Cadaff Xl 80mg Prolonged Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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