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Active substance(s): FLUVASTATIN SODIUM

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20 mg and 40 mg Capsules



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.
Package leaflet: Information for the user
Read all of this leaflet carefully before you start While you are on this medicine your doctor will
monitor you closely if you have diabetes or are
taking this medicine because it contains
at risk of developing diabetes. You are likely to
important information for you.
be at risk of developing diabetes if you have
• Keep this leaflet. You may need to read it
high levels of sugars and fats in your blood, are
overweight and have high blood pressure.
• If you have any further questions, ask your
Children and adolescents
doctor or pharmacist.
Fluvastatin Capsules has not been investigated
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm and is not intended for the use in children below
9 years. For dose information in children and
them, even if their signs of illness are the
adolescents over 9 years, see section 3.
same as yours.
• If you get any side effects, talk to your doctor There is no experience with the use of
or pharmacist. This includes any possible side Fluvastatin Capsules in combination with
effect not listed in this leaflet. See section 4.
nicotinic acid, cholestyramine or fibrates in
children and adolescents.
What is in this leaflet
1. What Fluvastatin Capsules are and what they Other medicines and Fluvastatin Capsules
Tell your doctor or pharmacist if you are taking,
are used for
have recently taken or might take any other
2. What you need to know before you take
Fluvastatin Capsules
Fluvastatin Capsules can be taken on its own or
3. How to take Fluvastatin Capsules
with other cholesterol-lowering medicines
4. Possible side effects
prescribed by your doctor.
5. How to store Fluvastatin Capsules
After intake of a resin, e.g. cholestyramine
6. Contents on the pack and other information
(primarily used to treat high cholesterol) wait at
least 4 hours before taking Fluvastatin Capsules.
Fluvastatin Capsules are and
1 What
Tell your doctor and pharmacist if you are taking
what they are used for
any of the following:
Fluvastatin Capsules contain the active
• Ciclosporin (a medicine used to suppress the
substance fluvastatin sodium which belongs to
immune system).
a group of medicines known as statins, which
• Fibrates (e.g. gemfibrozil), nicotinic acid or
are lipid-lowering medicines: they lower the fat
bile acid sequestrants (medicines used to
(lipids) in your blood. They are used in patients
lower bad cholesterol levels).
whose conditions cannot be controlled by diet
• Fluconazole (a medicine used to treat fungal
and exercise alone.
• Rifampicin (an antibiotic).
Fluvastatin Capsules 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
adults, in particular total cholesterol and so
used to reduce blood clotting).
called “bad” or LDL cholesterol, which is
• Glibenclamide (a medicine used to treat
associated with an increased risk of heart
disease and stroke
• Colchicines (used to treat gout).
• in adult patients with high blood levels of
If you need to take oral fusidic acid to treat a
• in adult patients with high blood levels of
bacterial infection you will need to temporarily
both cholesterol and triglycerides (another
stop using this medicine. Your doctor will tell
sort of blood lipid)
you when it is safe to restart Fluvastatin
Capsules. Taking Fluvastatin Capsules with
Your doctor can also prescribe Fluvastatin
fusidic acid may rarely lead to muscle
Capsules to prevent further serious cardiac
weakness, tenderness or pain (rhabdomyolysis).
events (e.g. heart attack) in patients after they
See more information regarding
already went through a heart catheterisation,
rhabdomyolysis in section 4.
with an intervention in the heart vessel.
Fluvastatin Capsules with food and drink
you need to know before you
You can take Fluvastatin Capsules with or
2 What
take Fluvastatin Capsules
without food.
Pregnancy and breast-feeding
Follow all instructions given to you by your
If you are pregnant or breast-feeding, think you
doctor carefully. They may differ from the
may be pregnant or are planning to have a
information contained in this leaflet.
Read the following explanations before you take baby, ask your doctor or pharmacist for advice
before taking this medicine
Fluvastatin Capsules.
Do not take Fluvastatin Capsules if you are
Do not take Fluvastatin Capsules:
pregnant or breast-feeding as the active
• if you are allergic to fluvastatin or to any of
ingredient may lead to harm to your unborn
the other ingredients of this medicine (listed
child, and it is not known whether the active
in section 6)
• if you currently have liver problems, or if you ingredient is excreted in human breast milk. If
you are pregnant, consult your doctor or
have unexplained, persistently high levels of
pharmacist before taking Fluvastatin Capsules.
certain liver enzymes (transaminases)
Use reliable contraception for the whole time
• if you are pregnant or breast-feeding (see
that you are taking Fluvastatin Capsules.
“Pregnancy and breast-feeding”).
If you become pregnant while taking this
If any of these apply to you, do not take
medicine, stop taking Fluvastatin Capsules and
Fluvastatin Capsules and tell your doctor.
see your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Driving and using machines
There is no information on the effects of
Fluvastatin Capsules:
Fluvastatin Capsules on your ability to drive and
• if you previously had a liver disease. Liver
use machines.
function tests will normally be done before
Fluvastatin Capsules contains lactose
you start Fluvastatin Capsules, when your
This medicinal product contains a small amount
dose is increased and at various intervals
of lactose which is a sugar: if you have been told
during treatment to check for side effects.
by your doctor that you have an intolerance to
• if you have a kidney disease
• if you have a thyroid disease (hypothyroidism) some sugars, contact your doctor before taking
this medicinal product.
• if you have a medical history of muscle
diseases yourself or in your family
• if you had muscle problems with another
3 How to take Fluvastatin Capsules
lipid-lowering medicine
• if you regularly drink large amounts of alcohol. Always take this medicine exactly as your
doctor has told you. Check with your doctor or
• if you have severe respiratory failure
• if you are over 70 years your doctor may want pharmacist if you are not sure.
to check if you have risk factors for muscular
Follow your doctor’s instructions carefully. Do
diseases. You may need specific blood tests.
not exceed the recommended dose.
• if you are taking or have taken in the last 7
Your doctor will recommend you to follow a
days a medicine called fusidic acid, (a
low-cholesterol diet. Stay on this diet while
medicine for bacterial infection) orally or by
injection. The combination of fusidic acid and taking Fluvastatin Capsules.
Fluvastatin Capsules can lead to serious
muscle problems (rhabdomyolysis).

