Luvinsta Xl 80 Mg Prolonged-Release Tablets
T00075-01 Malta Zejtun 190x380 PIL
Luvinsta XL 80mg Prolonged-Release Tablets
T00075-01 Malta Zejtun 190x380 PIL
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, 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:
T| What Luvinsta XL is and what it is used for 4 What you need to know before you take Luvinsta XL
4 How to take Luvinsta XL _4| Possible side effects 4 How to store Luvinsta XL 4 Contents of the pack and other information
T| 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.
4 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).
• If 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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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.
^1 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 low-cholesterol 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.
If you take more Luvinsta XL than you should
If you have accidentally taken too much Luvinsta XL, talk to your doctor straight away. You may need medical attention.
If you forget to take Luvinsta 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 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.
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
• 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.
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/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
^ 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.
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 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/A lu/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.
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Actavis, Barnstaple, EX32 8NS, UK