Rosuvastatin Sandoz

Patient Information Leaflet: Information for the User

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

Generic medicine
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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Rosuvastatin Sandoz is and what it is used for
2. What you need to know before taking Rosuvastatin Sandoz
3. How to take Rosuvastatin Sandoz
4. Possible side effects
5. How to store Rosuvastatin Sandoz
6. Package contents and other information

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

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

• your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Sandoz 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 Sandoz, you must continue a cholesterol-lowering diet and maintain physical exercise.
Or

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

Heart attack, stroke, and other health problems can be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits in the arteries.
Why is it important to continue taking Rosuvastatina Sandoz?
Rosuvastatina Sandoz is used to correct levels of fats 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 Sandoz can reduce "bad" cholesterol and increase "good" cholesterol.
• It works by helping to block 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, because it causes no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and leading to heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.
You must continue taking Rosuvastatina Sandoz, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to the formation of fatty deposits.
However, you must stop taking Rosuvastatina Sandoz if your doctor advises you to do so or if you become pregnant.

2. What you need to know before taking Rosuvastatin Sandoz

Do not take Rosuvastatin Sandoz:

• if you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).
• if you are pregnant or breastfeeding. If you become pregnant while being treated with Rosuvastatin Sandoz, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Sandoz by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle spasms or pain;
• 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), go back to your doctor and discuss this with him.

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

• if you have moderate kidney problems (if in doubt, ask your doctor);
• if your thyroid gland is not functioning properly;
• if you have had repeated or unexplained muscle spasms or pain, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering drugs;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and 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), go back to your doctor and discuss this with him.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin Sandoz:

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle spasms or pain, 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 spasms or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• 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. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• if you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir, atazanavir and/or tipranavir; refer to “Other medicines and Rosuvastatin Sandoz”;
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), either orally or by injection. The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis).
• if you are over 70 years old (as your doctor must choose the appropriate starting dose of Rosuvastatin Sandoz for you);
• if you have severe respiratory failure;
• if you are of Asian origin (i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor must choose the appropriate starting dose of Rosuvastatin Sandoz for you.

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

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

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin Sandoz.

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 Sandoz must not be given to children under 6 years of age.
• if the patient is under 18 years of age: Rosuvastatin Sandoz 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other 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 Rosuvastatin Sandoz. Taking Rosuvastatin Sandoz with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Tell your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplants), warfarin or clopidogrel (or any other medicine used to thin the blood), fibrates and other lipid-lowering medicines (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe), antacids (used to neutralize stomach acid), erythromycin (an antibiotic), an oral contraceptive (the pill), hormone replacement therapy, regorafenib (used to treat tumors), 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 Sandoz, or these medicines may alter the effects of Rosuvastatin Sandoz.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take Rosuvastatin Sandoz if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Sandoz, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Sandoz by using appropriate contraceptive measures.

Driving and using machines

Most people can drive and operate machinery while taking Rosuvastatin Sandoz, as it does not affect these abilities. However, some people may experience dizziness during treatment with Rosuvastatin Sandoz. If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatin Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Rosuvastatin Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free.”

3. How to take Rosuvastatin Sandoz

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

• your cholesterol level;
• your risk level of having a heart attack or stroke;
• whether you have any factors that may make you more sensitive to possible side effects.

Check with your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatin Sandoz 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 muscle weakness (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose so that you take the amount of Rosuvastatin Sandoz best suited to you. If you start with a 5 mg dose, your doctor, if necessary, may decide to double it to 10 mg, then to 20 mg, and then to 40 mg. If you start with 10 mg, your doctor may decide, if necessary, to double this dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatin Sandoz 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 sufficiently decreased with the 20 mg dose.
If you are taking Rosuvastatin Sandoz 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 mentioned above.
Use in children and adolescents aged 6 to 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to find the amount of Rosuvastatin Sandoz most suitable for you. The maximum daily dose of Rosuvastatin Sandoz is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years.
The dose should be taken once daily. Rosuvastatin Sandoz 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 Sandoz once daily. Rosuvastatin Sandoz can be taken at any time of day, with or without food.
Try to take the tablet at the same time each day; this may help you remember to take it.
Regular cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that your cholesterol reaches and maintains the correct levels.
Your doctor may decide to increase your dose so that you take the amount of Rosuvastatin Sandoz best suited to you.
If you take more Rosuvastatin Sandoz than you should
Contact your doctor or go to the nearest hospital.
If you go to the hospital or receive treatment for another condition, inform the medical staff that you are taking Rosuvastatin Sandoz.
If you forget to take Rosuvastatin Sandoz
Do not worry; take the next scheduled dose at your usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Rosuvastatin Sandoz
Inform your doctor if you intend to stop taking Rosuvastatin Sandoz. If you stop taking Rosuvastatin Sandoz, your cholesterol levels may rise again.
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 everybody gets them.
It is important to be aware of which side effects might occur. They are usually mild and disappear after a short time.

