Fluvastatin 80 mg. 30 tablets

What are Fluvastatin Accord and what it is used
Fluvastatin fluvastatin contain sodium, which belongs to a group of medicines known as statins, which are cholesterol-lowering agents: they reduce levels of fats (lipids) in the blood. Apply to patients who are not controlled on diet alone and exercise.
Accord Fluvastatin is a drug that is used for treatment of elevated levels of blood fat in adults, in particular total cholesterol, and so-called "bad" or LDL-cholesterol that are associated with an increased risk of heart disease and stroke :
in adult patients with high cholesterol levels in the blood;
in adult patients with high levels of cholesterol and triglycerides in the blood (other types of lipids in the blood).
Your doctor may also prescribe Fluvastatin Accord to prevent future serious cardiovascular events (eg. Heart attack) in patients after cardiac catheterization with sustained intervention on the blood vessels of the heart. If you feel unwell or your condition worsens, you should talk to a doctor.

2. What you need to know before taking Fluvastatin Accord
Follow all instructions of your doctor. They may differ from the information contained in this leaflet.
Read the following explanations carefully before you start taking Fluvastatin Accord.

Do not take Fluvastatin Accord:
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 persistent high levels of certain liver enzymes (transaminases);
if you are pregnant or breast-feeding (see. "Pregnancy and lactation").
If any of the above applies so do not take Fluvastatin Accord and tell your doctor.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Fluvastatin Accord:
if you have liver disease. Tests for liver function will usually be made before you start treatment with Fluvastatin Accord, a higher dose and at intervals during treatment to detect any adverse effects;
if you have kidney disease;
if you have thyroid disease (hypothyroidism);
if you have a personal or family history of muscle disease;
if you have muscle problems during treatment with other lipid-lowering agents;
if you regularly consume large amounts of alcohol;
While this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. Perhaps you are at risk of developing diabetes if you have high levels of sugar and fat in the blood, obesity and high blood pressure.
Ask your doctor or pharmacist before taking Fluvastatin Accord:
if you have severe respiratory failure.
If any of the above applies to you, tell your doctor before taking Fluvastatin Accord. Your doctor will take blood tests before prescribing Fluvastatin Accord

Fluvastatin Accord and people over 70 years
If you are aged over 70, your doctor may want to check whether you have risk factors for muscle disorders. You may need to undergo specific blood tests.

Fluvastatin Accord and children / adolescents
Fluvastatin Accord has not been studied and is not indicated for use in children under the age of 9 years.
For information on dosing in children and adolescents over 9 years, see section 3.
There is no experience with the use of Fluvastatin Accord in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin Accord
Tell your doctor or pharmacist if you are taking, have recently taken or take any other medicines.
Fluvastatin Accord can be taken alone or with other cholesterol-lowering drugs prescribed by your doctor.
Following administration of the resins, for example. cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatin Accord.

Tell your doctor and pharmacist if you are taking any of these medicines:
cyclosporin (a drug that is used to suppress the immune system);
fibrates (eg. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines that are used to reduce the "bad" cholesterol);
Fluconazole (a drug used to treat fungal infections);
rifampicin (antibiotic);
phenytoin (a medicine used for the treatment of epilepsy);
oral anticoagulants, such as warfarin (medicines used to reduce blood clotting);
glibenclamide (a drug that is used for treatment of diabetes);
colchicine (used for gout).
Fluvastatin Accord with food and drink
You can take Fluvastatin Accord prolonged-release tablets with or without food.

Pregnancy, lactation and fertility
Do not take Fluvastatin Accord if you are pregnant or breast-feeding as the active substance may cause damage to your unborn child and it is not known whether the active substance is excreted in human milk. Use reliable methods of contraception at all times while taking Fluvastatin Accord.
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
No information is available regarding the effects of Fluvastatin Accord on ability to drive and use machines.

