Ridlip

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ridlip (Rosuvastatine SUN 10 mg), 10 mg, film-coated tablets

Rosuvastatinum
Ridlip and Rosuvastatine SUN 10 mg are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Ridlip and what is it used for

Ridlip belongs to a group of medicines called statins.

Ridlip is recommended for use because:

• The patient has been found to have high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Ridlip is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has prescribed a statin because diet changes and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood. The patient taking Ridlip should also follow a low-cholesterol diet and exercise regularly.

or

• Ridlip is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in blood vessels.

Why is it important to take Ridlip regularly

Ridlip is used to achieve normal levels of fatty substances in the blood. The most common of these is cholesterol.
There are different types of cholesterol in the blood, so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Ridlip may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Ridlip is based on the inhibition of "bad" cholesterol production in the body. It also helps to remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, fatty deposits accumulate in the walls of blood vessels and their narrowing.
Sometimes, the narrowed blood vessel may become blocked, disrupting blood flow to the heart or brain, and consequently leading to a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.

Even if the cholesterol level is normal after taking Ridlip, the patient should still

take it. This prevents the cholesterol level from increasing again, which causes the accumulation of fatty substances. The use of Ridlip should be discontinued if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Ridlip

When not to take Ridlip

• if the patient has been found to be hypersensitive (allergic) to rosuvastatinor any of the other ingredients of Ridlip,
• if the patient is pregnantor breastfeeding. If a woman taking Ridlip becomes pregnant, she should immediately stop taking it and inform her doctor. Women taking Ridlip 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 weakness,
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection),
• if the patient is taking cyclosporin(a medicine used, for example, after organ transplantation),
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after taking Ridlip or other similar medicines.

If any of the above situations apply to the patient or the patient has doubts, they should contact their doctor again.

In addition, Ridlip 40 mg (the highest dose) should not be taken:

• if the patient has moderately severe kidney disease(in case of doubt, the doctor should be consulted),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines,
• if the patient regularly consumes 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 the patient has doubts), they should contact their doctor again.

Warnings and precautions

Before starting to take Ridlip, the patient should consult their 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 weakness, or if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines. The patient should immediately contact their doctor if they experience muscle pain or weakness of unknown origin, especially if it is accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness.
• if the patient regularly consumes large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient is taking cholesterol-lowering medicines from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before,
• if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir, the patient should read the information in the section: Ridlip and other medicines,
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid(an antibiotic used to treat bacterial infections). Taking fusidic acid at the same time as Ridlip may lead to severe muscle damage (rhabdomyolysis); see the section Ridlip and other medicines,
• if the patient is over 70 years old(because the doctor must choose the appropriate initial dose of Ridlip for the patient),
• if the patient has severe respiratory failure,
• if the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate initial dose of Ridlip.

If any of the above situations apply to the patient (or the patient has doubts):

• The patient should not take Ridlip 40 mg (the highest dose) and before taking Ridlip in any other dose, they should consult their doctor or pharmacist.

Severe skin reactions have been reported in association with the use of rosuvastatin-containing medicines, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient notices any of the symptoms described in section 4, they should stop taking Ridlip and immediately contact their doctor.
A small number of patients taking statins may experience liver problems. To confirm this, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends a liver enzyme activity test before starting and during treatment with Ridlip.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

• if the patient is under 6 years old: Ridlip should not be used in children under 6 years old.
• if the patient is under 18 years old: Ridlip 40 mg is not suitable for use in children and adolescents under 18 years old.

Ridlip and other medicines

The patient should tell their doctor or pharmacist 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:

• cyclosporin (used, for example, after organ transplantation),
• blood thinners: e.g., warfarin, acenocoumarol, or fluindione (their blood-thinning effect and the risk of bleeding may be increased if taken at the same time as rosuvastatin) or clopidogrel,
• a fibrate (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine,
• medicines used to treat indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and the section "Warnings and precautions"),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, taken alone or in combination with other medicines (see the section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Ridlip may affect the action of these medicines or these medicines may affect the action of Ridlip.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Ridlip. The doctor will inform the patient when they can safely start taking Ridlip again. Taking Ridlip with fusidic acid can rarely lead to

muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

Ridlip should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Ridlip, they should immediately stop taking Ridlipand contact their doctor. While taking Ridlip, the patient should avoid becoming pregnant and use effective methods of contraception.
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 Ridlip - it will not affect their ability. However, some patients may experience dizziness while taking Ridlip. If this symptom occurs, the patient should contact their doctor before driving a car or operating machinery.

Ridlip contains lactose monohydrate

If the patient has been found to be intolerant to some sugars (lactose, i.e., milk sugar), they should inform their doctor before taking Ridlip.

Ridlip contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
A full list of excipients can be found in the section: Package contents and other information.

