COLCARDIOL 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. COLCARDIOL 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What COLCARDIOL is and what it is used for
   2. What you need to know before taking COLCARDIOL
   3. How to take COLCARDIOL
   4. Possible side effects
   5. How to store COLCARDIOL
   6. Contents of the pack and other information

COLCARDIOL 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

COLCARDIOL 40 mg film-coated tablets
Rosuvastatin
Medicinal product
equivalent

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLCARDIOL is and what it is used for

COLCARDIOL belongs to a group of medicines called “statins”.
It has been prescribed for you because:

• Your cholesterol level is high. This means that you are at risk of heart attack or stroke. COLCARDIOL is used in adults, adolescents and children aged 6 years and over for the treatment of high cholesterol levels.
• You have been prescribed a statin because changes to your diet and increased exercise have not been sufficient to correct your cholesterol levels. While taking COLCARDIOL you should continue a cholesterol-lowering diet and continue exercising.

Or

• You have other factors that increase the risk of 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 formation of fat deposits inside the arteries.

Why it is important to continue taking COLCARDIOL
COLCARDIOL is used to correct the levels of fatty substances in the blood called lipids, the most common
of which is cholesterol.
There are several types of cholesterol in the blood: the so-called “bad” cholesterol (LDL-C) and the cholesterol
so-called “good” (HDL-C).

• COLCARDIOL can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by blocking the production of “bad” cholesterol by the body. It also improves the body's ability to remove “bad” cholesterol from the blood.

For many people, high cholesterol has no effect on how they feel, because it gives no symptoms.
However, if high cholesterol is not treated, fat deposits can accumulate in the walls of the blood
vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking blood flow to the heart or brain
and consequently causing a heart attack or stroke. Lowering cholesterol levels reduces the
risk of having a heart attack, stroke or related health problems.
You should continue to take COLCARDIOL, even if your cholesterol levels have returned to normal, to
prevent these levels from rising again, causing the formation of fat deposits.
However, you should stop taking COLCARDIOL on medical advice or if you are pregnant.

2. What you need to know before taking COLCARDIOL

Do not take COLCARDIOL

• if you have previously had an allergic reaction to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking COLCARDIOL, stop taking it immediately and tell your doctor. Women must avoid pregnancy while taking COLCARDIOL, using appropriate contraceptive measures;
• if you have a liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle aches or pains;
• if you are taking a combination of medicines consisting of sofosbuvir/velpatasvir/voxilaprevir (used to treat a liver viral infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you are in any of the above situations (or have any doubts), you should return to your doctor and inform them.
Also, do not take COLCARDIOL 40 mg (the highest dose):

• if you have moderate kidney problems (ask your doctor for any doubts);
• if your thyroid is not functioning properly;
• if you have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
• if you are taking other medicines to lower cholesterol called fibrates.

If you are in any of the above situations (or have any doubts), you should return to your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLCARDIOL.

• if you have kidney problems;
• if you have liver problems;
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).
• if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Immediately inform your doctor if you have unexplained muscle aches or pains, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have a constant muscle weakness.
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking COLCARDIOL or other related medicines;
• if you regularly consume large amounts of alcohol;
• if your thyroid is not functioning properly;
• if you are taking other medicines to lower cholesterol called fibrates. Read this carefully
• if you are taking medicines used to treat HIV infections, for example ritonavir with lopinavir/ and/or atazanavir, read the section “Other medicines and COLCARDIOL”;
• if you are taking or have taken in the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine for the treatment of bacterial infections). The combination of fusidic acid and COLCARDIOL can lead to serious muscle problems (rhabdomyolysis), read the section “Other medicines and COLCARDIOL;
• if you are over 70 years of age (the doctor needs to choose the initial dose of COLCARDIOL suitable for you);
• if you have severe respiratory failure;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). The doctor needs to choose the initial dose of COLCARDIOL suitable for you.

If you are in any of the above situations (or are not sure):

• do not take COLCARDIOL 40 mg (the highest dose) and check with your doctor or pharmacist before starting to take COLCARDIOL at any dosage.

Serious skin reactions have been reported in association with the treatment with COLCARDIOL,
including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using COLCARDIOL and seek immediate medical attention if you notice one
of the symptoms described in section 4.
In a small number of people, statins can have a negative effect on the liver, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood. For this
reason, the doctor will ask to perform this test (liver function test), before and during
treatment with COLCARDIOL.
During treatment with this medicine, the doctor will carefully check that you do not have diabetes or
are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars
and fats in the blood, if you are overweight and have high blood pressure.

Children and adolescents

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

Other medicines and COLCARDIOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell 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 - read the section “Warnings and precautions”),
• an oral contraceptive (the pill),
• regorafenib (used for the treatment of tumors),
• darolutamide (used for the treatment of tumors),
• capmatinib (used for the treatment of tumors),
• fostamatinib (used for the treatment of low platelet count),
• febuxostat (used for the treatment and prevention of high levels of uric acid in the blood),
• teriflunomide (used for the treatment of multiple sclerosis),
• hormone replacement therapy,
• one 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, 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).

The effects of these medicines may be altered by COLCARDIOL, or the effect of COLCARDIOL may
be altered by these medicines.
If you need to take fusidic acid orally to treat a bacterial infection, you will need to
temporarily interrupt the use of this medicine. Your doctor will tell you when you can start
using COLCARDIOL safely again. Taking COLCARDIOL with fusidic acid can rarely lead to
weakness, pain sensitivity or muscle pain (rhabdomyolysis). For more information regarding
rhabdomyolysis see section 4.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take COLCARDIOL if you are pregnant or breastfeeding. If you become pregnant while taking COLCARDIOL, you should
stop taking it immediately and tell your doctor.
Women must avoid pregnancy during treatment with COLCARDIOL using appropriate
contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive cars and use machines while taking
COLCARDIOL - it has no effect on their ability to drive vehicles and use machines. However, some
people may experience dizziness while taking COLCARDIOL. If you experience dizziness, consult
your doctor before driving vehicles or using machines.

