Patient leaflet - CADAFF XL 80 MG PROLONGED-RELEASE TABLETS
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,askyour doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on toothers. 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
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1. What Cadaff XL is and what it is used for
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2. What you need to know before you take Cadaff XL
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3. Howto take Cadaff XL
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4. Possible side effects
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5. How to store Cadaff XL
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6. Contents of the pack and other information
1. what cadaff xl is and what it is used for
Cadaff 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.
- 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.
o in adult patients with high blood levels of cholesterol
o 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 who have already had a heart catheterisation, with an intervention in the heart vessel.
If you have any questions about how Cadaff XL works or why this medicine has been prescribed foryou,askyourdoctor.
2. what you need to know before you take cadaff xl
Follow all your doctor's instructions carefully, even if they differ from the general 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 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).
- ifyou 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
Talk to your doctor or pharmacist before taking Cadaff XL.
- ifyou 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 Cadaff XL can lead to serious muscle problems (rhabdomyolysis).
- ifyou 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.
- ifyou have a kidney disease.
- ifyou have a thyroid disease (hypothyroidism).
- ifyou havea medical history of muscle diseases yourself or in your family.
- ifyou had muscle problems with another lipid-lowering medicine.
- ifyou regularly drink large amounts of alcohol.
- ifyou have a serious infection.
- ifyou have very low blood pressure (signs may include dizziness, light-headedness).
- ifyou have controlled or uncontrolled excessive muscle exercise. ifyou are about to have an operation.
- ifyou have severe metabolic, endocrine or electrolyte disorders such as decompensated diabetes and low blood potassium.
While you are on this medicine your doctor will monitor you closely ifyou have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes ifyou 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:
- ifyou 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.
Also tell your doctor or pharmacist ifyou have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
If during treatment with Cadaff 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.
Cadaff XL and people over 70 years
Ifyou are over 70 years your doctor may want to check ifyou have risk factors for muscular diseases. You may need specific blood tests.
Children and adolescents
Cadaff XL has not been investigated and is not intended forthe 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 medicinesand Cadaff XL
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.
Ifyou need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using Cadaff XL. Your doctor will tell you when it is safe to restart Cadaff XL. Taking Cadaff XL with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Cadaff XL can betaken 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 Cadaff XL. Tell your doctor and pharmacist ifyou 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).
Pregnancy and breast-feeding
Do not take Cadaff XL ifyou 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.
Ifyou are pregnant or breast-feeding,thinkyou may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.
Take adequate precaution against pregnancy while taking Cadaff XL.
Ifyou become pregnant while taking this medicine, stop taking Cadaff XL and see your doctor.
Your doctor will discuss with you the potential risk of taking Cadaff XL during pregnancy.
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou 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 Cadaff XL.
How much Cadaff XL to take
Recommended doses in adults
The dose range of fluvastatin 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.
Use in children and adolescents
For children (aged 9 years and older) the usual starting dose is 20 mg of fluvastatin 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
Yourdose ofCadaffXLcan be taken at anytime oftheday.
Cadaff XL can betaken with or without meals. Swallow whole with a glass of water.
If you take more Cadaff XL than you should
Ifyou 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.
Ifyou stop taking Cadaff XL
To maintain the benefits ofyour 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.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Likeall 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 upto 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 ini 0,000 people
Not known: frequency cannot be estimated from the
available data.
Some rare or very rare effects could be serious:get medical help immediately.
- ifyou 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).
- ifyou have unusual tiredness or fever,yellowing of the skin and eyes,dark coloured urine (signs of hepatitis).
- ifyou have signs of skin reactions such as skin rash, hives, redness, itching, swelling ofthe face, eyelids and lips.
- ifyou have skin swelling,difficulty in breathing, dizziness (signs of severe allergic reaction).
- ifyou bleed or bruise more easily than normal (signs of decreased number of blood platelets).
- ifyou have red or purple skin lesions (signs of blood vessel inflammation).
- ifyou 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).
- ifyou have severe upper stomach pain (signs of inflamed pancreas).
Ifyou 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 ofthe 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.
- Diarrhoea
Other possible side effects
- Sleep disturbances, including insomnia and nightmares
- Memory loss
- Sexual difficulties
- Depression
- Diabetes-This is more likely ifyou 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.
- Inflammation, swelling, and irritation of a tendon.
5. how to store cadaff xl
Keep this medicine out ofthe 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.
HDPEbottles: 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 ofthat 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 informationwhat 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 (El 72),titanium dioxide (El 71).
What Cadaff XL tablets look like and contents ofthe pack CadaffXL tablets are yellow, round, biconvex prolonged release tablets marked "F"on one side.
Pack sizes:
Blister packs (OPA/AIu/PVC/AIu): 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
Torrent Pharma (UK) Ltd.
Unit 4,Charlwood Court
County Oak Way
Crawley
West Sussex
RH11 7XA
United Kingdom
Manufacturer
Actavis hf.
Reykjavikurvegur78,
IS-220 Hafnarfjordur,
ICELAND
And/or
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
MALTA
This leaflet was last revised in 06/2019.