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FLUVASTATIN 40 MG CAPSULES

Active substance(s): FLUVASTATIN / FLUVASTATIN SODIUM / FLUVASTATIN SODIUM / FLUVASTATIN SODIUM

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ZINC Ref:

Version:

EAS1105B LEA FLUVASTATIN 20 & 40MG CAPS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
360 mm
160 mm
N/A
N/A

1

Colours Used:

BLACK
PANTONE® GREEN C
Template

Fluvastatin
20 mg and 40 mg Capsules
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
effect not listed in this leaflet. See section 4.
What is in this leaflet

1. What Fluvastatin Capsules are and what
they are used for
2. What you need to know before you take
Fluvastatin Capsules
3. How to take Fluvastatin Capsules
4. Possible side effects
5. How to store Fluvastatin Capsules
6. Contents on the pack and other information

Also tell your doctor or pharmacist if you have a
muscle weakness that is constant. Additional
tests and medicines may be needed to diagnose
and treat this.
While you are on this medicine your doctor will
monitor you closely if you have diabetes or are
at risk of developing diabetes. You are likely to
be at risk of developing diabetes if you have
high levels of sugars and fats in your blood, are
overweight and have high blood pressure.
Children and adolescents
Fluvastatin Capsules has not been investigated
and is not intended for the use in children below
9 years. For dose information in children and
adolescents over 9 years, see section 3.
There is no experience with the use of
Fluvastatin Capsules in combination with
nicotinic acid, cholestyramine or fibrates in
children and adolescents.

Other medicines and Fluvastatin Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Fluvastatin Capsules can be taken on its own or
with other cholesterol-lowering medicines
prescribed by your doctor.
After intake of a resin, e.g. cholestyramine
Fluvastatin Capsules are and
(primarily used to treat high cholesterol) wait at
1 What
what they are used for
least 4 hours before taking Fluvastatin Capsules.
Fluvastatin Capsules contain the active substance Tell your doctor and pharmacist if you are taking
any of the following:
fluvastatin sodium which belongs to a group of
• Ciclosporin (a medicine used to suppress the
medicines known as statins, which are
immune system).
lipid-lowering medicines: they lower the fat
• Fibrates (e.g. gemfibrozil), nicotinic acid or
(lipids) in your blood. They are used in patients
bile acid sequestrants (medicines used to
whose conditions cannot be controlled by diet
lower bad cholesterol levels).
and exercise alone.
• Fluconazole (a medicine used to treat fungal
Fluvastatin Capsules is a medicine used
infections).
• to treat raised levels of fats in the blood in
• Rifampicin (an antibiotic).
adults, in particular total cholesterol and so
• Phenytoin (a medicine used to treat epilepsy).
called “bad” or LDL cholesterol, which is
• Oral anticoagulants like warfarin (medicines
associated with an increased risk of heart
used to reduce blood clotting).
disease and stroke
• Glibenclamide (a medicine used to treat
• in adult patients with high blood levels of
diabetes).
cholesterol
• Colchicines (used to treat gout).
• in adult patients with high blood levels of both
If you need to take oral fusidic acid to treat a
cholesterol and triglycerides (another sort of
bacterial infection you will need to temporarily
blood lipid)
stop using this medicine. Your doctor will tell
Your doctor can also prescribe Fluvastatin
you when it is safe to restart Fluvastatin
Capsules to prevent further serious cardiac
Capsules. Taking Fluvastatin Capsules with
events (e.g. heart attack) in patients after they
fusidic acid may rarely lead to muscle weakness,
already went through a heart catheterisation,
tenderness or pain (rhabdomyolysis). See more
with an intervention in the heart vessel.
information regarding rhabdomyolysis in
section 4.
What you need to know before you

2

take Fluvastatin Capsules

Follow all instructions given to you by your
doctor carefully. They may differ from the
information contained in this leaflet.
Read the following explanations before you take
Fluvastatin Capsules.
Do not take Fluvastatin Capsules:
• if you are allergic to fluvastatin or to any of
the other ingredients of this medicine (listed
in section 6)
• if you currently have liver problems, or if you
have unexplained, persistently high levels of
certain liver enzymes (transaminases)
• if you are pregnant or breast-feeding (see
“Pregnancy and breast-feeding”).
If any of these apply to you, do not take
Fluvastatin Capsules and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Fluvastatin Capsules:
• if you previously had a liver disease. Liver
function tests will normally be done before
you start Fluvastatin Capsules, when your
dose is increased and at various intervals
during treatment to check for side effects.
• if you have a kidney disease
• if you have a thyroid disease (hypothyroidism)
• if you have a medical history of muscle
diseases yourself or in your family
• if you had muscle problems with another
lipid-lowering medicine
• if you regularly drink large amounts of alcohol.
• if you have severe respiratory failure
• if you are over 70 years your doctor may want
to check if you have risk factors for muscular
diseases. You may need specific blood tests.
• if you are taking or have taken in the last 7 days
a medicine called fusidic acid, (a medicine for
bacterial infection) orally or by injection. The
combination of fusidic acid and Fluvastatin
Capsules can lead to serious muscle problems
(rhabdomyolysis).

