Rosuvastatin Mylan

Patient Information Leaflet

Rosuvastatin Mylan 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine as 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Rosuvastatin Mylan is and what it is used for
2. What you need to know before taking Rosuvastatin Mylan
3. How to take Rosuvastatin Mylan
4. Possible side effects
5. How to store Rosuvastatin Mylan
6. Contents of the pack and other information

1. What Rosuvastatin Mylan is and what it is used for

Rosuvastatin Mylan contains the active substance rosuvastatin, which belongs to a group of
medicines called statins.
Your doctor has prescribed this medicine because:

• Your cholesterol level is high. This means you are at risk of having a heart attack or stroke. Rosuvastatin Mylan is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• You have been advised to take a statin because changes in diet and increased physical activity are not sufficient to correct your cholesterol levels. You must continue with a low-fat diet and regular exercise while taking Rosuvastatin Mylan.

Or

• You have other risk factors that increase your chance of having a heart attack, stroke, or related heart problems. Heart attacks, strokes, and other conditions can be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits in the arteries.

Why it is important to continue taking Rosuvastatin Mylan:

• Rosuvastatin Mylan is used to modify levels of fatty substances in the blood known as lipids, the most common of which is cholesterol.
• There are different types of cholesterol in the blood – “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
• Rosuvastatin Mylan can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by inhibiting the body’s production of “bad” cholesterol and also improves the body’s ability to remove it from the blood.
• For most people, high cholesterol does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
• Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
• You need to keep taking Rosuvastatin Mylan, even if your cholesterol levels are now within normal range, because it helps prevent cholesterol from rising again and stops the buildup of fatty deposits. However, treatment must be stopped if your doctor advises it or if you become pregnant.

2. What you need to know before taking Rosuvastatin Mylan

Do not take Rosuvastatin Mylan

• If you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid pregnancy during treatment with rosuvastatin by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have unexplained, repeated muscle pain or weakness.
• If you are taking a medicine called ciclosporin (used, for example, after organ transplant). If any of these apply to you (or if you have any doubts), please consult your doctor.

Also, do not take Rosuvastatin Mylan 40 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If you have an underactive thyroid gland.
• If you have experienced repeated or unexplained muscle pain, have a personal or family history of muscle disorders, or have previously experienced muscle problems while being treated with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.
• If any of these apply to you (or if you have any doubts), please consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Mylan

• If you have kidney problems.
• If you have liver problems.
• If you have a personal or family history of muscle disorders, or if you have previously experienced muscle problems while being treated with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you have an underactive thyroid gland.
• If you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol levels.
• If you are taking medicines used to treat HIV infection, such as lopinavir/ritonavir and/or atazanavir – see section “Other medicines and Rosuvastatin Mylan”.
• If you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and Rosuvastatin Mylan can lead to serious muscle problems (rhabdomyolysis). See “Other medicines and Rosuvastatin Mylan”.
• If you have severe respiratory failure.
• If you are of Asian origin – Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor must choose the correct starting dose of Rosuvastatin Mylan suitable for you.

During treatment
Inform your doctor or pharmacist immediately if you experience repeated or unexplained muscle pain, especially if you feel unwell and have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatment may be needed to diagnose and manage this condition.
Inform your doctor or pharmacist if you develop a persistent cough, shortness of breath or difficulty breathing. This medicine may cause lung scarring, and you may need to be monitored by your doctor.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin Mylan must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablet of Rosuvastatin Mylan is not suitable for use in children and adolescents under 18 years of age.

Elderly

• If you are over 70 years of age (your doctor will decide the correct starting dose of Rosuvastatin Mylan according to your needs).

If any of these apply to you (or if you have any doubts):
Do not take Rosuvastatin Mylan 40 mg (the highest dose) and consult your doctor or pharmacist before starting any dose of Rosuvastatin Mylan.
Statins may affect liver function in a small number of people. This is detected by a simple blood test that monitors increases in liver enzyme levels. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with Rosuvastatin Mylan.
While taking 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 levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Other medicines and Rosuvastatin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those listed below:

• ciclosporin (used, for example, after organ transplant)
• warfarin or clopidogrel (or any other medicine to prevent blood clots)
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe)
• antacids (used to neutralize stomach acid)
• erythromycin (an antibiotic)
• fusidic acid (an antibiotic – see section “Warnings and precautions”)
• oral contraceptives (the pill)
• regorafenib (used to treat tumours)
• hormone replacement therapy
• any of the following medicines used to treat viral infections, including HIV or Hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir

These medicines may alter the effect of Rosuvastatin Mylan, or the effect of these medicines may be altered by Rosuvastatin Mylan.
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin Mylan. Taking Rosuvastatin Mylan with fusidic acid may rarely cause muscle weakness, fatigue or muscle pain (rhabdomyolysis). See further information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take Rosuvastatin Mylan if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Mylan, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Mylan by using an appropriate contraceptive method.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin Mylan – the treatment does not affect their ability to drive or use machines. However, some people may experience dizziness while taking Rosuvastatin Mylan. If you feel dizzy, consult your doctor before driving or using machinery.