COLCARDIOL contains lactose
If your doctor has diagnosed you with intolerance to some sugars (lactose or milk sugar), contact
them before taking this medicine.

COLCARDIOL 40 mg contains the dyes sunset yellow (E110) and cochineal red (E124)
They may cause allergic reactions.

3. How to take COLCARDIOL

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.

Use in adults
If you are taking COLCARDIOL for high cholesterol:
Initial dose
Treatment with COLCARDIOL should begin with a dose of 5 mg or 10 mg, even if you have previously taken higher dosages with other statins. The choice of the initial dose depends on:

• your cholesterol level;
• the level of risk of having a heart attack or stroke;
• the possible presence of factors that may make you more sensitive to possible side effects. Check with your doctor or pharmacist what is the most suitable initial dose of COLCARDIOL for you. The doctor may decide to give you the lowest dose (5 mg) if you:
• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
• are over 70 years old;
• have moderate kidney problems;
• are at risk of muscle aches and pains (myopathy).

Dose increase and maximum daily dose
The doctor may decide to increase the dose. This is to determine the most suitable dose for you. If you start with a 5 mg dose, the doctor, if necessary, may decide to double the dose to 10 mg, then to 20 mg and then to 40 mg. If you start with 10 mg the doctor may decide, if necessary, to double this dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between one dose adjustment and another.
The maximum daily dose of COLCARDIOL is 40 mg. It is only administered to patients with high cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not lowered sufficiently with the 20 mg dose.
If you are taking COLCARDIOL to reduce the risk of heart attack, stroke or health problems related to them:
The recommended dose is 20 mg per day. However, the doctor may decide to use a lower dosage if you have any of the risk factors mentioned above.

Use in children aged between 6 and 17 years
The dosage range in children and adolescents aged between 6 and 17 years is from 5 mg to 20 mg once a day. The usual initial dose is 5 mg per day, and the doctor may gradually increase the dose to reach the most appropriate COLCARDIOL dosage for the patient. The maximum daily dose of COLCARDIOL is 10 mg or 20 mg for children aged between 6 and 17 years, depending on age and weight and depending on how the underlying condition is being treated. The dose must be taken once a day. COLCARDIOL 40 mg tabletsshould not be used in children.

Taking the tablets
Swallow each tablet whole with a glass of water.
COLCARDIOL should be taken once a day and can be taken at any time of the day with or without food.
Try to take the tablets at approximately the same time each day; this may help you not to forget to take them.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to be sure that your cholesterol has reached and maintains the correct levels. The doctor may decide to increase the dose to make you take the amount of COLCARDIOL most suitable for you.

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

If you forget to take COLCARDIOL
Do not worry, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking COLCARDIOL
Tell your doctor if you intend to stop taking COLCARDIOL. If you stop taking COLCARDIOL your cholesterol levels may rise again.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to be aware of which of these side effects may occur. Usually they are mild-to-moderate and of short duration.

Stop taking COLCARDIOL and seek immediate medical helpif you experience any of the following allergic reactions:

• difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of face, lips, tongue and/or throat that can cause difficulty in swallowing;
• severe itching of the skin (with raised bumps).
• Reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 COLCARDIOL and see your doctor immediately if you have:

• Unusual muscle aches or pains,that last longer than you would expect. 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 side effects and rarely these have progressed to a condition leading to muscle damage, potentially life-threatening, known as rhabdomyolysis.
• If you experience muscle rupture.
• If you have a lupus-like syndrome (which includes rash, joint disorders and effects on blood cells).

Possible side effects
Common (these may affect up to 1 in 10 and up to 1 in 100 patients)

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• an increase in the amount of protein in your urine - usually the values return to normal on their own without having to stop taking COLCARDIOL (only for COLCARDIOL 40 mg);
• Diabetes. This is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Not common (may affect up to 1 in 100 and up to 1 in 1000 patients)

• skin rash; itching and other skin reactions;
• an increase in the amount of protein in your urine - these usually return to normal on their own without the need to stop treatment with COLCARDIOL (only for COLCARDIOL 5mg, 10 mg and 20 mg).

Rare (may affect up to 1 in 1000 and up to 1 in 10,000 patients)

• severe allergic reactions - the signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, severe itching of the skin (with raised bumps); If you suspect you are having an allergic reaction, stop taking COLCARDIOL and seek immediate medical help;
• muscle damage in adults - as a precaution, stop taking COLCARDIOL and see your doctor immediately if you have unusual muscle aches or pains that persist longer than you would expect;
• severe stomach pain (inflamed pancreas);
• increased liver enzymes in the blood.
• Bleeding or bruising more easily than usual due to a low level of platelets in the blood;
• lupus-like syndrome (including rash, joint disorders and effects on blood cells);
• muscle rupture

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

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

Not known (frequency cannot be estimated from the available data):

• diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 COLCARDIOL

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from
light.
Do not use this medicine after the expiry date stated on the package and on the blister after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What COLCARDIOL contains
The active ingredient is rosuvastatin. COLCARDIOL film-coated tablets contain rosuvastatin calcium salt
equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other ingredients are:

Film-coated tablets 5 mg
Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin and quinoline yellow
(E104).

Film-coated tablets 10 mg
Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, allura red
(E129)

Film-coated tablets 20 mg
Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, carmine
(E120)

Film-coated tablets 40 mg
Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, sunset yellow
(E110), cochineal red (E124)

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

Marketing Authorisation Holder
Euro-Pharma S.r.l.
Via Garzigliana n. 8
10127 Torino

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