Patient Information Leaflet: Information for the User

Rosuvastatin Alter, 5 mg film-coated tablets

Rosuvastatin
Equivalent medicine
Please read all of 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 or pharmacist.
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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rosuvastatin Alter, 5 mg film-coated tablets is and what it is used for
What you need to know before taking Rosuvastatin Alter, 5 mg film-coated tablets
How to take Rosuvastatin Alter, 5 mg film-coated tablets
Possible side effects
How to store Rosuvastatin Alter, 5 mg film-coated tablets
Contents of the pack and other information

1. What is Rosuvastatina Alter 5 mg film-coated tablets and what is it used for?

Rosuvastatina Alter belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Alter 5 mg because:

your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Alter is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol. You have been prescribed a statin because changes in diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina Alter 5 mg, you must continue with a cholesterol-lowering diet and maintain regular physical exercise.

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

Why is it important to keep taking Rosuvastatina Alter 5 mg?
Rosuvastatina Alter 5 mg is used to correct levels of fatty substances in the blood, known as lipids,
the most common of which is cholesterol.
There are several types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and so-called “good” cholesterol (HDL-C).

Rosuvastatina Alter 5 mg 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, 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 Alter 5 mg, 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 Alter 5 mg on medical advice or if you become pregnant.

What you need to know before taking Rosuvastatina Alter 5 mg film-coated tablets

Do not take Rosuvastatina Alter 5 mg:

if you have previously had an allergic reaction to rosuvastatin or to any of the excipients (listed in section 6);
if you are pregnant or breastfeeding. If you discover you are pregnant while taking Rosuvastatina Alter 5 mg, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Alter 5 mg 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 spasms;
if you are taking cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Also, do not take Rosuvastatina Alter 40 mg (the highest dose):

if you have moderately severe kidney problems (if in doubt, consult your doctor);
if your thyroid gland is not functioning properly;
if you suffer from repeated or unexplained muscle pain or spasms, have 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 cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Alter 5 mg if:

you have kidney problems;
you have liver problems;
you have experienced repeated or unexplained muscle pain or spasms, have a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or spasms, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you notice persistent muscle weakness.
you regularly consume large amounts of alcohol;
your thyroid gland is not functioning properly;
you are taking other cholesterol-lowering medicines called fibrates. Read this 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 the section Other medicines and Rosuvastatina Alter 5 mg film-coated tablets;
if you are taking antibiotics containing fusidic acid, please read the section Other medicines and Rosuvastatina Alter 5 mg film-coated tablets.

Children and adolescents

if the patient is under 6 years of age: Rosuvastatina Alter 5 mg must not be given to children under 6 years of age.
if the patient is under 18 years of age: Rosuvastatina Alter 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
if you are over 70 years of age (your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you).
if you have severe respiratory insufficiency.
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you.

If you fall into any of the above categories (or are unsure):

do not take Rosuvastatina Alter 40 mg (the highest dose), and check with your doctor or pharmacist before starting any dose of Rosuvastatina Alter. 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 liver enzyme levels. For this reason, your doctor will ask you to undergo this test (liver function test) before and during treatment with Rosuvastatina Alter 5 mg.

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 fat in your blood, are overweight, and have high blood pressure.
Other medicines and Rosuvastatina Alter 5 mg film-coated tablets
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 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 section "Warnings and precautions"), an oral contraceptive (the pill), hormone replacement therapy, or ritonavir with lopinavir and/or atazanavir (used to treat HIV or hepatitis C infections – read the section “Warnings and precautions”). The effects of these medicines may be altered by Rosuvastatina Alter 5 mg, or the effect of Rosuvastatina Alter may be altered by these medicines.
Pregnancy and breastfeeding
Do not take Rosuvastatina Alter 5 mg if you are pregnant or breastfeeding.
If you discover you are pregnant while taking Rosuvastatina Alter, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Alter by using appropriate contraceptive measures. Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatina Alter 5 mg – it does not affect their ability to drive or use machinery.
However, some people may experience dizziness during treatment with Rosuvastatina Alter 5 mg. If you experience dizziness, consult your doctor before driving or operating machinery.
Rosuvastatina Alter 5 mg contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking Rosuvastatina Alter 5 mg.
For a complete list of other ingredients, see section Contents of the pack and other information.

3. How to take Rosuvastatina Alter 5 mg film-coated tablets

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

Usual dosage in adults
If you are taking Rosuvastatina Alter 5 mg for high cholesterol:
Starting dose
Treatment with Rosuvastatina Alter 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 initial dose depends on:

your cholesterol level;
your risk of having a heart attack or stroke;
the presence of 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 Rosuvastatina Alter 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 weakness (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most appropriate dose for you.
If you start with a 5 mg dose, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg. If you start with 10 mg, your doctor may, if necessary, decide to double this dose to 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg), up to 40 mg (4 tablets of 10 mg or 2 tablets of 20 mg). There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatina Alter is 40 mg (4 tablets of 10 mg or 2 tablets of 20 mg).
This dose is only given to 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 (2 tablets of 10 mg or 1 tablet of 20 mg).

If you are taking Rosuvastatina Alter to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily (2 tablets of 10 mg or 1 tablet of 20 mg). 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 usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate dose for you. The maximum daily dose is 10 mg for children aged 6 to 9 years and 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg) for children aged 10 to 17 years. The dose should be taken once daily.
The 40 mg dose must not be used in children.

Administration of the tablets
Swallow the tablets whole with a glass of water.
Rosuvastatina Alter should be taken once daily. It can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.

Regular cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels and ensure that your cholesterol has reached and maintains the desired levels. Your doctor may decide to increase your dose until you are taking the most appropriate amount of Rosuvastatina Alter for you.

If you take more Rosuvastatina Alter 5 mg than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for any other reason, inform the hospital doctor that you are taking Rosuvastatina Alter.

If you forget to take Rosuvastatina Alter 5 mg
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 Alter 5 mg
Inform your doctor if you intend to stop taking Rosuvastatina Alter 5 mg. If you stop taking Rosuvastatina Alter 5 mg, 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 gets them.
It is important to be aware of which of these side effects may occur. Usually they are mild and disappear within a short time.

Stop taking Rosuvastatina Alter 5 mg 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 in swallowing;
severe itching of the skin (with hives).

Also, stop taking Rosuvastatina Alter 5 mg and contact your doctor immediately
if you experience unusual muscle pains or cramps 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 unwanted muscle effects, and in rare cases these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.

Possible common 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 – values usually return to normal spontaneously without needing to stop taking rosuvastatin tablets (only if you are taking 40 mg)
diabetes: more likely if you have high levels of sugar and fats in the 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 people)

skin irritation, itching and other skin reactions
increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with rosuvastatin tablets (only if you are taking 5 mg, 10 mg or 20 mg).

Possible 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 hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina Alter and seek immediate medical help
muscle damage in adults – as a precaution, stop taking Rosuvastatina Alter and contact your doctor immediately if you have unusual muscle pains or cramps lasting longer than expected
severe stomach pain (inflamed pancreas)
increased liver enzymes in the blood.

Possible 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 arms and legs (numbness)
joint pain
memory loss
breast enlargement in men (gynaecomastia).

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

diarrhoea (passing loose stools)
Stevens-Johnson syndrome (characterised by the appearance of severe blisters on 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
persistent muscle weakness

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Alter 5 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of that month.
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 Alter 5 mg film-coated tablets contain
The active substance is rosuvastatin.
Each film-coated tablet contains 5 mg of rosuvastatin.
The other components are:
Monohydrate lactose, microcrystalline cellulose, magnesium oxide heavy, crospovidone, calcium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171).

Description of the appearance of Rosuvastatina Alter 5 mg and pack contents
Rosuvastatina Alter 5 mg film-coated tablets are white, round, biconvex, smooth, without a breakline.
Rosuvastatina Alter 5 mg is supplied in packages containing blisters of 20, 28, 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter srl
Via Egadi 7
20144 Milano
Italy

Manufacturer
LABORATORIOS ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Rosuvastatina Alter, 5 mg film-coated tablets
France: ROSUVASTATINE ALTER 5 mg, comprimé pelliculé
Portugal: Rosuvastatina Alter 5 mg comprimido revestido por pelicula MG
Spain: Rosuvastatina Alter 5 mg comprimidos recubiertos con película EFG

Package leaflet: Information for the user

Rosuvastatin Alter, 10 mg film-coated tablets

Rosuvastatin
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rosuvastatin Alter 10 mg film-coated tablets is and what it is used for
What you need to know before taking Rosuvastatin Alter 10 mg film-coated tablets
How to take Rosuvastatin Alter 10 mg film-coated tablets
Possible side effects
How to store Rosuvastatin Alter 10 mg film-coated tablets
Contents of the pack and other information

