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LUVINSTA XL 80 MG PROLONGED-RELEASE TABLETS

Active substance(s): FLUVASTATIN SODIUM

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T00075-01 Malta Zejtun 190x380 PIL

Luvinsta 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.
• K
 eep this leaflet. You may need to read it again.
• If
 you have any further questions, please 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 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 XL is and what it is used for

Luvinsta XL 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.
• Luvinsta 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 Luvinsta 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
Luvinsta 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 Luvinsta
XL:

Do not take Luvinsta XL:

• if you are allergic to fluvastatin or any of the other
ingredients of this medicine (listed in section 6 of this
leaflet).
• 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
and breast-feeding”).
If any of these apply to you, do not take Luvinsta XL and
tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Luvinsta XL
• If 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.
• 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 Luvinsta 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.
• 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.

Check with your doctor or pharmacist before
taking Luvinsta XL:
• if 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.
If during treatment with Luvinsta 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.
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.

Luvinsta 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

Luvinsta 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 Luvinsta XL in
combination with nicotinic acid, cholestyramine or fibrates
in children and adolescents.

Other medicines and Luvinsta XL

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Luvinsta
XL can be taken on its own or with other cholesterollowering 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
Luvinsta 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).
• I f 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 Luvinsta XL. Taking Luvinsta XL with fusidic acid
may rarely lead to muscle weakness, tenderness or
pain (rhabdomyolysis). See more information regarding
rhabdomyolysis in section 4.

Luvinsta XL with food and drink

You can take Luvinsta XL with or without food.

Pregnancy and breast feeding

Do not take Luvinsta XL 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 XL.

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AAAI5873

Fluvastatin 80mg PIL (Blister Packaging) UK

awstudio@actavis.co.uk

item no: AAAI5873

dimensions: 190x380 mm

print proof no: 1

pharmacode:

origination date: 10.2.15

min pt size: 9

1.black
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4.
5.
6.

originated by: MB
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colours/plates:

revision date:

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revised by:

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supplier: Malta Zejtun

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Non Printing Colours
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* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

T00075-01 Malta Zejtun 190x380 PIL

Use reliable contraception for the whole time that you are
taking Luvinsta XL.
If you become pregnant while taking this medicine, stop
taking Luvinsta XL and see your doctor.

Driving and using machines

There is no information on the effects of Luvinsta XL 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
Luvinsta XL.
How much Luvinsta XL to take
• The 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.
• For 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 XL
to take.
Depending on how you respond to the treatment, your
doctor may suggest a higher or lower dose.
Luvinsta XL 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 XL
You can take Luvinsta XL 80mg prolonged-release tablets
at any time of the day.
Luvinsta XL can be taken with or without meals. Swallow
whole with a glass of water.

Other side effects: tell your doctor if they worry you.
Common (may affect up to 1 in 10 people):
• Difficulty in sleeping, headache, stomach discomfort,
abdominal pain, nausea, abnormal blood test values for
muscle and liver.
Very rare (may affect up to 1 in 10, 000 people):
• Tingling or numbness of the hands or feet, disturbed or
decreased sensibility.
Not known (cannot be estimated from the available data):
• Impotence
• Muscle weakness that is constant.
Other possible side effects
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems including persistent cough and/or
shortness of breath or fever
•D
 iabetes. 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, 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: 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 Luvinsta XL

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Blisters: Keep the blisters in the outer carton in order to
protect from light.

If you take more Luvinsta XL than you should

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.

If you forget to take Luvinsta XL

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.

If you have accidentally taken too much Luvinsta XL,
talk to your doctor straight away. You may need medical
attention.
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 the one that you
missed.

If you stop taking Luvinsta XL

To maintain the benefits of your treatment, do not stop
taking Luvinsta XL unless your doctor tells you to. You
must continue to take Luvinsta XL as directed to keep
the levels of your ‘bad’ cholesterol down. Luvinsta 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.
Some rare (may affect up to 1 in 1,000 people) or very
rare (may affect up to 1 in 10,000 people) 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 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.

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
acid.
• The other ingredients are:
Tablet core:
Povidone, microcrystalline cellulose, hydroxyethyl
cellulose, mannitol, magnesium stearate
Film-coating:
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
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Iceland
Manufacturers:
Actavis ehf.
Reykjavikurvegi 78,
IS-220 Hafnarfjordur,
Iceland
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
This leaflet was last revised in December 2015

If you would like a leaflet
with larger text,
please contact
01271 385257.

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

AAAI5873

Fluvastatin 80mg PIL (Blister Packaging) UK

awstudio@actavis.co.uk

item no: AAAI5873

dimensions: 190x380 mm

print proof no: 1

pharmacode:

origination date: 10.2.15

min pt size: 9

1.black
2.
3.
4.
5.
6.

originated by: MB
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

date sent: N/A

supplier: Malta Zejtun

technically app. date*: N/A

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

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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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