FLUVASTATIN 20MG CAPSULES

Active substance: FLUVASTATIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
D
a
u
g
h
t
e
r
L
e
a
f
l
e
t

Lescol® 20mg Capsules / Fluvastatin 20mg Capsules
Lescol® 40mg Capsules / Fluvastatin 40mg Capsules
(fluvastatin sodium)
This product is available using any of the above names but will be referred to as Lescol throughout the
following leaflet.
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 Lescol is and what it is used for
2. What you need to know before you take Lescol
3. How to take Lescol
4. Possible side effects
5. How to store Lescol
6. Contents of the pack and other information
1. WHAT LESCOL IS AND WHAT IT IS USED FOR
Lescol 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.
• Lescol 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 Lescol 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 LESCOL
Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Read the following explanations before you take Lescol.
Do not take Lescol
• if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol 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 Lescol and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lescol.
• if you previously had a liver disease. Liver function tests will normally be done before you start Lescol,
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 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.
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 Lescol:
• if you have severe respiratory failure
If any of these apply to you, tell your doctor before taking Lescol. Your doctor will take a blood test
before prescribing Lescol.
If during treatment with Lescol, 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.
Lescol 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.
Lescol and children/adolescents
Lescol 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 Lescol in combination with nicotinic acid, cholestyramine or
fibrates in children and adolescents.
Other medicines and Lescol
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines
including medicines obtained without a prescription.
Lescol 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 Lescol.
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).
Lescol with food and drink
You can take Lescol with or without food.
Pregnancy and breast-feeding
Do not take Lescol 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 Lescol.
Take adequate precaution against pregnancy while taking Lescol.
If you become pregnant while taking this medicine, stop taking Lescol and see your doctor.
Your doctor will discuss with you the potential risk of taking Lescol during pregnancy.

Driving and using machines
There is no information on the effects of Lescol on your ability to drive and use machines.
3. HOW TO TAKE LESCOL
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 Lescol.
How much Lescol 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 capsules of Lescol to take.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
When to take Lescol
Take your Lescol dose in the evening or at bedtime.
If you are taking Lescol twice per day, take one capsule in the morning and one in the evening or at bedtime.
Lescol can be taken with or without meals. Swallow whole with a glass of water.
If you take more Lescol than you should
If you have accidentally taken too much Lescol, talk to your doctor straight away. You may need
medical attention.
If you forget to take Lescol
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 Lescol
To maintain the benefits of your treatment, do not stop taking Lescol unless your doctor tells you to. You must
continue to take Lescol as directed to keep the levels of your ‘bad’ cholesterol down. Lescol 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lescol can cause side effects, although not everybody gets them.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
Some rare or very rare side 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, abnormal blood test
values for muscle and liver.
Very rare:
Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.
Not known:
Impotence
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. You doctor may monitor you while you are taking this medicine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5. HOW TO STORE LESCOL
• Do not store above 25°C. Store in the original package.
• Keep all medicines out of the sight and reach of children.
• Do not take the medicine after the expiry date which is printed on the outside of the pack.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
• If the capsules become discoloured or show signs of any deterioration, you should seek the advice
of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lescol contains
Each Lescol 20mg Capsule contains 20mg fluvastatin (as fluvastatin sodium).
Each Lescol 40mg Capsule contains 40mg fluvastatin (as fluvastatin sodium).
The other ingredients of Lescol capsules are: magnesium stearate, sodium hydrogen carbonate, talc,
microcrystalline cellulose, pregelatinised starch, calcium carbonate, titanium dioxide (E 171), red iron
oxide (E 172), yellow iron oxide (E172), gelatin and red printing ink.
What Lescol looks like and contents of the pack
Lescol 20 mg Capsules are opaque hard gelatin capsules with a reddish brown cap and pale yellow
body printed ‘XU 20mg’ in red.
Lescol 40 mg Capsules are opaque hard gelatin capsules with a reddish brown cap and pale yellow
body printed ‘XU 40mg’ in red
Lescol is available in calendar blister packs of 28 capsules.
PL No: 29510/0047
Lescol® 20mg Capsules / Fluvastatin 20mg Capsules
POM
PL No: 29510/0048
Lescol® 40mg Capsules / Fluvastatin 40mg Capsules
Lescol is manufactured by Novartis Pharma GmbH, Roonstrasse 25, Nuremberg, D-90429, Germany
and is procured from within the EU by the Product Licence holder: Pharma-XL Ltd, Colonial Way,
Watford, Herts WD24 4PR. Repackaged by: OPD Laboratories Ltd., Unit 6 Colonial Way, Watford,
Herts WD24 4PR.
Lescol is a registered Trademark of Novartis AG, Switzerland.
Leaflet revision and issue date (Ref.): 31/05/2013.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)