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FLUVASTATIN 40 MG CAPSULES

Active substance(s): FLUVASTATIN / FLUVASTATIN SODIUM

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FLUVASTATIN
40mg CAPSULES

if you had muscle problems with another lipidlowering medicine
if you regularly drink large amounts of alcohol
if you have severe respiratory failure
PACKAGE LEAFLET
if you are over 70 years your doctor may want to
check if you have risk factors for muscular
INFORMATION FOR THE USER
diseases. You may need specific blood tests.
While you are on this medicine your doctor will
Read all of this leaflet carefully before you start
monitor you closely if you have diabetes or are at risk
taking this medicine.
of developing diabetes. You are likely to be at risk of
Keep this leaflet. You may need to read it again.
developing diabetes if you have high levels of sugars
If you have any further questions, ask your
and fats in your blood, are overweight and have high
doctor or pharmacist.
blood pressure.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
Children/adolescents
their symptoms are the same as yours.
Fluvastatin has not been investigated and is not
If you get any side effects, talk to your doctor or
intended for the use in children below 9 years. For
pharmacist. This includes any possible side
dose information in children and adolescents over 9
effects not listed in this leaflet.
years, see section 3. There is no experience with the
Fluvastatin 40mg Capsules hereinafter referred to
use of Fluvastatin in combination with nicotinic acid,
as Fluvastatin.
cholestyramine or fibrates in children and adolescents.
Other medicines and fluvastatin
IN THIS LEAFLET
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
1. What Fluvastatin is and what it is used for
Fluvastatin can be taken on its own or with other
2. What you need to know before you take
cholesterol-lowering medicines prescribed by your
Fluvastatin
doctor.
3. How to take Fluvastatin
After intake of a resin, e.g. cholestyramine (primarily
4. Possible side effects
used to treat high cholesterol) wait at least 4 hours
5. How to store Fluvastatin
before taking Fluvastatin.
6. Contents of the pack and other information
Tell your doctor and pharmacist if you are taking any
1 WHAT FLUVASTATIN IS AND WHAT
of the following:
IT IS USED FOR
Ciclosporin (a medicine used to suppress the
immune system)
Fluvastatin contains the active fluvastatin sodium
Fibrates (e.g. gemfibrozil), nicotinic acid or bile
which belongs to a group of medicines known as
acid sequestrants (medicines used to lower bad
statins, which are lipid-lowering medicines: they lower
cholesterol levels)
the fat (lipids) in your blood. They are used in patients
Fluconazole (a medicine used to treat fungal
whose conditions cannot be controlled by diet and
infections)
exercise alone.
Rifampicin (an antibiotic)
Fluvastatin is a medicine used
Phenytoin (a medicine used to treat epilepsy)
to treat raised levels of fats in the blood in
Oral anticoagulants like warfarin (medicines used to
adults, in particular total cholesterol and so
reduce blood clotting)
called "bad" or LDL cholesterol, which is
Glibenclamide
(a medicine used to treat diabetes)
associated with an increased risk of heart
Colchicines (used to treat gout).
disease and stroke
Taking Fluvastatin with food and drink
in adult patients with high blood levels of
You can take Fluvastatin with or without food.
cholesterol
Pregnancy and breast-feeding
in adult patients with high blood levels of both
Please ask your doctor or pharmacist for advice before
cholesterol and triglycerides (another sort of
taking any medicine.
blood lipid).
Do not take Fluvastatin if you are pregnant or breastYour doctor can also prescribe Fluvastatin to prevent
feeding as the active ingredient may lead to harm to
further serious cardiac events (e.g. heart attack) in
your unborn child, and it is not known whether the
patients after they already went through a heart
catheterisation, with an intervention in the heart vessel. active ingredient is excreted in human breast milk. If
you are pregnant, consult your doctor or pharmacist
2 WHAT YOU NEED TO KNOW BEFORE before taking Fluvastatin. Use reliable contraception
YOU TAKE FLUVASTATIN
for the whole time that you are taking Fluvastatin. If
you become pregnant whilst taking this medicine, stop
Follow all instructions given to you by your doctor
taking Fluvastatin and see your doctor.
carefully. They may differ from the information
Driving and using machines
contained in this leaflet. Read the following
There is no information on the effects of Fluvastatin on
explanations before you take Fluvastatin.
your ability to drive and use machines.
Do NOT take Fluvastatin:
Fluvastatin contains lactose
if you are allergic (hypersensitive) to
This medicinal product contains a small amount of
fluvastatin or to any of the other ingredients of
lactose which is a sugar: if you have been told by your
Fluvastatin listed in section 6 of this leaflet
doctor that you have an intolerance to some sugars,
if you currently have liver problems, or if you have
contact your doctor before taking this medicinal
unexplained, persistently high levels of certain
product.
liver enzymes (transaminases)
if you are pregnant or breast-feeding (see
3 HOW TO TAKE FLUVASTATIN
"Pregnancy and breast-feeding").
Always take Fluvastatin exactly as your doctor has told
If any of these apply to you, do not take Fluvastatin
you. Check with your doctor or pharmacist if you are
and tell your doctor.
not sure.
Warnings and precautions
Adults
Talk to your doctor or pharmacist before taking
Follow your doctor's instructions carefully. Do not
fluvastatin:
exceed
the recommended dose.Your doctor will
if you previously had a liver disease. Liver
recommend you to follow a low-cholesterol diet. Stay
function tests will normally be done before you
on this diet while taking Fluvastatin.
start Fluvastatin, 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
(continued overleaf)
yourself or in your family

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

130415-PIL-GF10-08
N/A

Fluvastatin 40mg PIL - Side 1
340 x 160mm
13 April 2015
14057/08 40mg PIL S1.ai
1 Colour - Black

M1

How much Fluvastatin to take
The dose range for adults is 20 to 80mg 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 usual starting dose is 20mg per day. The
maximum daily dose is 80mg. Dose adjustments may
be made by your doctor at 6-week intervals.
Your doctor will tell you exactly how many capsules or
tablets of Fluvastatin to take. Depending on how you
respond to the treatment, your doctor may suggest a
higher or lower dose.
When to take Fluvastatin
If you are taking Fluvastatin once per day, take your
dose in the evening or at bedtime. If you are taking
Fluvastatin twice per day, take one capsule in the
morning and one in the evening or at bedtime.
Fluvastatin can be taken with or without meals.
Swallow whole with a glass of water.
If you take more Fluvastatin than you should
If you have accidentally taken too many Fluvastatin,
talk to your doctor straight away. You may need
medical attention.
If you forget to take Fluvastatin
Take one dose as soon as you remember.
However, do not take it if there is less than 4 hours
before your next dose. In this case take your next dose
at the usual time.
Do not take a double dose to make up for the one that
you missed.
If you stop taking Fluvastatin
To maintain the benefits of your treatment, do not stop
taking Fluvastatin unless your doctor tells you to. You
must continue to take Fluvastatin as directed to keep
the levels of your 'bad' cholesterol down.
Fluvastatin will not cure your condition but it does help
control it. Your cholesterol levels need to be checked
regulatory to monitor your progress.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Fluvastatin can cause side effects,
although not everybody gets them.
If you get any of the following, stop taking
fluvastatin and go to your doctor or to the nearest
hospital straight away:
if you have unexplained muscle pain, tenderness
or weakness. These might be early signs of a
potentially severe muscle degradation called
rhabdomyolysis. This can be avoided if your doctor
stops your treatment with fluvastatin as quickly as
possible. These side effects have also been found
with similar medicines of this class (statins). This
side effect is very rare (may affect up to 1 in 10,000
people)
if you have unusual tiredness or fever, yellowing
of the skin and eyes, dark-coloured urine (signs
of hepatitis). This side effect is very rare (may effect
up to 1 in 10,000 people)
if you have signs of skin reactions such as skin
rash, hives, redness, itching, swelling of the face,
eyelids, and lips. This side effect is rare (may
affect up to 1 in 1,000 people)
if you have skin swelling, difficulty in breathing,
dizziness (signs of severe allergic reaction called
anaphylactic reaction). This side effect is very rare
(may affect up to 1 in 10,000 people)
if you bleed or bruise more easily than normal
(signs of decreased number of blood platelets
thrombocytopenia). This side effect is very rare
(may affect up to 1 in 10,000 people)
if you have red or purple skin lesions (signs of
blood vessel inflammation - vasculitis). This side
effect is very rare (may affect up to 1 in 10,000
people)
if you have a red blotchy rash mainly on the face
which may be accompanied by fatigue, fever,
nausea, loss of appetite (signs of lupus
erythematous-like reaction). This side effect is
very rare (may affect up to 1 in 10,000 people)

If you have severe upper stomach pain (signs of
an inflamed pancreas - pancreatitis). This side
effect is very rare (may affect up to 1 in 10,000
people).
Other side effects:
Common (may affect up to 1 in 10 people):
Difficulty in sleeping, headache, stomach discomfort,
abdominal pain, nausea.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness of the hands or feet, disturbed
or decreased sensitivity.
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the
safety of this medicine.

5 HOW TO STORE FLUVASTATIN
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister and carton. The expiry date refers
to the last day of the month.
Do not store above 30∞ C.
If you notice any signs of deterioration of this product,
please tell your pharmacist.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 CONTENTS OF THE PACK AND
OTHER INFORMATION
What Fluvastatin contains
The active ingredient is fluvastatin sodium.
One 40mg capsule contains 40mg fluvastatin (as
fluvastatin sodium).
The other ingredients are lactose monohydrate,
colloidal anhydrous silica, crospovidone, magnesium
stearate, red iron oxide (E172), yellow iron oxide
(E172), black iron oxide (E172), titanium dioxide
(E171), gelatin, shellac and propylene glycol.
What Fluvastatin looks like and contents of the
pack
Fluvastatin 40mg Capsules have a yellow opaque
body and pink opaque cap marked 93 7443.
Blister pack of 30 capsules.
The capsule should be pushed out carefully from the
blister as shown by the picture, in order to avoid
damaging the capsule.
Procured from within the EU.
PL holder: Manx Pharma Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA, UK.
PL 15833/0034
Fluvastatin is manufactured by Pharmachemie BV,
Swensweg 5, Postbus 552, 2003 RN, Harlem,
The Netherlands.
To request a copy of this leaflet in large print, audio or
Braille please call 01926 482511.
POM
This leaflet was revised in April 2015
WIP URN: 130415-PIL-GF10-PIL-08

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

130415-PIL-GF10-08
N/A

Fluvastatin 40mg PIL - Side 2
340 x 160mm
13 April 2015
14057/08 40mg PIL S2.ai
1 Colour - Black

M1

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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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