Rosuvastatin Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rosuvastatina Accord, 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 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, pharmacist, or nurse.
• 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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

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

• Your cholesterol level is high. This means you are at risk of a heart attack or stroke. Rosuvastatina Accord is used to treat high cholesterol in adults, adolescents, and children aged 6 years and older.

• You have been advised to take a statin because changes in diet and increased physical exercise are not sufficient to correct your cholesterol levels. You must continue
  with a low-cholesterol diet and physical exercise while taking
  Rosuvastatina Accord.
  Or

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

Why is it important to continue taking Rosuvastatina Accord?

• Rosuvastatina Accord is used to correct levels of fatty substances in the blood called 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).
• Rosuvastatina Accord can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by blocking your body’s production of “bad” cholesterol and also improves your body’s ability to remove it from the blood.
• High cholesterol usually causes no symptoms in most people. However, if left untreated, fatty deposits can build up on the walls of blood vessels, causing them to narrow.
• Sometimes, the narrowing of blood vessels can block blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, it is possible to reduce the risk of heart attack, stroke, or other related health problems.
• You must continue taking Rosuvastatina Accord even if your cholesterol levels are normal, because it prevents cholesterol from rising again, which could lead to the formation 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 Accord

Do not take Rosuvastatin Accord

• If you have ever had an allergic reaction 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 aware that you are pregnant while taking Rosuvastatin Accord, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Accord by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain.
• If you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplants).

If any of the above apply to you (or if you are unsure), you must return to your doctor and consult them.
In addition, do not take Rosuvastatin Accord 40 mg (the highest dose)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• 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 the above apply to you (or if you are unsure), you must return to your doctor and consult them.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Accord

• If you have kidney problems.
• If you have liver problems.
• If you have had repeated or unexplained muscle pain, a personal or family history of muscle disorders, or if you previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell and/or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Rosuvastatin film-coated tablets or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• 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 Ritonavir with lopinavir, and/or atazanavir; see section “Other medicines and Rosuvastatin Accord”.
• If you are currently taking, or have taken within the last 7 days, a medicine called fusidic acid, (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and Rosuvastatin Accord can lead to serious muscle problems (rhabdomyolysis); see section “Other medicines and Rosuvastatin Accord”.
• If you are over 70 years old (your doctor needs to choose the appropriate starting dose of Rosuvastatin Accord for you).
• If you have severe respiratory failure.
• If you are of Asian origin – i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must select the correct initial dose of Rosuvastatin Accord suitable for you.
• If you currently suffer or have previously suffered from myasthenia (a disease causing general muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If you are in any of the above situations (or are unsure):

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

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Rosuvastatin film-coated tablets. Discontinue use of Rosuvastatin film-coated tablets and consult a doctor immediately if you notice any of the symptoms described in section 4.
During treatment with this medicine, your doctor will carefully 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 your blood, are overweight, and have high blood pressure.
Children and Adolescents

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

Other medicines and Rosuvastatin Accord
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:
Regorafenib (used to treat cancer),

• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• cyclosporine (used, for example, after organ transplants),
• warfarin, ticagrelor, 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 – please read the Warnings and precautions section),
• an oral contraceptive (the pill),
• hormone replacement therapy,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• momelotinib (used to treat myelofibrosis in adults with anaemia).

The effects of these medicines may be altered by Rosuvastatin Accord, or the effect of Rosuvastatin Accord may be altered by these medicines.
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
taking Rosuvastatin Accord. Taking Rosuvastatin Accord with fusidic acid may rarely cause
weakness, tiredness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in
Section 4.
Pregnancy and breastfeeding
Do not take Rosuvastatin Accord film-coated tablets if you are pregnant or breastfeeding. If you become aware that you are pregnant while taking Rosuvastatin Accord, stop taking the medicine immediately and inform your doctor.
Women must avoid pregnancy during treatment with Rosuvastatin Accord by using an appropriate contraceptive method.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while being treated with Rosuvastatin Accord – the treatment does not affect their ability to drive or use machines.
However, some people may experience dizziness during treatment with Rosuvastatin Accord.
If you feel dizzy, consult your doctor before driving or operating machinery.
Rosuvastatin Accord contains lactose, sunset yellow and allura red
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rosuvastatin Accord 40 mg also contains the colouring agents sunset yellow FCF and allura red AC, which may cause allergic reactions.
For a complete list of other ingredients, see section “Contents of the pack and other information”.

3. How to take Rosuvastatin Accord

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

Usual doses in adults

If you are taking Rosuvastatin Accord for high cholesterol:

Starting dose
Treatment with Rosuvastatin Accord should begin with a dose of 5 mg or 10 mg, even if you previously took a different statin at a higher dose. The choice of starting dose depends on:

• your cholesterol level
• your risk of heart attack or stroke
• whether you are at increased risk of developing possible side effects

Consult your doctor or pharmacist to determine which starting dose of Rosuvastatin Accord 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, allowing you to take the amount of Rosuvastatin Accord appropriate for your needs. If you started with a 5 mg dose, your doctor may increase it to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started with 10 mg, your doctor may increase it to 20 mg and then to 40 mg if necessary. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatin Accord is 40 mg. This dose is recommended only for patients with high cholesterol levels who are at high risk of heart attacks or strokes, and whose cholesterol levels are not sufficiently lowered by a 20 mg dose.

If you are taking Rosuvastatin Accord to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may prescribe a lower dose if any of the conditions listed above apply to you.

Use in children and adolescents aged 6–17 years
The dose range for children and adolescents aged 6–17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg, and your doctor may gradually increase the dose until the required amount of Rosuvastatin Accord is reached. The maximum daily dose of Rosuvastatin Accord is 10 mg or 20 mg for children aged 6–17 years, depending on the underlying condition being treated. Take your dose once daily.
Rosuvastatin Accord 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 Accord once daily. It can be taken at any time of day, with or without food.
To help you remember, try to take the tablet at the same time each day.

Regular cholesterol level checks
It is important to return to your doctor regularly to monitor your cholesterol levels and ensure they have reached and remain within the target range.
Your doctor may decide to increase your dose of Rosuvastatin Accord until the required amount is achieved.

If you take more Rosuvastatin Accord than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or are receiving treatment for another condition, inform the medical staff that you are taking Rosuvastatin Accord.

If you forget to take Rosuvastatin Accord
Do not worry; 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 Rosuvastatin Accord
Talk to your doctor if you wish to stop taking Rosuvastatin Accord. Your cholesterol levels may rise again if you stop taking Rosuvastatin Accord.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
It is important that you are aware of these side effects. These are generally mild and
disappear after a short period of time.
Stop taking Rosuvastatina Accord and seek medical help immediately 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 in swallowing.
• Severe itching of the skin (with raised lumps). Reddish, non-elevated patches, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatina Accord and speak to your doctor immediately

• if you experience unusual muscle pain lasting 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 muscle damage that can be life-threatening, known as rhabdomyolysis.
• If you experience muscle tearing.
• If you develop a lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Rosuvastatina Accord may cause the following 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 stopping Rosuvastatina Accord tablets (only with Rosuvastatina Accord 40 mg)
• 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.

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

• Rash, itching or other skin reactions
• Increased amount of protein in the urine – which usually returns to normal without stopping Rosuvastatina Accord tablets (only Rosuvastatina Accord 5 mg, 10 mg and 20 mg).

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

• Severe stomach pain (inflammation of the pancreas)
• Increased liver enzymes in the blood
• Bleeding or bruising more easily than normal due to low platelet levels in the blood
• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps)

If you think you are having an allergic reaction, stop taking Rosuvastatina Accord and
seek medical help immediately.

• Muscle damage in adults – as a precaution, stop taking Rosuvastatina Accord and consult your doctor immediately if you have unusual muscle pain or muscle pain lasting longer than expected.
• Lupus-like disease syndrome (including skin rash, joint disorders and effects on blood cells).

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflamed liver)
• Blood traces in the urine
• Nerve damage in arms and legs (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)

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

• Diarrhoea (loose stools)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disorders, including difficulty sleeping and nightmares
• Sexual problems
• Breathing problems including persistent cough and/or shortness of breath or fever
• Tendon injuries
• Persistent muscle weakness
• Myasthenia gravis (a condition causing general muscle weakness, including in some cases the muscles used for breathing). Ocular myasthenia (a condition causing weakness of the eye muscles).
• Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.

