Colfri

Italy
Brand name Colfri
Form tablets, film-coated
Active substance / Dosage
ROSUVASTATIN
Prescription type Prescription only
ATC code
C10AA07
Registration number 043999
Manufacturer EPIFARMA S.R.L

Table of Contents

Package leaflet: Information for the user

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

Rosuvastatin
Generic medicine
Please read all of this leaflet carefully before 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.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLFRI is and what it is used for

COLFRI belongs to a group of medicines called "statins".
You have been prescribed COLFRI because:

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

Or

  • You have other factors that increase your risk of developing heart attack, stroke, or related health problems. Heart attack, stroke, and related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why it is important to continue taking COLFRI
COLFRI is used to correct 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: so-called "bad" cholesterol (LDL-C) and so-called "good" cholesterol (HDL-C).

  • COLFRI 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 "bad" cholesterol from the blood.

For many people, high cholesterol does not affect how they feel, as it causes no symptoms.
However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping blood flow to the heart or brain and resulting in heart attack or stroke.
By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You must continue taking COLFRI, even if your cholesterol levels have returned to normal, to prevent them from rising again and causing fatty deposits to form.
However, you must stop taking COLFRI on medical advice or if you become pregnant.

2. What you should know before taking COLFRI

Do not take COLFRI

  • if you have previously had an allergic reaction 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 COLFRI, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking COLFRI by using appropriate contraceptive measures;
  • if you have liver disease;
  • if you have severe kidney problems;
  • if you have repeated or unexplained muscle spasms or muscle pain;
  • if you are taking a combination of medicines consisting of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
  • if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If any of the above apply to you (or if you have any doubts), you must return to your doctor and inform them.
Additionally, do not take COLFRI 40 mg (the highest dose):

  • if you have moderate kidney problems (ask your doctor if in doubt);
  • if your thyroid gland is not functioning properly;
  • if you have repeated or unexplained muscle spasms or pain, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking 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 cholesterol-lowering medicines called fibrates.

If any of the above apply to you (or if you have any doubts), you must return to your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking COLFRI if:

  • you have kidney problems;
  • you have liver problems;
  • you have experienced repeated or unexplained muscle spasms or pain, a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle spasms or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
  • you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking COLFRI or other related medicines;
  • you regularly consume large amounts of alcohol;
  • your thyroid gland is not functioning properly;
  • you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
  • you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; please read section “Other medicines and COLFRI”;
  • you are over 70 years old (your doctor needs to choose the appropriate starting dose for you);
  • you have severe respiratory insufficiency;
  • you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose for you;
  • you are currently taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and COLFRI may lead to serious muscle problems (rhabdomyolysis); please read section “Other medicines and COLFRI”;
  • 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).

If any of the above apply to you (or if you are unsure):

  • do not take COLFRI 40 mg (the highest dose) and consult your doctor or pharmacist before starting COLFRI at any dosage.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with COLFRI. Stop using COLFRI and seek immediate medical attention if you notice any of the symptoms described in section 4.
In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test showing elevated liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with COLFRI.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
Children and adolescents

  • if the patient is under 6 years of age: COLFRI must not be administered to children under 6 years of age.
  • if the patient is under 18 years of age: COLFRI 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and COLFRI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines:

  • cyclosporine (used, for example, after organ transplantation);
  • warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood);
  • fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
  • antacids (used to neutralize stomach acids);
  • erythromycin (an antibiotic);
  • fusidic acid (an antibiotic – please read section “Warnings and precautions”);
  • an oral contraceptive (the pill);
  • hormone replacement therapy;
  • regorafenib (used to treat tumors);
  • darolutamide (used to treat tumors);
  • capmatinib (used to treat tumors);
  • fostamatinib (used to treat low platelet count);
  • febuxostat (used to treat and prevent high levels of uric acid in the blood);
  • 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, alone or in combination (see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
  • roxadustat (used to treat anemia in patients with chronic kidney disease);
  • tafamidis (used to treat a disease called transthyretin amyloidosis);
  • momelotinib (used to treat myelofibrosis in adults with anemia).

The effects of these medicines may be altered by COLFRI, or the effect of COLFRI may be altered by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart COLFRI. Taking COLFRI with fusidic acid may rarely cause weakness, tenderness to touch, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take COLFRI if you are pregnant or breastfeeding. If you become pregnant while taking COLFRI, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with COLFRI by using appropriate contraceptive measures.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive vehicles and operate machinery while taking COLFRI, as it does not affect their ability to do so. However, some people may experience dizziness during treatment with COLFRI. If you experience dizziness, consult your doctor before driving or operating machinery.
COLFRI 5 mg, 10 mg, 20 mg, and 40 mg contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
COLFRI 40 mg contains sunset yellow (E110) and cochineal red (E124), which may cause allergic reactions.

