Suvardio

Leaflet attached to the packaging: patient information

Suvardio, 5 mg, film-coated tablets

Suvardio, 10 mg, film-coated tablets

Suvardio, 20 mg, film-coated tablets

Suvardio, 40 mg, film-coated tablets

Rosuvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Suvardio and what is it used for
• 2. Important information before taking Suvardio
• 3. How to take Suvardio
• 4. Possible side effects
• 5. How to store Suvardio
• 6. Package contents and other information

1. What is Suvardio and what is it used for

Suvardio belongs to a group of medicines called statins (HMG-CoA reductase inhibitors).
The doctor has prescribed Suvardio to the patient because:

• The patient has high blood cholesterol levels. This means that they are at risk of heart attackor stroke. Suvardio is used to treat high cholesterol in adults, adolescents, and children aged 6 years or older.

The doctor has recommended taking a statin because changing the diet and increasing physical activity
has not been enough to make the patient's blood cholesterol levels normal. While taking Suvardio, the patient should continue to follow a low-cholesterol diet and exercise regularly.
Or

• The patient has other factors that increase the risk of heart attack, stroke, or related health problems.

Heart attack, stroke, and other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of lipid deposits in the arteries.

Why is taking Suvardio so important?

Suvardio is used to balance the levels of fats in the blood (lipids), most of which are cholesterol.
There are different types of cholesterol in the blood - so-called "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) and so-called "good" cholesterol (high-density lipoprotein cholesterol or HDL-C).
Suvardio can lower the level of "bad" cholesterol and increase the level of "good" cholesterol.
The medicine helps reduce the production of "bad" cholesterol in the body and improves the body's ability to remove it from the blood.
High cholesterol is symptom-free and does not affect the well-being of most people.
However, if left untreated, it can cause lipids to accumulate in the walls of blood vessels, leading to their narrowing. As a result of the narrowing, it is possible for the blood vessel to become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. Correcting blood cholesterol levels can reduce the risk of a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, and similar health problems can be reduced.
Suvardio must be taken continuously, even if cholesterol levels return to normal, because it prevents the cholesterol level from rising againand the accumulation of lipid deposits in the blood vessels. However, the medicine should be discontinued if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Suvardio

When not to take Suvardio

if the patient is allergic to rosuvastatinor any of the other ingredients of this medicine (listed in section 6).
if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Suvardio, they should stop taking the medicine immediatelyand inform their doctor.
During treatment with Suvardio, the patient should avoid becoming pregnant by using effective contraception methods.
if the patient has liver disease.
if the patient has severe kidney disease.
if the patient experiences recurring or unexplained muscle pain(myopathy).
if the patient is taking sofosbuvir with velpatasvir and voxilaprevir(used to treat viral hepatitis C infection).
if the patient is taking cyclosporin(a medicine used, for example, after organ transplantation).
If any of the above information applies to the patient (or if the patient has doubts), they should consult their doctor again.

In addition, Suvardio should not be taken at a dose of 40 mg (the highest) if:

the patient has experienced recurring or unexplained muscle pain(myopathy) in the past, or if muscle disorders have occurred in the patient or their family members, or if previous muscle problems were related to taking other cholesterol-lowering medicines.
the patient has moderate kidney function impairment(in case of doubt, the patient should ask their doctor).
the patient has abnormal thyroid function.
the patient regularly consumes large amounts of alcohol.
the patient is taking other medicines (fibrates)to lower cholesterol levels.
the patient is of Asian origin(is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If any of the above information applies to the patient (or if the patient has doubts), they should consult their doctor again.

Warnings and precautions

The patient should discuss this with their doctor or pharmacist if:
they have kidney function impairment;
they have liver function impairment;
they have severe respiratory failure;
they have experienced recurring or unexplained muscle pain(myopathy) in the past, or if muscle disorders have occurred in the patient or their family members, or if previous muscle problems were related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially with a feeling of being unwell or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about persistent muscle weakness.
the patient has or has had myasthenia(a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
the patient has or has had a severe skin rash or skin peeling and blisters and (or) ulcers in the mouth
after taking rosuvastatin or other similar medicines.
the patient regularly consumes large amounts of alcohol;
the patient has abnormal thyroid function;
the patient is taking other medicines (fibrates)to lower cholesterol levels. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before.
the patient is taking HIV treatment medicines(e.g., ritonavir with lopinavir, atazanavir, and (or) tipranavir), see "Suvardio and other medicines";
the patient is taking or has taken within the last 7 days, orally or by injection, a medicine called
fusidic acid(used to treat bacterial infections). Taking fusidic acid and rosuvastatin at the same time can lead to serious muscle disorders (rhabdomyolysis), see "Suvardio and other medicines".
the patient is over 70 years old(as the doctor will need to choose an appropriate starting dose of Suvardio for them);
the patient is of Asian origin(is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. The doctor will need to choose an appropriate starting dose of Suvardio for them).

