Sigrolem

Package leaflet: Information for the user

Sigrolem 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets, 30 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sigrolem is and what it is used for

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

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. Sigrolem is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• You have been advised to take a statin because changes in diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking Sigrolem, you must continue a cholesterol-lowering diet and maintain physical exercise.

or

• You 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 disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why it is important to keep taking Sigrolem
Sigrolem 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: "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Sigrolem 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, interrupting 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 Sigrolem, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to the formation of fatty deposits. However, you must stop taking Sigrolem if advised by your doctor or if you become pregnant.

2. What you need to know before taking Sigrolem

Do not take Sigrolem

• If you have ever had an allergic reaction to Sigrolem or to any of the ingredients of this medicine.
• If you are pregnant or breastfeeding. If you become pregnant while taking Sigrolem, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Sigrolem 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 you fall into any of the above categories (or have any doubts), you must go back to your doctor and inform them.

In addition, do not take Sigrolem 30 mg or 40 mg (the higher doses):

• If you have moderate kidney problems (if in doubt, ask your doctor).
• If your thyroid gland is not functioning properly.
• If you have repeated or unexplained muscle spasms or muscle pain, a personal or family history of muscle problems, 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, and 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 go back to your doctor and inform them.

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

• If you have kidney problems.
• If you have liver problems.
• If you have had repeated or unexplained muscle spasms or muscle pain, a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle spasms or muscle pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• 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 cause its onset (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Sigrolem or other related medicines.
• 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; please read the section “Other medicines and Sigrolem”.
• If you are taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Sigrolem can lead to serious muscle problems (rhabdomyolysis); please read the section “Other medicines and Sigrolem”.
• If you are over 70 years old (your doctor needs to choose the appropriate starting dose of Sigrolem for you).
• If you have severe respiratory failure.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor needs to choose the appropriate starting dose of Sigrolem for you.

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

• Do not take Sigrolem 30 mg or 40 mg (the higher doses) and check with your doctor or pharmacist before starting any dose of Sigrolem.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Sigrolem. Discontinue use of Sigrolem 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 Sigrolem.

During treatment with this medicine, your doctor will carefully 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: Sigrolem must not be administered to children under 6 years of age.
• If the patient is under 18 years of age: Sigrolem 30 mg and 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Sigrolem
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, 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),
• remedies for indigestion (used to neutralize stomach acids),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – please read the section “Warnings and precautions”),
• an oral contraceptive (the pill),
• regorafenib (used to treat tumors),
• darolutamide (used to treat tumors),
• capmatinib (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),
• 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.

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

If you need to take oral 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 Sigrolem. Taking Sigrolem with fusidic acid may rarely lead to muscle weakness, tenderness to touch, or muscle pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

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

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

Sigrolem contains lactose and sodium.

Lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Sigrolem

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual dosage in adults
If you are taking Sigrolem for high cholesterol:
Starting dose
Your treatment with Sigrolem should start at a dose of 5 mg or 10 mg, even if you previously took higher
doses of other statins. The choice of starting dose depends on:

• Your cholesterol level.
• Your risk level for 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 suitable starting dose of Sigrolem 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 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 appropriate dose for you.
If you started with a 5 mg dose, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and then to 40 mg. If you started with 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg. There must be an interval of four weeks between each dose adjustment.
The maximum daily dose of Sigrolem is 40 mg. This dose is given only to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not sufficiently decreased with the 20 mg dose.
If you are taking Sigrolem 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 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 daily, and your doctor may gradually increase the dose until the most appropriate Sigrolem dose for the patient is reached. The maximum daily dose of Sigrolem is 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. The 30 mg and 40 mg tablets of Sigrolem must not be used in children.
Administration of tablets
Swallow each tablet whole with a glass of water.
Sigrolem should be taken once daily. You may take it 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 checks
It is important that you return to your doctor for regular cholesterol level checks to ensure that your cholesterol has reached and remains at the appropriate levels.
Your doctor may decide to increase your dose until the most suitable amount of Sigrolem for you is reached.
If you take more Sigrolem than you should
Contact your doctor or the nearest hospital for advice.
If you go to the hospital or receive treatment for another condition, inform the hospital doctor that you are taking Sigrolem.
If you forget to take Sigrolem
Do not panic. 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 Sigrolem
Inform your doctor if you intend to stop taking Sigrolem. If you stop taking Sigrolem, 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 everybody gets them.
It is important to be aware of which of these side effects may occur. Usually
they are mild and disappear in a short time.
Stop taking Sigrolem 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).
• Reddish, flat 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 Sigrolem 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 experience muscle tearing.
• If you develop lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Possible common side effects (may occur in 1 out of 10 patients):

