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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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. Contents of the pack 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).
Your doctor has prescribed Suvardio for you because:

• You have high blood cholesterol levels. This means you are at risk of having a heart attackor stroke. Suvardio is used to treat high cholesterol in adults, adolescents, and children aged 6 years or older.

Your doctor has recommended taking a statin because changing your diet and increasing the amount of
physical exercise has not been enough to make your blood cholesterol levels normal. While taking Suvardio, you should continue to follow a low-cholesterol diet and exercise regularly.
Or

• You have other factors that increase your risk of having a heart attack, stroke, or related health problems.

Heart attacks, strokes, 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 (lipids) in the blood, 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 levels are symptom-free and do 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, you can reduce the risk of having a heart attack, stroke, and related health problems.
Suvardio must be taken continuously, even if your cholesterol levels return to normal, because it prevents the cholesterol levels from rising againand the buildup of lipid deposits in the blood vessels. However, the medicine should be stopped if your doctor advises you to do so or if you become pregnant.

2. Important information before taking Suvardio

When not to take Suvardio

if you are allergic to rosuvastatinor any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding. If you become pregnant while taking Suvardio, you should stop taking the medicine immediatelyand inform your doctor.
While taking Suvardio, you should avoid becoming pregnant, using effective methods of contraception.
if you have liver disease.
if you have severe kidney disease.
if you experience recurring or unexplained muscle pain(myopathy).
if you are taking sofosbuvir/velpatasvir(used to treat viral hepatitis C infection).
if you are taking cyclosporin(a medicine used, for example, after organ transplantation).
If any of the above applies to you (or you are unsure), you should consult your doctor again.

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

you have experienced recurring or unexplained muscle pain(myopathy) in the past, or if you or your family members have had muscle disorders, or if your previous muscle problems were related to taking other cholesterol-lowering medicines.
you have moderate kidney problems(if in doubt, ask your doctor).
you have abnormal thyroid function.
you regularly drink large amounts of alcohol.
you are taking other medicines (fibrates)to lower cholesterol levels.
you are of Asian origin(you are Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If any of the above applies to you (or you are unsure), you should consult your doctor again.

Warnings and precautions

You should discuss this with your doctor or pharmacist if:
you have kidney problems;
you have liver problems;
you have severe respiratory failure;
you have experienced recurring or unexplained muscle pain(myopathy) in the past, or if you or your family members have had muscle disorders, or if your previous muscle problems were related to taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if accompanied by a feeling of illness or fever, you should immediately consult your doctor. You should also inform your doctor or pharmacist about persistent muscle weakness.
you have or have 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 symptoms of the disease or lead to the development of myasthenia (see section 4).
you have or have had a severe skin rash or skin peelingand blistering or ulcers in the mouthafter taking rosuvastatin or similar medicines.
you regularly drink large amounts of alcohol;
you have abnormal thyroid function;
you are taking other medicines (fibrates)to lower cholesterol levels. You should read the leaflet carefully, even if you have taken other cholesterol-lowering medicines before.
you are taking HIV medicines(e.g., ritonavir with lopinavir, atazanavir, and/or tipranavir), see "Suvardio and other medicines";
you are taking or have 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 problems (rhabdomyolysis), see "Suvardio and other medicines".
you are over 70 years old(as your doctor will need to choose a suitable starting dose of Suvardio for you);
you are of Asian origin(you are Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor will need to choose a suitable starting dose of Suvardio for you).

Children and adolescents

If you are under 6 years old:Suvardio should not be given to children under 6 years old.If you are 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 applies to you (or you are unsure):
do not take Suvardio at the highest dose (40 mg) and consult your doctor or pharmacist before starting treatment with Suvardio at any dose.
There have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), with rosuvastatin. If you experience any of the symptoms described in section 4, you should stop taking Suvardio and contact your doctor immediately.
In rare cases, statins may affect liver function. This can be detected by a simple blood test to check for increased liver enzyme activity. For this reason, your doctor will usually order such tests before and during treatment with Suvardio.
While taking this medicine, your doctor will carefully monitor your condition if you have diabetes or are at risk of developing it. The risk of developing diabetes is more likely in people with high blood sugar and lipid levels, who are overweight, and have high blood pressure.