17 March 2016



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
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
day, take one capsule in the morning and one in
the evening or at bedtime.
Fluvastatin Capsules can be taken with or without
meals. Swallow whole with a glass of water.
If you take more Fluvastatin Capsules than you
If you have accidentally taken too many
Fluvastatin Capsules, talk to your doctor straight
away. You may need medical attention.
If you forget to take Fluvastatin Capsules
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 a
forgotten dose..
If you stop taking Fluvastatin Capsules
To maintain the benefits of your treatment, do
not stop taking Fluvastatin Capsules unless your
doctor tells you to. You must continue to take
Fluvastatin Capsules as directed to keep the
levels of your ‘bad’ cholesterol down.
Fluvastatin Capsules will not cure your condition
but it does help control it. Your cholesterol levels
need to be checked regularly to monitor your
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.


Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you get any of the following serious side
effects, stop taking Fluvastatin Capsules and go
to your doctor or to the nearest hospital straight
Rare: may affect up to 1 in 1,000 people
• 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 Capsules as quickly
as possible. These side effects have also been
found with similar medicines of this class
• if you have signs of skin reactions such as skin
rash or hives.
Very rare: may affect up to 1 in 10,000 people
• if you have a potentially severe muscle
degradation called rhabdomyolysis
• if you have unusual tiredness or fever,
yellowing of the skin and eyes, dark coloured
urine (signs of hepatitis).
• 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
• if you have red or purple skin lesions (signs of
blood vessel inflammation-vasculitis).
• 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.
Other possible side effects with Fluvastatin
Common: may affect up to 1 in 10 people
Difficulty in sleeping, headache, stomach
discomfort, abdominal pain, nausea and joint


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
• 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 or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide
more information on the safety of this medicine.


How to store Fluvastatin Capsules

Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the blister and carton after
EXP. The expiry date refers to the last day of the
Do not store above 30°C.
Do not use this medicine after the expiry date
which is stated on the label and carton after EXP.
The expiry date refers to the last day of the
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use.. These measures will help protect
the environment.


Contents of the pack and other

What Fluvastatin Capsules contain:
The active substance is fluvastatin sodium.
One 20 mg capsule contains 20 mg fluvastatin
(as fluvastatin sodium).
One 40 mg capsule contains 40 mg 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 Capsules look like and
contents of the pack
Fluvastatin 20 mg Capsules have an ivory
opaque body and pink opaque cap marked
Fluvastatin 40 mg Capsules have a yellow
opaque body and pink opaque cap marked
Blisters: 1, 14, 15, 20, 28, 30, 50, 50 x2, 56, 60, 84,
90, 98 and 100 capsules.
Hospital packs in blisters: 1, 50 and 100
Bottles: 100, 250 and 500 capsules.
Not all pack sizes may be
The capsule should be pushed
out carefully from the blister as
shown by the picture, in order
to avoid damaging the capsule.
Marketing Authorisation
Holder and Manufacturer
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 03/2016
PL 00289/0997-8


17 March 2016

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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.