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Active substance(s): FLUVASTATIN SODIUM

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Package leaflet: information for the user

Sinfatix 80mg XL
Prolonged release
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
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 Sinfatix 80mg XL is and what it is used
2. What you need to know before you take
Sinfatix 80mg XL
3. How to take Sinfatix 80mg XL
4. Possible side effects
5. How to store Sinfatix 80mg XL
6. Contents of the pack and other information

1. What Sinfatix 80mg XL is and
what it is used for
• Sinfatix 80mg XL contains the active substance
fluvastatin sodium which belongs to a group of
medicines known as statins, which are
lipid-lowering medicines: they reduce the fat
(lipids) level in your blood. They are used in
patients whose conditions cannot be controlled
by diet and exercise alone.
• Sinfatix 80mg XL is a medicine used to treat
raised levels of fat in the blood in adults, in
particular total cholesterol and so-called “bad”
or LDL cholesterol, which is associated with an
increased risk of heart disease and stroke.
- In adult patients with high blood levels of
- In adult patients with high blood levels of both
cholesterol and triglycerides (another sort of
blood lipid)
• Your doctor can also prescribe Sinfatix 80mg XL
to prevent further serious cardiac events (e.g.
heart attack) in patients after they already went
through a heart catheterisation, with an
intervention in the heart vessel.

2. What you need to know
before you take Sinfatix
80mg XL
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
Sinfatix 80mg XL.
Do not take Sinfatix 80mg XL
• if you are allergic to Fluvastatin or to any of the
other ingredients of this medicine (listed in
section 6)
• if you have liver problems currently, 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 Sinfatix
80mg XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Sinfatix 80mg XL
• If you previously had a liver disease. Liver
function tests will normally be done before you
start Sinfatix 80mg XL, 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 a serious infection
• If you have very low blood pressure (signs may
include dizziness, light-headedness).
• If you have controlled or uncontrolled excessive
muscle exercise.
• if you are about to have an operation.
• If you have severe metabolic, endocrine or
electrolyte disorders such as decompensated
diabetes and low blood potassium.
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.
Check with your doctor or pharmacist before
taking Sinfatix 80mg XL:
• If you have severe respiratory failure.
If any of these apply to you, tell your doctor before
you take Sinfatix 80mg XL. Your doctor will take a
blood test before prescribing Sinfatix 80mg XL.
If during treatment with Sinfatix 80 mg XL, you
develop symptoms or signs such as nausea,

vomiting, loss of appetite, yellow eye or skin,
confusion, euphoria or depression, mental
slowing, slurred speech, sleep disturbance,
tremors or easy bruising or bleeding, these may
be signs of liver failure. In such case contact a
doctor immediately.
Sinfatix 80mg XL and people over 70 years
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.
Sinfatix 80mg XL and children/adolescents
Sinfatix 80mg XL has not been investigated and
is not intended for 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 Sinfatix
80mg XL in combination with nicotinic acid,
cholestyramine or fibrates in children and
Other medicines and Sinfatix 80mg XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including medicines obtained without
Sinfatix 80mg XL can be taken on its own or with
other cholesterol-lowering medicines prescribed
by your doctor.
After intake of a resin, e.g. cholestyramine
(primarily used to treat high cholesterol), wait at
least 4 hours before taking Sinfatix 80mg XL.
Tell your doctor and pharmacist if you are taking
any of the following:
• Ciclosporin (a medicine used to suppress the
immune system)
• Fibrates (e.g. gemfibrozil), nicotinic acid or bile
acid sequestrants (medicines used to lower bad
cholesterol levels)
• Fluconazole (a medicine used to treat fungal
• Rifampicin (an antibiotic)
• Phenytoin (a medicine used to treat epilepsy)
• Oral anticoagulants like warfarin (medicines
used to reduce blood clotting)
• Glibenclamide (a medicine used to treat
• Colchicines (used to treat gout)
Sinfatix 80mg XL with food and drink
You can take Sinfatix 80mg XL with or without
Pregnancy, breast-feeding and fertility
Do not take Sinfatix 80mg XL 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. Use reliable contraception
for the whole time that you are taking Sinfatix
80mg XL.
In animal studies no effects on male and female
fertility were observed.
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.
Driving and using machines
There is no information on the effects of Sinfatix
80mg XL on your ability to drive and use machines.