3. How to take COLFRI

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in adults
If you are taking COLFRI for high cholesterol:
Starting dose
Treatment with COLFRI should begin at a dose of 5 mg or 10 mg, even if you have previously taken higher doses of other statins. The choice of starting dose depends on:

  • your cholesterol level;
  • your risk of having a heart attack or stroke;
  • whether you have any factors that may make you more susceptible to possible side effects.

Check with your doctor or pharmacist to determine the most appropriate starting dose of COLFRI 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);
  • are over 70 years of age;
  • have moderate kidney problems;
  • are at risk of muscle pain or muscle aches (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most suitable dose for you. If starting at 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and subsequently to 40 mg. If starting at 10 mg, your doctor may, if necessary, decide to double the dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of COLFRI is 40 mg. This dose should be used only in patients with high cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not been sufficiently reduced with the 20 mg dose.

If you are taking COLFRI to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg once daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.

Use in children aged 6 to 17 years
The dosage range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg once daily. Your doctor may gradually increase the dose until the most appropriate COLFRI dose for the patient is reached. The maximum daily dose of COLFRI is either 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. The dose should be taken once daily. COLFRI 40 mg tablets must not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.
COLFRI should be taken once daily. COLFRI 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 cholesterol monitoring
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains at the appropriate levels. Your doctor may decide to increase your dose to achieve the most suitable amount of COLFRI for you.

If you take more COLFRI than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the hospital doctor that you are taking COLFRI.

If you forget to take COLFRI
Do not panic. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking COLFRI
Inform your doctor if you intend to stop taking COLFRI. If you stop taking COLFRI, your cholesterol levels may rise again.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. It is important to be aware of which of these side effects may occur.
They are usually mild and disappear in a short time.
Stop taking COLFRI and seek immediate medical help 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 swallowing;
  • severe skin itching (with raised hives);
  • red, non-elevated spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
  • widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking COLFRI and contact your doctor immediately if:

  • you have unusual muscle aches or pain lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis;
  • you experience muscle tearing;
  • you develop lupus-like syndrome (which includes rash, joint problems, and effects on blood cells).

Possible side effects:
Common (may affect up to 1 in 10 people)

  • headache;
  • stomach pain;
  • constipation;
  • feeling unwell;
  • muscle pain;
  • feeling weak;
  • dizziness;
  • increased levels of protein in the urine – levels usually return to normal on their own without needing to stop taking COLFRI (only for COLFRI 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 (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

  • severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives). If you suspect you are having an allergic reaction, stop taking COLFRI and seek immediate medical help;
  • muscle damage in adults – as a precaution, stop taking COLFRI and contact your doctor immediately if you have unusual muscle aches or pain lasting longer than expected;
  • severe stomach pain (inflamed pancreas);
  • increased liver enzymes in the blood;
  • bleeding or bruising more easily than normal due to low platelet levels in the blood;
  • lupus-like syndrome (which includes rash, joint problems, and effects on blood cells).

Very rare (may affect up to 1 in 10,000 people)

  • jaundice (yellowing of the skin and eyes);
  • hepatitis (liver inflammation);
  • traces of blood in the urine;
  • nerve damage in arms and legs (numbness);
  • joint pain;
  • memory loss;
  • breast enlargement in men (gynecomastia).

Not known (cannot be estimated from the available data)

  • diarrhoea (passing liquid stools);
  • Stevens-Johnson syndrome (characterized by blisters on the skin, mouth, eyes, and genitals);
  • cough;
  • shortness of breath;
  • oedema (swelling);
  • sleep disorders, including insomnia and nightmares;
  • sexual problems;
  • depression;
  • breathing problems, including persistent cough and/or shortness of breath or fever;
  • tendon injury;
  • persistent muscle weakness;
  • myasthenia gravis (a condition causing generalized muscle weakness, in some cases affecting muscles used for breathing);
  • ocular myasthenia (a condition 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 shortness of breath.
Reporting of side effects
If you experience any side effects, 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 COLFRI

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 COLFRI contains

  • The active substance is rosuvastatin. COLFRI film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
  • The other components are:
    Film-coated tablets 5 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, quinoline yellow (E104).
    Film-coated tablets 10 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, allura red (E129).
    Film-coated tablets 20 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, carmine (E120).
    Film-coated tablets 40 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, sunset yellow (E110), cochineal red (E124).

Description of the appearance of COLFRI and package contents
COLFRI 5 mg tablets are yellowish, film-coated, round-shaped tablets with " 5 " imprinted on one side.
COLFRI 10 mg tablets are light pink, film-coated, round-shaped tablets with " 10 " imprinted on one side.
COLFRI 20 mg tablets are dark pink, film-coated, round-shaped tablets with " 20 " imprinted on one side.
COLFRI 40 mg tablets are red, film-coated, round-shaped tablets with " 40 " imprinted on one side.
The tablets are available in PA/Aluminum/PVC-ALU blisters, pack size: 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ), Italy

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland