose in the
evening.
The
80mg
dose
is
only
recommended
in
patients
with
severe
hypercholesterolaemia and 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 section 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. Th
                                
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