Rosuvastatin HCS

Patient Information Leaflet

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

Rosuvastatin
Generic medicine
Please read 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• you have high cholesterol levels. This means you are at risk of heart attack or stroke. Rosuvastatina HCS is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been advised to take a statin because changes in diet and increased physical activity are not sufficient to correct your cholesterol levels. While taking Rosuvastatina HCS to lower your cholesterol, you must continue with a healthy diet and regular physical activity.
Alternatively

• you have other factors that increase your risk of heart attack, stroke, or related health problems. Heart attack, stroke, and other conditions may be caused by a disease called atherosclerosis. Atherosclerosis is due to a build-up of fatty deposits in the arteries.

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Why is it important to continue taking Rosuvastatina HCS?
Rosuvastatina HCS is used to correct levels of fatty substances, called lipids, in the blood, the most common of which is cholesterol.
There are different types of cholesterol measurable in the blood – “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).

• Rosuvastatina HCS can reduce levels of “bad” cholesterol and increase levels of “good” cholesterol.
• It works by helping to block the body’s production of “bad” cholesterol and also improves your body’s ability to remove it from the blood.

In most people, the effects of high cholesterol are not noticeable because this condition does not cause symptoms. However, if left untreated, fatty deposits can build up along the walls of blood vessels, causing them to narrow.
This narrowing can sometimes block blood flow to the heart and brain, leading to heart attack or stroke. By reducing cholesterol levels, the risk of heart attack, stroke, or related health problems is reduced.
You must continue taking Rosuvastatina HCS even after correct cholesterol levels have been achieved, because it prevents cholesterol levels from rising again and causing further build-up of fatty deposits. However, you must stop treatment if your doctor advises it, or if you become pregnant.

2. What you need to know before taking Rosuvastatin HCS

Do not take Rosuvastatin HCS:

• 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 discover you are pregnant while taking Rosuvastatin HCS, stop taking it immediately and contact your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatin HCS by using appropriate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you repeatedly experience unexplained muscle pain or tenderness.
• If you are taking a medicine called cyclosporine (used, for example, after an organ transplant). If any of the situations listed above apply to you (or if you have any doubts), contact your doctor again.

Also, do not take Rosuvastatin HCS 30 mg or 40 mg (the highest dose):

• If you have moderately impaired kidney function (if in doubt, consult your doctor).
• If your thyroid gland is not working properly.
• If you have a history of repeated or unexplained muscle pain or tenderness, personal or family history of muscle disorders, or previous muscle problems related to 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 your cholesterol levels.

If any of the situations listed above apply to you (or if you have any doubts), contact your doctor again.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin HCS if:

• You have kidney problems.
• You have liver problems.
• You have a history of repeated or unexplained muscle pain or tenderness, personal or family history of muscle disorders, or previous muscle problems related to taking other cholesterol-lowering medicines. Inform your doctor immediately if you develop unexplained muscle pain or tenderness, especially if associated with malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• You regularly drink large amounts of alcohol.
• Your thyroid gland is not functioning properly.
• You are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully even if you have previously taken other medicines to lower cholesterol levels.
• You are taking medicines for HIV infection, such as ritonavir with lopinavir and/or atazanavir; refer to section “Other medicines and Rosuvastatin HCS”.
• You are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used for bacterial infections). The combination of fusidic acid and Rosuvastatin HCS may lead to serious muscle problems (rhabdomyolysis).
• You are over 70 years of age (as your doctor must determine the appropriate starting dose of Rosuvastatin HCS for you).
• You suffer from severe respiratory insufficiency.
• You are of Asian origin – i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must determine the appropriate starting dose of Rosuvastatin HCS for you.

Children and adolescents:

• If the patient is under 6 years of age: Rosuvastatin HCS must not be given to children under 6 years old.
• If the patient is under 18 years of age: Rosuvastatin HCS 30 mg and 40 mg must not be used in children and adolescents under 18 years of age.

