Simvastatin 20mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Simvastatin

זמין מ:

Genesis Pharmaceuticals Ltd

קוד ATC:

C10AA01

INN (שם בינלאומי):

Simvastatin

כמות:

20mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02120000; GTIN: 5060014442055

עלון מידע

Product:
MA Holder:
CHELONIA
PL No.:
33414/0101-0104
Pack Size:
-
Livery:
GENESIS
Manufacturer:
-
Market:
UK
Component:
LEAFLET
Dimensions:
148 X 297 MM
Created By:
DTAWDE
Artwork Code:
CL0101-0102-0103-0104/O/PIL/G6
Bar Code:
-
Font Type:
ARIAL NARROW
Font Size:
7.25 PT
Printing Colours:
Non-Printing Colours:
Black
Profile
Final Preparation Date For Submission:
06/12/2019
Packing Site Technical Approval:
00/00/0000
Authority Approval Date:
09/01/2020
Latest Implementation Deadline:
09/07/2020
Print Proof Approval:
00/00/0000
SIMVASTATIN 5, 10, 20
& 40 MG TABLETS
Simvastatin has not been studied in children under the age of 10
years. For more information, talk to your doctor.
DRIVING AND USING MACHINES
Simvastatin is not expected to interfere with your ability to drive or
to
use machinery. Simvastatin may cause dizziness in rare cases. If
you feel dizzy, then do not drive or operate any machines.
SIMVASTATIN TABLETS CONTAIN LACTOSE
This medicine contains LACTOSE. If you have been told by your doctor
that you have an intolerance to lactose or other sugars, contact your
doctor before taking this medicine.
Your doctor will determine the appropriate tablet strength for you,
depending
on
your
condition,
your
current
treatment
and
your
personal risk status. Always take Simvastatin exactly as your doctor
has told you. You should check with your doctor or pharmacist if you
are not sure.
Swallow the tablets with water. Simvastatin tablets may be taken with
or without food. Remember to keep to a low-fat diet and exercise
while taking Simvastatin.
DOSAGE:
The recommended dose is Simvastatin 10 mg, 20 mg, 40 mg or 80
mg by mouth once a day.
ADULTS:
The usual starting dose is 10, 20 or, in some cases, 40 mg a day.
Your doctor may adjust your dose after at least 4 weeks to a
maximum of 80 mg a day. Do not take more than 80 mg a day.
Your doctor may prescribe lower doses, particularly if you are taking
certain medicinal products listed above or certain kidney conditions.
The 80 mg dose is only recommended for adult patients wit

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 20 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of the active ingredient
simvastatin.
Excipient with known effect
Lactose monohydrate (tablet core and tablet coat)
144.06_ _mg per film-coated tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
Simvastatin 20 mg film-coated tablets are presented as dark tan
coloured, oval
shaped, film-coated tablets with “G” on one side and “SM”
breakline“20” on the
other side. The tablet can be divided 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 hypercholaesterolemia (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
the potential
risks (see sections 4.4 and 5.1).
Hypercholesterolaemia
The p