Children and adolescents

If the patient is under 6 years old:Suvardio should not be given to children under 6 years old.If the patient is under 18 years old: Suvardio 40 mg tablets should not be used in children and adolescents under 18 years old.
If any of the above situations apply to the patient (or if the patient is unsure):
do not take Suvardio at the highest strength (40 mg) and consult a doctor or pharmacist before starting treatment with Suvardio at any strength.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If the patient experiences any of the symptoms described in section 4, they should stop taking Suvardio and contact their doctor immediately.
A small number of patients taking statins may experience liver function impairment. This can be detected by a simple blood test to check for increased liver enzyme activity. For this reason, the doctor usually orders such tests before and during treatment with Suvardio.
During treatment with this medicine, the doctor will closely monitor the condition of patients with diabetes or at risk of developing diabetes. The risk of developing diabetes is more likely in people with high blood sugar and fat levels, who are overweight, and have high blood pressure.

Suvardio and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor if they are taking any of the following medicines:
cyclosporin(used, for example, after organ transplantation)
warfarin, ticagrelor, or clopidogrelor other anticoagulant medicines
fibrates and other lipid-lowering medicines(such as gemfibrozil, fenofibrate)
any medicines used to lower cholesterol levels(such as ezetimibe)
medicines used to treat indigestion(used to neutralize stomach acid)
erythromycin(an antibiotic), fusidic acid (an antibiotic - see below and "Warnings and precautions")
oral contraceptives(birth control pills) or hormone replacement therapy
regorafenib(used to treat cancer)
darolutamide(a medicine used to treat cancer)
camptothecin(used to treat cancer),
fostamatinib(used to treat low platelet count)
febuxostat(used to treat and prevent high uric acid levels in the blood)
teriflunomide(used to treat multiple sclerosis)
any of the following medicines used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
Suvardio may affect the way these medicines work, or these medicines may affect the way Suvardio works.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to stop taking Suvardio temporarily. The doctor will tell them when it is safe to restart Suvardio

Taking Suvardio and fusidic acid at the same time can rarely cause muscle weakness, muscle tenderness, or muscle pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Suvardio with food and drink

Suvardio can be taken with or without food.

Pregnancy and breastfeeding

Suvardio should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Suvardio, they should stop taking the medicine immediatelyand inform their doctor.
During treatment with Suvardio, the patient should avoid becoming pregnant by using effective contraception methods.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Suvardio, as it does not affect their ability to perform these activities. However, some patients may experience dizziness while taking Suvardio, so they should consult their doctor before driving or using machines.

Suvardio contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".
A full list of excipients can be found in the section: Package contents and other information.

3. How to take Suvardio

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Usual doses for adults

Taking Suvardio to lower cholesterol levels

Starting dose

Treatment starts with a dose of 5 mg or 10 mg, even if the patient has taken a higher dose of another statin before. The choice of starting dose will depend on:

• cholesterol levels,
• the patient's risk of heart attack or stroke,
• the presence of factors that may increase the risk of side effects in the patient.

The patient should consult their doctor or pharmacist about the most suitable starting dose of Suvardio.
The doctor may recommend that the patient take the lowest dose (5 mg) if:

• the patient is of Asian origin (is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderate kidney function impairment,
• the patient is at risk of muscle pain (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose of Suvardio so that the patient receives the most suitable dose. If the starting dose is 5 mg, the doctor may decide to double it to 10 mg, then to 20 mg, and if necessary, to 40 mg. If the starting dose is 10 mg, the doctor may decide to double it to 20 mg and if necessary to 40 mg. Dose changes are made every 4 weeks.
The maximum dose of Suvardio is 40 mg. It is intended only for patients with high cholesterol levels and a high risk of heart attack or stroke, for whom the 20 mg dose did not sufficiently lower cholesterol levels.

Taking Suvardio to reduce the risk of heart attack, stroke, or related health problems

The recommended dose is 20 mg per day. However, the doctor may recommend a lower dose for patients who have any of the above risk factors.

Taking Suvardio in children and adolescents aged 6 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The starting dose is usually 5 mg per day, and the doctor may gradually increase it to determine the most suitable dose of Suvardio for the patient. The maximum daily dose of Suvardio is 10 mg or 20 mg for children aged 6 to 17 years, depending on the disease being treated. The prescribed dose should be taken once daily. Suvardio 40 mg tablets should not be usedin children.

