Suvardio

Package leaflet: information for the patient

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
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Suvardio is and what it is 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 Suvardio is and what it is used for

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

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

Your doctor has recommended a statin because changes in diet and increased physical activity have not been sufficient to normalize your blood cholesterol levels. While taking Suvardio, you should continue to follow a cholesterol-lowering diet and maintain physical activity.
Or

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

Heart attack, stroke, and other health problems may be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits (plaques) in the arteries.
Why is taking Suvardio so important?
Suvardio is used to correct levels of fats (lipids) in the blood, the most important of which is cholesterol.
There are different types of cholesterol in the blood – so-called “bad” cholesterol (low-density lipoprotein cholesterol or LDL-C) and “good” cholesterol (high-density lipoprotein cholesterol or HDL-C).
Suvardio can reduce levels of “bad” cholesterol and increase levels 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 usually cause no symptoms and do not affect how most people feel.
However, if left untreated, lipids can accumulate in the walls of blood vessels, causing them to narrow. This narrowing may eventually block blood flow to the heart or brain, leading to heart attack or stroke. Correcting blood cholesterol levels can reduce the risk of 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 cholesterol levels from rising again and stops further buildup of fatty deposits in blood vessels. However, the medicine should be discontinued if your doctor advises so, or if you become pregnant.