If any of the above situations apply to you (or if you have any doubts):
Do not take Rosuvastatin HCS 30 mg or 40 mg (the highest dose) and consult your doctor or pharmacist before taking any dose of Rosuvastatin HCS.

In a small number of people, statins may affect liver function. This can be checked with a simple blood test to detect any increase in liver enzyme levels. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin HCS.

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, or have high blood pressure.

Other medicines and Rosuvastatin HCS
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 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,
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• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will inform you when it is safe to resume treatment with Rosuvastatin HCS. Taking Rosuvastatin HCS with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4,
• Regorafenib (used to treat tumors),
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effect of these medicines may be altered by Rosuvastatin HCS, or they may alter the effect of Rosuvastatin HCS.

Rosuvastatin HCS with food and drink
You may take Rosuvastatin HCS with or without food.

Pregnancy and breastfeeding
Do not take Rosuvastatin HCS if you are pregnant or breastfeeding. If you find out you are pregnant while taking Rosuvastatin HCS, stop taking it immediately and contact your doctor. Women should avoid pregnancy during treatment with Rosuvastatin HCS by using appropriate contraceptive methods.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin HCS – it does not affect this ability. However, some people may experience dizziness during treatment with Rosuvastatin HCS. If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatin HCS contains lactose
If your doctor has informed you that you have an intolerance to certain sugars (lactose or milk sugars), inform your doctor before taking this medicine.

3. How to take Rosuvastatin HCS

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

Usual dose in adults
If you are taking Rosuvastatin HCS for high cholesterol:
Starting dose
Treatment with Rosuvastatin HCS should begin with a 5 mg or 10 mg dose, even if you have previously taken a higher dose of a different statin. Your starting dose will depend on:

• Your cholesterol level.
• Your risk of having a heart attack or stroke.
• Whether you have conditions that may make you more susceptible to possible side effects.

Check with your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatin HCS for you.
Your doctor will prescribe the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have mild kidney problems.
• You 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 ensure you receive the amount of Rosuvastatin HCS appropriate for you. If you started at 5 mg, your doctor may increase it to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started at 10 mg, your doctor may increase it to 20 mg and then to 40 mg if necessary. There should be an interval of four weeks between each dose adjustment.

The maximum daily dose of Rosuvastatin HCS is 40 mg. This dose is indicated only for patients with high cholesterol levels and a high risk of heart attack or stroke, in whom cholesterol levels are not sufficiently reduced with the 20 mg dose.

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

Use in children and adolescents aged 6 to 17 years
The starting dose is 5 mg. Your doctor may increase the dose to find the appropriate amount of Rosuvastatin HCS for you. The maximum daily dose of Rosuvastatin HCS is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take one dose per day. Rosuvastatin HCS 30 mg and 40 mg tablets must not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.
Take Rosuvastatin HCS once daily. You may take it at any time of day, with or without food. Try to take the tablet at the same time each day to help you remember.

Regular cholesterol checks
It is important to visit your doctor regularly for cholesterol checks to ensure your cholesterol is reaching or has reached the target level.
Your doctor may decide to increase your dose to ensure you receive the most appropriate amount of Rosuvastatin HCS.

If you take more Rosuvastatin HCS than you should
Contact your doctor or the nearest hospital for advice.
If you go to the hospital or receive treatment for other conditions, inform the medical staff that you are taking Rosuvastatin HCS.

If you forget to take Rosuvastatin HCS
Do not worry. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Rosuvastatin HCS
Inform your doctor if you wish to stop taking Rosuvastatin HCS. Your cholesterol levels may rise again if you stop taking Rosuvastatin HCS.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to be aware of which side effects may occur. Usually they are mild and disappear in a short time.

Stop taking Rosuvastatin HCS and seek immediate medical advice if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
• Severe itching sensation (with raised lumps).

