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STEFLUVIN XL 80MG PROLONGED RELEASE TABLET

Active substance(s): FLUVASTATIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Stefluvin XL 80mg prolonged-release Tablets
Fluvastatin
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 Stefluvin XL is and what it is used for
2. What you need to know before you take Stefluvin XL
3. How to take Stefluvin XL
4. Possible side effects
5. How to store Stefluvin XL
6. Contents of the pack and other information
1. What Stefluvin XL is and what it is used for
Stefluvin XL contains the active ingredient fluvastatin sodium which belongs to a group
of medicines known as statins, which are lipid-lowering medicines: they lower the fat
(lipids) in your blood. They are used in patients whose conditions cannot be controlled by
diet and exercise alone.
Stefluvin XL is a medicine used to treat raised levels of fats 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 cholesterol
In adult patients with high blood levels of both cholesterol and triglycerides (another
sort of blood lipid).
Your doctor can also prescribe Stefluvin 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 Stefluvin XL

Follow all your doctor’s instructions carefully. They may differ from the general
information contained in this leaflet.
Read the following explanations before you take Stefluvin XL.
Do not take Stefluvin XL
if you are allergic to fluvastatin or any of the other ingredients of this medicine
(listed in section 6).

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if you currently have liver problems, or if you have unexplained, persistently high
level of certain liver enzymes (transaminases).
if you are pregnant or breast-feeding (see "Pregnancy, breast-feeding and fetility").

If any of these apply to you, do not take Stefluvin XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Stefluvin XL
If you previously had a liver disease. Liver function tests will normally be done
before you start Stefluvin 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, lightheadedness).
If you have controlled or uncontrolled excessive muscle exercise.
If you are about to have an operation.
If you have severe respiratory failure.
If you have severe metabolic, endocrine or electrolyte disorders such as
decompensating diabetes and low blood potassium.
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 Stefluvin XL can lead to serious muscle problems (rhabdomyolysis).
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.
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.
If any of these apply to you, tell your doctor before you take Stefluvin XL. Your doctor
will take a blood test before prescribing Stefluvin XL.
If during treatment with Stefluvin XL, you develop symptoms or signs such as nausea,
vomiting, loss of appetite, yellow eyes 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.
Stefluvin 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.
Children and adolescents

Fluvastatin 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 Stefluvin XL in combination with nicotinic acid,
cholestyramine or fibrates in children and adolescents.
Other medicines and Stefluvin XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Stefluvin 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 Stefluvin 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 infections).
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 diabetes).
Colchicines (used to treat gout).
Fusidic acid – if you need to take oral fusidic acid to treat a bacterial infection you
will need to temporarily stop using this medicine. Your doctor will tell you when it
is safe to restart Stefluvin XL. Taking Stefluvin XL with fusidic acid may rarely
lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more
information regarding rhabdomyolysis in section 4.
Stefluvin XL with food and drink
You can take Stefluvin XL with or without food.
Pregnancy, breast-feeding and fertility
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 Stefluvin 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. Take adequate precautions against pregnancy while
taking Stefluvin XL.
If you become pregnant while taking this medicine, stop taking Stefluvin XL and see
your doctor. Your doctor will discuss with you the potential risk of taking Stefluvin XL
during pregnancy.
Driving and using machines
There is no information on the effects of Stefluvin XL on your ability to drive and use
machines.

3. How to take Stefluvin 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 to follow a low-cholesterol diet. Stay on this diet while
taking Stefluvin XL.
How much Stefluvin XL to take
The recommended doses are:
- 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 usual starting dose is 20 mg per day. The
maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6week intervals.
Your doctor will tell you exactly how much fluvastatin to take. Depending on how you
respond to the treatment, your doctor may suggest a higher or lower dose.
If you need a dose less than 80 mg the doctor will prescribe fluvastatin 20mg or 40mg
capsules.
When to take Stefluvin XL
You can take your Stefluvin XL dose at any time of the day.
Stefluvin XL can be taken with or without meals. Swallow whole with a glass of water.
If you take more Stefluvin XL than you should
If you have accidentally taken too much Stefluvin XL, talk to your doctor straight away.
You may need medical attention.
If you forget to take Stefluvin 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 Stefluvin XL
To maintain the benefits of your treatment, do not stop taking Stefluvin XL unless your
doctor tells you to. You must continue to take Stefluvin XL as directed to keep the levels
of your “bad” cholesterol down. Stefluvin 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 people
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 side effects could be serious: get medical help immediately.
if you have unexplained muscle pain, tenderness or weakness. These might be early
signs of a potentially severe muscle degradation. This can be avoided if your doctor
stops your treatment with Stefluvin XL 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 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).
If you experience any of these, tell your doctor straight away.
Other side effects: tell your doctor if they worry you.
Common:
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 sensitivity.
Not known:
Impotence, muscle weakness that is constant, breathing problems including persistent
cough and/or shortness of breath or fever.
Other possible side effects
Sleep disturbances, including insomnia and nightmares
Memory loss
Sexual difficulties
Depression

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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 may monitor you
while you are taking this medicine
Tendon disorders, sometimes complicated by rupture.

Reporting 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: 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 Stefluvin XL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from 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 Stefluvin XL contains:
The active substance is: fluvastatin sodium.
Each prolonged-release tablet contains 84.2 mg of fluvastatin sodium (corresponding to
80 mg of fluvastatin).
The other ingredients are:
Tablet core: Carrageenan, Magnesium stearate
Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow, Titanium
dioxide, Macrogol 8000, Iron oxide red
What Stefluvin XL looks like and contents of the pack
Dark yellow, round, biconvex tablets.
Stefluvin XL is available in packs of 10, 14, 20, 28, 30, 42, 50, 56, 98, 100 or 300
prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Winthrop Pharmaceuticals,

PO Box 611,
Guildford,
Surrey,
GU1 4YS,
UK
or
Zentiva,
One Onslow Street
Guildford,
Surrey,
GU1 4YS,
UK
Manufacturer:
Pharmathen S.A.,
6 Dervenakion str,
153 51 Pallini,
Attiki,
Greece
This leaflet was last revised in December2015.
Winthrop is a registered trademark © 2015 Winthrop Pharmaceuticals
Or
Zentiva is a registered trademark © 2015 Zentiva

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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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