Crativ

Package leaflet: Information for the patient

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

Rosuvastatin
Equivalent medicine
Please read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CRATIV is and what it is used for

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

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. CRATIV is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels. You have been prescribed a statin because changes in diet and increased physical exercise have not been sufficient to correct your cholesterol levels. While taking CRATIV, you must continue with a cholesterol-lowering diet and maintain physical exercise. Alternatively, you may have other risk factors that increase the likelihood of developing heart attack, stroke, or related health problems. Heart attack, stroke, and related health problems can be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why it is important to continue taking CRATIV
CRATIV 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 "good" cholesterol (HDL-C).

• CRATIV 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 their narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping blood flow to the heart or brain, 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 CRATIV 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 CRATIV on medical advice or if you become pregnant.

2. What you need to know before taking CRATIV

Do not take CRATIV

• 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 CRATIV, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking CRATIV by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle pain or spasms;
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Additionally, do not take CRATIV 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 pain or spasms, 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 you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking CRATIV if:

• you have kidney problems;
• you have liver problems;
• you have experienced repeated or unexplained muscle pain or spasms, have 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 pain or spasms, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• 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 CRATIV”;
• you are taking antibiotics containing fusidic acid; please read section “Other medicines and CRATIV”;
• you are over 70 years of age (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;
• 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).

Children and adolescents

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

If you fall into any of the above categories (or are unsure):

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

In a small number of people, statins may have a negative effect on the liver, which can be detected through a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with CRATIV.
During treatment with this medicine, your doctor will closely 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, are overweight, and have high blood pressure.
Other medicines and CRATIV
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation);
• warfarin 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);
• antacids (used to neutralize stomach acid);
• erythromycin (an antibiotic);
• 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 CRATIV. Taking CRATIV with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
• hormone replacement therapy;
• antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat HIV infections – see section “Warnings and Precautions”).

The effects of these medicines may be altered by CRATIV, or the effect of CRATIV may be altered by these medicines.

• Regorafenib (used to treat tumours);
• any of the following medicines used to treat viral infections, including HIV or Hepatitis C, either alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take CRATIV if you are pregnant or breastfeeding. If you become pregnant while taking CRATIV, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with CRATIV by using appropriate contraceptive measures.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking CRATIV – it does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with CRATIV. If you experience dizziness, consult your doctor before driving or operating machinery.
CRATIV contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take CRATIV

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

• your cholesterol level;
• your risk level for heart attack or stroke;
• the possible presence of factors that may make you more sensitive to potential side effects.

Check with your doctor or pharmacist to determine the most appropriate starting dose of CRATIV for you. Your doctor may decide to prescribe the lower dose (5 mg) if you:

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

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most suitable dose for you. If treatment starts at 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg. If treatment starts at 10 mg, your doctor may, if necessary, decide to double the dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between one dose adjustment and the next.
The maximum daily dose of CRATIV is 40 mg. This dose is given only to patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels have not been sufficiently reduced with the 20 mg dose.
If you are taking CRATIV to reduce the risk of developing heart attack, stroke, or related health problems:
The recommended dose is 20 mg 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 usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate CRATIV dosage for you. The maximum daily dose of CRATIV is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily. CRATIV 40 mg tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
CRATIV should be taken once daily, 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.
Periodic cholesterol checks
It is important to return to 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 CRATIV dosage for you.
If you take more CRATIV 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 CRATIV.
If you forget to take CRATIV
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
If you stop taking CRATIV
Inform your doctor if you intend to stop taking CRATIV. If you stop taking CRATIV, your cholesterol levels may rise again.
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 experiences them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear within a short time.
Stop taking CRATIV 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 itching of the skin (with raised, itchy lumps);
• lupus-like syndrome (including skin rash, joint problems and effects on blood cells);
• muscle breakdown.

Also, stop taking CRATIV and contact your doctor immediately if you have unusual muscle pains or aches
that last longer than expected. Muscle-related 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.

Possible side effects:
Common (may occur in 1 to 100 and 1 to 10 patients)

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• increased amount of protein in the urine – usually values return to normal on their own without needing to stop CRATIV (only for CRATIV 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 occur in 1 to 1000 and 1 to 100 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 CRATIV (only for CRATIV 5-10 mg and 20 mg).

Rare (may occur in 1 to 10,000 and 1 to 1000 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, itchy lumps). If you suspect you are having an allergic reaction, stop taking CRATIV and seek immediate medical help;
• muscle damage in adults – as a precaution, stop taking CRATIV and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected;
• severe stomach pain (inflamed pancreas);
• increased liver enzymes in the blood.

Very rare (may occur in less than 1 in 10,000 patients)

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

Not known (cannot be estimated from the available data)

• diarrhoea (passing loose or watery stools);
• Stevens-Johnson syndrome (characterised by blistering of 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 generalised muscle weakness, including in some cases the muscles used for breathing);
• ocular myasthenia (a condition causing weakness of the eye muscles).

Contact your doctor if you experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
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 CRATIV

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 pack 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 CRATIV contains
The active substance is rosuvastatin. CRATIV 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 CRATIV and contents of the pack
CRATIV 5 mg tablets are yellowish, film-coated, round-shaped, with “5” imprinted on one side.
CRATIV 10 mg tablets are light pink, film-coated, round-shaped, with “10” imprinted on one side.
CRATIV 20 mg tablets are dark pink, film-coated, round-shaped, with “20” imprinted on one side.
CRATIV 40 mg tablets are red, film-coated, round-shaped, 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
AGIPS Farmaceutici S.r.l.
Via Amendola No. 4
16035 Rapallo (Genova), Italy

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