3. How to take Ridlip

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Ridlip is available in the following doses: 5 mg, 10 mg, 20 mg, 40 mg.

Adults

Taking Ridlip to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of other statins before. The size of the initial dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• the presence of factors that increase the patient's susceptibility to side effects. The patient should ask their doctor which initial dose of Ridlip is most suitable for them.

The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderately severe kidney disease,
• the patient is at risk of muscle diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose so that it is suitable for the patient's needs.
If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, and then to 20 mg or 40 mg if necessary. If the patient started treatment with a dose of 10 mg, the doctor may decide to increase it to 20 mg, and then to 40 mg if necessary.
The treatment period with a fixed dose between each dose increase is 4 weeks.
The maximum daily dose of Ridlip is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, for whom a dose of 20 mg was not sufficient to lower cholesterol levels.

Taking Ridlip to reduce the risk of heart attack or stroke or similar health problems

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors described above.

Taking Ridlip in children and adolescents aged 6-17 years

The dose range for children and adolescents aged 6-17 years is 5-20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Ridlip in children aged 6-17 years is 10 mg or 20 mg, depending on the disease being treated. The medicine should be taken once daily. Ridlip 40 mg should not be used in children.

Taking the medicine

The tablet should be swallowed whole, with a glass of water.
Ridlip should be taken once a dayat any time, with or without food.
It is recommended to take the medicine at the same time every day to make it easier to remember.

Cholesterol checks

To ensure that cholesterol levels have decreased and are normal, regular check-ups and blood tests should be performed.
The doctor may decide to increase the dose of Ridlip to suit the patient's needs.

Taking a higher dose of Ridlip than recommended

In case of taking a higher dose of Ridlip than recommended, the patient should contact their doctor or go to the nearest hospital.
If the patient is in the hospital or is being treated for another illness, they should inform their doctor or other medical staff that they are taking Ridlip.

Missing a dose of Ridlip

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 Ridlip

The patient should tell their doctor if they want to stop taking Ridlip. Cholesterol levels may increase again if Ridlip is stopped.
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, Ridlip can cause side effects, although not everybody gets them.
It is essential for the patient to know which side effects can occur. They are usually mild and disappear shortly after starting treatment.
The patient should immediately stop taking Ridlip and seek medical helpif they experience the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without;
• swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing;
• severe itching of the skin (with hives);
• red, flat, target-like spots or round spots on the torso, often with centrally located blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin changes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should stop taking Ridlip and immediately contact their doctor if they experience:

• muscle pain or other muscle symptomsthat last longer than expected. Muscle 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. In rare cases, these patients have experienced potentially life-threatening muscle damage (rhabdomyolysis)
• muscle rupture
• symptoms of a lupus-like syndrome(such as rash, joint diseases, and hematological changes).

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients)

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Weakness
• Dizziness
• Increased protein in the urine. This symptom usually resolves on its own and does not require discontinuation of Ridlip (only for the 40 mg dose).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor patients at risk while they are taking this medicine.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 patients)

• Rash, itching, or other skin reactions,
• Increased protein in the urine. This symptom usually resolves on its own and does not require discontinuation of Ridlip (for the 5 mg, 10 mg, and 20 mg doses).

Rare side effects (occurring 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 itching of the skin (with hives). If the patient suspects an allergic reaction, they should immediately stop taking Ridlip and seek medical help.
• Muscle damage in adults, the patient should take precautions, i.e., stop taking Ridlip and immediately contact their doctor if they experience muscle pain or other muscle symptomsthat last longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme levels in the blood.
• Increased tendency to bleed or bruise due to low platelet count.
• Symptoms of a lupus-like syndrome (such as rash, joint diseases, and hematological changes).

Very rare side effects (occurring in less than 1 in 10,000 patients)

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

Side effects with unknown frequency:

• Diarrhea (loose stools)
• Cough
• Shortness of breath
• Swelling
• Sleep disturbances (insomnia and nightmares)
• Sexual dysfunction
• Depression
• Breathing problems (persistent cough and (or) shortness of breath or fever)
• Tendon damage
• Persistent muscle weakness.

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ridlip

• Keep out of the sight and reach of children.
• Do not take Ridlip after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Do not store above 30°C. Store in the original packaging.

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 Ridlip contains

The active substance of Ridlip is rosuvastatin. Ridlip contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium citrate, magnesium stearate, crospovidone.
Opadry Pink 03B24082: hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172).

What Ridlip looks like and what the package contains

Pale pink to pink, round, film-coated tablets with the inscription "RT 2" on one side and smooth on the other side.
Ridlip is available in blister packs of 30 and 90 tablets in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH Hoofddorp, Netherlands

Manufacturer:

S.C. Terapia S.A.
Str. Fabricii nr. 124, Cluj-Napoca, Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp, Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 118013

Parallel import authorization number: 162/23

Leaflet approval date: 18.08.2023

[Information about the trademark]