Rosanta: detailed information

Patient Information Leaflet

ROSANTA 5 mg, film-coated tablets, 10 mg, film-coated tablets, 15 mg, film-coated tablets, 20 mg, film-coated tablets, 30 mg, film-coated tablets, 40 mg, film-coated tablets

Rosuvastatin
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 others, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ROSANTA is and what it is used for

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

You have high cholesterol levels. This means you are at risk of heart attack or stroke. ROSANTA is used in adults, adolescents, and children over 6 years of age to treat high cholesterol.
Your doctor has advised you to take a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. You should continue your cholesterol-lowering diet and exercise regimen while taking ROSANTA.

There are other factors that increase your risk of having a heart attack, stroke, or related health problems.

Heart attacks, strokes, and other problems can be caused by a condition called atherosclerosis.
Atherosclerosis is due to the buildup of fatty deposits in the arteries.
Why it is important to keep taking ROSANTA
ROSANTA 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).

ROSANTA can reduce "bad" cholesterol and increase "good" cholesterol.
It works by helping to block your body's production of "bad" cholesterol and also improves your body's ability to remove it from the blood.

In most people, high cholesterol does not affect how you feel, as it produces 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 causing a heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of heart attack, stroke, or related health problems.
You must continue taking ROSANTA, even if you have brought your cholesterol to the desired level, because it prevents your cholesterol levels from rising again and causing fatty deposits to accumulate. However, you should stop taking the medicine only on the advice of your doctor or if you become pregnant.

2. What you need to know before taking ROSANTA

Do not take ROSANTA

If you have ever had an allergic reaction to ROSANTA or any of its ingredients.
If you are pregnant or breastfeeding. If you become pregnant while taking ROSANTA, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant while taking ROSANTA by using an adequate 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 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 situations apply to you (or you have any doubts), consult your doctor again.

Also, do not take ROSANTA 30 mg or 40 mg (the higher doses):

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 pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines.
If you regularly drink 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 situations apply to you (or you have any doubts), consult your doctor again.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSANTA if:

You have kidney problems.
You have liver problems.
You have had repeated or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking ROSANTA or other related medicines.
You regularly drink large amounts of alcohol.
Your thyroid gland is not functioning properly.
You are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken other medicines for high cholesterol before.
You are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir. See "Other medicines and ROSANTA".
You are 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 ROSANTA can cause serious muscle problems (rhabdomyolysis). See "Other medicines and ROSANTA".
You are over 70 years of age (as your doctor must choose the appropriate starting dose of ROSANTA for you).
You have severe respiratory failure.
You are of Asian origin (i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate starting dose of ROSANTA for you.

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

Do not take ROSANTA 30 mg or 40 mg (the higher doses) and consult your doctor or pharmacist before starting any dose of ROSANTA.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with ROSANTA treatment.
Stop using ROSANTA and seek immediate medical advice if you notice any of the symptoms described in section 4.
In a small number of people, statins may affect the liver. This is detected by a simple blood test that checks for elevated levels of liver enzymes. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with ROSANTA.
While taking this medicine, your doctor will monitor you closely if 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 fats in your blood, are overweight, and have high blood pressure.
Children and adolescents

If the patient is under 6 years of age: ROSANTA must not be given to children under 6 years of age.
If the patient is under 18 years of age: ROSANTA 30 mg and 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and ROSANTA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:

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),
remedies for indigestion (used to neutralize stomach acid),
erythromycin (an antibiotic), fusidic acid (an antibiotic, see below and Warnings and precautions),
an oral contraceptive (the pill),
regorafenib (used to treat cancer),
darolutamide (used to treat cancer),
capmatinib (used to treat cancer),
hormone replacement therapy,
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),
- 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by ROSANTA, or they may alter the effect of ROSANTA.
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 ROSANTA. Taking ROSANTA with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
Pregnancy and breastfeeding
Do not take ROSANTA if you are pregnant or breastfeeding. If you become pregnant while taking ROSANTA, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant while taking ROSANTA by using an adequate contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and use machines while taking ROSANTA, as it will not affect their ability. However, some people may experience dizziness during treatment with ROSANTA. If you experience dizziness, consult your doctor before attempting to drive or use machines.
ROSANTA contains lactose and sodium.
Lactose:
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact your doctor before taking ROSANTA.
Sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take ROSANTA

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are unsure.
Dosage in adults
If you are taking this medicine for high cholesterol:
Starting dose
Your treatment with ROSANTA should start with a dose of 5 mg or 10 mg, even if you previously took a
higher dose of a different statin. The choice of starting dose will depend on:

Your cholesterol levels.
Your risk level of having a heart attack or stroke.
Whether you have any factor that might make you more sensitive to possible side effects.

Check with your doctor or pharmacist which starting dose of ROSANTA is most suitable for you.
Your doctor might 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 might decide to increase your dose. This is to ensure you are taking the right amount of
ROSANTA for you. If you started with a 5 mg dose, your doctor might decide to double it to 10 mg, then to 20 mg, and then to 40 mg, if necessary. If you started with 10 mg, your doctor might decide to double it to 20 mg and then to 40 mg, if necessary. There will be an interval of four weeks between each dose adjustment.
The maximum daily dose of ROSANTA is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of heart attacks or strokes whose cholesterol levels are not sufficiently lowered with 20 mg.
If you are taking ROSANTA to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor might decide to use a lower dose if you have any of the factors mentioned above.
Use in children and adolescents aged 6 to 17 years
The dose range in children and adolescents aged 6 to 17 years is between 5 and 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose to find the right amount of ROSANTA for you. The maximum daily dose of ROSANTA is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose once daily. The 30 mg and 40 mg tablets of ROSANTA must not be used by children.
How to take the tablets
Swallow each tablet whole with a glass of water.
Take ROSANTA once daily. You may take it 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 checks
It is important to return to your doctor for regular cholesterol checks to ensure your cholesterol reaches and remains at the correct level.
Your doctor may decide to increase your dose so that you take the right amount of ROSANTA for you.
If you take more ROSANTA than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the medical staff that you are taking ROSANTA.
If you forget to take ROSANTA
Do not worry. Simply take the next scheduled dose at the correct time. Do not take a double dose to make up for the missed dose.
If you stop taking ROSANTA
Talk to your doctor if you wish to stop taking ROSANTA. Your cholesterol levels may rise again if you stop taking ROSANTA.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everyone will experience them.
It is important that you are aware of what these side effects might be. Usually they are mild and disappear after a short time.
Stop taking ROSANTA 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).
Red, non-raised 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 ROSANTA and contact your doctor immediately:

If you have unusual muscle pain or discomfort lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, and rarely these have developed into potentially life-threatening muscle damage known as rhabdomyolysis.
If you have muscle breakdown.
If you develop a lupus-like illness syndrome (including rash, joint disorders, and effects on blood cells).

Possible common side effects (may affect up to 1 in 10 patients):

Headache
Stomach ache
Constipation
Feeling unwell
Muscle pain
Feeling of weakness
Dizziness
Increased amount of protein in the urine, which usually returns to normal on its own without needing to stop taking ROSANTA tablets (only ROSANTA 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.

Possible uncommon side effects (may affect up to 1 in 100 patients):

Skin rash, itching, or other skin reactions.
Increased amount of protein in the urine: usually returns to normal on its own without needing to stop taking ROSANTA tablets (only ROSANTA 5 mg, 10 mg, and 20 mg).

