Ridlip

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Ridlip (Rosuvastatine SUN 20 mg)
20 mg, film-coated tablets
Rosuvastatinum
Ridlip and Rosuvastatine SUN 20 mg are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 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.

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 indicates an increased 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 continue to follow a cholesterol-lowering diet and engage in regular physical exercise.

or

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

Heart attack, stroke, and other related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why is it important to take Ridlip consistently?
Ridlip is used to achieve normal levels of blood lipids (fats).
The most common lipid 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 cause any noticeable symptoms or changes in well-being.
However, if left untreated, fatty deposits accumulate in the walls of blood vessels, leading to their narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood flow to the heart or brain, resulting in a heart attack or stroke.
Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.
Even if cholesterol levels become normal after using 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 using Ridlip

When not to use 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 should immediately stop taking it and inform her doctor. Women using Ridlip should use effective contraceptive 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 sofosbuvir/velpatasvir/voxilaprevir (used in the treatment of viral hepatitis C),
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation),
• if the patient has ever had severe skin rash, skin peeling, blisters and (or) oral mucosal 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.
Additionally, do not use Ridlip 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (if in 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 their family members have 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 fibrate medicines (i.e. other cholesterol-lowering drugs).

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 their family 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 they develop unexplained muscle pain or discomfort, especially if accompanied by general malaise or fever. The doctor should also be informed 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 package 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 with other medicines",
• if the patient is taking or has taken within the last 7 days, orally or by injection, a 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 with 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). In these patients, the doctor will determine the appropriate starting dose of Ridlip.

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 rosuvastatin-containing medicines, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. If any of the symptoms described in section 4 occur, Ridlip should be discontinued immediately and the patient should contact their doctor without delay.
In a small number of patients, statins may affect liver function. To monitor this effect, blood tests to assess liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in the 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 with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Tell your doctor if you are taking:

• cyclosporine (used, for example, after organ transplantation),
• anticoagulant medicines: e.g. warfarin, acenocoumarol or fluindione (their anticoagulant effect and risk of bleeding may be increased when taken concomitantly with rosuvastatin) or clopidogrel,
• a fibrate medicine (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 in cancer treatment),
• darolutamide (used in cancer treatment),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered 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 a bacterial infection,
Ridlip should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Ridlip.
Concomitant use of Ridlip with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Further information on rhabdomyolysis is provided in section 4.
Pregnancy and breastfeeding
Ridlip should not be used during pregnancy or breastfeeding. If a woman becomes pregnant while taking Ridlip, treatment should be stopped immediately and the doctor should be contacted. While taking Ridlip, pregnancy should be avoided and effective contraception used.
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 symptom occurs, the patient should contact their doctor before driving or operating machinery.
Ridlip contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars [lactose (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, meaning it 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 according to your doctor's instructions. If in doubt, consult your
doctor or pharmacist.
Adults
Use of Ridlip to lower cholesterol levels
Starting dose
Treatment should begin with a 5 mg or 10 mg dose, even if the patient previously used
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 the patient's susceptibility to adverse effects.

Ask your doctor which starting dose of Ridlip is most appropriate for you.
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 treatment was started at 5 mg, your doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If treatment was started at 10 mg, your doctor may decide to increase it to 20 mg, then to 40 mg, if necessary.
The treatment period with each dose level before any increase should last 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 the 20 mg dose was insufficient to reduce cholesterol levels.
Use of Ridlip to reduce the risk of heart attack or stroke or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce it if the patient has any of the risk 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 your 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. The 40 mg dose of Ridlip should not be used in children.
How to take the medicine
Swallow the tablet 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 it.
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.
Missing a 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 treatment
Tell your doctor if you wish to stop taking Ridlip. Cholesterol levels may rise again if Ridlip treatment is stopped.
If you have any further questions 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 which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
Stop taking Ridlip immediately 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 lesions on the trunk, often with centrally located blisters, peeling skin, and ulcers in the mouth, throat, nose, genital organs, and eyes. These serious skin reactions 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).

Discontinue Ridlip and contact your doctor immediately if the following occur:

• Muscle pain or other muscle symptoms that 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;
• Fatigue;
• Dizziness;
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Ridlip (applies only to the 40 mg dose);
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and lipid 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 (applies only to doses of 5 mg, 10 mg, and 20 mg).

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, and severe skin itching (with hives). If an allergic reaction is suspected, stop taking Ridlip immediately and seek medical help;
• Muscle damage in adults – exercise caution, i.e. discontinue Ridlip and contact your doctor immediately if muscle pain or other muscle symptoms occur that persist longer than expected;
• Severe abdominal pain (pancreatitis);
• Increased blood levels of liver enzymes;
• Increased tendency to bleed or bruise due to low platelet count;
• Lupus-like syndrome symptoms (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 disturbances (insomnia and nightmares);
• Sexual dysfunction;
• 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, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Ridlip

• Keep this medicine out of sight and reach of children.
• Do not use this medicine 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 Ridlip contains
The active substance is rosuvastatin. Ridlip contains rosuvastatin calcium in a dose corresponding to 20 mg of rosuvastatin.
The other ingredients are: lactose monohydrate, 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
Ridlip 20 mg are light pink to pink, round, film-coated tablets marked with "RT 3" 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 marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, country of export:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The 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, The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Netherlands, country of export: RVG 118014
Parallel Import Licence Number: 352/22