ROSANTA 5 mg Film-Coated Tablets

Зміст інструкції

1. 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
   1. What is ROSANTA and what is it used for
   2. What you need to know before taking ROSANTA
   3. How to take ROSANTA
   4. Possible side effects
   5. How to store ROSANTA
   6. Package Contents and Other Information

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

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ROSANTA and what is it used for

ROSANTA belongs to a group of medicines called statins.

ROSANTA has been prescribed for you because:

• You have a high level of cholesterol. This means that 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.
• You have been advised to take a statin, because changing your diet and exercising more have not been enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while taking ROSANTA.

or

• There are 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 disease called atherosclerosis.
Atherosclerosis is due to the build-up of fatty deposits in the arteries.

Why it is important to continue taking ROSANTA
ROSANTA is used to correct the 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).

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

In most people, high cholesterol does not affect how they feel because it
does not produce any 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, which can interrupt the flow of blood to the
heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your
risk of having a heart attack, stroke or related health problems.

You must continue to take ROSANTA, even if you have brought your cholesterol to the right level, because
it prevents your cholesterol level from risingand causing the build-up of fatty deposits. However,
stop taking the medicine on your doctor's advice 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 to any of its ingredients.
• If you are pregnant or breastfeeding. If you become pregnant while taking ROSANTA stopimmediately and inform your doctor.Women must avoid becoming pregnant while taking ROSANTA by using adequate contraception.
• If you have a liver disease.
• If you have severe kidney problems.
• If you have recurrent or unexplained muscle pain.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications (used for liver viral infection called hepatitis C).
• If you are taking a medication called cyclosporine (used, for example, after organ transplants). If any of the above situations apply to you (or you have 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 recurrent or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medications.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian).
• If you are taking other medications called fibrates to lower cholesterol.

If any of the situations listed above apply to you (or you have doubts), consult your doctor again.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSANTA.

• If you have kidney problems.
• If you have liver problems.
• If you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medications. Immediately inform your doctor if you have unexplained muscle pain, especially if you do not feel well 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 or scaling of the skin, blisters and/or sores in the mouth after taking ROSANTA or other related medications.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medications called fibrates to lower cholesterol. Read carefully
• If you are taking medications used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see "Other medicines and ROSANTA".
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), orally or by injection. The combination of fusidic acid and ROSANTA can cause serious muscle problems (rhabdomyolysis), see "Othermedicines and ROSANTA".
• If you are over 70 years of age (as your doctor needs to choose the right starting dose of ROSANTA suitable for you).
• If you have severe respiratory failure.
• If you are of Asian origin, namely Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right starting dose of ROSANTA suitable for you.

If any of the above conditions 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 actually starting to take 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 treatment with ROSANTA.
Stop using ROSANTA and consult a doctor immediately if you notice any of the symptoms described in section 4.
In a small number of people, statins can affect the liver. This is identified by a simple test that looks for high 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
ROSANTA.
While taking this medicine, your doctor will carefully monitor you if you suffer from diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars 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 should 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
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 will
temporarily need to stop using this medicine. Your doctor will tell you when it will be
safe to resume ROSANTA. Taking ROSANTA with fusidic acid can rarely
cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information
on rhabdomyolysis, see paragraph 4.
Pregnancy and breastfeeding
Do not take ROSANTAif you are pregnant or breastfeeding. If you become pregnant during the taking of
ROSANTA , stop taking it immediatelyand inform your doctor. Women must avoid
becoming pregnant while taking ROSANTA by using adequate contraception.
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, which will not affect their ability. However, some people may experience dizziness
during treatment with ROSANTA. If you feel dizzy, consult your doctor before trying to drive
or use machines.
ROSANTA contains lactose and sodium .
Lactose:
If your doctor has diagnosed you with intolerance to some sugars (lactose or milk sugar), contact them 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 as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

Dosage in adults
If you are taking the medicine for high cholesterol:
Starting dose
Your treatment with ROSANTA must begin with a dose of 5 mg or 10 mg,even if you have taken a
higher dose of a different statin before. The choice of the starting dose will depend on:

• Your cholesterol levels.
• The level of risk you have of having a heart attack or stroke.
• If you have a factor that may 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 may decide to give you the lowest dose (5 mg) if:

• you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean and 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
The doctor may decide to increase the 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 may 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
may 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 is only for patients with high cholesterol levels and a high risk of heart attacks or strokes whose cholesterol levels are not lowered sufficiently
with 20 mg.