3. How to take Sinfatix 80mg XL
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Follow your doctor’s instructions carefully. Do not
exceed the recommended dose.
Your doctor will recommend you follow a
low-cholesterol diet. Stay on this diet while taking
this medicine.
How much to take
The recommended 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 usual
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 tablets
to take. Depending on how you respond to the
treatment, your doctor may suggest a higher or
lower dose.
When to take Sinfatix 80mg XL
• If you are taking Sinfatix 80mg XL, you can take
your dose at any time of the day.
• Sinfatix 80mg XL can be taken with or without
meals. Swallow whole with a glass of water.
If you take more Sinfatix 80mg XL than you
If you have accidentally taken too much Sinfatix
80mg XL, talk to your doctor straight away. You
may need medical attention.
If you forget to take Sinfatix 80mg XL
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 Sinfatix 80mg XL
To maintain the benefits of your treatment, do not
stop taking Sinfatix 80mg XL unless your doctor
tells you to. You must continue to take Sinfatix
80mg XL as directed to keep the levels of your
‘bad’ cholesterol down. Sinfatix 80mg XL will not
cure your condition but it does help control it.
Your cholesterol levels need to be checked
regularly to monitor your progress.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common: may affect more than 1 in 10
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from
the available data
Some rare or very rare effects could be serious:
get medical help immediately.
• If you have unexplained muscle pain,
tenderness or weakness. These might be early
signs of potentially severe muscle degradation.
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).
• If you have unusual tiredness or fever, yellowing
of the skin and eyes, dark-coloured urine (signs
of hepatitis).
• If you have signs of skin reactions such as skin
rash, hives, redness, itching, swelling of the
face, eyelids, and lips.
• If you have skin swelling, difficulty in breathing,
dizziness (signs of severe allergic 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).
• 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
erythematosus-like reaction).
• If you have severe upper stomach pain (sign of
an inflamed pancreas).
If you experience any of these, tell your doctor
straight away.
Other side effects: tell your doctor if they worry
Difficulty in sleeping, headache, stomach
discomfort, abdominal pain, nausea, abnormal
blood test values for muscle and liver.
Very rare:
Tingling or numbness of the hands or feet,
disturbed or decreased sensibility.
Not known:
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
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: By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Sinfatix 80mg XL
• Keep this medicine out of the sight and reach of
• 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
that month.
• Store below 30°C in the original container in
order to protect from light and moisture.
• 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.

6. Contents of the pack and
other information
What Sinfatix 80mg XL contains
The active substance is fluvastatin sodium.
Each prolonged release tablet contains 84.280
mg of Fluvastatin sodium equivalent to 80 mg

The other ingredients are:
Tablet core:
Cellulose microcrystalline, Potassium hydrogen
carbonate, Povidone K-30, Hydroxy propyl
cellulose, Hypromellose K 100, Hypromellose K
4M, Magnesium stearate
Film coat:
Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol 3350, Talc, Iron oxide yellow (E172)
What Sinfatix 80mg XL looks like and
contents of the pack
Yellow colored, round, biconvex, beveled edged
film coated tablets, debossed with “F80” on one
side and plain on other side.
Sinfatix 80mg XL is available in OPA-Al-PVC/Al
blisters packs containing 7, 14,28,30,56,70,84,90
and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation holder and
Accord Healthcare Limited
Sage House,
319, Pinner Road
North Harrow
Middlesex HA1 4HF
United Kingdom
This leaflet was last revised in 02/2014

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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.