Rosuvastatin Mylan contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

Rosuvastatin Mylan also contains the colouring agents Sunset Yellow (E110) and Allura Red (E129), which may cause allergic reactions.

For the full list of ingredients, please see section 6 of this leaflet.

3. How to take Rosuvastatin Mylan

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usual doses in adults
If you are taking Rosuvastatin Mylan for high cholesterol:
Starting dose
Treatment with Rosuvastatin Mylan should begin with a dose of 5 mg or 10 mg, even if you were previously taking a different statin at a higher dose. The choice of starting dose depends on:

• Your cholesterol level
• Your risk level for heart attack or stroke
• Whether you are at increased risk of developing possible side effects. Please consult your doctor or pharmacist to find out which starting dose of Rosuvastatin Mylan is most suitable for you.

Your doctor may decide to prescribe the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of muscle pain (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose. This will allow you to take the amount of Rosuvastatin Mylan appropriate for your needs. If you started with a 5 mg dose, your doctor may decide to double it to 10 mg, then to 20 mg and then to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double it to 20 mg and then to 40 mg, if necessary. There will be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatin Mylan is 40 mg. This dose is recommended only for patients with high cholesterol levels and at high risk of heart attacks or strokes, whose cholesterol levels are not sufficiently lowered with a 20 mg dose.
If you are taking Rosuvastatin Mylan to reduce the risk of heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. However, your doctor may prescribe lower doses if any of the conditions listed above apply to you.
Usual doses in children and adolescents aged 6–17 years
The dosage range for children and adolescents aged 6–17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg daily. Your doctor may gradually increase the dose until the required amount of Rosuvastatin Mylan is reached. The maximum daily dose of Rosuvastatin Mylan is 10 mg or 20 mg for children aged 6–17 years, depending on the condition being treated. Take the dose once daily. Rosuvastatin Mylan 40 mg tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Mylan once daily. It can be taken at any time of day, with or without food.
Try to take the tablet at the same time each day to help you remember.
Regular cholesterol level checks
It is important to return to your doctor regularly to check your cholesterol levels and ensure they have reached and remain within the normal range.
Your doctor may increase your dose of Rosuvastatin Mylan until the required amount is achieved.
If you take more Rosuvastatin Mylan than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or are being treated for another condition, inform the medical staff that you are taking Rosuvastatin Mylan.
If you forget to take Rosuvastatin Mylan
Do not worry; take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rosuvastatin Mylan
Talk to your doctor if you wish to stop taking Rosuvastatin Mylan. Your cholesterol levels may rise again if you stop taking Rosuvastatin Mylan.
If you have any further 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 everyone gets them.
It is important that you are aware of these side effects. These are generally mild and disappear after a short period of time; however, some of them may be serious and require medical attention.
Stop taking Rosuvastatin Mylan and seek immediate medical help if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat
• Swelling of the face, lips, tongue, and/or throat which may cause difficulty swallowing
• Severe itching of the skin (with raised lumps)

Additionally, stop taking Rosuvastatin Mylan and contact your doctor immediately if you have unusual muscle weakness or pain that lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a small number of people have experienced unpleasant muscle effects, which rarely progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.

You may also notice the following side effects, which could be signs of serious problems. Seek immediate medical help if you notice any of the following:

• You feel very tired and thirsty, and you urinate much more often than usual, especially at night – these are signs of diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Severe stomach pain spreading to your back (this may be a sign of inflammation of the pancreas)
• Bruising or bleeding more often or more easily than usual – these may be signs of a low platelet count in the blood (thrombocytopenia)
• Yellowing of the skin and eyes (jaundice), with fever, stomach pain, pale stools or dark urine (may be signs of liver problems)
• Numbness, tingling or burning sensation in the arms or legs (may be signs of nerve damage)
• Severe skin reaction causing blisters and peeling, especially around the mouth, eyes and genitals (Stevens-Johnson syndrome)
• Breathing problems including persistent cough and/or shortness of breath or fever (may be signs of lung scarring known as interstitial lung disease)
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• Muscle breakdown (muscle damage due to rupture of muscle fibres; symptoms may include pain, swelling, bruising, weakness and loss of function)

Other possible side effects
Common (may affect up to 1 in 10 people):

