Emthexate Xl 80 Mg Prolonged-Release Film-Coated Tablets
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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 onl y. Do not pass it on to ot hers. 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 ph armacist. This includes an y 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 fl uvastatin sodium which belong s to a group of medicines known as statins, which are lipid-lowerin g medicines: they lower th e fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet a nd exercise alone.
• Emthexate X L 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 atta ck) in patients after they already went through a he art cathet erisation, with an intervention in the heart vessel.
2. What you need to know before you take Emthexate XL
Follow all i nstructions given to you by your doctor carefully. They may differ from the inform ation contained in this leaflet.
Read the following explanations before you take Emthexate XL.
Do not take Emthexate XL
• If you are allergic to Flu vastatin or an y of t he other ingredien ts of this m edicine (listed in section 6);
• If you currently have l iver 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 previ ously had a li ver disease. Liver func tion tests will norm ally 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 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 o ver 70 years your doctor may want to check if you have risk factors for m uscular diseases. You may need specific blood tests.
Also tell y our doctor or phar macist if you have a muscle weakness that is constant. Addi tional 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 likel y 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 be en investigated and is not intended for use in childr en below 9 years. For dose information in children and adolescents over 9 years, see section 3.
There is no experience with the use of E mthexate XL in co mbination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Other medicines and Emthexate XL
Tell y our doctor or pharmaci st if y ou are taking, have recent ly taken or might take a ny othe r medicines.
Emthexate XL can be taken on its own or with other cholesterol-lowering m edicines prescribed b y your doctor.
After intake of a resin, e.g. cholestyramine (primarily used to tr eat 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)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a b aby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take E mthexate XL if you are pregnant or breast-f eeding as the a ctive 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-ch olesterol 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 adjust ments may be made by your doctor at 4-week or longer intervals.
For children (aged 9 years and older), the r ecommended starting dose i s 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 m uch 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 y our treatment, do not stop taking Em thexate 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. Em thexate XL will not cure y our condition but it does help control it. You r 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 Em thexate 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).This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have unusual tiredness or fever , yellowing of the skin and ey es, dark-coloured urine (signs of hepatitis). This side effect is very rare (may affect up to 1 in 10 000 people)
• If you have s igns of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips. This side effect is rare (may affect up to 1 in 1 000 people)
• If you bleed or bruise m ore easily than norm al (signs of decreased nu mber 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 (s igns 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 l upus erythematosus-like reaction). This side effect is ver y 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,
diabetesThis is m ore likely if you have high levels of su gars and fats in y our b lood, 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/vellowcard.
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 th is 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 aw ay any medicines via wa stewater or household waste. Ask y our pharmacist how to throw away medicines y ou 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, hy droxyethylcellulose, microcrystalline cellulose, magnesium stearate in the tablet core and a fil m-coat of Opadry II 85F18378 white, which contains pol y(vinyl al cohol) partly hy drolyzed, 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 avail able in pack si zes of 28, 30, 90, 98 tablets. Not all p ack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne BN22 9AG, UNITED KINGDOM
This leaflet was last revised in March 2015.
PL 00289/1061