REG0044055

Version 6.3

13 June 2017

Fluvastatin Capsules with food and drink
You can take Fluvastatin Capsules with or
without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine
Do not take Fluvastatin Capsules if you are
pregnant or breast-feeding as the active
ingredient may lead to harm to your unborn
child, and it is not known whether the active
ingredient is excreted in human breast milk. If
you are pregnant, consult your doctor or
pharmacist before taking Fluvastatin Capsules.
Use reliable contraception for the whole time
that you are taking Fluvastatin Capsules.
If you become pregnant while taking this
medicine, stop taking Fluvastatin Capsules and
see your doctor.
Driving and using machines
There is no information on the effects of
Fluvastatin Capsules on your ability to drive and
use machines.
Fluvastatin Capsules contains lactose
This medicinal product contains a small amount
of lactose which is a sugar: if you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this medicinal product.

3

How to take Fluvastatin Capsules

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Adults
Follow your doctor’s instructions carefully. Do
not exceed the recommended dose.
Your doctor will recommend you to follow a
low-cholesterol diet. Stay on this diet while
taking Fluvastatin Capsules.

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ZINC Ref:

EAS1105B LEA FLUVASTATIN 20 & 40MG CAPS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
360 mm
160 mm
N/A
N/A

Version:

1

Colours Used:

BLACK
PANTONE® GREEN C
Template

How much Fluvastatin Capsules to take
The dose range for adults is 20 to 80 mg per day
and depends on the extent of cholesterol
lowering which needs to be achieved. Dose
adjustments may be made by your doctor at
4-week or longer intervals.
For children (aged 9 years and older) the
recommended starting dose is 20 mg per day.
The maximum daily dose is 80 mg. Dose
adjustments may be made by your doctor at
6-week intervals.
Your doctor will tell you exactly how many
capsules to take.
Depending on how you respond to the
treatment, your doctor may suggest a higher or
lower dose.
When to take Fluvastatin Capsules

Very rare: may affect up to 1 in 10,000 people
Tingling or numbness of the hands or feet,
disturbed or decreased sensitivity.
Not known: frequency cannot be estimated from
the available data
Muscle weakness that is constant.
Other possible side effects
• Sleep disturbances, including insomnia and
nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems including persistent
cough and/or shortness of breath or fever.
• Diabetes. This is more likely if you have high
levels of sugars and fats in your blood, are
overweight and have high blood pressure.
Your doctor will monitor you while you are
taking this medicine.

If you are taking Fluvastatin Capsules once per
day, take your dose in the evening or at bedtime.
If you are taking Fluvastatin Capsules twice per Reporting of side effects
day, take one capsule in the morning and one in If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
the evening or at bedtime.
effects not listed in this leaflet. You can also
Fluvastatin Capsules can be taken with or without report side effects directly via the Yellow Card
meals. Swallow whole with a glass of water.
Scheme at: www.mhra.gov.uk/yellowcard.
If you take more Fluvastatin Capsules than you By reporting side effects you can help provide
more information on the safety of this medicine.
should
If you have accidentally taken too many
How to store Fluvastatin Capsules
Fluvastatin Capsules, talk to your doctor straight 5
away. You may need medical attention.
Keep this medicine out of the sight and reach of
children.
If you forget to take Fluvastatin Capsules
Take one dose as soon as you remember.
Do not use this medicine after the expiry date
However, do not take it if there is less than 4 hours which is stated on the blister or label and carton
before your next dose. In this case take your
after EXP. The expiry date refers to the last day
next dose at the usual time.
of the month.
Do not take a double dose to make up for a
Do not store above 30°C.
forgotten dose..
Do not throw away any medicines via
If you stop taking Fluvastatin Capsules
wastewater or household waste. Ask your
To maintain the benefits of your treatment, do
pharmacist how to throw away medicines you
not stop taking Fluvastatin Capsules unless your no longer use.. These measures will help protect
doctor tells you to. You must continue to take
the environment.
Fluvastatin Capsules as directed to keep the
levels of your ‘bad’ cholesterol down. Fluvastatin 6 Contents of the pack and other
information
Capsules will not cure your condition but it does
help control it. Your cholesterol levels need to be What Fluvastatin Capsules contain:
checked regularly to monitor your progress.
The active substance is fluvastatin sodium.
If you have any further questions on the use of
One 20 mg capsule contains 20 mg fluvastatin
this medicine, ask your doctor or pharmacist.
(as fluvastatin sodium).
One 40 mg capsule contains 40 mg fluvastatin
Possible
side
effects
4
(as fluvastatin sodium).
Like all medicines, this medicine can cause side The other ingredients are lactose monohydrate,
effects, although not everybody gets them.
colloidal anhydrous silica, crospovidone,
If you get any of the following serious side effects, magnesium stearate, red iron oxide (E172),
yellow iron oxide (E172), black iron oxide (E172),
stop taking Fluvastatin Capsules and go to your
titanium dioxide (E171), gelatin, shellac and
doctor or to the nearest hospital straight away:
propylene glycol
Rare: may affect up to 1 in 1,000 people
What Fluvastatin Capsules look like and
• if you have unexplained muscle pain,
tenderness or weakness. These might be early contents of the pack
signs of a potentially severe muscle
Fluvastatin 20 mg Capsules have an ivory
degradation called rhabdomyolysis. This can
opaque body and pink opaque cap marked
be avoided if your doctor stops your
93/7442.
treatment with Fluvastatin Capsules as quickly Fluvastatin 40 mg Capsules have a yellow
as possible. These side effects have also been opaque body and pink opaque cap marked
found with similar medicines of this class
93/7443.
(statins).
Blisters: 1, 14, 15, 20, 28, 30, 50, 50 x2, 56, 60, 84,
• if you have signs of skin reactions such as skin 90, 98 and 100 capsules.
rash or hives.
Hospital packs in blisters: 1, 50 and 100
capsules.
Very rare: may affect up to 1 in 10,000 people
Bottles: 100, 250 and 500 capsules.
• if you have a potentially severe muscle
degradation called rhabdomyolysis
Not all pack sizes may be marketed.
• if you have unusual tiredness or fever,
The capsule should be pushed out carefully
yellowing of the skin and eyes, dark coloured
from the blister as shown by the picture, in
urine (signs of hepatitis).
order to avoid damaging the capsule.
• if you have skin swelling, difficulty in
breathing, dizziness (signs of severe allergic
reaction called anaphylactic reaction).
• if you bleed or bruise more easily than normal
(signs of decreased number of blood platelets
thrombocytopenia).
• if you have red or purple skin lesions (signs of
Marketing Authorisation Holder and
blood vessel inflammation-vasculitis).
Manufacturer
• if you have red blotchy rash mainly on the
face which may be accompanied by fatigue,
fever, nausea, loss of appetite (signs of lupus
erythematous-like reaction).
• if you have severe upper stomach pain (signs
of inflamed pancreas-pancreatitis).
• if you have signs of skin reactions such as
redness, itching, swelling of the face, eyelids,
and lips.