2. Important information before using Suvardio

When not to use Suvardio
if the patient is allergic to roxithromycin or to any of the other ingredients of this
medicine (listed in section 6).
if the patient is pregnant or breastfeeding. If the patient becomes pregnant during treatment
with Suvardio, she should immediately stop taking it and inform her doctor.
While being treated with Suvardio, pregnancy should be avoided by using effective contraceptive
methods.
if the patient has been diagnosed with liver disease.
if the patient has been diagnosed with severe kidney disease.
if the patient experiences recurrent or unexplained muscle pain (myopathy).
if the patient is taking a combination of sofosbuvir with velpatasvir and voxilaprevir
(used in the treatment of viral liver infection known as hepatitis C).
if the patient is receiving cyclosporine (a medicine used, for example, after organ transplantation).
If any of the above applies to the patient (or if the patient has any doubts), the patient should
consult a doctor again.
Additionally, Suvardio must not be used at the 40 mg dose (the highest dose) if:
the patient has previously experienced recurrent or unexplained muscle pain (myopathy),
previously had muscle disorders (either personally or in family members), or previously had
muscle-related problems while taking other cholesterol-lowering medicines.
the patient has been diagnosed with moderate kidney dysfunction (in case of doubt, ask the doctor).
the patient has abnormal thyroid function.
the patient regularly consumes large amounts of alcohol.
the patient is taking other medicines (so-called fibrates) to reduce cholesterol levels.
the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If any of the above applies to the patient (or if the patient has any doubts), the patient should
consult a doctor again.
Warnings and precautions
Please discuss with your doctor or pharmacist if:
the patient has kidney dysfunction;
the patient has liver dysfunction;
the patient has severe respiratory insufficiency;
the patient has experienced recurrent or unexplained muscle pain (myopathy), previously had
muscle disorders (either personally or in family members), or previously had muscle-related
problems while taking other cholesterol-lowering medicines. In case of unexplained muscle pain,
especially if associated with malaise or fever, the patient should immediately consult a doctor. The
doctor or pharmacist should also be informed about persistent muscle weakness.
the patient has had or currently has myasthenia gravis (a disease causing general muscle
weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease
causing weakness of eye muscles), because statins may sometimes worsen symptoms of the
disease or lead to the development of myasthenia (see section 4).
the patient has ever experienced a severe skin rash or skin peeling, blisters and (or) oral ulcers
after taking roxithromycin or other similar medicines.
the patient regularly consumes large amounts of alcohol;
the patient has abnormal thyroid function;
the patient is taking other medicines (so-called fibrates) to reduce cholesterol levels. The patient
should read the leaflet carefully, even if previously used other cholesterol-lowering medicines.
the patient is receiving medicines used in the treatment of HIV infection (e.g. ritonavir with
lopinavir, atazanavir and (or) tipranavir), see section “Suvardio and other medicines”;
the patient is receiving or has received within the last 7 days, orally or by injection, a medicine
called fusidic acid (used in the treatment of bacterial infections). Concurrent use of fusidic acid
and roxithromycin may lead to serious muscle disorders (rhabdomyolysis), see section “Suvardio
and other medicines”.
the patient is over 70 years old (because the doctor will need to choose an appropriate
starting dose of Suvardio);
the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The
doctor will need to choose an appropriate starting dose of Suvardio.
Children and adolescents
If the patient is under 6 years of age: Suvardio should not be given to children under 6 years
If the patient is under 18 years of age: Suvardio 40 mg tablets should not be used in children
and adolescents under 18 years of age.
If any of the above situations apply to the patient (or if the patient is uncertain):
do not use Suvardio at the highest strength (40 mg) and consult a doctor or pharmacist before
starting treatment with any strength of Suvardio.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and
systemic symptoms (DRESS), have been reported with the use of roxithromycin. If any of the
symptoms described in section 4 occur, treatment with Suvardio should be stopped immediately and
the doctor contacted without delay.
In a small number of patients, statins may affect liver function. This is detected by a simple blood
test measuring increased liver enzyme activity. Therefore, the doctor usually orders such tests before
and during treatment with Suvardio.
While taking this medicine, the doctor will closely monitor patients with diabetes or risk factors for
developing diabetes. The risk of developing diabetes is higher in people with high blood sugar and
fat levels, overweight, and high blood pressure.
Suvardio and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the
patient plans to take.
Tell your doctor if taking any of the following medicines:
cyclosporine (used, for example, after organ transplantation)
warfarin, ticagrelor or clopidogrel or other anticoagulant medicines
fibrates and other lipid-lowering medicines (such as gemfibrozil, fenofibrate)
any medicines used to reduce cholesterol levels (such as ezetimibe)
medicines used to treat indigestion (used to neutralize stomach hydrochloric acid)
erythromycin (an antibiotic), fusidic acid (an antibiotic – see below and section “Warnings and
precautions”)
oral contraceptives (birth control pills) or medicines used in hormone replacement therapy
regorafenib (used in cancer treatment)
darolutamide (a medicine used in cancer treatment)
copanlisib (used in cancer treatment)
fostamatinib (used in the treatment of low platelet count)
febuxostat (used in the treatment and prevention of high blood uric acid levels)
teriflunomide (used in the treatment of multiple sclerosis)
any of the following medicines used in the treatment of viral infections, including HIV or
hepatitis C virus, administered alone or in combination with other medicines (see “Warnings and
precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir,
dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
Suvardio may alter the effect of these medicines, or these medicines may alter the effect of Suvardio.
If the patient needs to take fusidic acid orally for the treatment of a bacterial infection,
temporary discontinuation of Suvardio will be necessary. The doctor will inform when it is safe
to restart Suvardio.
Concomitant use of Suvardio and fusidic acid may rarely cause muscle weakness, tenderness or
pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4.
Suvardio with food and drink
Suvardio can be taken regardless of meals.
Pregnancy and breastfeeding
Suvardio must not be used during pregnancy or breastfeeding. If the patient becomes pregnant
during treatment with Suvardio, she should immediately stop taking the medicine and inform her
doctor. While taking Suvardio, pregnancy should be avoided by using effective methods of
contraception.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Most people can drive and operate machinery while taking Suvardio, as it does not affect the ability
to perform these activities. However, dizziness may occur in some patients during Suvardio treatment;
in such cases, consult a doctor before driving or operating machinery.
Suvardio contains lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine
is considered “sodium-free”.
A full list of excipients is provided in section: Contents of the pack and other information.

3. How to use Suvardio

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Usual doses for adults

Use of Suvardio to lower cholesterol levels

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

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

Consult your doctor or pharmacist regarding the most appropriate starting dose of Suvardio.

Your doctor may recommend the lowest dose (5 mg) if:

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

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose of the medicine to achieve the most appropriate dose of Suvardio for the patient. If the starting dose is 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 is 10 mg, your doctor may double it to 20 mg and, if necessary, to 40 mg. Dose adjustments should be made at intervals of 4 weeks.

The maximum dose of Suvardio is 40 mg. This dose is intended only for patients with high cholesterol levels and high risk of heart attack or stroke in whom cholesterol levels have not been sufficiently reduced with a 20 mg dose.

Use of Suvardio to reduce the risk of heart attack, stroke, or related health problems
The recommended dose is 20 mg once daily. However, for patients with any of the risk factors listed above, your doctor may recommend a lower dose.