• Headache
• Stomach pain
• Constipation
• Feeling unwell
• Muscle pain
• Feeling weak
• Dizziness
• Increased amount of protein in the urine – values usually return to normal on their own without needing to stop taking Sigrolem (only for Sigrolem 40 mg).
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (may occur in 1 out of 100 patients):

• 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 Sigrolem (only for Sigrolem 5 mg, 10 mg and 20 mg).

Possible rare side effects (may occur in 1 out of 1,000 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 hives). If you suspect an allergic reaction, stop taking Sigrolem and seek immediate medical help.
• Muscle damage in adults – as a precaution, stop taking Sigrolem and contact your doctor immediately if you have unusual muscle aches or pains that last 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 (including skin rash, joint problems and effects on blood cells).

Possible very rare side effects (may occur in 1 out of 10,000 patients):

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflammation of the liver)
• Blood traces in the urine
• Nerve damage in arms and legs (numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)

Side effects of unknown frequency may include:

• Diarrhoea (passing liquid stools)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, 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 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 arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or laboured breathing.

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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sigrolem

Do not store above 30 °C. 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 packaging 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 Sigrolem contains
The active substance is rosuvastatin.
Sigrolem 5 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin.
Sigrolem 10 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin.
Sigrolem 15 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 15 mg of rosuvastatin.
Sigrolem 20 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin.
Sigrolem 30 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 30 mg of rosuvastatin.
Sigrolem 40 mg film-coated tablets:
Each tablet contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin.

The other components are:
Tablet core:
Microcrystalline cellulose
Monohydrate lactose
Crospovidone
Hydroxypropylcellulose
Sodium hydrogen carbonate
Magnesium stearate

Coating:
Monohydrate lactose
Hypromellose
Titanium dioxide (E 171)
Triacetin
Yellow iron oxide (E 172) in Sigrolem 5 mg, 15 mg and 30 mg film-coated tablets
Red iron oxide (E 172) in Sigrolem 10 mg, 20 mg and 40 mg film-coated tablets

Description of the appearance of Sigrolem and contents of the pack
Sigrolem 5 mg film-coated tablets:
Film-coated, round, biconvex, yellow tablet, imprinted with "5" on one side and smooth on the other side, diameter: 5.5 mm.
Sigrolem 10 mg film-coated tablets:
Film-coated, round, biconvex, pink tablet, with a break line on one side, diameter: 7 mm.
Sigrolem 15 mg film-coated tablets:
Film-coated, round, convex, yellow tablet, imprinted with "15" on one side and smooth on the other, diameter: 8 mm.
Sigrolem 20 mg film-coated tablets:
Film-coated, round, biconvex, pink tablet, with a score line on one side and "20" imprinted on the other, diameter: 9 mm.
Sigrolem 30 mg film-coated tablets:
Film-coated, round, convex, yellow tablet, with a score line on one side and "30" imprinted on the other, diameter: 8 mm.
Sigrolem 40 mg film-coated tablets:
Film-coated, oval, biconvex, pink tablet, with a score line on one side and "40" imprinted on the other, dimensions: 11.5 x 7 mm.

Sigrolem 10 mg, 20 mg and 40 mg film-coated tablets:
The tablets can be divided into two equal halves.

Sigrolem is supplied in blister packs containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome, Italy

Manufacturer
Teva Pharma S.L.U.
C/C, n° 4, Poligono Industriale
Malpica, 50016, Zaragoza, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
FI: Sigrolem
IT: Sigrolem