Simvastatin 10mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Simvastatin

থেকে পাওয়া:

Dexcel-Pharma Ltd

এটিসি কোড:

C10AA01

INN (International Name):

Simvastatin

ডোজ:

10mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 02120000; GTIN: 5033847000600

তথ্য লিফলেট

PACKAGE LEAFLET
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.
WHAT IS IN THIS LEAFLET
1. What Simvador is and what it is used for
2. What you need to know before you take Simvador
3. How to take Simvador
4. Possible side effects
5. How to store Simvador
6. Contents of the pack and other information
1. WHAT SIMVADOR IS AND WHAT IT IS USED FOR
Simvador contains the active substance simvastatin.
is a
Simvador
medicine used to lower levels of total cholesterol, “bad”
cholesterol (LDL
cholesterol), and fatty substances called triglycerides in your blood.
In
addition, Simvador raises levels of “good” cholesterol (HDL
cholesterol).
While taking this medicine you should stick to a cholesterol-lowering
diet.
This medicine belongs to the class of drugs called statins.
Cholesterol is one of several fatty substances found in the
bloodstream.
Your total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in
the walls of your arteries forming plaque. Eventually this plaque
build-up can
lead to a narrowing of the arteries. This narrowing can slow or block
blood
flow to vital organs such as the heart and brain. This blocking of
blood flow
can result in a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it
helps keep the
bad cholesterol from building up in the arteries and protects against
heart
disease.
Triglyceri

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of the active ingredient
simvastatin.
Excipient with known effect:
Lactose monohydrate (tablet core and tablet coat)
72.03 mg per film-coated tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 10 mg film-coated tablets are presented as “dark peach
to pink” coloured,
oval shaped, film-coated tablets with “G” on one side and “SM”
scoreline “10” on the
other side. The score line is only to facilitate breaking for ease of
swallowing and not
to divide 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 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 5-80 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