Ridlip

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Ridlip (Rosuvastatine SUN 10 mg), 10 mg, film-coated tablets
Rosuvastatinum
Ridlip and Rosuvastatine SUN 10 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

1. What Ridlip is and what it is used for
2. Important information before taking Ridlip
3. How to take Ridlip
4. Possible side effects
5. How to store Ridlip
6. Contents of the pack and other information

1. What Ridlip is and what it is used for

Ridlip belongs to a group of medicines called statins.
Ridlip is recommended for use because:

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

or

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

Heart attack, stroke, and other problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why it is important to take Ridlip consistently
Ridlip is used to achieve normal levels of blood lipids (fats).
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 reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
• Ridlip works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol does not affect how they feel, as it causes no symptoms.
However, if left untreated, fatty deposits build up in the walls of blood vessels, causing them to narrow.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke.
Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after taking Ridlip, you must continue taking the medicine. This prevents cholesterol levels from rising again,
which could lead to further accumulation of fatty deposits. You should stop taking the medicine only if your doctor advises you to do so, or if you become pregnant.

2. Important information before taking Ridlip

When not to take Ridlip

• if the patient has a known allergy (hypersensitivity) to rosuvastatin or any of the other ingredients of Ridlip,
• if the patient is pregnant or breastfeeding. If a woman taking Ridlip becomes pregnant, she must immediately stop taking it and inform her doctor. Women taking Ridlip should use effective contraception methods,
• 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 of 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 severe skin rash, skin peeling, blisters and/or oral ulcers after taking Ridlip or other similar medicines.

If any of the above situations apply to the patient or if the patient has any doubts,
the patient should contact their doctor again.
In addition, do not take Ridlip 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, consult a doctor),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or a family member has a history of muscle disorders, or if the patient previously experienced muscle-related side effects while taking lipid-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 (other cholesterol-lowering medicines).

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should contact their doctor again.
Warnings and precautions
Before starting Ridlip, consult a 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 a family member has a history of muscle disorders, or if the patient previously experienced muscle-related side effects while taking 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 patient should also inform the doctor if persistent muscle weakness occurs,
• if the patient regularly consumes large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient is taking fibrates (other cholesterol-lowering medicines). The patient should read the leaflet carefully, even if they have 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 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 (used to treat bacterial infections). Concomitant use of fusidic acid with Ridlip may lead to severe muscle damage (rhabdomyolysis); see section Ridlip and other medicines,
• if the patient is over 70 years old (as the doctor must determine the appropriate starting dose of Ridlip),
• if the patient has severe respiratory insufficiency,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate starting dose of Ridlip for these patients.

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

• Do not take Ridlip 40 mg (the highest dose), and before taking Ridlip at any other dose, consult a doctor or pharmacist.

Severe skin reactions associated with medicines containing rosuvastatin have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, discontinue Ridlip immediately and contact a doctor without delay.
In a small number of patients, statins may affect liver function. To monitor this effect, blood tests assessing liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in blood before starting and during treatment with Ridlip.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
Children and adolescents

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

Ridlip and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Inform your doctor if you are taking:

• cyclosporine (used, for example, after organ transplantation),
• anticoagulant medicines: e.g. warfarin, acenocoumarol or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with rosuvastatin) or clopidogrel,
• 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),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, taken alone or in combination with other medicines (see section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Ridlip may alter the effect of these medicines, or these medicines may alter the effect of Ridlip.
If the patient needs to take oral fusidic acid for bacterial infection treatment,
Ridlip should be temporarily discontinued. The doctor will inform the patient when it is safe to resume Ridlip.
Concomitant use of Ridlip with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Further information on rhabdomyolysis can be found in section 4.
Pregnancy and breastfeeding
Ridlip must not be used during pregnancy or breastfeeding. If a woman becomes pregnant while taking Ridlip, treatment must be stopped immediately and the doctor contacted. Effective contraception must be used to avoid pregnancy while taking Ridlip.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Ridlip – the medicine does not impair these abilities. However, some patients may experience dizziness during treatment with Ridlip. If this occurs, the patient should consult their doctor before driving or operating machinery.
Ridlip contains lactose monohydrate
If the patient has been diagnosed with intolerance to certain sugars [lactose (milk sugar)], inform the doctor before taking Ridlip.
Ridlip contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
A complete list of excipients is provided in section: Contents of the pack and other information.

3. How to take Ridlip

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Ridlip is available in the following doses: 5 mg, 10 mg, 20 mg, 40 mg.
Adults
Use of Ridlip for lowering cholesterol levels
Starting dose
Treatment should be initiated with a 5 mg or 10 mg dose, even if the patient has previously taken 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 Ridlip is most appropriate for the patient.

Your doctor may decide to use a 5 mg dose as the starting dose 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 diseases 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 with 10 mg, the doctor may increase the dose to 20 mg, then to 40 mg, if necessary.
The treatment period at each dose level between dose increases should be 4 weeks.
The maximum daily dose of Ridlip 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 Ridlip 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 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 5 mg once daily, and the doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Ridlip 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. Ridlip 40 mg should not be used in children.
How to take the medicine
The tablet should be swallowed whole with water.
Ridlip should be taken once daily, at any time of day, with or without food.
It is recommended to take the medicine at the same time each day to help remember.
Cholesterol monitoring tests
To ensure that cholesterol levels have decreased and remain within the target range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Ridlip as appropriate for the patient.
Taking more Ridlip than prescribed
If you take more Ridlip than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform your doctor or medical staff that you are taking Ridlip.
Missed dose of Ridlip
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Ridlip
Tell your doctor if you wish to stop taking Ridlip. Cholesterol levels may rise again if treatment with Ridlip is stopped.
If you have any further questions about the use of 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 which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
The patient should immediately stop taking Ridlip and seek medical help 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 hives);
• Red, flat, target-shaped or circular rash on the trunk, often with centrally located blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin changes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient should stop taking Ridlip and contact a doctor immediately if:

• Muscle pain or other muscle symptoms 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).

Common adverse reactions (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 urine. This symptom usually resolves spontaneously and does not require discontinuation of Ridlip (occurs only with the 40 mg dose).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight, and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Uncommon adverse reactions (occurring in more than 1 in 1000 but less than 1 in 100 patients)

• Rash, itching, or other skin reactions
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Ridlip (occurs only with 5 mg, 10 mg, and 20 mg doses).

Rare adverse reactions (occurring in more than 1 in 10,000 but less than 1 in 1000 patients)

• Severe allergic reactions – symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe skin itching (with hives). If the patient suspects an allergic reaction, they should immediately stop taking Ridlip and seek medical help.
• Muscle damage in adults – caution is advised; stop taking Ridlip and contact a doctor immediately if muscle pain or other muscle symptoms persist longer than expected.
• Severe abdominal pain (pancreatitis)
• Increased blood levels of liver enzymes
• Increased tendency to bleeding or bruising due to low platelet count
• Symptoms of lupus-like syndrome (such as rash, joint disorders, and hematological changes)

Very rare adverse reactions (occurring in less than 1 in 10,000 patients)

• Jaundice (yellowing of the skin and eyes)
• Hepatitis
• Blood in urine
• Nerve damage in upper and lower limbs (felt as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)

Adverse reactions with unknown frequency include:

• 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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions 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 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Ridlip

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Ridlip contains
The active substance is rosuvastatin. The medicine Ridlip contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin.
Other components: monohydrate lactose, microcrystalline cellulose, sodium citrate, magnesium stearate, crospovidone.
Coating Opadry Pink 03B24082: hypromellose 6 cP, titanium dioxide (E 171), polyethylene glycol 400, iron oxide red (E 172).
What Ridlip looks like and contents of the pack
Light pink to pink, round coated tablets with the imprint "RT 2" on one side and smooth on the other.
Ridlip is available in blister packs of 30 and 90 tablets, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Netherlands, 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Netherlands, country of export: RVG 118013
Parallel Import Authorisation number: 162/23