Ridlip

Package leaflet: Information for the patient

Ridlip, 5 mg, film-coated tablets
Ridlip, 10 mg, film-coated tablets
Ridlip, 20 mg, film-coated tablets
Ridlip, 40 mg, film-coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents:

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. Patients taking Ridlip should also follow a cholesterol-lowering diet and engage in regular physical exercise.

or

• Ridlip is also recommended if you have other risk factors that increase the 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 regularly?
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, known as "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 symptoms and therefore does not affect how you feel. However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, resulting in 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 using Ridlip, you should continue taking it. This prevents cholesterol levels from rising again, which could lead to further accumulation of fatty deposits. You should stop taking Ridlip 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 is allergic (hypersensitive) 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 taking 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 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 had severe skin rash, skin peeling, blisters and (or) mouth 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 the 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 ever had muscle disorders, or if muscle-related side effects occurred during previous treatment with lipid-lowering medicines,
• if the patient regularly consumes large amounts of alcohol,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian),
• if the patient is taking fibrates, i.e. 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 their family members have previously had 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 and fever. The doctor should also be informed if persistent muscle weakness occurs;
• if the patient has or has had myasthenia (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 or lead to the development of myasthenia (see section 4);
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid disease;
• if the patient is taking fibrates, cholesterol-lowering medicines. Read the leaflet carefully, even if the patient has 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, orally or by injection, a medicine containing fusidic acid (used for bacterial infections). Taking fusidic acid together with Ridlip may lead to severe muscle damage (rhabdomyolysis); see section "Ridlip and other medicines";
• if the patient is over 70 years of age (because 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, and 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, contact 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, stop taking Ridlip immediately and contact a doctor without delay.

In a small number of patients, statins may affect liver function. To confirm this effect, a blood test measuring liver enzyme activity is performed. Usually, the doctor recommends checking liver enzyme activity in blood before 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 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Inform the doctor if the patient is 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 together with rosuvastatin), ticagrelor, 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 hydrochloric 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),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high blood uric acid levels),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis),
• 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,
• roxadustat (used to treat anaemia in patients with chronic kidney disease),
• tafamidis (used to treat transthyretin amyloidosis),
• momelotinib (used to treat myelofibrosis in adults with anaemia).

Ridlip may alter the effects of these medicines, or these medicines may alter the effect of Ridlip.
If the patient needs to take oral fusidic acid to treat a bacterial infection,
temporarily discontinue Ridlip. The doctor will inform the patient when it is safe to restart Ridlip.
Taking Ridlip with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information about 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. While taking Ridlip, pregnancy must 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 – it will not impair their 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.
If the patient has been diagnosed with an 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 full 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 as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Adults
Use of Ridlip to lower cholesterol levels
Starting dose
Treatment should be initiated 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 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 moderately severe kidney disease,
• the patient is at risk of developing muscle disorders 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 a 5 mg dose, 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 10 mg dose, 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 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 a 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
any of the above-mentioned risk factors are present in the patient.
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 aged 6 to 17 years is
10 mg or 20 mg, depending on the type of disease being treated. The medicine should be taken
once daily. Ridlip 40 mg 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, 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 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 an overdose of Ridlip is taken, contact your doctor or go to the nearest hospital immediately.
If the patient is in hospital or being treated for another condition, inform the doctor or medical
staff that Ridlip is being taken.
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
Inform your doctor if the patient wishes to stop taking Ridlip. Cholesterol levels may rise again if
Ridlip treatment is discontinued.
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 know 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 lumps);
• Red, flat spots resembling a target or circular patches on the trunk, often with centrally located blisters, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes. These serious skin changes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Stop taking 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 very 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).

Adverse reactions occurring commonly (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 (applies only to the 40 mg dose).
• Diabetes. The likelihood 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.

Adverse reactions occurring uncommonly (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).

Adverse reactions occurring rarely (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 lumps). If the patient suspects an allergic reaction, stop taking Ridlip immediately and seek medical help.
• Muscle damage in adults – caution is advised; stop taking Ridlip and contact your doctor immediately if muscle pain or other muscle symptoms occur that persist longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme activity in blood.
• Increased tendency to bleeding or bruising due to low platelet count.
• Lupus-like syndrome symptoms (such as rash, joint disorders and hematological changes).

Adverse reactions occurring very rarely (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
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles). Talk to your doctor if you experience weakness in hands or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your 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
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 indicated 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 pack and other information

What Ridlip contains
The active substance is rosuvastatin. Ridlip contains rosuvastatin calcium in a strength corresponding to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium citrate, magnesium stearate, crospovidone.
Coating:
Tablets 5 mg
Opadry Yellow 02B82338 [hypromellose 5 cP, titanium dioxide (E171), polyethylene glycol 400, iron oxide yellow (E172)]
Tablets 10 mg, 20 mg, 40 mg
Opadry Pink 03B24082 [hypromellose 6 cP, titanium dioxide (E171), polyethylene glycol 400, iron oxide red (E172)]

What Ridlip looks like and contents of the pack
Ridlip 5 mg, light yellow to yellow, round coated tablets with the imprint "RT 1" on one side and smooth on the other side.
Ridlip 10 mg, light pink to pink, round coated tablets with the imprint "RT 2" on one side and smooth on the other side.
Ridlip 20 mg, light pink to pink, round coated tablets with the imprint "RT 3" on one side and smooth on the other side.
Ridlip 40 mg, light pink to pink, oval coated tablets with the imprint "RT 4" on one side and smooth on the other side.
Ridlip is available in blister packs of 28, 56, and 90 tablets in cardboard boxes.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Poland
Tel.: +48 22 642 07 75

Manufacturer:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands
Terapia SA, 124 Fabricii Street, 400632 Cluj-Napoca, Cluj County, Romania