• Headache
• Stomach pain
• Constipation
• Feeling unwell
• Muscle pain
• Feeling weak
• Dizziness
• Increased amount of protein in the urine – which usually returns to normal without needing to stop taking Rosuvastatin Mylan tablets (only Rosuvastatin Mylan 40 mg)

Uncommon (may affect up to 1 in 100 people):

• Rash, itching, raised itchy rash on the skin (urticaria)
• Increased amount of protein in the urine – which usually returns to normal, without needing to stop taking Rosuvastatin Mylan tablets (only Rosuvastatin Mylan 5 mg, 10 mg and 20 mg)

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

• Increased liver enzymes, detected in blood tests

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

• Traces of blood in the urine
• Joint pain
• Memory loss
• Enlargement of the breast in men (gynaecomastia)

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

• Diarrhoea (loose stools)
• Cough
• Shortness of breath
• Swelling (oedema)
• Sleep disorders, including difficulty sleeping and nightmares
• Sexual problems
• Tendon disorders, sometimes complicated by ruptures or tears

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 the following website:
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 Rosuvastatin Mylan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton/blister pack/label after Exp. The expiry date refers to the last day of that month.
• Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
• Rosuvastatin Mylan supplied in bottle packs should be used within 3 months of first opening the bottle.
• Do not dispose of any medicine 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 Rosuvastatina Mylan contains
The active substance is rosuvastatin.
Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium salt).

The other components are:
Tablet core:
Microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silicon dioxide, crospovidone, magnesium oxide, magnesium stearate, red iron oxide (E172).
Film coating:
Monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, quinoline yellow (E104) (only in 5 mg tablets), sunset yellow (E110) (only in 10 mg, 20 mg, or 40 mg tablets), allura red (E129) and indigo carmine (E132).

Description of the appearance of Rosuvastatina Mylan and pack sizes
Rosuvastatina Mylan 5 mg: a yellow, round, biconvex, film-coated tablet, engraved with "M" on one side and "RS" on the opposite side.
Rosuvastatina Mylan 10 mg: a pink, round, biconvex, film-coated tablet, engraved with "M" on one side and "RS1" on the opposite side.
Rosuvastatina Mylan 20 mg: a pink, round, biconvex, film-coated tablet, engraved with "M" on one side and "RS2" on the opposite side.
Rosuvastatina Mylan 40 mg: a pink, oval, biconvex, film-coated tablet, engraved with "M" on one side and "RS4" on the opposite side.

Rosuvastatina Mylan is available in blister packs containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 tablets, or in plastic bottles containing 28, 30, 56, 60, 84, or 90 tablets.
The bottles have a screw cap containing a desiccant. Do not ingest the desiccant.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A
Via Vittor Pisani, 20
20124 Milano - Italy

Manufacturer responsible for batch release:
McDermott Laboratories Ltd T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics (UK) Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Rosuvastatin Mylan 5 mg, 10 mg, 20 mg, 40 mg Filmtabletten
Belgium: Rosuvastatine Mylan 5 mg, 10 mg, 20 mg, 40 mg filmomhulde tabletten
Czech Republic: Rosuvastatin Mylan 10 mg, 20 mg, 40 mg
Finland: Rosuvastatin Mylan 10 mg, 20 mg, tabletti, kalvopäällysteinen
France: Rosuvastatine Mylan 5 mg, 10 mg, 20 mg comprimé pelliculé
Greece: Rosuvastatin / Mylan
Hungary: Rosuvastatin Mylan 5 mg, 10 mg, 20 mg, 40 mg filmtabletta
Ireland: Rosuvastatin Mylan 5 mg, 10 mg, 20 mg, 40 mg film-coated tablet
Italy: Rosuvastatina Mylan
Luxembourg: Rosuvastatine Mylan 5 mg, 10 mg, 20 mg, 40 mg comprimés pelliculés
Netherlands: Rosuvastatine Mylan 5 mg, 10 mg, 20 mg, 40 mg filmomhulde tabletten
Poland: Rosugen 5 mg, 10 mg, 20 mg, 40 mg tabletka powlekana
Portugal: Rosuvastatina Mylan
Romania: Rosuvastatină Mylan 5 mg, 10 mg, 20 mg comprimate filmate
Slovakia: Rosuvastatin Mylan 5 mg, 10 mg, 20 mg, 40 mg
Slovenia: Rosuvastatin Mylan 10 mg, 20 mg, 40 mg filmsko obložene tablete
Spain: Rosuvastatina Mylan 5 mg, 10 mg, 20 mg, 40 mg comprimidos recubiertos con película EFG
United Kingdom: Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg film-coated tablets