If you are taking ROSANTA to reduce the risk of heart attack, stroke or health problems related to them:
The recommended dose is 20 mg per day. However, the doctor may decide to use a lower dose if you have one 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 a day. The usual starting dose is 5 mg per day and the doctor may gradually increase
the dose to find the right amount of ROSANTA for you. The maximum daily dose
of ROSANTA is 10 or 20 mg for children aged 6 to 17 years depending on the underlying condition
to be treated. Take the dose once a day. ROSANTA 30 mg and 40 mg
tablets should not be used by children.

Taking the tablets
Swallow each tablet whole with a glass of water.

Take ROSANTA once a day.You can take it at any time of the 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 make sure your
cholesterol has reached and remains at the correct level.
The doctor may decide to increase the 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, tell the medical staff that you are
taking ROSANTA.

If you forget to take ROSANTA
Do not worry, just 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 want 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 side effects, although not everyone will experience them.
It is important that you are aware of what these side effects might be. They are usually
mild and disappear after a short time.

Stop taking ROSANTA and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with raised bumps).
• Reddish, non-raised patches, target-shaped or circular on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking ROSANTA and speak to your doctor immediately:

• If you have unusual muscle pain or discomfort that lasts longer than you would expect. 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 progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.
• If you have a muscle rupture.
• If you have a lupus-like illness syndrome (including rash, joint disorders and effects on blood cells).

Common possible side effects (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 on its own without having to stop taking ROSANTA tablets (only ROSANTA 40 mg).
• Diabetes. This is more likely if you have high blood sugar and fat levels, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

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

Rare possible 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 bumps). If you think you

are having an allergic reaction, stop taking ROSANTA and seek immediate
medical attention.

• Muscle damage in adults: as a precaution, stop taking ROSANTA and speak to your doctor immediately if you have unusual muscle pain or discomfort that lasts longer than expected.
• • Muscle damage in adults - as a precaution, stop taking ROSANTA and consult your doctor immediately if you experience unusual muscle pain or soreness that persists longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzyme levels in the blood.
• Easier bleeding or bruising than usual due to low levels of platelets 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 people):

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

Side effects with unknown frequency may include:

• Diarrhea (loose stools)
• Cough
• Shortness of breath
• Edema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
• Constant muscle weakness
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 at a temperature 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 pack after Scad.. The expiry date refers to the last day of the month.
Do not dispose of any medicine in 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 5mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin.

ROSANTA 10mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin.

ROSANTA 15mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 15 mg of rosuvastatin.

ROSANTA 20mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin.

ROSANTA 30mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 30 mg of rosuvastatin.

ROSANTA 40mg, film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin.
The other ingredients are:

Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Hydroxypropylcellulose
Sodium bicarbonate
Magnesium stearate

Film coating:
Lactose monohydrate
Hypromellose
Titanium dioxide (E 171)
Triacetin
Yellow iron oxide (E 172) in ROSANTA 5 mg, 15 mg and 30 mg, film-coated tablets
Red iron oxide (E 172) in ROSANTA 10 mg, 20 mg and 40 mg, film-coated tablets

Description of ROSANTA and package contents

ROSANTA 5 mg, film-coated tablets:
Round, biconvex, film-coated tablet, yellow in colour, with “5” imprinted on one side and smooth
on the other, diameter: 5.5 mm.

ROSANTA 10 mg film-coated tablets:
Round, biconvex, pink tablet, with a break line on one side, diameter: 7 mm.

ROSANTA 15 mg, film-coated tablets:
Round, convex, film-coated tablet, yellow in colour, with “15” imprinted on one side and smooth
on the other, diameter: 8 mm.

ROSANTA 20 mg, film-coated tablets:
Round, biconvex, film-coated tablet, pink in colour, with a break line on one side, with “20” imprinted
on the other, diameter: 9 mm.

ROSANTA 30 mg, film-coated tablets:
Round, convex, film-coated tablet, yellow in colour,
with a break line on one side, with “30” imprinted on the other, diameter: 8 mm.

ROSANTA 40 mg, film-coated tablets:
Oval, biconvex, film-coated tablet, pink in colour, with a break line on one side, with “40” imprinted
on the other, dimensions: 11.5 x 7 mm.

ROSANTA 10, 20, 40 mg, film-coated tablets:
The tablets can be divided into two equal halves.
ROSANTA is available in blisters containing 28, 30, 60, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Community with the following
denominations:
Finland - Rosanta
Italy - ROSANTA