How to take the medicine

The tablets should be swallowed whole with water.
Suvardio should be taken once a day, at any time of day, with or without food.
The patient should try to take the tablets at the same time every day to help them remember to take the medicine.

Regular cholesterol level checks

It is essential to visit the doctor for regular cholesterol level checks and to ensure that the target level has been achieved and maintained.
The doctor may decide to increase the dose of Suvardio to achieve the most suitable dose for the patient.

Taking a higher dose of Suvardio than recommended

The patient should contact their doctor or the nearest hospital for advice.
If the patient goes to the hospital or is treated for another reason, they should inform the medical staff that they are taking Suvardio.

Missing a dose of Suvardio

If a dose is missed, the patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping Suvardio treatment

The patient should inform their doctor if they want to stop taking Suvardio. If Suvardio is stopped, cholesterol levels may rise again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Suvardio can cause side effects, although not everybody gets them.
It is essential for the patient to know what side effects may be associated with taking Suvardio.
These effects are usually mild and go away on their own.
If the patient experiences any of the following allergic reactions, they should stop taking Suvardio and seek medical help immediately:
difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without swelling;
swelling of the face, lips, tongue, and (or) throat, which may make swallowing difficult;
severe itching of the skin (with raised lumps);
red, flat, round patches on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome).

Suvardio treatment should also be stopped and medical help sought immediately if the patient experiences:

persistent, unexplained muscle pain.Muscle symptoms occur more frequently in children and adolescents than in adults. As with other statins, very rare cases of unpleasant muscle symptoms have been reported, which can progress to life-threatening muscle damage, known as rhabdomyolysis;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
muscle rupture.
Common side effects(may affect up to 1 in 10 people)
headache
dizziness
constipation
nausea
stomach pain
muscle pain
feeling weak
increased protein in the urine, which usually goes away on its own without the need to stop taking Suvardio tablets (only 40 mg)
diabetes - this is more likely in patients with high blood sugar and fat levels, who are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking Suvardio.
Uncommon side effects(may affect up to 1 in 100 people)
rash, itching, or other skin reactions
increased protein in the urine, which usually goes away on its own without the need to stop taking Suvardio tablets (5 mg, 10 mg, and 20 mg)
Rare side effects(may affect up to 1 in 1,000 people)
severe allergic reaction - with symptoms such as swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). If the patient suspects they have had an allergic reaction, they should stop taking Suvardioand seek medical help immediately
muscle damage in adults - as a precaution, the patient should stop taking Suvardio and seek medical help immediately if they experience persistent, unexplained muscle pain
severe stomach pain (pancreatitis)
increased liver enzyme activity in the blood
abnormal bruising and bleeding due to a low platelet count
symptoms of lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
Very rare side effects(may affect up to 1 in 10,000 people)
jaundice (yellowing of the skin and eyes)
liver inflammation
trace amounts of blood in the urine
nerve damage in the arms and legs (e.g., numbness)
joint pain
memory loss
breast enlargement in men (gynecomastia)
Side effects with unknown frequency(frequency cannot be estimated from available data):
diarrhea (loose stools)
cough
shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual disorders
depression
breathing difficulties, including persistent cough and (or) shortness of breath or fever
tendon disorders, sometimes complicated by rupture
persistent muscle weakness
myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
ocular myasthenia (a disease that causes muscle weakness in the eyes).
The patient should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Suvardio

The medicine should be kept out of sight and reach of children.
Suvardio should not be taken after the expiry date stated on the carton, label, and blister after "EXP". The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging to protect it from moisture.
The shelf life after opening the HDPE bottle is 100 days.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Suvardio contains

The active substance of Suvardio is rosuvastatin.
Each film-coated tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin in the form of rosuvastatin calcium.
The other ingredients are: lactose, anhydrous colloidal silica, microcrystalline cellulose, cornstarch, talc, sodium stearyl fumarate.
Coating: hypromellose, mannitol, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.

What Suvardio looks like and contents of the pack

5 mg tablets: brown, round, film-coated tablets.
10 mg tablets: brown, round, film-coated tablets with the symbol "RSV 10" embossed on one side.
20 mg tablets: brown, round, film-coated tablets with the symbol "RSV 20" embossed on one side.
40 mg tablets: brown, round, film-coated tablets with the symbol "RSV 40" embossed on one side.
The film-coated tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil or in HDPE bottles with a PP cap and a desiccant, and placed in a cardboard box.
Package sizes:
Blisters: 28, 30, 56, 60, 84, and 100 film-coated tablets.
Bottles: 30 and 100 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków

For more information about Suvardio and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:05/2025
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