Emthexate Xl 80 Mg Prolonged-Release Film-Coated Tablets
Package leaflet: Information for the user Emthexate XL 80 mg Prolonged-Release Film-coated Tablets
Fluvastatin Sodium
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. See section 4.
What is in this leaflet:
1. What Emthexate XL is and what it is used for
2. What you need to know before you take Emthexate XL
3. How to take Emthexate XL Prolonged Release Tablets
4. Possible side effects
5. How to store Emthexate XL Prolonged Release Tablets
6. Contents of the pack and other information
1. What Emthexate XL is and what it is used for
• Emthexate 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.
• Emthexate XL is a medicine used to treat raised levels of fat 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 Emthexate 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 Emthexate 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 Emthexate XL.
Do not take Emthexate XL
• If you are allergic 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 levels 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 Emthexate XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Emthexate XL
• If you previously had a liver disease. Liver function tests will normally be done before you start Emthexate 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 Fluvastatin 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 severe respiratory failure.
• 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.
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.
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.
Children and adolescents
Emthexate XL has not been investigated and is not intended for 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 Emthexate XL in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Other medicines and Emthexate XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Emthexate XL can be taken 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 Emthexate 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)
• Fusidic acid (to treat bacterial infection).
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 Fluvastatin. Taking Fluvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Emthexate 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..
Use reliable contraception for the whole time that you are taking Emthexate XL.
If you become pregnant while taking this medicine, stop taking Emthexate XL and see your doctor.
Driving and using machines
There is no information on the effects of Emthexate XL on your ability to drive and use machines.
If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.
3. How to take Emthexate XL
Always take this medicine exactly as your doctor 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 follow a low-cholesterol diet. Stay on this diet while taking this medicine.
How much 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 recommended 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 to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
When to take Emthexate XL
• If you are taking Emthexate XL tablets, you can take your dose at any time of the day.
• Emthexate XL can be taken with or without meals. Swallow whole with a glass of water.
If you take more Emthexate XL than you should
If you have accidentally taken too much Emthexate XL, talk to your doctor straight away. You may need medical attention.
If you forget to take Emthexate 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 a forgotten tablet.
If you stop taking Emthexate XL
To maintain the benefits of your treatment, do not stop taking Emthexate XL unless your doctor tells you to. You must continue to take Emthexate XL as directed to keep the levels of your ‘bad’ cholesterol down. Emthexate 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.
If you feel one of the following, stop taking Emthexate XL and go to your doctor or nearest hospital
right away:
• If you have unexplained muscle pain, tenderness or weakness. These might be early signs of potentially severe muscle degradation (rhabdomyolysis). 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).These side effects are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10 000 people)
• If you have unusual tiredness or fever, yellowing of the skin and eyes, dark-coloured urine (signs of hepatitis). This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips. These side effects are rare (may affect up to 1 in 1 000 people) or very rare (may affect up to 1 in 10,000 people)
• If you have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction called anaphylactic reaction). This side effect is very rare (may affect up to 1 in 10,000 people).
• If you bleed or bruise more easily than normal (signs of decreased number of platelets-thrombocytopenia). This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have red or purple skin lesions (signs of blood vessel inflammation-vasculitis). This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have a red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction). This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have severe upper stomach pain (sign of an inflamed pancreas-pancreatitis). This side effect is very rare (may affect up to 1 in 10 000 people)
Other side effects:
Common (may affect up to 1 in 10 people):
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea. Very rare (may affect up to 1 in 10 000 people):
Tingling or numbness of the hands or feet, disturbed or decreased sensations.
Not known (frequency cannot be estimated from the available data):
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 or pharmacist. 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 Emthexate XL Prolonged Release Tablets
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the cartons and blister packs after 'EXP'. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package in order to protect from light.
• 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 Emthexate XL contains
• The active substance is fluvastatin. One prolonged-release tablet contains 80 mg fluvastatin (as fluvastatin sodium).
• The other ingredients are microcrystalline cellulose, crospovidone, hydroxyethylcellulose, microcrystalline cellulose, magnesium stearate in the tablet core and a film-coat of Opadry II 85F18378 white, which contains poly(vinyl alcohol) partly hydrolyzed, titanium dioxide (E171), macrogol 3350 and talc.
What Emthexate XL looks like and contents of the pack
• White to off-white, film-coated round tablet, debossed with "93" on one side and "7446" on the other side of the tablet
• Emthexate XL is available in pack sizes of 28, 30, 90, 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne BN22 9AG, UNITED KINGDOM
This leaflet was last revised in December 2015. PL 00289/1061