Fluvastatin Mylan Generics: detailed information

Package leaflet: Information for the patient

Fluvastatin Mylan Generics 80 mg prolonged-release tablets

Fluvastatin
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Fluvastatin Mylan Generics is and what it is used for
What you need to know before taking Fluvastatin Mylan Generics
How to take Fluvastatin Mylan Generics
Possible side effects
How to store Fluvastatin Mylan Generics
Contents of the pack and other information

1. What Fluvastatin Mylan Generics is and what it is used for

Fluvastatin Mylan Generics contains the active substance sodium fluvastatin, which belongs to a group
of medicines known as statins, which are lipid-lowering agents: they reduce fats (lipids) in the
blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Fluvastatin is a medicine used to treat high levels of fats in the blood in adults, in particular total cholesterol and so-called "bad" cholesterol 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 cholesterol and triglycerides (another type of lipid in the blood)

Your doctor may also prescribe Fluvastatin Mylan Generics to prevent further serious cardiac events
(e.g. heart attack) in patients who have already undergone cardiac catheterization with an intervention on the heart vessels.

2. What you should know before taking Fluvastatin Mylan Generics

Follow carefully the instructions given to you by your doctor. These may differ from the general instructions contained in this leaflet.
Read the following information before taking Fluvastatin Mylan Generics.

Do not take Fluvastatin Mylan Generics:

if you are allergic to fluvastatin or to any of the ingredients of this medicine (listed in section 6).
if you currently have liver disease, or if you have persistently elevated and unexplained levels of certain liver enzymes in the blood (transaminases).
if you are pregnant or breastfeeding (see “Pregnancy, breastfeeding and fertility”).

If any of these cases apply to you, do not take Fluvastatin Mylan Generics and discuss this with your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluvastatin Mylan Generics:

If you are taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections), either orally or by injection. The combination of fusidic acid and fluvastatin may lead to serious muscle problems (rhabdomyolysis).
If you have a history of liver disease. You will normally have liver function tests before starting treatment with Fluvastatin Mylan Generics, when the dose is increased, and at regular intervals during treatment, to monitor for possible adverse effects.
If you have kidney disease.
If you have thyroid disorders (hypothyroidism).
If you or a family member has a history of muscle disorders.
If you have experienced muscle problems with other lipid-lowering medicines.
If you regularly consume large amounts of alcohol.
If you have a severe infection.
If you suffer from low blood pressure (symptoms may include dizziness, lightheadedness).
If you engage in excessive physical exercise, whether controlled or uncontrolled.
If you are scheduled for surgery.
If you suffer from serious metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood. During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

If any of these conditions apply to you, talk to your doctor before taking Fluvastatin Mylan Generics.
Your doctor will perform a blood test before prescribing Fluvastatin Mylan Generics to you.
If, during treatment with Fluvastatin Mylan Generics, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the skin or eyes, confusion, euphoria or depression, mental slowing, slurred speech, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver failure. In such cases, contact a doctor immediately.
If you experience breathing difficulties, including persistent cough and/or shortness of breath or fever, contact your doctor.
Also inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.

Fluvastatin Mylan Generics and patients over 70 years of age
If you are over 70 years old, your doctor may want to assess whether you have risk factors for muscle disorders. You may require specific blood tests.

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

Other medicines and Fluvastatin Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you need to take fusidic acid to treat a bacterial infection, you must temporarily stop taking fluvastatin. Your doctor will tell you when it is safe to restart fluvastatin. Taking fluvastatin and fusidic acid together may rarely cause muscle weakness, pain or tenderness (rhabdomyolysis). See section 4 for more information about rhabdomyolysis.

Fluvastatin Mylan Generics may be taken alone or together with other cholesterol-lowering medicines prescribed by your doctor.
After taking a resin such as cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatin Mylan Generics.

Inform your doctor or pharmacist if you are taking any of the following:

medicines used to reduce the activity of the immune system (e.g. cyclosporine)
fibrates (e.g. gemfibrozil), nicotinic acid (niacin), or bile acid sequestrants (medicines used to lower levels of bad cholesterol)
fluconazole (a medicine used to treat fungal infections)
rifampicin or erythromycin (medicines used to treat bacterial infections)
phenytoin (a medicine used to treat epilepsy)
oral anticoagulants such as warfarin (a medicine used to reduce blood clotting)
glibenclamide (a medicine used to treat diabetes)
colchicine (used to treat gout).

Pregnancy, breastfeeding and fertility
Do not take Fluvastatin Mylan Generics if you are pregnant or breastfeeding, as the active substance may be harmful to the fetus, and it is unknown whether the active substance is excreted in human breast milk.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use an effective method of contraception (e.g. a reliable contraceptive) throughout the entire duration of treatment with Fluvastatin Mylan Generics.
If you become pregnant while taking this medicine, stop taking Fluvastatin Mylan Generics and consult your doctor.
Your doctor will discuss with you the potential risks associated with taking fluvastatin during pregnancy.

Fertility
Animal studies have not shown effects on male or female fertility.

Driving and using machines
There is no information available on the effects of fluvastatin on the ability to drive or use machinery.

3. How to take Fluvastatina Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not exceed the recommended dose.
Your doctor will advise you to follow a low-cholesterol diet. Maintain this diet
during treatment with Fluvastatina Mylan Generics.
How to take Fluvastatina Mylan Generics

The recommended dose range for adults is 20 to 80 mg of fluvastatin per day, depending on the required reduction in cholesterol levels. Dose adjustments may be made by your doctor at intervals of 4 weeks or longer.