1. What Rosuvastatina Alter 10 mg film-coated tablets is and what it is used for

Rosuvastatina Alter belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Alter 10 mg because:

your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Alter is used in adults, adolescents and children aged 6 years and older to treat high cholesterol. You have been prescribed a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina Alter, you must continue your cholesterol-lowering diet and maintain regular physical activity. Or
you have other factors that increase your risk of heart attack, stroke or related health problems. Heart attack, stroke and related health problems can be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why is it important to continue taking Rosuvastatina Alter 10 mg?
Rosuvastatina Alter 10 mg is used to correct levels of fatty substances in the blood, known as lipids,
the most common of which is cholesterol.
There are several types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and so-called “good”
cholesterol (HDL-C).

Rosuvastatina Alter 10 mg 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 high cholesterol is not treated, 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, the risk of heart attack, stroke or related health
problems is reduced.
You must continue taking Rosuvastatina Alter 10 mg, 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 Alter 10 mg on medical advice or if you become pregnant.

What you need to know before taking Rosuvastatina Alter 10 mg film-coated tablets

Do not take Rosuvastatina Alter 10 mg:

if you have previously had an allergic reaction to rosuvastatin or to any of the excipients (listed in section 6);
if you are pregnant or breastfeeding. If you become aware that you are pregnant while taking Rosuvastatina Alter 10 mg, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rosuvastatina Alter 10 mg 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 tenderness;
if you are taking cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.
Also, do not take Rosuvastatina Alter 40 mg (the highest dose):

if you have moderately severe kidney problems (if in doubt, consult your doctor);
if your thyroid gland is not functioning properly;
if you have repeated or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or if muscle problems occurred previously 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 cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Alter 10 mg if:

you have kidney problems;
you have liver problems;
you have had repeated or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or if muscle problems occurred previously with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or tenderness, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness;
you regularly consume large amounts of alcohol;
your thyroid gland is not functioning properly;
you are taking other cholesterol-lowering medicines called fibrates. Read this 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 Rosuvastatina Alter 10 mg film-coated tablets;
if you are taking antibiotics containing fusidic acid, please read section Other medicines and Rosuvastatina Alter 10 mg film-coated tablets.

Children and adolescents

if the patient is under 6 years of age: Rosuvastatina Alter 10 mg must not be given to children under 6 years of age.
if the patient is under 18 years of age: Rosuvastatina Alter 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
if you are over 70 years of age (your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you).
if you have respiratory insufficiency.
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you.

If you fall into any of the above categories (or are unsure):

do not take Rosuvastatina Alter 40 mg (the highest dose) and check with your doctor or pharmacist before starting Rosuvastatina Alter at any dosage.

In a small number of people, statins can have a negative effect on the liver, which can be detected
through a simple blood test measuring liver enzyme levels. For this reason, your doctor will ask you to undergo this test (liver function test) before and during treatment with Rosuvastatina Alter 10 mg.
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 the blood, if you are overweight, and if you have high blood pressure.
Other medicines and Rosuvastatina Alter 10 mg film-coated tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplantation), warfarin (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 section "Warnings and precautions"), an oral contraceptive (the pill), hormone replacement therapy, or ritonavir with lopinavir and/or atazanavir (used to treat HIV or hepatitis C infections – read section "Warnings and precautions"). The effects of these medicines may be altered by Rosuvastatina Alter 10 mg film-coated tablets, or the effect of Rosuvastatina Alter may be altered by these medicines.
Pregnancy and breastfeeding
Do not take Rosuvastatina Alter 10 mg if you are pregnant or breastfeeding.
If you become aware that you are pregnant while taking Rosuvastatina Alter, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Alter by using appropriate contraceptive measures. Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatina Alter 10 mg – it does not affect their ability to drive or operate machinery.
However, some people may experience dizziness during treatment with Rosuvastatina Alter 10 mg.
If you experience dizziness, consult your doctor before driving or operating machinery.
Rosuvastatina Alter 10 mg contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact him/her before taking Rosuvastatina Alter 10 mg.
For the complete list of other components, see section Contents of the pack and other information.

3. How to take Rosuvastatina Alter, 10 mg film-coated tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatina Alter 10 mg for high cholesterol:
Starting dose
Treatment with Rosuvastatina Alter should begin with a dose of 5 mg or 10 mg, even if you
previously took 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 any factors that may make you more susceptible to possible side effects.

Check with your doctor or pharmacist which starting dose of Rosuvastatina Alter 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);
are over 70 years old;
have moderate kidney problems;
are at risk of muscle pain or aches (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most appropriate dose for you.
If treatment starts with a 5 mg dose, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg. If treatment starts with 10 mg, your doctor may, if necessary, decide to double the dose to 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg) and then to 40 mg (4 tablets of 10 mg, 2 tablets of 20 mg). There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatina Alter is 40 mg (4 tablets of 10 mg, 2 tablets of 20 mg).
This dose is only given to patients with high cholesterol and a high risk of heart attack or stroke, whose cholesterol levels have not sufficiently decreased with the 20 mg dose (2 tablets of 10 mg or 1 tablet of 20 mg).
If you are taking Rosuvastatina Alter to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg per day (2 tablets of 10 mg or 1 tablet of 20 mg). 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 usual starting dose is 5 mg. Your doctor may increase the dose to reach the most appropriate dose for you. The maximum daily dose is 10 mg for children aged 6 to 9 years and 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg) for children aged 10 to 17 years. The dose should be taken once daily.
The 40 mg dose must not be used in children.
Administration of the tablets
Swallow the tablets whole with a glass of water.
Rosuvastatina Alter should be taken once daily. It can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Regular cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels and ensure that your cholesterol has reached and maintains the correct levels. Your doctor may decide to increase your dose until you are taking the amount of Rosuvastatina Alter most suitable for you.
If you take more Rosuvastatina Alter 10 mg than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for any other reason, inform the hospital doctor that you are taking Rosuvastatina Alter.
If you forget to take Rosuvastatina Alter 10 mg
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Rosuvastatina Alter 10 mg
Inform your doctor if you intend to stop taking Rosuvastatina Alter 10 mg. If you stop taking Rosuvastatina Alter 10 mg, 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 gets them.
It is important to be aware of which of these side effects may occur. They are usually mild and disappear quickly.
Stop taking Rosuvastatina Alter 10 mg 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 formation of hives).

Also, stop taking Rosuvastatina Alter 10 mg and contact your doctor immediately
if you experience unusual muscle spasms or muscle pain that last 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 unwanted muscle effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.

Possible common 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 – values usually return to normal spontaneously without needing to stop taking rosuvastatin tablets (only if taking 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 people)

skin irritation, itching and other skin reactions
increased amount of protein in the urine – values usually return to normal on their own without needing to stop treatment with rosuvastatin tablets (only if taking 5 mg, 10 mg or 20 mg).

Possible 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 and breathing, intense itching of the skin (with formation of hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina Alter and seek immediate medical help
muscle damage in adults – as a precaution, stop taking Rosuvastatina Alter and contact your doctor immediately if you have unusual muscle spasms or muscle pain that persist longer than expected
severe stomach pain (inflamed pancreas)
increased liver enzymes in the blood.

Possible very rare side effects (may affect up to 1 in 10,000 people)

jaundice (yellowing of the skin and eyes)
hepatitis (liver inflammation)
traces of blood in the urine
nerve damage in arms and legs (numbness)
joint pain
memory loss
breast enlargement in men (gynecomastia).

Side effects of unknown frequency (frequency cannot be estimated from available data) may include:

diarrhoea (passing liquid stools)
Stevens-Johnson syndrome (characterised by the appearance of severe blisters on 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
persistent muscle weakness

5. How to store Rosuvastatin Alter 10 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
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 Alter 10 mg film-coated tablets contain
The active substance is rosuvastatin.
Each film-coated tablet contains 10 mg of rosuvastatin.
The other components are:
Monohydrate lactose, microcrystalline cellulose, heavy magnesium oxide, crospovidone, calcium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171).

Description of the appearance of Rosuvastatina Alter 10 mg and package contents
Rosuvastatina Alter 10 mg film-coated tablets are white, round, biconvex, with a score line on one side.
Rosuvastatina Alter 10 mg is supplied in packages containing blisters of 20, 28, 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter srl
Via Egadi 7
20144 Milano
Italy

Manufacturer
LABORATORIOS ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Rosuvastatina Alter, 10 mg film-coated tablets
France: ROSUVASTATINE ALTER 10 mg, film-coated tablet
Portugal: Rosuvastatina Alter 10 mg film-coated tablet MG
Spain: Rosuvastatina Alter 10 mg film-coated tablets EFG

Package leaflet: information for the user

Rosuvastatin Alter, 20 mg film-coated tablets

Rosuvastatin
Generic medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rosuvastatin Alter 20 mg film-coated tablets is and what it is used for
What you need to know before taking Rosuvastatin Alter 20 mg film-coated tablets
How to take Rosuvastatin Alter 20 mg film-coated tablets
Possible side effects
How to store Rosuvastatin Alter 20 mg film-coated tablets
Contents of the pack and other information

1. What is Rosuvastatina Alter 20 mg film-coated tablets and what is it used for

Rosuvastatina Alter belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Alter 20 mg because:

your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Alter 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 Alter, you must continue with a cholesterol-lowering diet and maintain regular physical activity.

