Simvastatin 10mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Simvastatin

Dostępny od:

Milpharm Ltd

Kod ATC:

C10AA01

INN (International Nazwa):

Simvastatin

Dawkowanie:

10mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02120000; GTIN: 8901175038787

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10 MG FILM-COATED TABLETS
SIMVASTATIN 20 MG FILM-COATED TABLETS
SIMVASTATIN 40 MG FILM-COATED TABLETS
SIMVASTATIN 80 MG FILM-COATED 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 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 is a medicine used to lower levels of total cholesterol,
“bad” cholesterol (LDL
cholesterol) and fatty substances called triglycerides in the blood.
In addition this medicine
raises levels of “good” cholesterol (HDL cholesterol). This
medicine is 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 ar

Charakterystyka produktu

OBJECT 1
Simvastatin 10mg Tablets
Summary of Product Characteristics Updated 04-Feb-2022 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Simvastatin 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg simvastatin.
Excipient with known effect: Lactose monohydrate
One film-coated tablet contains 70 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Light pink, round [diameter 6.1 mm] and biconvex film-coated tablets
with “SI” debossed on one side
and “10” on the other side.
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 a