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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Accord

• This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture and light.
• HDPE bottles should be used within 3 months of first opening.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister pack/labelling after Exp. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice the packaging is damaged or shows signs of tampering.
• 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 Accord Contains
The active substance is rosuvastatin (as rosuvastatin calcium salt).
Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium salt).
Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium salt).
Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium salt).
Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium salt).

The other components are:
Tablet core:
Anhydrous lactose
Microcrystalline cellulose (E460)
Magnesium oxide, light
Magnesium stearate (E470b)
Crospovidone type A (E1202)

Film coating:
5 mg tablets -
Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, Iron oxide yellow (E172).

10 mg and 20 mg tablets -
Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, Iron oxide yellow (E172), Aluminium lake - Quinoline Yellow (E104), Aluminium lake - Brilliant Blue FCF (E133).

40 mg tablets -
Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, Aluminium lake - Sunset Yellow FCF (E110), Aluminium lake - Allura Red AC (E129), and Aluminium lake - Brilliant Blue FCF (E133).

Description of the Appearance of Rosuvastatina Accord and Contents of the Package
This medicine is available as 5 mg, 10 mg, 20 mg, and 40 mg film-coated tablets.

• 5 mg: Yellow, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, with "5" engraved on one side and "R" on the other.
• 10 mg: Pink, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, with "10" engraved on one side and "R" on the other.
• 20 mg: Pink, round, biconvex film-coated tablet, approximately 9.0 mm in diameter, with "20" engraved on one side and "R" on the other.
• 40 mg: Pink, oval, biconvex film-coated tablet, 11.5 mm x 6.9 mm, with "40" printed on one side and "R" on the other.

The tablets are packaged in Alu-Alu blisters and HDPE bottles (white opaque HDPE bottles with white opaque polypropylene caps and white opaque desiccant container with blue print).

Pack sizes:

• 5 mg: Blisters: 7, 28, 30, 60, 84, 90, or 98 tablets.
  HDPE bottles: 30 or 500 tablets (hospital pack).
• 10 mg: Blisters: 7, 28, 30, 60, 84, 90, 98, or 100 tablets.
  HDPE bottles: 30 or 500 tablets (hospital pack).
• 20 mg: Blisters: 7, 28, 30, 60, 84, 90, 98, or 100 tablets.
  HDPE bottles: 30 or 500 tablets (hospital pack).
• 40 mg: Blisters: 7, 28, 30, 60, 90, 98, or 100 tablets.
  HDPE bottles: 500 tablets (hospital pack).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
Accord Healthcare Limited,
Ground Floor, Sage House, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

| Country | Proposed Name | |----------------------|--------------------------------------------------------| | Austria | Rosuvastatin Accord 5/10/20/40 mg Filmtabletten | | Bulgaria | Rosuvastatin Акорд 5/10/20/40 мг филмирани таблетки | | Cyprus | Rosuvastatin Accord 5/10/20/40 mg Film-coated Tablets | | Czech Republic | Rosuvastatin Accord | | Denmark | Rosuvastatin Accord 5/10/20/40 mg filmovertrukne tabletter | | Estonia | Rosuvastatin Accord | | Finland | Rosuvastatin Accord 5/10/20/40 mg tabletti, kalvopäällysteinen | | France | ROSUVASTATIN ACCORD 5/10/20 mg comprimé pelliculé | | Germany | Rosuvastatin Accord 5/10/20/40 mg Filmtabletten | | Ireland | Rosuvastatin 5/10/20/40 mg Film-coated Tablets | | Italy | Rosuvastatina Accord | | Lithuania | Rosuvastatin Accord 5/10/20/40 mg plėvele dengtos tabletės | | Latvia | Rosuvastatin Accord 5/10/20/40 mg apvalkotās tabletes | | Malta | Rosuvastatin 5/10/20/40 mg Film-coated Tablets | | Netherlands | Rosuvastatine Accord 5/10/20/40 mg filmomhulde tabletten | | Norway | Rosuvastatin Accord | | Poland | Astrium | | Romania | Astrium, 5/10/20/40 mg, comprimate filmate | | Spain | Rosuvastatina Accord 5/10/20/40 mg comprimidos recubiertos con película EFG | | Sweden | Rosuvastatin Accord 5/10/20/40 mg filmdragerad tablet | | United Kingdom | Rosuvastatin 5/10/20/40 mg Film-coated Tablets |