The Marketing Authorisation holder is TEVA UK
Limited, Eastbourne, BN22 9AG and the
company responsible for manufacture is TEVA
Pharmaceutical Works Private Limited Company,
Pallagi ùt 13, 4042 Debrecen, Hungary
This leaflet was last revised in 06/2017
PL 00289/0997-8

Other possible side effects with Fluvastatin
Capsules
Common: may affect up to 1 in 10 people
Difficulty in sleeping, headache, stomach
discomfort, abdominal pain, nausea and joint
pain.

REG0044055

Version 6.3

13 June 2017

Approved

EAS1105b

Page 2 of 4

ZINC Ref:

Version:

EAS1105B LEA FLUVASTATIN 20 & 40MG CAPS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

PL Number(s),
MA Holder & Packer:

No
360 mm
160 mm
N/A
N/A

1

Colours Used:

13 June 2017

BLACK
PANTONE® GREEN C
Template

PL 00289/0997-8.
TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Debrecen, Hungary.

Trackwise Parent:

673938

Trackwise Child:

673964

Reason for revision: Version 1: Storage condition change for bottle.

SKU (s):
EAN Code:
Perforated:
Shelf Ready:

231-10-04991 / 80019690
231-10-05001 / 80019700
N/A
No
-

Pharma Code:
Edge Code:
PIP Code:
ULM Code:
Packing Site Code:

TBC
N/A
N/A
N/A
TBC

Fonts:

Univers.

For Eastbourne packed
components only:
Please refer to the latest version
of the full base material
specification:

Base Font Size:

8.5 Pt

92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for
reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.
Artwork Drawn by:

Proof Reader;
Sign & Date:

Digitally signed by Peter
Horton
DN: cn=Peter Horton,
o=TEVA UK,
ou=Origination - New
Products,
email=peter.horton@tevau
k.com, c=GB
Date: 2017.06.22 07:47:42
+01'00'

Artwork 2

REG0044055

Version 6.3

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Approved by Regulatory for submission to the
authorities / internal Approval / implementation;
Sign & Date:

Packing Site / Technical Approval;
Sign & Date:
Technically approved by
TEVA Pharmaceutical Works
Private Limited Company

Eva
Gyorffy

Digitálisan aláírta: Eva Gyorffy
DN: dc=Corp, dc=Teva, dc=HU,
ou=DEB, ou=USR, cn=Eva
Gyorffy,
email=Eva.Gyorffy@teva.hu
Dátum: 2017.06.22 09:52:40
+02'00'

Digitally signed by
michael.silvester@tevapharm.co
m
DN:
cn=michael.silvester@tevapharm
.com
Date: 2017.06.23 09:26:10 +01'00'

Internal/Final Approval and/or implementation from
the MA holder confirming full approval for release of
components; Sign & Date:

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-0997-0998-fluvastatin-20mg-40mg-capsules

APPROVALS
Signed by
Michael Silvester

REG0044055

Meaning of Signature
Regulatory Affairs Approval

Version 6.3

Approved

Server Date
23-Jun-2017 08:34:03 AM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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