KOLEROS 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. Koleros 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What Koleros is and what it is used for
   2. What you need to know before taking Koleros
   3. How to take Koleros
   4. Possible side effects
   5. How to store Koleros
   6. Package Contents and Other Information

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

rosuvastatin
Generic medicine

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

1. What Koleros is and what it is used for

Koleros belongs to a group of medicines called statins

Koleros has been prescribed for you because:

• your cholesterol level is high. This means you are at risk of heart attack or stroke. Koleros is used in adults, adolescents and children, 6 years of age and older, to treat high cholesterol.

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 Koleros, you should continue the
diet to reduce your cholesterol levels and continue exercising.
Or

• You have other factors that increase the risk of developing a heart attack, stroke or health problems related to them. Heart attack, stroke and related problems can be caused by

a disease called atherosclerosis. Atherosclerosis is caused by the formation of fat deposits
inside the arteries.

Why it is important to continue taking Koleros
Koleros 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 (C-LDL) and the
so-called "good" cholesterol (C-HDL).

• Koleros 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 does not affect how you feel, because it gives no symptoms.
However, if high cholesterol is not treated, fat deposits can build up along the walls of the
blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked, blocking blood flow to the heart or brain
and consequently causing a 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 to take Koleros, 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 Koleros on medical advice or if you become pregnant.

2. What you need to know before taking Koleros

Do not take Koleros:

• if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnantor breastfeeding. If you discover that you are pregnant while taking Koleros, stop taking it immediately and tell your doctor. Women must avoid pregnancy while taking Koleros, 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 have ever developed a severe skin rash or peeling of the skin, blisters and/orulcers in the mouth after taking Koleros or other related medicines;
• if you are taking a combination of the drugs sofosbuvir/velpatasvir/voxilaprevir (used forliver viral infection called hepatitis C);
• if you are taking a medicine called cyclosporine(used for example after organ transplantation).

If you fall into any of the above cases (or if you have any doubts), you should return to your doctor and inform them.

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

• if you have moderate kidney problems(if in doubt, ask your doctor);
• if your thyroid is not working 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 medicinesto lower cholesterol, called fibrates.

If you fall into any of the above cases (or if you have any doubts), you should return to your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking Koleros

• 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 kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle aches or pains, a personal or family history ofmuscle problems,or have previously had muscle problems while taking other medicines to lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by malaise or fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness;
• if severe skin reactions, includingStevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms(DRESS) have been reported in association with treatment with Koleros. Stop using Koleros and seek immediate medical attention if you notice anyof the symptoms described in section 4;
• if you regularly consume large amounts of alcohol;
• if your thyroid is not working 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, please read the section “Other medicines and Koleros”;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for the treatment of bacterial infections) orally or by injection. The combination of fusidic acid and Koleros can lead to serious muscle problems (rhabdomyolysis);
• if you are over 70 years of age (as your doctor needs to choose the correct starting dose of Koleros suitable for you);
• if you have severe respiratory failure;
• if you are of Asian origin - i.e. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the correct starting dose of Koleros suitable for you.

If any of the above cases apply to you (or if you are not sure):

• Do not take Koleros 40 mg (the highest dose) and check with your doctor or pharmacist before starting to take KOLEROS at any dose.

In a small number of people, statins can have effects on the liver. This case is identified
with a simple test that reveals any increases in liver enzyme levels in the blood. For this
reason, your doctor will ask you to have this blood test (liver function test) before
and during treatment with Koleros.
During the intake of this medicine, the doctor will carefully check if you have diabetes or are at risk
of developing it. You are likely to be at risk of diabetes if you have high levels of sugars and fats in
your blood, if you are overweight or if you have high blood pressure.

Children and adolescents

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

Other medicines and Koleros
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, ticagrelor or clopidogrel (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),
• remedies for indigestion (used to neutralize stomach acidity),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - please read the section “Warnings and precautions”),
• an oral contraceptive (the pill),
• 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 levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines can be modified by Koleros, or the effect of Koleros can be
modified by these medicines.

If you need to take fusidic acid orally to treat a bacterial infection
you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe
to start taking Koleros again. Taking Koleros with fusidic acid can rarely lead to
muscle weakness, tenderness or pain (rhabdomyolysis). See section 4 for more
information on rhabdomyolysis.
Pregnancy and breastfeeding
Do not take Koleros if you are pregnant or if you are breastfeeding. If you discover that you are pregnant during treatment with Koleros, you must stop taking the
medicine immediatelyand inform your doctor. Women must avoid pregnancy during treatment with
Koleros using appropriate contraceptive measures.
Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
Most people can drive vehicles and use machines while taking Koleros,
treatment does not alter this ability. However, some people may feel dizzy during
treatment with Koleros. If you feel dizzy, consult your doctor before driving or using machines.