Possible rare side effects (may affect up to 1 in 1,000 patients):

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 ROSANTA and seek immediate
medical help.
Muscle damage in adults: as a precaution, stop taking ROSANTA and talk to your doctor immediately if you have unusual muscle pain or discomfort lasting longer than expected.
• Muscle damage in adults – as a precaution, stop taking ROSANTA and contact your doctor immediately if you experience unusual muscle pain or discomfort that persists longer than expected.
Severe stomach pain (inflamed pancreas).
Increased liver enzymes in the blood.
Bleeding or bruising more easily than normal due to low platelet levels in the blood.
Lupus-like illness syndrome (including rash, joint disorders, and effects on blood cells).

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

Jaundice (yellowing of the skin and eyes)
Hepatitis (inflammation of the liver)
Blood in the urine
Nerve damage in the arms and legs (such as numbness)
Joint pain
Memory loss
Enlargement of the breasts in men (gynecomastia)

Side effects with unknown frequency may include:

Diarrhoea (loose stools)
Cough
Shortness of breath
Oedema (swelling)
Sleep disorders, including insomnia and nightmares
Sexual difficulties
Depression
Breathing problems, including persistent cough and/or shortness of breath or fever
Tendon injury
Persistent muscle weakness
Ocular myasthenia (a condition causing weakness of the eye muscles)

Reporting of side effects:
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. 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 ROSANTA

Do not store above 30 °C. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What ROSANTA contains
The active substance is rosuvastatin.
ROSANTA 5 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 5 mg of rosuvastatin.
ROSANTA 10 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 10 mg of rosuvastatin.
ROSANTA 15 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 15 mg of rosuvastatin.
ROSANTA 20 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 20 mg of rosuvastatin.
ROSANTA 30 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 30 mg of rosuvastatin.
ROSANTA 40 mg, film-coated tablets:
Each tablet contains calcium rosuvastatin equivalent to 40 mg of rosuvastatin.

The other ingredients are:
Tablet core:
Microcrystalline cellulose
Monohydrate lactose
Crospovidone
Hydroxypropylcellulose
Sodium hydrogen carbonate
Magnesium stearate

Film coating:
Monohydrate lactose
Hypromellose
Titanium dioxide (E 171)
Triacetin
Iron oxide yellow (E 172) in ROSANTA 5 mg, 15 mg and 30 mg, film-coated tablets
Iron oxide red (E 172) in ROSANTA 10 mg, 20 mg and 40 mg, film-coated tablets

Description of the appearance of ROSANTA and contents of the pack
ROSANTA 5 mg, film-coated tablets:
Film-coated, round, biconvex, yellow tablet, imprinted with “5” on one side and smooth on the other, diameter: 5.5 mm.
ROSANTA 10 mg, film-coated tablets:
Round, biconvex, pink tablet, with a breakline on one side, diameter: 7 mm.
ROSANTA 15 mg, film-coated tablets:
Film-coated, round, convex, yellow tablet, imprinted with “15” on one side and smooth on the other, diameter: 8 mm.
ROSANTA 20 mg, film-coated tablets:
Film-coated, round, biconvex, pink tablet, with a breakline on one side and imprinted with “20” on the other, diameter: 9 mm.
ROSANTA 30 mg, film-coated tablets:
Film-coated, round, convex, yellow tablet, with a breakline on one side and imprinted with “30” on the other, diameter: 8 mm.
ROSANTA 40 mg, film-coated tablets:
Film-coated, oval, biconvex, pink tablet, with a breakline on one side and imprinted with “40” on the other, dimensions: 11.5 x 7 mm.

ROSANTA 10 mg, 20 mg, 40 mg, film-coated tablets:
The tablets can be divided into two equal parts.

ROSANTA is available in blisters containing 28, 30, 60, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
PIAM Farmaceutici S.p.A.
Via XII Ottobre, 10
16121 Genova
Italy

Manufacturer
TEVA Pharma, S.L.U.
Polígono Industrial Malpica, calle C, número 4
50016 Zaragoza
Spain

This medicinal product is authorized in the European Union Member States under the following names:
Finland - Rosanta
Italy - ROSANTA