LUVINSTA 80 mg. 30 tablets

What is LUVINSTA and what is it used?
LUVINSTA contains the active substance fluvastatin sodium, belonging to the group of medicines known as statins, which regulate cholesterol levels: they reduce the level of fats (lipids) in the blood. Used in patients whose condition can not be controlled only by a change in diet and lifestyle.
LUVINSTA is a drug that is used for treatment of elevated levels of blood fat in adults, in particular total cholesterol, and the so-called "bad" or LDL-cholesterol, which is associated with 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 (another form of lipids in the blood)
Your doctor also may prescribe LUVINSTA for prevention of serious cardiovascular events (eg. Stroke) in patients who have recently suffered a heart catheterization with intervention of the vessels of the heart.

2. What you need to know before taking Fluvastatin?
Strictly follow any instructions that your doctor has given you. They may differ from the information in this leaflet.
Read the following explanations before taking LUVINSTA.

Do not take LUVINSTA
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from liver disease or have unexplained, persistently high levels of certain liver enzymes (transaminases).
If you are pregnant or breast-feeding (see "Pregnancy and lactation")
If any of the above apply to you, stop taking Fluvastatin and consult a doctor.

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking LUVINSTA If you have a history of liver disease. Usually you do liver function tests before initiation of treatment with LUVINSTA, increasing the dose and at various intervals during treatment to check for side effects.
If you have kidney disease
If you suffer from thyroid disease (hypothyroidism)
If you or someone in the family have had a disease of the muscles
If you had muscle problems while receiving another lipid lowering drug.
If you regularly consume large amounts of alcohol.
If you have severe respiratory failure.
If any of the above apply to you, tell your doctor before taking Fluvastatin. In these circumstances, will take a blood sample for analysis before the physician prescribing Fluvastatin
While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in the blood, if you are overweight and have high blood pressure.

LUVINSTA and patients over 70 years of age
If you are over 70, your doctor may check whether you have risk factors for muscle disease. This may require some specific blood tests.

Children and adolescents
LUVINSTA has not been studied and is not intended for use in children below 9 years of age. The dosage in children and adolescents over 9 years, see section 3.
There is no experience from the use of LUVINSTA in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Other medicines, LUVINSTA
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines without a prescription.
LUVINSTA can be taken alone or with other cholesterol-lowering medicines prescribed by your doctor.
Following administration of resin, such as cholestyramine (used mainly to treat high cholesterol) wait at least 4 hours before taking Fluvastatin.
Tell your doctor if you are taking any of the following: ciclosporin / medicine to suppress the immune system /
Fibrates (such as gemfibrozil), nicotinic acid or bile acid / drugs, which are used to reduce the cholesterol / Fluconazole (a drug used to treat fungal infections) rifampicin (antibiotic) Phenytoin (medicine for the treatment of epilepsy)
Oral anticoagulants like warfarin (medicines to reduce blood clotting)
Glibenclamide (for diabetes), colchicine (for gout)
LUVINSTA with food and drink
You can take LUVINSTA with or without food. Pregnancy and lactation
Do not take LUVINSTA if you are pregnant or breast-feeding as the active ingredient may cause damage to your unborn child and it is not known whether the active substance is excreted in human milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin. Use effective contraception throughout the taking Fluvastatin.
If you become pregnant while taking this medicine, stop taking Fluvastatin and consult your doctor.

Driving and using machines
No information on the effects of LUVINSTA on ability to drive and use machines.

3. How to take LUVINSTA?
Always take this medicine exactly as you have been told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Do not exceed the recommended dose.
Your doctor will advise you to follow a cholesterol-lowering diet that should continue during treatment with LUVINSTA.

How LUVINSTA should not take
The dose for adults is 20 to 80 mg per day and depends on the level of cholesterol lowering, you have to reach. Your doctor may adjust the dose at intervals of 4 weeks or more.
For children (age 9 and up) the usual starting dose is 20 mg daily. The maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at intervals of 6 weeks.
Your doctor will give you precise instructions for dosage LUVINSTA, you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.
LUVINSTA is only available as 80 mg prolonged release. For lower doses (20 mg and 40 mg) Your doctor will prescribe other drugs with fluvastatin.

When taking LUVINSTA?
You can take LUVINSTA 80 mg prolonged-release tablets at any time of day. LUVINSTA can be taken with or without food. The tablets should be swallowed with water.

If you take more dose LUVINSTA
If you accidentally take more LUVINSTA, tell your doctor immediately. You may need medical attention.

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

If you stop taking Fluvastatin
To maintain the benefits of treatment should not stop taking Fluvastatin without first consulting a doctor. You should continue taking Fluvastatin as directed to keep a low level of "bad" cholesterol. LUVINSTA will not cure your disease, but will help to control it. It is necessary to regularly check your cholesterol levels to track progress treatment.
If you have further questions on the use of this product, consult your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: more than 1 in 10 patients
Common: 1 to 10 of 100 patients
Uncommon: 1 to 10 of 1000 patients
Rare: 1 to 10 of 10,000 patients
Very rare: less than 1 in 10,000 patients
Unknown: frequency can not be estimated from the available data
Some rare or very rare side effects can be serious: get medical help immediately
If you have unexplained muscle pain, tenderness or weakness. They may be early signs of a potentially severe muscle degradation which can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects occur in the treatment with drugs of the same class / statin /. If you have unusual tiredness or fever, yellowing of the skin and eyes, dark 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 breathing, dizziness (signs of severe allergic reaction).
If you bleed or hurt more easily than normal / signs of decreased number of platelets /
If you have redness or bruising / signs of inflammation of blood vessels /
If you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite / signs of reactions similar to lupus erythematosus /
If you have severe pain in the upper stomach / signs of inflamed pancreas /. If any of these side effects occur in you, tell your doctor immediately.

Other side effects: tell your doctor if you are worried
common:
Sleep disturbances, headache, stomach discomfort, abdominal pain, nausea.
Very rare:
Numbness in hands or feet, disturbed or decreased sensibility.

Other possible side effects:
- Sleep disorders, including insomnia and nightmares, memory loss, 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, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet

5. How to store LUVINSTA?
Keep out of the reach and sight of children.
Blisters: Keep the blisters in the outer carton in order to protect them from light. Tablet container (glass or plastic HDPE bottle): Keep container tightly closed in order to protect from moisture and light.
Do not use this medicine after the expiry date stated on the blister, carton and bottle after "EXP". The expiry date refers to the last day of that month.
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 other information

What LUVINSTA:
The active substance is fluvastatin sodium.
One tablet LUVINSTA 80 mg prolonged-release tablet contains 84,48 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid
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 / view How LUVINSTA and contents of container