Rosuvastatin Sun

Patient Information Leaflet: Information for the User

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

Generic Medicine
Rosuvastatin
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Rosuvastatina SUN is and what it is used for

Rosuvastatina SUN belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina SUN because:

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina SUN is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• You have been prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina SUN, you must continue following a cholesterol-lowering diet and maintain regular physical exercise.

Or

• You have other risk factors that increase your likelihood of developing heart attack, stroke, or related health problems.

Heart attacks, strokes, and other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is due to the buildup of fatty deposits in your arteries.
Why is it important to keep taking Rosuvastatina SUN?
Rosuvastatina SUN is used to correct 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: so-called “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
Rosuvastatina SUN can reduce “bad” cholesterol and increase “good” cholesterol. It works by blocking the body's production of “bad” cholesterol and also improves the body’s ability to remove “bad” cholesterol from the blood.
For many people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and causing a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You must continue taking Rosuvastatina SUN even if your cholesterol levels have returned to normal, to prevent them from rising again and causing fatty deposits to form.
However, you must stop taking it upon your doctor’s instruction or if you become pregnant.

2. What you need to know before taking Rosuvastatin SUN

Do not take Rosuvastatin SUN

• If you have previously had an allergic reaction to rosuvastatin or to any of the ingredients of this medicine (listed in section 6)
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin SUN, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin SUN by using appropriate contraceptive measures
• If you have liver disease
• If you have severe kidney problems
• If you have repeated or unexplained muscle pain or cramps
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation)

If any of the above apply to you (or if you have any doubts), you must consult your doctor.
Also, do not take Rosuvastatin SUN 40 mg (the highest dose):

• If you have moderate kidney problems (in case of any doubt, please consult your doctor)
• If your thyroid gland is not functioning properly
• If you have had repeated or unexplained muscle pain or cramps, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking 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 the above 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 SUN if:

• You have kidney problems
• You have liver problems
• You have had repeated or unexplained muscle pain or cramps, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness
• You regularly consume large amounts of alcohol
• Your thyroid gland is not functioning properly
• You are taking other medicines called fibrates to lower cholesterol. Please read this patient information leaflet carefully, even if you have previously taken other medicines for high cholesterol
• You are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; please read section "Other medicines and Rosuvastatin SUN"
• You are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis); please see section "Other medicines and Rosuvastatin SUN"
• You are over 70 years of age (as your doctor needs to select the appropriate starting dose of Rosuvastatin SUN for you)
• You suffer from severe respiratory insufficiency
• You are of Asian origin – such as Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor needs to select the appropriate starting dose of Rosuvastatin SUN for you.

If any of the above apply to you (or if you are in doubt):

• Do not take Rosuvastatin SUN 40 mg (the highest dose), and check with your doctor or pharmacist before starting any dose of Rosuvastatin SUN.

In a small number of people, statins may affect the liver. This can be detected by a simple blood test that measures increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin SUN.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin SUN 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 SUN is not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Inform your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplantation), warfarin or clopidogrel (or any other medicine used to thin the blood), 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), an oral contraceptive (the pill), hormone replacement therapy, regorafenib (used to treat tumours), or any of the following medicines used to treat viral infections, including HIV or Hepatitis C, either alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
  The effects of these medicines may be altered by Rosuvastatin SUN, or the effect of Rosuvastatin SUN may be altered by these medicines.
  If oral fusidic acid is required to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when you can restart Rosuvastatin SUN. Taking Rosuvastatin SUN with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
  Rosuvastatin SUN with food and drink
  You may take Rosuvastatin SUN with or without food.
  Pregnancy and breastfeeding
  Do not take Rosuvastatin SUN if you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin SUN by using appropriate contraceptive measures.
  Ask your doctor or pharmacist for advice before taking any medicine.
  Driving and using machines
  Most people can drive and operate machinery while taking Rosuvastatin SUN – it does not affect their ability. However, some people may experience dizziness during treatment with this medicine. If you experience dizziness, consult your doctor before driving or using machines.
  Rosuvastatin SUN contains lactose
  If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact your doctor before taking Rosuvastatin SUN.

3. How to take Rosuvastatina SUN

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended doses in adults

If you are taking Rosuvastatina SUN for high cholesterol:

Starting dose
Treatment with Rosuvastatina SUN should begin with a dose of 5 mg or 10 mg, even if you have previously taken higher doses of other statins. The choice of starting dose depends on:

• your cholesterol level
• your risk of having a heart attack or stroke
• the presence of factors that may make you more susceptible to possible side effects.

Please check with your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatina SUN 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)
• Are over 70 years old
• Have moderate kidney problems
• Are at risk of muscle pain or cramps (myopathy).

Dose increase and maximum daily dose:
Your doctor may decide to increase your dose to determine the most suitable dose of Rosuvastatina SUN for you. If starting at 5 mg, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and finally to 40 mg. If starting at 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.

The maximum daily dose of Rosuvastatina SUN is 40 mg. This dose is reserved only for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not been sufficiently reduced with the 20 mg dose.

If you are taking Rosuvastatina SUN to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.

Use in children and adolescents aged 6 to 17 years
The dosage range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until the appropriate amount of Rosuvastatina SUN is reached. The maximum daily dose of Rosuvastatina SUN is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Rosuvastatina SUN should not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.

Take Rosuvastatina SUN once daily. It can be taken at any time of day, with or without food. Try to take the tablet at approximately the same time each day; this may help you remember to take it.

Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks to ensure that your cholesterol has reached and remains at the appropriate levels.

Your doctor may decide to increase your dose until you are taking the most appropriate amount of Rosuvastatina SUN for you.

If you take more Rosuvastatina SUN than you should
Contact your doctor or the nearest hospital for advice.

If you go to a hospital or receive treatment for another condition, inform the hospital doctor that you are taking Rosuvastatina SUN.

If you forget to take Rosuvastatina SUN
Do not panic. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Rosuvastatina SUN
Inform your doctor if you intend to stop taking Rosuvastatina SUN. If you stop taking this medicine, your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is important that you are aware of which of these side effects may occur.
They are usually mild and disappear within a short time.
Stop taking Rosuvastatina SUN 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 hives)

Also, stop taking Rosuvastatina SUN and contact your doctor immediately if you experience unusual
muscle pains or cramps that last longer than expected. Muscle-related symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and in rare cases these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.

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

• Headache; stomach pain; constipation; feeling unwell; muscle pain; feeling of weakness; dizziness
• Increase in the amount of protein in the urine – usually levels return to normal on their own without needing to stop Rosuvastatina SUN tablets (only for Rosuvastatina SUN 40 mg)
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

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

• Skin rash, itching and other skin reactions
• Increase in the amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with Rosuvastatina SUN tablets (only for Rosuvastatina SUN 5 mg, 10 mg and 20 mg)

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

• Severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing, severe itching of the skin (with raised hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina SUN and seek immediate medical help
• Muscle damage in adults – as a precaution, stop taking Rosuvastatina SUN and contact your doctor immediately if you have unusual muscle pains or cramps that last longer than expected
• Severe stomach pain (inflamed pancreas)
• Increase in liver enzymes in the blood
• Increased bleeding or bruising due to low platelet count in the blood

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

• Jaundice (yellowing of the skin and eyes); hepatitis (liver inflammation); blood in the urine; nerve damage in arms and legs (numbness); joint pain; memory loss; enlargement of the breasts in men (gynaecomastia)

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

• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (characterised by blisters on the skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual problems
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
• Persistent muscle weakness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin SUN

• 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 label after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

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 SUN contains

• The active substance of Rosuvastatina SUN is rosuvastatin. Rosuvastatina SUN contains rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, magnesium stearate, sodium citrate, hypromellose, titanium dioxide (E171), macrogol 400. Rosuvastatina SUN 5 mg film-coated tablets also contain yellow iron oxide (E172). Rosuvastatina SUN 10 mg, 20 mg and 40 mg film-coated tablets also contain red iron oxide (E172).

Description of the appearance of Rosuvastatina SUN and contents of the pack
Rosuvastatina SUN 5 mg film-coated tablets: light yellow to yellow in colour, round,
film-coated tablets, marked with ‘RT 1’ on one side and plain on the other side.
The tablets have a diameter of approximately 5.85 mm.
Rosuvastatina SUN 10 mg film-coated tablets: light pink to pink in colour, round,
film-coated tablets, marked with ‘RT 2’ on one side and plain on the other side.
The tablets have a diameter of approximately 7.35 mm.
Rosuvastatina SUN 20 mg film-coated tablets: light pink to pink in colour, round,
film-coated tablets, marked with ‘RT 3’ on one side and plain on the other side.
The tablets have a diameter of approximately 9.15 mm.
Rosuvastatina SUN 40 mg film-coated tablets: light pink to pink in colour, oval,
film-coated tablets, marked with ‘RT 4’ on one side and plain on the other side. The tablets
have a length of approximately 15.65 mm and a width of approximately 7.85 mm.
Rosuvastatina SUN is available in packs of 28 tablets.
Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Legal representative in Italy
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1
20143 Milano
Italy
Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
Str. Fabricii Nr 124,
400 632 Cluj-Napoca
Romania
This medicinal product is authorized in the European Economic Area countries under the
following names:
The Netherlands Rosuvastatine Sun 5 mg, filmomhulde tabletten
(RMS) Rosuvastatine Sun 10 mg, filmomhulde tabletten
Rosuvastatine Sun 20 mg, filmomhulde tabletten
Rosuvastatine Sun 40 mg, filmomhulde tabletten
United Kingdom Rosuvastatin 5mg Film-coated Tablets
Rosuvastatin 10mg Film-coated Tablets
Rosuvastatin 20mg Film-coated Tablets
Rosuvastatin 40mg Film-coated Tablets
Italy Rosuvastatina Sun 5 mg compresse rivestite con film
Rosuvastatina Sun 10 mg compresse rivestite con film
Rosuvastatina Sun 20 mg compresse rivestite con film
Rosuvastatina Sun 40 mg compresse rivestite con film