Stop taking Rosuvastatin Sandoz and contact your doctor 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 causing difficulty swallowing;
• severe skin itching (with raised hives).

Also, stop taking Rosuvastatin Sandoz and contact your doctor immediately if you have
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 unwanted muscle effects, and rarely these have progressed to muscle damage, potentially fatal, 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
• increased amount of protein in the urine – usually values return to normal on their own without needing to stop taking Rosuvastatin Sandoz (only for Rosuvastatin Sandoz 40 mg)
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and 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 or other skin reactions
• increased amount of protein in the urine – usually values return to normal on their own without needing to stop taking Rosuvastatin Sandoz (only for Rosuvastatin Sandoz 5 mg, 10 mg and 20 mg).

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

• severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives). If you think you are having an allergic reaction, stop taking Rosuvastatin Sandoz and seek immediate medical help
• muscle damage in adults – as a precaution, stop taking Rosuvastatin Sandoz and contact your doctor immediately if you have unusual muscle pains or cramps that last longer than expected
• severe stomach pain (inflamed pancreas)
• increased liver enzymes in the blood
• unusual bruising and bleeding 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 (such as numbness)
• joint pain
• memory loss
• breast enlargement in men (gynaecomastia).

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• diarrhoea (loose stools)
• Stevens-Johnson syndrome (a serious condition presenting with blistering of the skin, mouth, eyes and genitals)
• cough
• shortness of breath
• oedema (swelling)
• sleep disorders, including insomnia and nightmares
• sexual problems
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• tendon injury, sometimes complicated by ruptures
• persistent muscle weakness.

Reporting of side effects
If you get any side effects, including any 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 Rosuvastatin Sandoz

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 and blister after
Exp. The expiry date refers to the last day of that month.
The shelf life after first opening of the HDPE bottle is 100 days.
Store in the original packaging to protect the medicine from moisture.
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. Pack contents and other information

What Rosuvastatina Sandoz contains

• The active substance is rosuvastatin.

Rosuvastatina Sandoz 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).
Rosuvastatina Sandoz 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).
Rosuvastatina Sandoz 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).
Rosuvastatina Sandoz 40 mg film-coated tablets
Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).

• The other components are:

Tablet core:
Lactose, anhydrous colloidal silica, microcrystalline cellulose, maize starch, talc, sodium stearate fumarate
Tablet coating:
Hypromellose, mannitol (E421), macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Rosuvastatina Sandoz and pack contents
Film-coated tablets
Rosuvastatina Sandoz 5 mg film-coated tablets
Film-coated, brown, round tablets with a diameter of 5 mm.
Rosuvastatina Sandoz 10 mg film-coated tablets
Film-coated, brown, round tablets with a diameter of 6 mm, marked "RSV 10" on one side.
Rosuvastatina Sandoz 20 mg film-coated tablets
Film-coated, brown, round tablets with a diameter of 8 mm, marked "RSV 20" on one side.
Rosuvastatina Sandoz 40 mg film-coated tablets
Film-coated, brown, round tablets with a diameter of 10 mm, marked "RSV 40" on one side.

Rosuvastatina Sandoz 5/10/20/40 mg film-coated tablets are available in:
OPA-Al-PVC/Al blisters: 7, 10, 14, 20, 21, 28, 30, 40, 42, 60, 70, 100 film-coated tablets.
HDPE bottles with PP cap and silica gel desiccant: 30, 90, 100 film-coated tablets.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, Târgu Mureş, Mureş, 540472, Romania
Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia
Lek S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany (20 mg only)

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Rosuvastatin 1A Pharma 5 mg – Film tablets
Rosuvastatin 1A Pharma 10 mg – Film tablets
Rosuvastatin 1A Pharma 20 mg – Film tablets
Rosuvastatin 1A Pharma 40 mg – Film tablets
Germany RosuHEXAL 5 mg Film tablets
RosuHEXAL 10 mg Film tablets
RosuHEXAL 20 mg Film tablets
RosuHEXAL 40 mg Film tablets
Italy Rosuvastatina Sandoz
Portugal Rosuvastatina Vedixal