Crosuvo: detailed information

Package leaflet: Information for the patient

Crosuvo, 5 mg, coated tablets
Crosuvo, 10 mg, coated tablets
Crosuvo, 20 mg, coated tablets
Crosuvo, 40 mg, coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Crosuvo is and what it is used for
Important information before taking Crosuvo
How to take Crosuvo
Possible side effects
How to store Crosuvo
Contents of the pack and other information

1. What Crosuvo is and what it is used for

Crosuvo belongs to a group of medicines called statins.
Crosuvo is recommended because:

You have been diagnosed with high cholesterol levels. This indicates an increased risk of heart attack (myocardial infarction) or stroke. Crosuvo is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.
Your doctor has recommended a statin because changes in diet and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. While taking Crosuvo, you should also follow a cholesterol-lowering diet and engage in regular physical exercise.

Crosuvo may also be recommended if you have other risk factors that increase your likelihood of heart attack (myocardial infarction), stroke, or similar conditions.

Heart attack, stroke, and related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of fatty plaques in blood vessels.
Why it is important to take Crosuvo regularly
Crosuvo is used to achieve normal levels of blood lipids (fats). The most common lipid is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Crosuvo may reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
Crosuvo works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the bloodstream.

In most people, high cholesterol does not cause any noticeable symptoms or changes in well-being. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood flow to the heart or brain, resulting in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels return to normal after taking Crosuvo, you should continue treatment. This prevents cholesterol levels from rising again and further accumulation of fatty deposits.
You should stop taking Crosuvo if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Crosuvo

When not to use Crosuvo:

if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
if the patient is pregnant or breastfeeding. If a woman taking Crosuvo becomes pregnant, she should immediately stop taking the medicine and inform her doctor. Women taking Crosuvo should use effective methods of contraception.
if the patient has liver disease,
if the patient has severe kidney disease,
if the patient experiences frequent or unexplained muscle pain or discomfort,
if the patient is taking the combination sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection),
if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation),
if the patient has ever developed a severe skin rash, skin peeling, blisters and/or oral ulcers after taking Crosuvo or other medicines in the same group (other statins).

If any of the above situations apply to the patient, or if the patient has any doubts,
they should contact their doctor again.
Additionally, do not use Crosuvo 40 mg (the highest dose):

if the patient has moderate kidney disease (if in doubt, consult the doctor),
if the patient has thyroid disease,
if the patient experiences frequent or unexplained muscle pain or discomfort, if the patient or family members have a history of muscle disorders, or if muscle-related side effects occurred previously during treatment with lipid-lowering medicines,
if the patient regularly drinks large amounts of alcohol,
if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
if the patient is taking fibrates, i.e. other cholesterol-lowering medicines.

If any of the above situations apply to the patient (or if the patient has any doubts),
they should contact their doctor again.
Warnings and precautions
Before starting treatment with Crosuvo, discuss the following with your doctor or pharmacist:

if the patient has kidney disease,
if the patient has liver disease,
if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or family members have a history of muscle disorders, or if muscle-related side effects occurred previously during treatment with lipid-lowering medicines. The patient should contact their doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by general malaise or fever. The doctor should be informed if persistent muscle weakness occurs.
if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms or trigger the onset of myasthenia (see section 4),
if the patient regularly drinks large amounts of alcohol,
if the patient has thyroid disease,
if the patient is taking fibrates, i.e. other cholesterol-lowering medicines. Read the leaflet carefully, even if the patient has previously taken other cholesterol-lowering medicines.
if the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, refer to the section: "Crosuvo with other medicines",
if the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used to treat bacterial infections). Concomitant use of fusidic acid with Crosuvo may lead to severe muscle damage (rhabdomyolysis); see section "Crosuvo with other medicines".
if the patient is over 70 years of age (as the doctor must determine the appropriate starting dose of Crosuvo),
if the patient has severe respiratory insufficiency,
if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In such patients, the doctor will determine the appropriate starting dose of Crosuvo.

If any of the above situations apply to the patient (or if the patient has
doubts):
Do not take Crosuvo 40 mg (the highest dose), and before taking Crosuvo at any other dose,
consult your doctor or pharmacist.
A small number of patients may experience effects on liver function with statin medicines. To
confirm such effects, blood tests to check liver enzyme activity are performed. Usually, the doctor
will recommend checking liver enzyme activity in blood before starting and during treatment with
Crosuvo.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision
during treatment with this medicine. Patients with high blood sugar and lipid levels, overweight, and
high blood pressure may be at increased risk of developing diabetes.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and
systemic symptoms (DRESS), have been reported with the use of Crosuvo. If any of the symptoms
described in section 4 occur, stop taking Crosuvo and contact your doctor immediately.
Children and adolescents

if the patient is under 6 years of age: Crosuvo should not be used in children under 6 years of age.
if the patient is under 18 years of age: Crosuvo 40 mg is not suitable for use in children and adolescents under 18 years of age.

Crosuvo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or
plan to take.
Inform your doctor if you are taking:

cyclosporine (used, for example, after organ transplantation),
a fibrate (such as gemfibrozil, fenofibrate), or any other medicine that lowers blood cholesterol (e.g. ezetimibe),
medicines used for indigestion (used to neutralize stomach acid),
erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and section "Warnings and precautions"),
oral contraceptives,
regorafenib (used to treat cancer),
darolutamide (used to treat cancer),
capmatinib (used to treat cancer),
hormone replacement therapy,
fostamatinib (used to treat low platelet count),
febuxostat (used to treat and prevent high blood uric acid levels),
teriflunomide (used to treat multiple sclerosis),
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, used alone or in combination with other medicines (see: "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
roxadustat (used to treat anemia in patients with chronic kidney disease),
tafamidis (used to treat transthyretin amyloidosis),
anticoagulant medicines, e.g. warfarin, acenocoumarol or fluindione (their blood-thinning effect and risk of bleeding may be increased when used together with this medicine), ticagrelor or clopidogrel.

Crosuvo may alter the effect of these medicines, or these medicines may alter the effect of Crosuvo.
If the patient needs to take oral fusidic acid to treat a bacterial infection,
temporarily discontinue Crosuvo. The doctor will inform the patient when it is safe to
restart Crosuvo. Concomitant use of Crosuvo with fusidic acid may rarely lead to muscle
weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
Crosuvo with food and drink
Crosuvo can be taken with or without food.
Pregnancy, breastfeeding and fertility
Crosuvo must not be taken during pregnancy or breastfeeding. If a woman becomes pregnant while
taking Crosuvo, she should immediately stop taking the medicine and contact her doctor. While
taking Crosuvo, pregnancy should be avoided and effective contraception used.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Crosuvo - it will not impair their ability.
However, some patients may experience dizziness while taking Crosuvo. If the patient experiences
such symptoms, they should contact their doctor before driving or operating machinery.
Crosuvo contains monohydrate lactose and quinoline yellow (E 104)
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
Due to the presence of quinoline yellow (E 104), the medicine may cause allergic reactions.
A full list of excipients is provided in the section: "Contents of the pack and other information".

3. How to use Crosuvo

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Adults
Use of Crosuvo for lowering cholesterol levels
Starting dose
Treatment should be initiated with a dose of 5 mg or 10 mg, even if the patient has previously used higher doses of other statins. The choice of starting dose depends on:

cholesterol levels,
the patient's risk level for heart attack or stroke,
the presence of factors increasing susceptibility to adverse effects.

Ask your doctor which starting dose of Crosuvo is most appropriate for the patient.
Your doctor may decide to use a starting dose of 5 mg if:

the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India),
the patient is over 70 years of age,
the patient has moderate to severe kidney disease,
the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose as appropriate for the patient's needs. If the patient started treatment with 5 mg, the doctor may increase the dose to 10 mg, then to 20 mg or 40 mg, if necessary. If the patient started treatment with 10 mg, the doctor may increase the dose to 20 mg, then to 40 mg, if necessary. The treatment period at a given dose between each increase should be 4 weeks.
The maximum daily dose of Crosuvo is 40 mg. This dose is used in patients with high cholesterol levels and high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.
Use of Crosuvo to reduce the risk of heart attack, stroke, or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce the dose if the patient has any of the risk factors described above.
Use in children and adolescents aged 6–17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is typically 5 mg once daily, and the doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Crosuvo in children and adolescents aged 6 to 17 years is 10 mg or 20 mg, depending on the condition being treated.
The medicine should be taken once daily. The 40 mg dose of Crosuvo should not be used in children.
How to take the medicine
Swallow the tablet whole with water.
Crosuvo should be taken once daily at any time, with or without food.
It is recommended to take the medicine at the same time each day to help with remembering.
Cholesterol monitoring tests
To ensure cholesterol levels have decreased and remain within normal limits, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Crosuvo as appropriate for the patient.
Taking more than the recommended dose of Crosuvo
If you take more than the recommended dose of Crosuvo, contact your doctor or go to the nearest hospital immediately.
If the patient is admitted to a hospital or is being treated for another condition, they should inform the doctor or medical staff about taking Crosuvo.
Missed dose of Crosuvo
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping treatment with Crosuvo
Inform your doctor if the patient wishes to stop taking Crosuvo. Cholesterol levels may rise again if treatment with Crosuvo is discontinued.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
It is important for the patient to be aware of which adverse effects may occur. Usually, they are
mild and resolve shortly after starting treatment.
The use of Crosuvo must be stopped immediately and medical help must be sought if the
following allergic reactions occur:

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 lumps),
red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genital organs and around the eyes. Such potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The use of Crosuvo must be stopped and the doctor must be contacted immediately if the
following occur:

muscle pain or other muscle symptoms that persist longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a small number of patients have experienced adverse effects on muscles. Rarely, these patients developed potentially life-threatening muscle damage (rhabdomyolysis).
muscle rupture,
symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Adverse effects occurring frequently (in more than 1 in 100, but less than 1 in 10 patients):

Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
Increased protein in urine. This symptom usually resolves spontaneously and treatment does not need to be discontinued (applies only to the 40 mg dose).
Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Adverse effects occurring uncommonly (in more than 1 in 1,000, but less than 1 in 100
patients):

Rash, itching or other skin reactions.
Increased protein in urine. This symptom usually resolves spontaneously and treatment with Crosuvo does not need to be discontinued (applies only to the 5 mg, 10 mg and 20 mg doses).

Adverse effects occurring rarely (in more than 1 in 10,000, but less than 1 in 1,000
patients):

Severe allergic reactions - symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe skin itching (with lumps). If an allergic reaction is suspected, the use of Crosuvo must be stopped immediately and medical help must be sought.
Muscle damage in adults - caution should be exercised, i.e. stop using Crosuvo and contact the doctor immediately if muscle pain or other muscle symptoms persist longer than expected.
Severe abdominal pain (pancreatitis).
Increased liver enzyme levels in blood.
Increased tendency to bleeding or bruising due to low platelet count.
Symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Adverse effects occurring very rarely (in less than 1 in 10,000 patients):

Jaundice (yellowing of the skin and eyes), hepatitis, presence of blood in urine, damage to nerves in upper and lower limbs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Adverse effects occurring with unknown frequency (frequency cannot be determined from
available data):

Diarrhea (loose stools), cough, shallow breathing, swelling, sleep disorders (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and/or shallow breathing or fever), tendon damage, persistent muscle weakness.
Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
Ocular myasthenia (a disease causing weakness of eye muscles).

Patients should talk to their doctor if they experience weakness in the arms or legs, worsening after
periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Crosuvo

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of package damage.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Crosuvo contains

The active substance is rosuvastatin. Crosuvo film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
Other ingredients are:
Tablet core: microcrystalline cellulose, type 102, lactose monohydrate, spray-dried, crospovidone, type A, magnesium oxide, heavy, magnesium stearate.
Coating composition: OPADRY II 31K34257 Pink: lactose monohydrate, triacetin,
hypromellose, titanium dioxide (E 171), quinoline yellow, lacquer (E 104), iron oxide red (E 172).

What Crosuvo looks like and contents of the pack
The cardboard pack of Crosuvo contains 28, 30, 56 or 98 film-coated tablets in blisters.
Not all pack sizes may be available on the market.

Crosuvo, 5 mg, film-coated tablets: pink, round, biconvex tablets with embossed marking “5” on one side and “6” on the other.
Crosuvo, 10 mg, film-coated tablets: pink, round, biconvex tablets with embossed marking “10” on one side and “6” on the other.
Crosuvo, 20 mg, film-coated tablets: pink, round, biconvex tablets with embossed marking “20” on one side and “6” on the other.
Crosuvo, 40 mg, film-coated tablets: pink, round, biconvex tablets with embossed marking “40” on one side and “6” on the other.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów