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CADAFF XL 80MG PROLONGED RELEASE TABLETS

Active substance(s): FLUVASTATIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cadaff XL 80 mg 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.
What is in this leaflet:
1. What Cadaff XL is and what it is used for
2. What you need to know before you take Cadaff XL
3. How to take Cadaff XL
4. Possible side effects
5. How to store Cadaff XL
6. Contents of the pack and other information

1. What Cadaff XL is and what it is used for
Cadaff XL contains the active 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.





Cadaff 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 Cadaff 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
Cadaff 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 Cadaff XL.
Do not take Cadaff XL
• if you are allergic (hypersensitive) to fluvastatin or any of the
other ingredients of Cadaff XL 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 Cadaff XL and tell your
doctor.
Warnings and precautions
• if you previously had a liver disease. Liver function tests will
normally be done before you start Cadaff 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.
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 Cadaff XL:
• if you have severe respiratory failure
If any of these apply to you, tell your doctor before you take
Cadaff XL. Your doctor will take a blood test before prescribing
Cadaff XL.
Cadaff 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.
Cadaff XL and children/adolescents
Cadaff 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 Cadaff XL in combination
with nicotinic acid, cholestyramine or fibrates in children and
adolescents.
Other medicines and Cadaff XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines including medicines
obtained without a prescription.
Cadaff 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 Cadaff 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).
Cadaff XL with food and drink
You can take Cadaff XL with or without food.
Pregnancy and breast-feeding
Do not take Cadaff 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. If you are pregnant, consult your doctor or
pharmacist before taking Cadaff XL. Use reliable contraception
for the whole time that you are taking Cadaff XL.
If you become pregnant while taking this medicine, stop taking
Cadaff XL and see your doctor.
Driving and using machines
There is no information on the effects of Cadaff XL on your
ability to drive and use machines.

3. How to take Cadaff XL
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 Cadaff XL.
How much Cadaff XL 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 6 week intervals.

Your doctor will tell you exactly how many tablets of Cadaff XL
to take.
Depending on how you respond to the treatment, your doctor
may suggest a higher or lower dose.
When to take Cadaff XL
Your dose of Cadaff XL can be taken at any time of the day.
Cadaff XL can be taken with or without meals. Swallow whole
with a glass of water.
If you take more Cadaff XL than you should
If you have accidentally taken too much Cadaff XL, talk to your
doctor straight away. You may need medical attention.
If you forget to take Cadaff 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 the one that you missed.
If you stop taking Cadaff XL
To maintain the benefits of your treatment, do not stop taking
Cadaff XL unless your doctor tells you to. You must continue to
take Cadaff XL as directed to keep the levels of your ‘bad’
cholesterol down. Cadaff 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, Cadaff XL 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 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.
• 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
Very rare:
Tingling or numbness of the hands or feet, disturbed or
decreased sensibility.

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
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet

5. How to store Cadaff 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.
HDPE bottles: Keep the container tightly closed in order to
protect from moisture and light.
Do not use Cadaff XL after the expiry date, which is stated on
the carton and blister 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 dispose of medicines you no
longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Cadaff XL contains:
- The active substance is fluvastatin sodium.
Each Cadaff XL tablet contains 84.48 mg fluvastatin sodium
equivalent to 80 mg fluvastatin.
- The other ingredients of Cadaff XL tablets are povidone,
microcrystalline cellulose, hydroxyethyl cellulose, mannitol,
magnesium stearate, hypromellose 50, macrogol 6000, iron
oxide yellow (E172), titanium dioxide (E171).
What Cadaff XL tablets look like and contents of the pack
Cadaff XL tablets are yellow, round, biconvex prolonged release
tablets marked “F” on one side.
Pack sizes:
Blister packs (OPA/Alu/PVC/Alu): 10, 20, 28, 30, 50 and 100
HDPE container with desiccant and LDPE cap: 250
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
Ealing, London
W5 5TL
Manufacturer
Actavis hf.
Reykjavikurvegur 78,
IS-220 Hafnarfjordur,
ICELAND
And/or
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
MALTA
This leaflet was last revised in 11/2012.

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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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