Koleros contains lactose
If your doctor has diagnosed you with intolerance to some sugars (lactose or milk sugar), contact
them before taking Koleros.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

Koleros contains Allura Red AC (E129)
May cause allergic reactions.

3. How to take Koleros

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

Usual dose in adults
If you are taking Koleros for high cholesterol:
Starting dose:
Treatment with Koleros must begin with a 5 mg or 10 mgdose, even if you have previously taken higher dosages with other statins. The choice of the starting dose depends on:

• your cholesterol level;
• your risk level 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 the most appropriate starting dose of Koleros is 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 of age;
• 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. All of this in order to determine the most suitable dose of Koleros 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 the other.
The maximum daily dose of Koleros is 40 mg. This dose is only administered to patients with high cholesterol levels and at high risk of heart attack or stroke, and whose cholesterol levels have not lowered sufficiently with the 20 mg dose.

If you are taking Koleros 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 usual starting dose is 5 mg. The doctor may increase the dose up to the dosage of Koleros most appropriate for you. The maximum daily dose of Koleros is 10 mg for children aged between 6 and 9 years and 20 mg for children aged between 10 and 17 years. The dose must be taken once a day. Koleros 40 mg tablets should not be used in children.

Administration of the tablets
Swallow each tablet whole with a glass of water.

Koleros must be taken once a day.Koleros 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 up to the amount of Koleros most suitable for you.

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

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

If you stop taking Koleros
Tell your doctor if you intend to stop taking Koleros. If you stop taking Koleros, 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 everyone will experience them.
It is important to be aware of which of these side effects may occur. Usually
they are mild and disappear after a short time.

Stop taking Koleros and seek immediate medical attention if 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 the face, lips, tongue and/or throat that can cause difficulty in swallowing;
• severe itching of the skin (with raised hives).
• 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Koleros and consult your doctor immediately:

• if you have unusual muscle aches or painsthat last longer than you would expect. 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 tearing;
• if you have lupus-like syndrome(which includes rash, joint disorders and effects on blood cells).

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

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

Uncommon possible side effects (may affect up to 1 in 100 people):

• rash, itching and other skin reactions;
• an increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking Koleros (only for Koleros 5 mg, 10 mg and 20 mg).

Rare possible side effects (may affect up to 1 in 1000 people):

• 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). Ifyou suspect you are having an allergic reaction, stop taking Kolerosand seek immediate medical attention;
• muscle damage in adults - as a precaution, stop taking Koleros and consultyour doctor immediately if you have unusual muscle aches or painsthat 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 low platelet levels in the blood;
• lupus-like syndrome (which includes rash, joint disorders and effects on blood cells).

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

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

Side effects with unknown frequency (frequency cannot be estimated on the basis of
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 and constant muscle weakness;
• nerve diseases that can cause weakness, tingling or numbness (peripheral neuropathy).
• myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens 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, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects, you can contribute to providing more information on the safety of this medicine.

5. How to store Koleros

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 package/blisters, after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Koleros Contains

• The active ingredient of Koleros is rosuvastatin. Koleros film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are: Tablet Core:lactose monohydrate, microcrystalline cellulose, crospovidone type A, sodium carbonate monohydrate, sodium lauryl sulfate, magnesium stearate. Tablet Coating [5mg]: Opadry II 85F62533 Yellow;partially hydrolyzed polyvinyl alcohol, Titanium dioxide (E171), polyethylene glycol, talc, Yellow Iron Oxide (E172). Tablet Coating [10mg, 20mg, 40mg]:Opadry II 85F64743 Pink, partially hydrolyzed polyvinyl alcohol, Titanium dioxide (E171), polyethylene glycol, talc, Yellow Iron Oxide (E172), Red Iron Oxide (E172), Allura Red AC (E129), Indigo Carmine (E132).

Description of the Appearance of Koleros and Package Contents
Koleros is available in 4 dosages:

5 mg tablets:yellow, round, 7 mm, biconvex with “RU5” imprinted on one side and smooth on the other.

10 mg tablets:pink, round, 7 mm, biconvex with “RU10” imprinted on one side and smooth on the other.

20 mg tablets:pink, round, 9 mm, biconvex with “RU20” imprinted on one side and smooth on the other.

40 mg tablets:pink, oval, 15.5 mm x 8 mm, biconvex with “RU40” imprinted on one side and smooth on the other.
Koleros is available in blister packs (Al/Al) of 28 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Konpharma s.r.l.
Via Pietro Della Valle n. 1
00193 Roma
Italy

Manufacturer Responsible for Batch Release

• 1) Actavis Ltd. BLB016, Bulebel Industrial Estate Zejtun ZTN 3000 Malta
• 2) Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. Dupnitza 2600 Bulgaria

• 3) PharmaPath S.A. 28is Oktovriou 1, Agia Varvara, 123 51, Greece