Exorta

Package leaflet: Information for the user

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

1. What EXORTA is and what it is used for

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

• your cholesterol level is high. This means you are at risk of heart attack or stroke. EXORTA 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 EXORTA, you must continue a cholesterol-lowering diet and maintain regular physical exercise.

Or

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

Why is it important to keep taking EXORTA?
EXORTA is used to correct levels of fatty substances in the blood known as 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).

• EXORTA 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, cutting off blood flow to the heart or brain, thereby 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 taking EXORTA, even if your cholesterol levels have returned to normal, to prevent these levels from rising again, which could lead to the formation of fatty deposits.
However, you must stop taking EXORTA on medical advice or if you become pregnant.

2. What you need to know before taking EXORTA

Do not take EXORTA:

• if you have ever 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 EXORTA, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking EXORTA by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle cramps 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 you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.
In addition, do not take EXORTA 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 cramps or pain, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking EXORTA or other related 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 him/her.

Warnings and precautions
Talk to your doctor or pharmacist before taking EXORTA:

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle cramps or pain, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle cramps or pain, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• if you regularly consume large amounts of alcohol;
• if your thyroid gland is not functioning properly;
• if you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• if you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; see section “Other medicines and EXORTA”;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), either orally or by injection. The combination of fusidic acid and EXORTA film-coated tablets may lead to serious muscle problems (rhabdomyolysis); see section “Other medicines and EXORTA”;
• If you are over 70 years of age (since your doctor needs to choose the appropriate starting dose for you);
• If you have severe respiratory insufficiency;
• If you are of Asian origin – i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor needs to select the appropriate starting dose of EXORTA 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), since statins may sometimes worsen myasthenia or trigger its onset (see section 4).

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

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with EXORTA treatment.
Discontinue use of EXORTA 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 may request this test (liver function test) before and during treatment with EXORTA.
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.

Children and adolescents

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

Other medicines and EXORTA
Inform your doctor or pharmacist if you are 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, 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),
• antacids (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – see below and Warnings and precautions),
• darolutamide (used to treat tumors),
• capmatinib (used to treat tumors),
• an oral contraceptive (the pill),
• regorafenib (used to treat tumors),
• 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),
• 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 and vadadustat (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 EXORTA, or the effect of EXORTA may be altered by these medicines.

If you need to take 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 EXORTA film-coated tablets. Taking EXORTA film-coated tablets with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy, breastfeeding, and fertility
Do not take EXORTA if you are pregnant or breastfeeding. If you become pregnant while taking EXORTA, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with EXORTA by using appropriate contraceptive measures.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Most people can drive and operate machinery while taking EXORTA – it will not affect their ability to drive or use machines. However, some people may experience dizziness during treatment with EXORTA. If you experience dizziness, consult your doctor before driving or operating machinery.

EXORTA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact him/her before taking this medicine.
For the full list of ingredients, see section 6 “Contents of the pack and other information”.

3. How to take EXORTA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual doses in adults:
If you are taking EXORTA for high cholesterol:
Starting dose
Treatment with EXORTA should begin with 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 level for having a heart attack or stroke;
• whether you have any factors that may make you more sensitive to possible side effects. Check with your doctor or pharmacist to determine the most appropriate starting dose of EXORTA 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 ensure you receive the most appropriate EXORTA
dose for your condition. 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,
double the dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between each
dose adjustment.
The maximum daily dose of EXORTA is 40 mg. This dose is only given to patients with high
cholesterol levels 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 EXORTA to reduce the risk of 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 dosing range in children aged 6 to 17 years is 5 to 20 mg once daily.
The usual starting dose is 5 mg daily. Your doctor may gradually increase the dose to achieve the
most appropriate EXORTA dose for the child. The maximum daily dose of EXORTA is 10 mg or 20 mg
for children and adolescents aged 6 to 17 years, depending on the underlying condition being treated.
EXORTA 40 mg tablets must not be used in children.
Administration of tablets

• Swallow each tablet whole with a glass of water.
• Take EXORTA once daily.
• You may take EXORTA at any time of day, with or without food.
• Try to take the tablets at 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 check your cholesterol levels, to ensure that
cholesterol has reached and remains at the correct levels.
Your doctor may decide to increase your dose to achieve the most appropriate EXORTA dose for you.
If you take more EXORTA 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 EXORTA.
If you forget to take EXORTA
Do not worry; 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 EXORTA
Inform your doctor if you intend to stop taking EXORTA. Your cholesterol levels may rise again if
you stop taking this medicine.
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 gets them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear quickly.
Stop taking EXORTA 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 hives);
• flat, red 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 EXORTA and contact your doctor immediately

• if you have unusual muscle aches or pains 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 fatal, known as rhabdomyolysis.
• if you develop lupus-like syndrome (including rash, joint problems and effects on blood cells);
• if you feel muscle tearing.

Common: may affect more than 1 in 10 people:

• headache
• stomach pain
• constipation
• feeling unwell
• muscle pain
• feeling weak
• dizziness
• increased levels of protein in the urine – usually values return to normal on their own without needing to stop EXORTA tablets (only for EXORTA 40 mg)
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon: may affect more than 1 in 100 people:

• skin 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 EXORTA tablets (only for EXORTA 5 mg, 10 mg and 20 mg).

Rare: may affect more than 1 in 1,000 people:

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

Very rare: may affect more than 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 (such as numbness)
• joint pain
• memory loss
• breast enlargement in men (gynaecomastia)

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

• diarrhoea (watery stools)
• 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
• ongoing 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 weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
Reporting of side effects
If you get 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 EXORTA

• This medicine does not require any special storage conditions.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister pack/labelling after EXP. The expiry date refers to the last day of that month.
• 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 EXORTA contains

• The active substance of EXORTA film-coated tablets is rosuvastatin calcium. EXORTA film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other components are: microcrystalline cellulose, monohydrate lactose, anhydrous dibasic calcium phosphate, hypromellose 2910, crospovidone, magnesium stearate (E572), titanium dioxide (E171), triacetin, red iron oxide (E172) [for 10 mg, 20 mg and 40 mg] and yellow iron oxide (E172) [for 5 mg].

Description of the appearance of EXORTA and package contents
5 mg: Yellow, round, biconvex, film-coated tablets marked with “CL” on one side and “86” on the other side (approximate size: 5.1 mm).
10 mg: Pink, round, biconvex, film-coated tablets marked with “CL87” on one side and smooth on the other side (approximate size: 6.1 mm).
20 mg: Pink, round, biconvex, film-coated tablets marked with “CL88” on one side and smooth on the other side (approximate size: 8.1 mm).
40 mg: Pink, oval, biconvex, film-coated tablets marked with “CL89” on one side and smooth on the other side (approximate size: 13.6 x 7.6 mm).

Cold-formed blister packs: The blister pack is made of a cold-formed laminate composed of 25 μm OPA / 45 μm aluminium foil / 60 μm PVC, and a simple aluminium foil lid of 30 μm / 6-8 gsm HSL as the cover material.
Pack sizes: 7, 28, 30, 60, 90, 100 tablets.
Not all pack sizes may be marketed.

Container pack: The container pack consists of a white, round HDPE container with child-resistant closure, containing a paper liner disc and a silica gel desiccant packet.
Pack sizes: 7, 28, 30, 90, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Via Sette Santi 3
Firenze
Italy

Manufacturer
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzędz,
62-020,
Poland

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands: Rosuvastatine Macleods filmomhulde tabletten
United Kingdom (Northern Ireland): Rosuvastatin film-coated Tablets