3. How to take Fluvastatin Accord
Always take this medicine exactly as you have been told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Carefully follow your doctor's instructions. Do not exceed recommended dose.
Your doctor will advise you to follow a diet low in cholesterol. Follow your diet while taking this medicine.

How much to take
The dose range for adults is 20 to 80 mg per day depending on the degree of reduction of the cholesterol that is needed to be achieved. Dose adjustments may be made by your doctor 4-week or longer intervals.
In children (aged 9 years and over) the usual starting dose is 20 mg daily. The maximum daily dose is 80 mg. Dose adjustments may be made by the physician at 6-week intervals.
Your doctor will tell you exactly how many tablets to take. Depending on the response to treatment, your doctor may suggest a higher or lower dose.

When taking Fluvastatin Accord
If you are taking Fluvastatin Accord can take your dose at any time of day.
Fluvastatin Accord can be taken with or without food. Swallow them whole with a glass of water.

If you take more than the amount of Fluvastatin Accord
If you accidentally take too much Fluvastatin Accord, tell your doctor immediately. You may need medical attention.

If you forget to take Fluvastatin Accord
Take a dose as soon as you remember. Do not take it if your next dose is less than 4 hours. In this case, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Fluvastatin Accord
To keep the beneficial effects of treatment should not stop taking Fluvastatin Accord until your doctor tells you to do so. You should continue taking Fluvastatin Accord as prescribed by your doctor, you can keep low levels of "bad" cholesterol. Fluvastatin Accord will not cure your condition, but you can control it. Regularly examine cholesterol levels in order to track the effects of treatment.

If you have any questions about using 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.
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;
Not known: can not be estimated from the available data.
Rare or very rare side effects can be serious, seek medical help immediately.
if you have unexplained muscle pain, tenderness or weakness. These may be early symptoms of potentially serious muscle damage. It could be avoided if your doctor discontinued treatment with fluvastatin immediately. These side effects occur with similar drugs of this class (statins);
if you feel unusual tiredness or fever, yellowing of skin and eyes, dark urine (signs of hepatitis);
if you have signs of skin reactions such as rash, hives, redness, itching, swelling of the face, eyelids and lips;
if you bleed or bruise more easily than normal (signs of low blood platelets);
if you have red or purple skin lesions (signs of inflammation of blood vessels);
If you have spotted red rash predominantly on the face, which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of reaction as in lupus erythematosus);
if you have severe pain in the upper stomach (symptoms of inflamed pancreas).
If you have any of these symptoms, tell your doctor immediately.

Other side effects, tell your doctor if you are worried.
common:
Sleep disorders, headaches, stomach discomfort, abdominal pain, nausea.
Very rare:
Tingling or numbness in the arms or legs, abnormal or extreme sensitivity.
Other possible side effects:
Sleep disorders, including insomnia and nightmares;
Loss of memory;
Sexual dysfunction;
depression;
Breathing problems including persistent cough and / or shortness of breath or fever;
Diabetes: This is more likely if you have high levels of sugar and fat in the blood, obesity, and high blood pressure. Your doctor will monitor you while you are taking this medicine.
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Fluvastatin Accord
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30 ° C in the original package to protect from light and moisture.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information
What contain Fluvastatin Accord
The active substance is fluvastatin sodium.
Each prolonged-release tablet contains 84,280 mg fluvastatin sodium equivalent to 80 mg fluvastatin.

Other ingredients are:
Core:
Microcrystalline cellulose, potassium bicarbonate, povidone K-30, hydroxypropyl cellulose, hypromellose K100, K100 hypromellose, magnesium stearate.

Film coating:
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E 172).

Fluvastatin Accord looks like and contents of the pack
Yellow, round, biconcave tablets, engraved with "F80" on one side and plain on the other.
Fluvastatin Accord prolonged-release tablets are available in OPA-Al-PVC / Al blister packs containing 7, 14, 28, 30, 56, 70, 84, 90 and 98 tablets.
Not all pack sizes may be marketed.