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Active substance(s): FLUVASTATIN SODIUM

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Luvinsta XL 80mg 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.
•  f you have any further questions, please ask your
doctor or pharmacist.
•  his medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms of illness are the same as
•  f you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
1. What Luvinsta XL is and what it is used for
2. What you need to know before you take Luvinsta XL
3. How to take Luvinsta XL
4. Possible side effects
5. How to store Luvinsta XL
6. Contents of the pack and other information
1. What Luvinsta is and what it is used for
Luvinsta contains the active fluvastatin (as 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.
•  uvinsta 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.
- n adult patients with high blood levels of cholesterol
- n adult patients with high blood levels of both
cholesterol and triglycerides (another sort of blood
•  our doctor can also prescribe Luvinsta 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
2.  hat you need to know before you take Luvinsta XL
Follow all instructions given to you by your doctor
carefully. They may be differ from the information
contained in this leaflet.
Read the following explanations before you take
Luvinsta XL:
Do not take Luvinsta XL:
• f you are allergic to fluvastatin or any of the other
ingredients of this medicine (listed in section 6 of this
• f you currently have liver problems, or if you have
unexplained, persistently high level of certain liver
enzymes (transaminases).
• f you are pregnant or breast-feeding (see “pregnancy
and breast-feeding”).
If any of these apply to you, do not take Luvinsta and
tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Luvinsta XL
•  f you previously had a liver disease. Liver function
tests will normally be done before you start Luvinsta
XL, when your dose is increased and at various
intervals during treatment to check for side effects.
•  f you have a kidney disease.


•  f you have a thyroid disease (hypothyroidism).
•  f you have a medical history of muscle diseases
yourself or in your family.
•  f you had muscle problems with another lipidI
lowering medicine.
•  f you regularly drink large amounts of alcohol.
•  f you have severe respiratory failure.
If any of these apply to you, tell your doctor before
you take Luvinsta XL.Your doctor will take a blood test
before prescribing Luvinsta XL.
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.
Luvinsta 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
Luvinsta 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 Luvinsta in
combination with nicotinic acid, cholestyramine or
fibrates in children and adolescents.
Other medicines and Luvinsta
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Luvinsta can be taken on its own or with other
cholesterol-lowering medicines prescribed by your
After intake of a resin, e.g. cholestyramine (primarily
used to treat high cholesterol) wait at least 4 hours
before taking Luvinsta.
Tell your doctor and pharmacist if you are taking any of
the following:
•  iclosporin (a medicine used to suppress the immune
•  ibrates (e.g. gemfibrozil), nicotinic acid, or bile acid
sequestrants (medicines used to lower bad cholesterol
•  luconazole (a medicine used to treat fungal
•  ifampicin (an antibiotic).
•  henytoin (a medicine used to treat epilepsy)
•  ral anticoagulants like warfarin (medicines used to
reduce blood clotting).
•  libenclamide (a medicine used to treat diabetes)
•  olchicines (used to treat gout).
Luvinsta XL with food and drink
You can take Luvinsta with or without food.
Pregnancy and breast feeding
Do not take Luvinsta if you are pregnant or breastfeeding 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. If
you are pregnant, consult your doctor or pharmacist
before taking Luvinsta. Use reliable contraception for
the whole time that you are taking Luvinsta.
If you become pregnant while taking this medicine,
stop taking Luvinsta and see your doctor.
Driving and using machines
There is no information on the effects of Luvinsta on
your ability to drive and use machines.


3. How to take Luvinsta 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.
Do not exceed the recommended dose.
Your doctor will recommend you to follow a lowcholesterol diet. Stay on this diet while taking
How much Luvinsta to take
•  he 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.
•  or 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 much of Luvinsta
to take.
Depending on how you respond to the treatment, your
doctor may suggest a higher or lower dose.
Luvinsta is only available as 80mg prolonged-release
tablets. For lower doses (20mg and 40mg), your doctor
will prescribe other fluvastatin medicines.
When to take Luvinsta
You can take Luvinsta 80mg prolonged-release tablets
at any time of the day.
Luvinsta can be taken with or without meals. Swallow
whole with a glass of water.
If you take more Luvinsta XL than you should
If you have accidentally taken too much Luvinsta, talk
to your doctor straight away. You may need medical
If you forget to take Luvinsta XL
Take one 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 Luvinsta XL
To maintain the benefits of your treatment, do not
stop taking Luvinsta unless your doctor tells you to.
You must continue to take Luvinsta as directed to keep
the levels of your ‘bad’ cholesterol down. Luvinsta 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, Luvinsta can cause side effects,
although not everybody gets them.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the
available data.
Some rare or very rare effects could be serious: get
medical help immediately.
• f 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).
• f you have unusual tiredness or fever, yellowing of the
skin and eyes, dark coloured urine (signs of hepatitis).
• f you have signs of skin reactions such as skin rash,
hives, redness, itching, swelling of the face, eyelids,
and lips.
• f you have skin swelling, difficulty in breathing,
dizziness (signs of severe allergic reaction).
• f you bleed or bruise more easily than normal (signs of
decreased number of blood platelets).
• f you have red or purple skin lesions (signs of blood
vessel inflammation).
• f 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).
• f you have severe upper stomach pain (signs of
inflamed pancreas).
If you experience any of these, tell your doctor straight

Other side effects: tell your doctor if they worry you.
Common: Difficulty in sleeping, headache, stomach
discomfort, abdominal pain, nausea.
Very rare: Tingling or numbness of the hands or feet,
disturbed or decreased sensibility.
Other possible side effects
•  leep disturbances, including insomnia and
•  emory loss
•  exual difficulties
•  epression
•  reathing 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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
5. How to store Luvinsta XL
Keep this medicine out of the reach and sight of
Do not store above 30 ºC.
Blisters: Keep the blisters in the outer carton in order to
protect from light.
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 that month.
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 Luvinsta XL contains:
The active substance is: Fluvastatin sodium.
Each prolonged-release tablet contains 84.48mg
fluvastatin sodium equivalent to 80mg fluvastatin free
The other ingredients are:
Tablet core:

Povidone, microcrystalline cellulose, hydroxyethyl
cellulose, mannitol, magnesium stearate

Hypromellose 50, macrogol 6000, iron oxide yellow
(E172), titanium dioxide (E171).
What Luvinsta XL looks like and contents of the pack
Luvinsta XL 80mg Prolonged-Release are yellow, round,
biconvex prolonged release tablets.
Pack sizes:
Blister (OPA/Alu/PVC-Alu): 10, 20, 28, 30, 50, 60, 98 and
100 prolonged release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Actavis hf.
Reykjavikurvegi 78,
P.O. Box 420,
220 Hafnarfjordur,
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
This leaflet was last revised in April 2012

If you would like a
leaflet with larger
text, please contact
01271 311257.
Actavis, Barnstaple, EX32 8NS, UK

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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.