Rosuvastatin Doc Generici

DK/H/2597/1-2/DC

Package leaflet: Information for the user

ROSUVASTATIN DOC Generics 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicinal product
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:

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

1. What ROSUVASTATINA DOC Generici is and what it is used for

ROSUVASTATINA DOC Generici belongs to a group of medicines called statins.
You have been prescribed ROSUVASTATINA DOC Generici because:

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. ROSUVASTATINA DOC Generici 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 DOC Generici, you must continue to follow a cholesterol-lowering diet and
maintain regular physical exercise.
Alternatively

• 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 disease called
atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why is it important to keep taking ROSUVASTATINA DOC Generici?
ROSUVASTATINA DOC Generici is used to correct levels of fatty substances in the blood
called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and
so-called “good” cholesterol (HDL-C).

• ROSUVASTATINA DOC Generici 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 left untreated, 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, thereby causing a 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 DOC Generici, 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
DOC Generici if your doctor has told you to do so or if you become pregnant.

2. What you should know before taking ROSUVASTATINA DOC Generici

Do not take ROSUVASTATINA DOC Generici:

• if you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding. If you become pregnant while taking ROSUVASTATINA DOC Generici, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with ROSUVASTATINA DOC Generici 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 a medicine called cyclosporine (used, for example, after organ transplants). If any of these situations apply to you (or you have any doubts), you must consult your doctor and inform him/her.

Also, do not take ROSUVASTATINA DOC Generici 40 mg (the highest dose):

• if you have moderate kidney problems (ask your doctor if you are unsure);
• if your thyroid gland is not functioning properly;
• if you have had repeated or unexplained muscle pain or spasms, a personal or family history of muscle disorders, or have previously experienced 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 these situations apply to you (or you have any doubts), you must consult your doctor and inform him/her.

Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUVASTATINA DOC Generici if:

• you have kidney problems;
• you have liver problems;
• you have had repeated or unexplained muscle pain or spasms, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or spasms, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• you regularly drink 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 infection or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir; please read section "Other medicines and ROSUVASTATINA DOC Generici";
• you are taking fusidic acid antibiotics. If you are currently taking or have taken within the last 7 days oral or injectable medicines containing fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis).

Children and adolescents
If the patient is under 6 years of age: ROSUVASTATINA DOC Generici must not be administered to children under 6 years of age.
If the patient is under 18 years of age: ROSUVASTATINA DOC Generici 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

• If you are over 70 years old (because your doctor needs to choose the appropriate starting dose of ROSUVASTATINA DOC Generici for you);
• If you have severe respiratory insufficiency;
• If you are of Asian origin, i.e. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor needs to choose the appropriate starting dose of ROSUVASTATINA DOC Generici for you. If any of these situations apply to you (or you are unsure):
• Do not take ROSUVASTATINA DOC Generici 40 mg (the highest dose) and consult your doctor or pharmacist before starting ROSUVASTATINA DOC Generici at any dosage.

In a small number of people, statins may have a negative effect on the liver. This can be detected by a simple blood test measuring liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with ROSUVASTATINA DOC Generici.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased 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 DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with ROSUVASTATINA DOC Generici. Taking ROSUVASTATINA DOC Generici with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). You can find further information on rhabdomyolysis in section 4.

Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation);
• warfarin or clopidogrel (or any other medicine used to thin the blood);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• antacids (used to neutralize stomach acid);
• erythromycin (an antibiotic);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat HIV infection or hepatitis C infection – see section "Warnings and precautions").

The effects of these medicines may be altered by ROSUVASTATINA DOC Generici, or the effect of ROSUVASTATINA DOC Generici may be altered by these medicines.

Pregnancy and breastfeeding
Do not take ROSUVASTATINA DOC Generici if you are pregnant or breastfeeding. If you become pregnant while taking ROSUVASTATINA DOC Generici, you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with ROSUVASTATINA DOC Generici by using appropriate contraceptive measures.
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 DOC Generici – it does not affect their ability. However, some people may experience dizziness during treatment with ROSUVASTATINA DOC Generici. If you experience dizziness, inform your doctor before driving or operating machinery.

ROSUVASTATINA DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
For the complete list of ingredients, see section "Contents of the pack and other information".

3. How to take ROSUVASTATINA DOC Generici

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

Recommended dose in adults
If you are taking ROSUVASTATINA DOC Generici for high cholesterol:

Starting dose
Treatment with ROSUVASTATINA DOC Generici should begin with a 5 mg or 10 mg dose, 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;
• whether you have factors that may make you more sensitive to possible side effects.

Check with your doctor or pharmacist which starting dose of ROSUVASTATINA DOC Generici 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 weakness (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most appropriate dose of ROSUVASTATINA DOC Generici for you. If you start with a 5 mg dose, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and finally to 40 mg. If you start with 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg.
There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of ROSUVASTATINA DOC Generici is 40 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 been sufficiently reduced with the 20 mg dose.

If you are taking ROSUVASTATINA DOC Generici to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.

Use in children aged 6 to 17 years
The recommended starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate dose of ROSUVASTATINA DOC Generici for you. The maximum daily dose of ROSUVASTATINA DOC Generici is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily.
ROSUVASTATINA DOC Generici 40 mg tablets must not be used in children.

Taking the tablets
Swallow each tablet whole with a glass of water.
ROSUVASTATINA DOC Generici 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, to ensure that your cholesterol has reached and remains at the desired level.
Your doctor may decide to increase your dose to achieve the most appropriate amount of ROSUVASTATINA DOC Generici for you.

If you take more ROSUVASTATINA DOC Generici 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 hospital staff that you are taking ROSUVASTATINA DOC Generici.

If you forget to take ROSUVASTATINA DOC Generici
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 DOC Generici
Inform your doctor if you intend to stop taking ROSUVASTATINA DOC Generici. If you stop taking ROSUVASTATINA DOC Generici, 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 within a short time.
Stop taking ROSUVASTATIN DOC Generics 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 raised hives).

Also, stop taking ROSUVASTATIN DOC Generics 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 muscle-related side 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 on their own without needing to stop taking ROSUVASTATIN DOC Generics (only for ROSUVASTATIN DOC Generics 40 mg),
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and 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 rash, itching or 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 DOC Generics (only for ROSUVASTATIN DOC Generics 5 mg, 10 mg and 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 raised hives). If you suspect you are having an allergic reaction, stop taking ROSUVASTATIN DOC Generics and seek immediate medical help,
• muscle damage in adults – as a precaution, stop taking ROSUVASTATIN DOC Generics and contact your doctor immediately if you have unusual muscle pains or aches 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 (gynaecomastia).

Side effects of unknown frequency may include:

• diarrhoea (loose stools),
• Stevens-Johnson syndrome (characterised by 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 the website
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 ROSUVASTATINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The 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. Contents of the pack and other information

What ROSUVASTATINA DOC Generici contains
The active substance is rosuvastatin.
ROSUVASTATINA DOC Generici 5 mg, 10 mg, 20 mg or 40 mg film-coated tablets
contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone (type IB),
hydroxypropylcellulose, sodium bicarbonate, magnesium stearate
Tablet coating: lactose monohydrate, hypromellose 6 cP, titanium dioxide, triacetin,
yellow iron oxide (E172) in the 5 mg tablets, red iron oxide (E172) in the 10 mg, 20 mg and 40 mg tablets.

Description of the appearance of ROSUVASTATINA DOC Generici and contents of the pack
ROSUVASTATINA DOC Generici 5 mg film-coated tablets: round, biconvex, yellow, diameter 5.5 mm
ROSUVASTATINA DOC Generici 10 mg film-coated tablets: round, biconvex, pink with a break line, diameter 7 mm
ROSUVASTATINA DOC Generici 20 mg film-coated tablets: round, biconvex, pink with a break line, diameter 9 mm
ROSUVASTATINA DOC Generici 40 mg film-coated tablets: oval, biconvex, pink with a break line, dimensions 11.5x7 mm.
The 10 mg, 20 mg and 40 mg tablets can be divided into two equal parts.
ROSUVASTATINA DOC Generici is available in blisters, in packs of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milano, Italy

Manufacturer responsible for batch release
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren,
Germany
or
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
Zagreb 10000
Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Rovatina
Italy: ROSUVASTATINA DOC Generici