Your doctor will tell you exactly how many tablets of Fluvastatina Mylan Generics you should take.
Depending on your response to treatment, your doctor may adjust your dose upward or downward.
Please note that you cannot use Fluvastatina Mylan Generics 80 mg prolonged-release tablets
for all the dosage strengths listed above. Fluvastatina Mylan Generics is available only as
80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe
other fluvastatin-containing medicines.
When to take Fluvastatina Mylan Generics
When taking Fluvastatina Mylan Generics, you may take your dose at any time of day.
Fluvastatina Mylan Generics may be taken with or without food. Swallow the tablets whole with a
glass of water; do not divide, chew or crush the tablet.
Use in children and adolescents
For children (from 9 years of age) 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 intervals of 6 weeks.
If you take more Fluvastatina Mylan Generics than you should
If you have accidentally taken too high a dose of the medicine, contact your doctor immediately.
You may require medical attention.
If you forget to take Fluvastatina Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, do not take it if less than 4 hours remain before your next scheduled dose. In this case, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Fluvastatina Mylan Generics
To maintain the benefits of treatment, do not stop taking Fluvastatina Mylan Generics without first consulting your doctor. You must continue taking Fluvastatina Mylan Generics as prescribed to keep your “bad” cholesterol levels low. Fluvastatina Mylan Generics will not cure your condition, but it will help control it. Your cholesterol levels should be monitored regularly to assess your progress.
If you have further questions about 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 everyone experiences them.
Some side effects can be serious. If you think you have any of the following side effects,
stop taking this medicine immediately and contact your doctor or go to the nearest emergency room.

Rare (may affect up to 1 in 1,000 people):

If you experience unexplained muscle pain, tenderness, or weakness (rhabdomyolysis), especially if persistent. These may be early signs of potentially severe muscle breakdown, which can be prevented if your doctor stops fluvastatin treatment as soon as possible. These side effects have also been observed with other medicines in this class (statins).

Very rare (may affect up to 1 in 10,000 people):

If you experience unusual tiredness or have fever, yellowing of the skin or eyes, dark urine (signs of hepatitis).
If you bleed or bruise more easily than usual (signs of reduced platelet count in the blood).
If you develop red or purple skin lesions (signs of capillary inflammation).
If you develop rashes with reddish spots mainly on the face, possibly accompanied by fatigue, fever, nausea, and loss of appetite (signs of a lupus-like reaction).
If you experience severe pain in the upper abdomen (signs of pancreas inflammation).
If you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
If you experience signs of skin reactions such as rashes, hives, redness, itching, swelling of the face, eyelids, or lips.

Not known (frequency cannot be estimated from available data):

If you experience signs of inflammation, swelling, and irritation in a tendon. In some cases, this may lead to tendon rupture.
Respiratory problems including persistent cough and/or shortness of breath or fever.
Diabetes: you may feel very hungry, very thirsty, and urinate frequently. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

If any of these symptoms occur, inform your doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people):
Difficulty sleeping, headache, stomach discomfort (e.g. indigestion), abdominal pain, nausea (feeling unwell), abnormal blood test results related to liver and muscle function.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness in the hands or feet, altered or reduced sensation.
Not known (frequency cannot be estimated from available data):

Impotence.
Sleep disorders, including insomnia and nightmares.
Memory loss.
Sexual dysfunction.
Depression.
Diarrhea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluvastatin Mylan Generics

Keep out of the sight and reach of children.
Blister packs: keep blisters in the outer packaging to protect them from light.
Glass and plastic bottles: keep the bottle tightly closed to protect it from moisture and light.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the blister, packaging, and bottle, after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluvastatin Mylan Generics contains

The active substance is fluvastatin. Each prolonged-release tablet contains 80 mg of fluvastatin (as fluvastatin sodium).
The other ingredients are:
Tablet core: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol, magnesium stearate.
Coating film: hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Description of the appearance of Fluvastatin Mylan Generics and package contents
Fluvastatin Mylan Generics tablets are yellow, round, biconvex prolonged-release tablets.

Packaging:
Blister packs (OPA/Alu/PVC-Alu). Packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 490 prolonged-release tablets.
Polyethylene bottle with desiccant (do not ingest the desiccant) and safety cap (LDPE) with tamper-evident ring. Pack containing 250 prolonged-release tablets.
Glass container with desiccant (do not ingest the desiccant) and polyethylene cap (HDPE) containing 28, 98, 100, 250 or 500 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan (Italy)

Manufacturers:
Actavis hf.
Reykjavikurvegur 78,
IS-220 Hafnarfjordur
Iceland
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, 13
Dublin – Ireland
Mylan Hungary Kft.
H-2900, Komárom
Mylan utca 1
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Finland: ‘Fluvastatin Mylan 80 mg depottabletti’
France: ‘Fluvastatine Mylan L.P. 80 mg, comprimé pelliculé à libération prolongée’
Italy: ‘Fluvastatina Mylan Generics’
Netherlands: ‘Fluvastatine Retard Mylan 80 mg, tabletten met verlengde afgifte’
Portugal: ‘Fluvastatina Mylan’
Spain: ‘Fluvastatina MYLAN 80 mg comprimidos de liberación prolongada EFG’
United Kingdom: ‘Pinmactil 80mg prolonged release tablet’