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Package leaflet: Information for the patient

SNAPTAG 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 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SNAPTAG is and what it is used for

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

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

Or

• you have other risk factors that increase the likelihood of developing heart attack, stroke, or related health problems (cardiac disorders).

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

• SNAPTAG 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 and resulting in 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 SNAPTAG, 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 should stop taking SNAPTAG on medical advice or if you become pregnant.

2. What you need to know before taking SNAPTAG

Do not take SNAPTAG:

• if you have previously had an allergic reaction to SNAPTAG 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 SNAPTAG, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with SNAPTAG 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 medicine called cyclosporine (used, for example, after organ transplantation);
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking SNAPTAG or other related medicines.

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

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

Additionally, do not take SNAPTAG 40 mg (the highest dose):

• if you have moderate kidney problems (ask your doctor if you are uncertain);
• if your thyroid gland is not functioning properly;
• if you have repeated or unexplained muscle spasms or pain, 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 return to your doctor and
inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking SNAPTAG:

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle spasms 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 spasms or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have 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 SNAPTAG”;
• if you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and SNAPTAG may lead to serious muscle problems (rhabdomyolysis); see section “Other medicines and SNAPTAG”;
• if you are over 70 years old (your doctor needs to choose the appropriate starting dose for you);
• if you have severe respiratory failure;
• if 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 cause its onset (see section 4).

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

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

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with SNAPTAG.
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, if you are overweight, and if you have high blood pressure.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with SNAPTAG.
Stop using SNAPTAG and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents

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

Other medicines and SNAPTAG
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);
• blood anticoagulants such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may increase when taken together with this medicine), ticagrelor, or clopidogrel;
• 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 – see section “Warnings and precautions”);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• regorafenib (used to treat tumors);
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. The effects of these medicines may be altered by SNAPTAG, or the effect of SNAPTAG may be altered by these medicines.

Pregnancy and breastfeeding
Do not take SNAPTAG if you are pregnant or breastfeeding. If you become pregnant while taking SNAPTAG,
you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with SNAPTAG 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 SNAPTAG, as SNAPTAG has no effect on the ability to drive or use machines.
However, some people may experience dizziness during treatment with SNAPTAG. If you experience dizziness, consult your doctor before driving or using machinery.
SNAPTAG contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
For the complete list of other ingredients, see section “Contents of the pack and other information”.

3. How to take SNAPTAG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Usual dose in adults

If you are taking SNAPTAG for high cholesterol:

Starting dose
Treatment with SNAPTAG 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 of 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 SNAPTAG 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 damage (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 with 5 mg, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and subsequently to 40 mg. If treatment starts with 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.

The maximum daily dose of SNAPTAG is 40 mg. This dose should only be given 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 SNAPTAG 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 and adolescents aged 6 to 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate SNAPTAG dosage for you. The maximum daily dose of SNAPTAG 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. SNAPTAG 40 mg tablets must not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.

SNAPTAG should be taken once daily. SNAPTAG can be taken 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 to return to your doctor for periodic cholesterol checks to ensure that your cholesterol has reached and remains at the appropriate levels. Your doctor may decide to increase your dose to find the most suitable amount of SNAPTAG for you.

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

If you forget to take SNAPTAG
Do not panic. 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 SNAPTAG
Inform your doctor if you intend to stop taking SNAPTAG. If you stop taking SNAPTAG, your cholesterol levels may rise again.

If you have any doubts 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 everybody gets them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear in a short time.
Stop taking SNAPTAG and seek immediate medical help if you experience any of the following reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat that may cause difficulty swallowing;
• severe itching of the skin (with raised hives);
• lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
• muscle tear;
• flat, red, target-shaped or circular spots 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 SNAPTAG and contact your doctor immediately if you have
unusual muscle aches or pains that last 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.

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

• headache; stomach pain; constipation; feeling unwell; muscle pain; feeling of weakness; dizziness;
• increased amount of protein in the urine – values usually return to normal on their own without needing to stop taking SNAPTAG (only for SNAPTAG 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 possible side effects (may occur in 1 to 100 and 1 to 1,000
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 SNAPTAG (only for SNAPTAG 5 mg, 10 mg and 20 mg).

Rare possible side effects (may occur in 1 to 1,000 and 1 to 10,000
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 you are having an allergic reaction, stop taking SNAPTAG and seek immediate medical help;
• muscle damage in adults – as a precaution, stop taking SNAPTAG 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.

Very rare possible side effects (may occur in less than 1 in 10,000
patients)
jaundice (yellowing of the skin and eyes); hepatitis (liver inflammation), blood traces in the urine, nerve damage in arms and legs (numbness), joint pain, memory loss, breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:
diarrhoea (passing loose 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, 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 worsening weakness in arms or legs 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SNAPTAG

• This medicinal product does not require any special storage conditions.
• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the carton after “EXP.”. The expiry date refers to the last day of that month.
• Do not dispose of any medicinal product 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 SNAPTAG contains

• The active substance is rosuvastatin. "SNAPTAG film-coated tablets" contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other components are: Tablet core: Lactose monohydrate, microcrystalline cellulose (Type 102), crospovidone, tribasic magnesium citrate, magnesium stearate.

Coating of the 5 mg tablet:
OPADRY® II Yellow (32K220023):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, yellow iron oxide.
Coating of the 10 mg, 40 mg tablets:
OPADRY® II Pink (32K240026):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, red iron oxide.
Coating of the 20 mg tablet:
OPADRY® II Pink (32K240034):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, red iron oxide.

Description of the appearance of SNAPTAG and contents of the pack
SNAPTAG tablets are available in packs of 28, 60 or 90 film-coated tablets in PA/Al/PVC-Al blisters.
SNAPTAG is available in the following strengths:

• 5 mg film-coated tablets – yellow, round.
• 10 mg film-coated tablets – pink, round.
• 20 mg film-coated tablets – brick red, round.
• 40 mg film-coated tablets – pink, oval, biconvex.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica n. 26, 84083 – Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora -84084 Fisciano (SA)
Exclusive distributor for sale:
ESSECORE S.r.l., Via Giuseppe Saverio Poli, 23 Bari