Use 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 usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose to determine the optimal dose of Suvardio for the patient. The maximum daily dose of Suvardio is 10 mg or 20 mg for children and adolescents aged 6 to 17 years, depending on the condition being treated. The prescribed dose should be taken once daily. Tablets of Suvardio 40 mg should not be used in 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.
Try to take the tablets at the same time each day to help remember your dose.

Regular monitoring of cholesterol levels
It is important to attend regular check-ups with your doctor to monitor cholesterol levels and ensure that target levels have been achieved and maintained.

Your doctor may decide to increase the dose of Suvardio to achieve the dose appropriate for the patient.

Taking more Suvardio than prescribed
Contact your doctor or the nearest hospital for advice immediately.

If you go to the hospital or are treated for another reason, inform the medical staff that you are taking Suvardio.

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

Stopping Suvardio
Inform your doctor if you intend to stop taking Suvardio. If Suvardio is discontinued, cholesterol levels may rise again.

If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of the adverse reactions that may occur with the use of this medicine.
These reactions are usually mild and resolve within a short time.
If the patient experiences any of the following allergic reactions, treatment with Suvardio must be stopped and immediate medical help must be sought:
difficulty breathing with swelling of the face, lips, tongue, and (or) throat 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, disc-shaped or round spots on the trunk, often with blisters in the center,
peeling of the skin, mouth ulcers, throat, nose, genital organs
and around the eyes. The occurrence of such serious skin rashes may be preceded by fever
and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or
drug hypersensitivity syndrome).
Treatment with Suvardio must also be stopped and immediate medical advice must be sought if the patient experiences:
persistent, unexplained muscle pain. Muscle symptoms occur more frequently in children
and adolescents than in adults. As with other statins, a very small number of
patients have experienced unpleasant muscle-related symptoms, rarely progressing to
life-threatening muscle damage known as rhabdomyolysis;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
muscle rupture.
Common adverse reactions (may occur in up to 1 in 10 people)
headache
dizziness
constipation
nausea
stomach pain
muscle pain
feeling of weakness
increased protein in urine, which usually resolves spontaneously without the need to discontinue
Suvardio tablets (only 40 mg strength)
diabetes – more likely in patients with high levels of sugar and fats in the blood,
with overweight and high blood pressure. The doctor will monitor the patient's condition during
treatment with Suvardio.
Uncommon adverse reactions (may occur in up to 1 in 100 people)
rash, itching, or other skin reactions
increased protein in urine, which usually resolves spontaneously without the need to discontinue
Suvardio tablets (only 5 mg, 10 mg, and 20 mg strengths)
Rare adverse reactions (may occur in 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 the patient
suspects an allergic reaction has occurred, they must stop taking Suvardio and
seek immediate medical help
muscle damage in adults – as a precaution, treatment with Suvardio must be stopped
and immediate medical advice must be sought if the patient experiences persistent,
unexplained muscle pain
severe abdominal pain (pancreatitis)
increased liver enzyme activity in blood
abnormal bruising and bleeding due to low platelet count
symptoms of lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
Very rare adverse reactions (may occur in up to 1 in 10,000 people)
jaundice (yellowing of the skin and eyes)
hepatitis
trace amounts of blood in urine
nerve damage in arms and legs (e.g. numbness)
joint pain
memory loss
gynaecomastia (enlargement of breasts in men)
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
diarrhoea (loose stools)
cough
shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual dysfunction
depression
respiratory disorders, including persistent cough and (or) shortness of breath or fever
tendon disorders, sometimes complicated by rupture
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 speak to their doctor if they experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Suvardio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, and blister pack following "EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
The shelf life after first opening the HDPE bottle is 100 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Suvardio contains
The active substance is rosuvastatin.
Each 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,
corn 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 coated tablets.
10 mg tablets: brown, round coated tablets with the imprint “RSV 10” on one side.
20 mg tablets: brown, round coated tablets with the imprint “RSV 20” on one side.
40 mg tablets: brown, round coated tablets with the imprint “RSV 40” on one side.
The coated tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium or in HDPE bottles with a PP screw cap and a desiccant, and placed in a cardboard box.

Pack sizes:
Blister packs: 28, 30, 56, 60, 84 and 100 coated tablets.
Bottles: 30 and 100 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
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 Warszawa, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland

For further information about this medicinal product and its names in the countries of the
European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel: 22 209 70 00