Simvastatin 10mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Simvastatin

Saadav alates:

Accord-UK Ltd

ATC kood:

C10AA01

INN (Rahvusvaheline Nimetus):

Simvastatin

Annus:

10mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02120000; GTIN: 5060149311714 5055565751107

Infovoldik

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Simvastatin Tablets
all strengths x 28’s (UK)
296x210 (Reel Fed)
50945897
Leaflet for Blisters
4298
R.Wrey
07/03/18
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approved for print/date
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DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
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5.
6.
1.
2.
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FMD info
NA (not a carton)

No

Yes
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Details
SIMVASTATIN 10MG, 20MG & 40MG 28 TABLETS PIL - UK
Black
Profile
BBBA1793
S.Anson
07.03.18
296 x 210
7pt
Actavis UK
n/a
n/a
1
Version 2
01.11.2017
page 4
page 1
50945897 BBBA1793
SIMVASTATIN 10MG,
20MG, 40MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 SIMVASTATIN IS AND WHAT IT IS
USED FOR.
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SIMVASTATIN.
3 HOW TO TAKE SIMVASTATIN.
4 POSSIBLE SIDE EFFECTS.
5 HOW TO STORE SIMVASTATIN.
6 CONTENTS OF THE PACK AND OTHER
INFORMATION.
1 WHAT SIMVASTATIN IS AND WHAT IT IS
USED FOR
Simvastatin contains the active substance
simvastatin and belongs to a group of medicines
known as statins. These work by reducing the
amount of total ch

Toote omadused

OBJECT 1
SIMVASTATIN 10MG TABLETS
Summary of Product Characteristics Updated 01-Mar-2016 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
•
11. Dosimetry
•
12 Instructions for preparation of radiopharmaceuticals
1. Name of the medicinal product
Simvastatin 10mg Tablets
2. Qualitative and quantitative composition
One film-coated Simvastatin 10mg tablet contains 10 mg of simvastatin;
Excipient with known effect:
Each tablet contains 65.73 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Simvastatin 10mg Tablets is a peach-coloured, oval, biconvex,
film-coated tablet, scored on one 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 famil