Koleklin

Package leaflet: Information for the patient

KOLEKLIN 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Rosuvastatin
Generic medicine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What KOLEKLIN is and what it is used for

KOLEKLIN belongs to a group of medicines called statins.
You have been prescribed this medicine because:

• Your cholesterol level is high. This means you are at risk of a heart attack or stroke. KOLEKLIN is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• You have been prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking KOLEKLIN, you must continue with a cholesterol-lowering diet and maintain regular physical exercise.

Or

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

Heart attacks, strokes, and other conditions may be caused by a disease called atherosclerosis.
Atherosclerosis is due to the buildup of fatty deposits in the arteries.
Why it is important to continue taking KOLEKLIN:

• KOLEKLIN is used to modify levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
• There are different types of cholesterol in the blood – “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
• KOLEKLIN can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by helping to block the body's production of “bad” cholesterol and also improves the body’s ability to remove it from the blood.
• For most people, high cholesterol does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
• Sometimes, this narrowing of blood vessels can block the flow of blood to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, it is possible to reduce the risk of heart attack, stroke, or other related health problems.
• You must continue taking KOLEKLIN, even if your cholesterol levels are normal, to prevent them from rising again, which could lead to the formation of fatty deposits. However, treatment must be discontinued if your doctor decides so or if you become pregnant.

2. What you need to know before taking KOLEKLIN

Do not take KOLEKLIN

• If you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with rosuvastatin by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have unexplained, repeated muscle pain or weakness.
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If any of these situations apply to you (or if you have any doubts), please consult your doctor.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking KOLEKLIN.

Also, do not take KOLEKLIN 40 mg (the highest dose):

• If you have moderately severe kidney problems (if in doubt, consult your doctor).
• If you have a thyroid gland that is not functioning properly.
• If you have had unexplained, repeated muscle pain, a personal or family history of muscle disorders, or if you previously experienced muscle problems while being treated with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.
• If any of these situations apply to you (or if you have any doubts), please consult your doctor.

Warnings and precautions
Ask your doctor or pharmacist for advice before taking KOLEKLIN

• If you have kidney problems.
• If you have liver problems.
• If you have a personal or family history of muscle disorders, or if you previously experienced muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly consume large amounts of alcohol.
• If you have a thyroid gland that is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Please read this patient information leaflet carefully, even if you have previously taken other medicines for high cholesterol levels.
• If you are taking medicines used to treat HIV infection, such as lopinavir/ritonavir and/or atazanavir – see section “Other medicines and KOLEKLIN”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and KOLEKLIN can lead to serious muscle problems (rhabdomyolysis) – see section “Other medicines and KOLEKLIN”.
• If you are over 70 years of age (your doctor must choose the correct initial dose of KOLEKLIN suitable for you).
• If you have severe respiratory insufficiency.
• If you are of Asian origin – Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must choose the correct initial dose of KOLEKLIN suitable for you.
• If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Inform your doctor or pharmacist if you develop a persistent cough, shortness of breath, or difficulty breathing.
This medicine may cause lung scarring, and you may need to be monitored by your doctor (interstitial lung disease).
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with KOLEKLIN.
Stop taking KOLEKLIN and seek immediate medical help if you notice any of the symptoms described in section 4.

Children and adolescents

• If the patient is under 6 years of age: KOLEKLIN must not be given to children under 6 years of age.
• If the patient is under 18 years of age: the 40 mg tablet of KOLEKLIN is not suitable for use in children and adolescents under 18 years of age.

If any of these situations apply to you (or if you have any doubts):
Do not take KOLEKLIN 40 mg (the highest dose) and consult your doctor or pharmacist before starting
to take any dose of KOLEKLIN.
Statins may affect liver function in a small number of people. This is detected by a simple blood test that monitors increases in liver enzyme levels. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with KOLEKLIN.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, or if you have high blood pressure.

Other medicines and KOLEKLIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those listed below:

• cyclosporine (used, for example, after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other medicine to prevent blood clots),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• antacids (used to neutralize stomach acid), erythromycin (an antibiotic),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• antiviral medicines such as ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (used to treat HIV or hepatitis C infection – see section “Warnings and precautions”).

These medicines may alter the effect of KOLEKLIN, or the effect of these medicines may be altered by KOLEKLIN.
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart taking KOLEKLIN. Taking KOLEKLIN with fusidic acid may rarely cause muscle weakness, fatigue, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take KOLEKLIN if you are pregnant or breastfeeding. If you become pregnant while taking KOLEKLIN, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with KOLEKLIN by using an appropriate contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive vehicles and operate machinery while being treated with KOLEKLIN, as the treatment does not affect their ability to drive or use machines. However, some people may experience dizziness while being treated with KOLEKLIN. If you feel dizzy, consult your doctor before driving or operating machinery.

KOLEKLIN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
For the full list of ingredients, please see section 6 of this leaflet.

3. How to take KOLEKLIN

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual doses in adults
If you are taking KOLEKLIN for high cholesterol:
Starting dose
Treatment with KOLEKLIN should begin with a dose of 5 mg or 10 mg, even if you were previously taking a different statin at a higher dose. The choice of starting dose depends on:

• Your cholesterol level.
• Your risk level for heart attack or stroke.
• Whether you are at increased risk of developing possible side effects.

Please consult your doctor or pharmacist to find out which starting dose of KOLEKLIN is most suitable for you.
Your doctor may decide to prescribe the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of muscle pain (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose. This will allow you to take an amount of KOLEKLIN appropriate for your needs. If you started with a 5 mg dose, your doctor may decide to double it to 10 mg, then to 20 mg, and then to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double it to 20 mg and then to 40 mg, if necessary. There will be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of KOLEKLIN is 40 mg. This dose is recommended only for patients with high cholesterol levels and at high risk of heart attacks or strokes, whose cholesterol levels are not sufficiently lowered with a 20 mg dose.
If you are taking KOLEKLIN to reduce the risk of heart attack, stroke, or related health problems
The recommended dose is 20 mg daily. However, your doctor may prescribe lower doses if any of the conditions listed above apply to you.
Usual doses in children and adolescents aged 6–17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to reach the amount of KOLEKLIN you need. The maximum daily dose of KOLEKLIN is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose once daily. KOLEKLIN 40 mg tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
KOLEKLIN must be taken once daily. KOLEKLIN can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Regular monitoring of cholesterol levels
It is important to return to your doctor regularly to monitor your cholesterol levels and ensure they have reached and remain within the target range.
Your doctor may increase your dose of KOLEKLIN until the appropriate amount for you is reached.
If you take more KOLEKLIN than you should
Contact your doctor or the nearest hospital for advice.
If you go to the hospital or are being treated for another condition, inform the medical staff that you are taking KOLEKLIN.
If you forget to take KOLEKLIN
Do not worry; take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking KOLEKLIN
Talk to your doctor if you wish to stop taking KOLEKLIN. Your cholesterol levels may rise again if you stop taking KOLEKLIN.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important that you are aware of these side effects. These are generally mild and
disappear after a short period of time. Stop taking KOLEKLIN and seek immediate medical attention if you experience any of the following allergic reactions:

• 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 in swallowing.
• Severe itching of the skin (with raised lumps).

Additionally, stop taking KOLEKLIN and contact your doctor immediately if:

• You experience unusual muscle weakness and pain that persists longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a small number of people have experienced unpleasant muscle effects, which rarely progressed to potentially life-threatening muscle damage known as rhabdomyolysis.
• You experience muscle tearing.
• You develop lupus-like syndrome (characterized by skin rash, joint problems, and effects on blood cells).
• You develop flat, non-raised reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• You develop widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects
Common (may affect up to 1 in 10 and 1 in 100 patients):

• Headache;
• Stomach pain;
• Constipation;
• Feeling unwell;
• Muscle pain;
• Feeling of weakness;
• Dizziness;
• Increased amount of protein in the urine, which usually returns to normal without needing to stop taking KOLEKLIN tablets (only for KOLEKLIN 40 mg);
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon possible side effects (may occur in 1 in 100 to 1 in 1,000 patients):

• Skin rash, itching, and other skin reactions;
• Increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with KOLEKLIN (only for KOLEKLIN 5 mg, 10 mg, and 20 mg).

Rare possible side effects (may affect up to 1 in 1,000 and 1 in 10,000 patients):

• Severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised hives). If you suspect you are having an allergic reaction, stop taking KOLEKLIN and seek immediate medical help;
• Muscle damage in adults – as a precaution, stop taking KOLEKLIN and contact your doctor immediately if you have unusual muscle aches or pains that last longer than expected;
• Severe stomach pain (inflamed pancreas);
• Bruising or bleeding more often or more easily than usual, which may be signs of a low platelet count in the blood (thrombocytopenia);
• Increased liver enzymes in the blood;
• Lupus-like syndrome (characterized by skin rash, joint problems, and effects on blood cells).

Very rare possible side effects (may affect up to 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes);
• Hepatitis (liver inflammation);
• Blood traces in the urine;
• Nerve damage in arms and legs (numbness);
• Joint pain;
• Memory loss;
• Gynecomastia (enlargement of breast tissue in men).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (swelling);
• Sleep disorders, including difficulty sleeping and nightmares;
• Sexual problems;
• Depression;
• Tendon disorders, sometimes complicated by ruptures or tears;
• Persistent muscle weakness;
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing);
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or labored breathing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KOLEKLIN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton/blister pack/labelling after Exp. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What KOLEKLIN contains
The active substance is rosuvastatin.
Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium salt).
The other ingredients are:
Tablet core:
Calcium hydrogen phosphate dihydrate; Microcrystalline cellulose; Lactose monohydrate; Crospovidone; Magnesium stearate.
Film coating:
5 mg tablets
Opadry II 32K520157 Yellow: Hypromellose HPMC (E464); Lactose monohydrate; Titanium dioxide (E171); Triacetin; Yellow iron oxide (E172); Red iron oxide (E172).
(E132)
10 mg, 20 mg, and 40 mg tablets
Opadry II 32K540093 Pink: Hypromellose HPMC (E464); Lactose monohydrate; Titanium dioxide (E171); Triacetin; Yellow iron oxide (E172); Red iron oxide (E172).

Description of the appearance of KOLEKLIN and pack contents
KOLEKLIN 5 mg: A yellow, round, biconvex, film-coated tablet, engraved with "5" on one side and "B" on the opposite side.
KOLEKLIN 10 mg: A pink, round, biconvex, film-coated tablet, engraved with "10" on one side and "B" on the opposite side.
KOLEKLIN 20 mg: A pink, round, biconvex, film-coated tablet, engraved with "20" on one side and "B" on the opposite side.
KOLEKLIN 40 mg: A pink, oval, biconvex, film-coated tablet, engraved with "40" on one side and "B" on the opposite side.
KOLEKLIN is available in packs containing 28 tablets.

Marketing Authorization Holder:
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) – Italy

Responsible manufacturer for batch release:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy