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Active substance(s): FLUVASTATIN SODIUM

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Package leaflet: Information for the user
Mithestan XL
80 mg prolonged-release tablets
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 Mithestan XL is and what it is used for
2. What you need to know before you take Mithestan XL
3. How to take Mithestan XL
4. Possible side effects
5. How to store Mithestan XL
6. Contents of the pack and other information

1. What Mithestan XL is and what it is used for
Mithestan XL contains the active substance 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.
Mithestan 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 Mithestan 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 Mithestan 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 Mithestan XL.
Do not take Mithestan XL
if you are allergic to fluvastatin or 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
level of certain liver enzymes (transaminases).
if you are pregnant or breast-feeding (see “pregnany and breast-feeding”).

If any of these apply to you, do not take Mithestan XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mithestan XL if you are taking fusidic acid
(medicine to treat bacterial infections). Taking Fluvastatin with fusidic acid can increase the
risk of muscle problems (see section 4).
Talk to your doctor or pharmacist before taking Mithestan XL name
if you previously had a liver disease. Liver function tests will normally be done
before you start Mithestan XL, when your dose is increased and at various intervals
during treatment to check for side effects.
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 Mithestan XL can lead to serious muscle problems (rhabdomyolysis).
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.
Check with your doctor or pharmacist before taking Mithestan XL
if you have severe respiratory failure
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
If any of these apply to you, tell your doctor before you take Mithestan XL. Your doctor will
take a blood test before prescribing Mithestan XL.
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.
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
Mithestan XL 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 in combination with nicotinic acid,
cholestyramine or fibrates in children and adolescents.
Other medicines and Mithestan XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
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 Mithestan XL.
Taking Mithestan XL with fusidic acid may rarely lead to muscle weakness, tenderness or
pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Mithestan 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 Mithestan XL.
Tell your doctor and pharmacist if you are taking any of the following:
Fusidic acid (a medicine used to treat bacterial infections). Do not take Mithestan XL
while taking fusidic acid or within 7 days after you have taken fusidic acid.
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).
Phenprocoumon or Warfarin (medicines used to reduce blood clotting).
Glibenclamide (a medicine used to treat diabetes).
Colchicine (used to treat gout).
Mithestan XL with food and drink
You can take Mithestan XL 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 Mithestan 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 Mithestan XL.
If you become pregnant while taking this medicine, stop taking Mithestan XL and see your
Driving and using machines
There is no information on the effects of Mithestan XL on your ability to drive and use

3. How to take Mithestan XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Do not exceed the recommended dose.
Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while
taking Mithestan XL.
How much fluvastatin 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 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
For lower dosages other dosage forms are available.

When to take Mithestan XL
You can take Mithestan XL at any time of the day.
Mithestan XL can be taken with or without meals. Swallow whole with a glass of water.
If you take more Mithestan XL than you should
If you have accidentally taken too much Mithestan XL, talk to your doctor straight away. You
may need medical attention.
If you forget to take Mithestan 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 Mithestan XL
To maintain the benefits of your treatment, do not stop taking Mithestan XL unless your
doctor tells you to. You must continue to take Mithestan XL as directed to keep the levels of
your ‘bad’ cholesterol down. Mithestan 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 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 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
if you bleed or bruise more easily than normal (signs of decreased number of blood
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.
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Very rare:
Tingling or numbness of the hands or feet, disturbed or decreased sensibility.
Not known:
Muscle weakness that is constant.
Other possible side effects:
Sleep disturbances, including nightmares
Memory loss
Sexual difficulties
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
5. How to store Mithestan XL:
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and blister after
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
6. Contents of the pack and other information
What Mithestan XL contains:
The active substance is: fluvastatin. Each tablet contains 80 mg of fluvastatin as
fluvastatin sodium.

The other ingredients are:
Tablet core: Carageenan, Magnesium stearate
Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow,
Titanium dioxide, Macrogol 8000, Iron oxide red

What Mithestan XL looks like and contents of the pack

Mithestan XL are dark yellow, round, biconvex tablets and are packed in
Aluminium/Aluminium blisters strips.
Each pack of Mithestan XL contains 10, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany
Manufacturer: Pharmathen S.A., 6 Dervenakion str, 153 51 Pallini, Attiki, Greece
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
This leaflet was last revised in September 2015
PL 15773/0896

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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.