Simvastatin 80mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Simvastatin

זמין מ:

Arrow Generics Ltd

קוד ATC:

C10AA01

INN (שם בינלאומי):

Simvastatin

כמות:

80mg

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: 5060034832164

עלון מידע

SIMVASTATIN 80MG TABLETS
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 80MG IS AND WHAT IT IS
USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SIMVASTATIN 80MG
3 HOW TO TAKE SIMVASTATIN 80MG
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE SIMVASTATIN 80MG
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT SIMVASTATIN 80MG IS AND WHAT IT IS
USED FOR
Simvastatin is a medicine used to lower
levels of total cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition, Simvastatin
raises levels of “good” cholesterol (HDL cholesterol).
You should stay on a cholesterol-lowering diet
while taking this medicine. Simvastatin is a
member of 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.
Triglycerides are another form of fat in your blood
that may increase your risk for heart disease.
Simvastati

מאפייני מוצר

OBJECT 1
SIMVASTATIN 80MG TABLETS
Summary of Product Characteristics Updated 09-Mar-2020 | 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 Fertility, 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
1. Name of the medicinal product
Simvastatin 80mg film-coated tablets
2. Qualitative and quantitative composition
One film-coated Simvastatin 80mg tablets contains 80 mg of
simvastatin.
Excipient(s) with known effect
Each tablet contains 525.84mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Simvastatin 80mg is a dark pink-coloured, oblong shaped, film-coated
tablet, scored on one side, containing
80mg simvastatin.
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 hypercholesterolaemia (