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

Why is it important to keep taking Rosuvastatina Alter 20 mg?
Rosuvastatina Alter 20 mg is used to correct levels of fatty substances in the blood known as lipids,
the most common of which is cholesterol.
There are several types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and so-called “good”
cholesterol (HDL-C).

Rosuvastatina Alter 20 mg 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, 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
leading to 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 Alter 20 mg, 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 Alter 20 mg on medical advice or if you become pregnant.

What you need to know before taking Rosuvastatina Alter 20 mg film-coated tablets

Do not take Rosuvastatina Alter 20 mg:

if you have previously had an allergic reaction to rosuvastatin or to any of the excipients (listed in section 6);
if you are pregnant or breastfeeding. If you become aware that you are pregnant while taking Rosuvastatina Alter 20 mg, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rosuvastatina Alter 20 mg 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 tenderness;
if you are taking cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
In addition, do not take Rosuvastatina Alter 40 mg (the highest dose):

if you have moderately severe kidney problems (if in doubt, consult your doctor);
if your thyroid gland is not functioning properly;
if you suffer from repeated or unexplained muscle pain or tenderness, have 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 cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Alter 20 mg,

if you have kidney problems;
if you have liver problems;
if you have had repeated or unexplained muscle pain or tenderness, 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 or tenderness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
if you regularly consume large amounts of alcohol;
if your thyroid gland is not functioning properly;
if you are taking other cholesterol-lowering medicines called fibrates. 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 and/or atazanavir, see section Other medicines and Rosuvastatina Alter 20 mg film-coated tablets;
If you are taking antibiotics containing fusidic acid, please read the section Other medicines and Rosuvastatina Alter 20 mg film-coated tablets.

Children and adolescents

if the patient is under 6 years of age: Rosuvastatina Alter 20 mg film-coated tablets must not be given to children under 6 years of age.
if the patient is under 18 years of age: Rosuvastatina Alter 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
if you are over 70 years of age (your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you).
if you have severe respiratory failure.
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the most appropriate starting dose of Rosuvastatina Alter for you.

If you fall into any of the above categories (or are unsure):

do not take Rosuvastatina Alter 40 mg (the highest dose) and check with your doctor or pharmacist before starting Rosuvastatina Alter at any dosage.

In a small number of people, statins may have a negative effect on the liver, which can be detected
by a simple blood test showing increased levels of liver enzymes. For this reason, your
doctor will ask you to have this test (liver function test) before and during treatment
with Rosuvastatina Alter 20 mg.
During treatment with this medicine, your doctor will closely 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.
Other medicines and Rosuvastatina Alter 20 mg film-coated tablets
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 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 section "Warnings and precautions"), an oral contraceptive (the pill), hormone replacement therapy, or ritonavir with lopinavir and/or atazanavir (used to treat HIV infections or hepatitis C infections – see section “Warnings and precautions”). The effects of these medicines may be altered by Rosuvastatina Alter 20 mg, or the effect of Rosuvastatina Alter may be altered by these medicines.
Pregnancy and breastfeeding
Do not take Rosuvastatina Alter 20 mg if you are pregnant or breastfeeding.
If you become aware that you are pregnant while taking Rosuvastatina Alter, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Alter by using appropriate contraceptive measures. Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatina Alter 20 mg – it does not affect their ability to drive or operate machinery.
However, some people may experience dizziness during treatment with Rosuvastatina Alter 20 mg.
If you experience dizziness, consult your doctor before driving or operating machinery.
Rosuvastatina Alter 20 mg contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them
before taking Rosuvastatina Alter 20 mg.
For a complete list of other components, see section Contents of the pack and other information.

3. How to take Rosuvastatin Alter, 20 mg film-coated tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatin Alter 20 mg for high cholesterol:
Starting dose
Treatment with Rosuvastatin Alter 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 possible presence of factors that may make you more susceptible to potential side effects.

Check with your doctor or pharmacist which starting dose of Rosuvastatin Alter 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);
are over 70 years old;
have moderate kidney problems;
are at risk of muscle pain or muscle damage (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most appropriate dose for you.
If treatment is started at 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and finally to 40 mg. If treatment is started at 10 mg, your doctor may, if necessary, decide to double the dose to 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg) and then to 40 mg (4 tablets of 10 mg, 2 tablets of 20 mg). There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatin Alter is 40 mg (4 tablets of 10 mg, 2 tablets of 20 mg).
This dose is only administered to 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 (2 tablets of 10 mg or 1 tablet of 20 mg).
If you are taking Rosuvastatin Alter to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily (2 tablets of 10 mg or 1 tablet of 20 mg). 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 usual starting dose is 5 mg. Your doctor may increase the dose to reach the most appropriate dose for you. The maximum daily dose is 10 mg for children aged 6 to 9 years and 20 mg (2 tablets of 10 mg or 1 tablet of 20 mg) for children aged 10 to 17 years. The dose should be taken once daily. The 40 mg dose must not be used in children.
Administration of the tablets
Swallow the tablets whole with a glass of water.
Rosuvastatin Alter should be taken once daily. It can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Periodic cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels and ensure that your cholesterol has reached and remains at the correct levels. Your doctor may decide to increase your dose until you are taking the amount of Rosuvastatin Alter most suitable for you.
If you take more Rosuvastatin Alter 20 mg than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for any other reason, inform the hospital doctor that you are taking Rosuvastatin Alter.
If you forget to take Rosuvastatin Alter 20 mg
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 Rosuvastatin Alter 20 mg
Inform your doctor if you intend to stop taking Rosuvastatin Alter 20 mg. If you stop taking Rosuvastatin Alter 20 mg, 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 experiences them.
It is important to be aware of which of these side effects may occur. They are usually mild and disappear quickly.
Stop taking Rosuvastatina Alter 20 mg 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 skin itching (with formation of hives).

Also, stop taking Rosuvastatina Alter 20 mg and contact your doctor immediately if you experience unusual muscle pains or aches 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 a disease causing muscle damage, potentially life-threatening, known as rhabdomyolysis.

Possible common 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 – usually values return to normal spontaneously without needing to stop taking rosuvastatin tablets (only if you are taking 40 mg)
diabetes. This is more likely if you have high levels of sugar and fats in the 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 people)

skin irritation, itching, and other skin reactions
increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with rosuvastatin tablets (only if you are taking 5 mg, 10 mg, or 20 mg).

Possible 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 and breathing, severe skin itching (with formation of hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina Alter and seek immediate medical help
muscle damage in adults – as a precaution, stop taking Rosuvastatina Alter and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected
severe stomach pain (inflamed pancreas)
increased liver enzymes in the blood.

Possible very rare side effects (may affect up to 1 in 10,000 people)

jaundice (yellowing of the skin and eyes)
hepatitis (liver inflammation)
traces of blood in the urine
nerve damage in arms and legs (numbness)
joint pain
memory loss
breast enlargement in men (gynecomastia).

Side effects of unknown frequency (frequency cannot be estimated from available data) may include:

diarrhoea (passing liquid stools)
Stevens-Johnson syndrome (characterized by the appearance of severe blisters on 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
persistent muscle weakness

5. How to store Rosuvastatin Alter, 20 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after EXP. The
expiry date refers to the last day of that month.
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 Alter 20 mg film-coated tablets contain
The active substance is rosuvastatin.
Each tablet contains 20 mg of rosuvastatin.
The other components are:
monohydrate lactose, microcrystalline cellulose, heavy magnesium oxide, crospovidone, calcium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171).

Description of the appearance of Rosuvastatina Alter 20 mg and package contents
Rosuvastatina Alter 20 mg film-coated tablets are white, round, biconvex tablets with a cross inscribed on one side.
Rosuvastatina Alter 20 mg is supplied in packages containing 28, 30 or 60 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter srl
Via Egadi 7
20144 Milano
Italy

Manufacturer
LABORATORIOS ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Rosuvastatina Alter, 20 mg film-coated tablets
Portugal: Rosuvastatina Alter 20 mg comprimido revestido por pelicula MG
Spain: Rosuvastatina Alter 20 mg comprimidos recubiertos con película EFG