Suvardio and other medicines

You should tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You should tell your doctor if you 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 also "Warnings and precautions" and section "Suvardio and other medicines")
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 you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking Suvardio temporarily. Your doctor will tell you 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 you become pregnant while taking Suvardio, you should stop taking the medicine immediatelyand inform your doctor.
While taking Suvardio, you should avoid becoming pregnant, using effective methods of contraception.
Before taking any medicine, you should consult your 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 in such cases, you should consult your doctor before driving or operating machinery.

Suvardio contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".
A full list of excipients is found in the section: Contents of the pack and other information.

3. How to take Suvardio

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist.

Doses usually used in adults

Taking Suvardio to lower cholesterol levels

Starting dose

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

• cholesterol levels,
• the risk of heart attack or stroke for you,
• the presence of factors that may increase the risk of side effects.

You should consult your doctor or pharmacist about the most suitable starting dose of Suvardio.
Your doctor may recommend that you take the lowest dose (5 mg) if:

• you are of Asian origin (you are Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are over 70 years old,
• you have moderate kidney problems,
• you are at risk of muscle pain (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase the dose of Suvardio so that you receive the most suitable dose of Suvardio. If the starting dose was 5 mg, your doctor may decide to double it to 10 mg, then to 20 mg, and if necessary, to 40 mg. If the starting dose was 10 mg, your 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 once daily. However, your doctor may recommend a lower dose if you 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 once daily, and your doctor may gradually increase it to find the most suitable dose of Suvardio for you. The maximum daily dose of Suvardio is 10 mg or 20 mg for children aged 6 to 17 years, depending on the type of disease being treated. The prescribed dose is taken once daily. Suvardio 40 mg tablets should not be usedin children.

How to take the medicine

Tablets should be swallowed whole with water.
Suvardio should be taken once daily, at any time of day, with or without food.
You should try to take your tablets at the same time every day to help you remember to take your medicine.

Regular monitoring of cholesterol levels

It is important to visit your doctor regularly to check your cholesterol levels and make sure you have achieved and maintained a normal level.
Your doctor may decide to increase the dose of Suvardio to achieve the most suitable dose for you.

Taking more Suvardio than prescribed

You should contact your doctor or the nearest hospital for advice.
If you go to the hospital or are treated for another reason, you should tell the medical staff that you are taking Suvardio.

Missing a dose of Suvardio

If you miss a dose, you should take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Suvardio treatment

You should inform your doctor if you want to stop taking Suvardio. If you stop taking Suvardio, your cholesterol levels may rise again.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Suvardio can cause side effects, although not everybody gets them.
It is important that you know what side effects may occur with Suvardio.
These effects are usually mild and go away on their own.
If you experience any of the following allergic reactions, you 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 skin itching (with raised lumps);
red, flat, round, or oval patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome).

You should also stop taking Suvardio and consult your doctor immediately if you experience:

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, sometimes progressing to life-threatening muscle damage, known as rhabdomyolysis, have been reported;
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 - is more likely in patients with high blood sugar and lipid levels, who are overweight, and have high blood pressure. Your doctor will monitor your 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 (only 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 skin itching (with raised lumps). If you suspect that you have had an allergic reaction, you should stop taking Suvardioand seek medical help immediately
muscle damage in adults - as a precaution, you should stop taking Suvardio and seek medical help immediately if you experience persistent, unexplained muscle pain
severe abdominal pain (pancreatitis)
increased liver enzyme activity in the blood
abnormal bruising or 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
gynecomastia (breast enlargement in men)
Side effects with unknown frequency(frequency cannot be estimated from the 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).
You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 to gather more information on the safety of this medicine.

5. How to store Suvardio

The medicine should be kept out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton, label, and on the blister after "EXP". The expiry date refers to the last day of the month.
Store in the original package to protect from moisture.
The shelf life after first opening the HDPE bottle is 100 days.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Suvardio contains

The active substance 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, maize starch, 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 packed 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.
Pack 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
tel. 22 209 70 00
Date of last revision of the leaflet:05/2025
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