Also, stop taking Rosuvastatin HCS and contact your doctor immediately if you experience any of the following symptoms:

• Unusual or persistent muscle pain lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a small number of people have experienced unpleasant muscle effects, and rarely these have progressed to a condition causing muscle damage, potentially fatal, known as rhabdomyolysis.
• Lupus-like syndrome (including skin rash, joint problems and effects on blood cells).
• Muscle tearing.

Common side effects (may occur in up to 1 in 10 and 1 in 100 patients):

• Headache.
• Stomach pain.
• Constipation.
• Feeling unwell.
• Muscle pain.
• Feeling weak.
• Dizziness.
• Increased levels of protein in the urine – these usually return to normal spontaneously without the need to stop taking Rosuvastatin HCS tablets (only if you are taking the 40 mg dose).
• Diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Possible uncommon side effects (may occur in up to 1 in 100 and 1 in 1,000 patients):

• Skin rash, itching sensation, or other skin reactions.
• Increased levels of protein in the urine – these usually return to normal spontaneously without the need to stop taking Rosuvastatin HCS tablets (only if you are taking the 5 mg or 20 mg doses).

Possible rare side effects (may occur in up to 1 in 1,000 and 1 in 10,000 patients):

• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing, and severe itching (with raised lumps). If you think you are having an allergic reaction, stop taking Rosuvastatin HCS and seek immediate medical advice.
• Muscle damage in adults – as a precaution, stop taking Rosuvastatin HCS and speak to your doctor immediately if you have unexplained muscle pain that lasts longer than expected.
• Severe abdominal pain (inflammation of the pancreas).
• Increased liver enzymes in the blood.
• Lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Possible very rare side effects (may occur in fewer than 1 in 10,000 patients):

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

Side effects of unknown frequency may include:

• Diarrhoea (loss of faeces).
• Stevens-Johnson syndrome (severe blistering of the skin, mouth, eyes and genitals).
• Cough.
• Shortness of breath.
• Oedema (swelling).
• Sleep disorders, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Breathing problems, including persistent cough and/or shortness of breath or fever.
• Tendon injury.
• Persistent muscle weakness.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin HCS

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 expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Keep the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina HCS contains

• The active substance is rosuvastatin. Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

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Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 15 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 30 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).

• The other components are: in the tablet core: anhydrous lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica. In the tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) (only in 5 mg and 15 mg tablets) and iron oxide yellow (E172) (only in 10 mg and 40 mg tablets).

Description of the appearance of Rosuvastatina HCS and pack contents
Rosuvastatina HCS 5 mg film-coated tablets are red-brown, round, slightly biconvex film-coated tablets with bevelled edges, marked with the number 5 on one side (diameter: 6 mm).
Rosuvastatina HCS 10 mg film-coated tablets are yellow-brown, round, slightly biconvex film-coated tablets with bevelled edges, marked with the number 10 on one side (diameter: 8 mm).
Rosuvastatina HCS 15 mg film-coated tablets are pink, round, biconvex film-coated tablets with bevelled edges, marked with the number 15 on one side (diameter: 9 mm).
Rosuvastatina HCS 20 mg film-coated tablets are white or almost white, round, slightly biconvex film-coated tablets with bevelled edges, marked with the number 20 on one side (diameter: 10 mm).
Rosuvastatina HCS 30 mg film-coated tablets are white or almost white, capsule-shaped, biconvex film-coated tablets, marked with the number 30 on one side (dimensions: 15 mm x 8 mm).
Rosuvastatina HCS 40 mg film-coated tablets are yellow-brown, capsule-shaped, biconvex film-coated tablets, marked with the number 40 on one side (dimensions: 16 mm x 9 mm).
Rosuvastatina HCS is available in boxes containing 28 film-coated tablets in blister packs.
Rosuvastatina HCS is available in boxes containing 28 x 1 film-coated tablets in perforated single-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H. Kennisstraat 53 B 2650 Edegem, Belgium

Local representative in Italy
Krka Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5 – 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
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This leaflet was last reviewed on: 08/2017
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