Rosuvastatin and omega-3 Spa Societa Prodotti Antibiotici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici 5 mg/1000 mg soft capsules

rosuvastatin / omega-3 acid ethyl esters 90
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, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici is and what it is used for
What you need to know before taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
How to take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
Possible side effects
How to store Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
Contents of the pack and other information

1. What Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici is and what it is used for

Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici contains the active substances rosuvastatin and omega-3 acid ethyl esters 90.
Rosuvastatin belongs to a group of medicines called statins. Omega-3 acid ethyl esters 90 belong to a group of medicines called cholesterol and triglyceride-lowering agents.
You have been prescribed Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici for the treatment of high levels of cholesterol and triglycerides in the blood.
If you have high cholesterol and triglyceride levels, this means you are at risk of heart attack or stroke.
You have been prescribed Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol and triglyceride levels. While taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici, you must continue following a cholesterol-lowering diet and maintain regular physical exercise.

Why it is important to keep taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
For many people, high cholesterol and triglyceride levels do not affect how they feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and causing a heart attack or stroke. By lowering cholesterol and triglyceride levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You must continue taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici, even if your cholesterol and triglyceride levels have returned to normal, to prevent them from rising again. However, you must stop taking it on medical advice or if you become pregnant.

2. What you need to know before taking Rosuvastatina e Omega 3 SPA Società Prodotti

Antibiotics
Do not take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics:

If you are allergic to rosuvastatin, omega-3 ethyl esters 90, soy, or any of the other ingredients of this medicine (listed in section 6). Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics may contain traces of soybean oil.
If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics 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 pain.
If you are taking a medicine called cyclosporine (used, for example, after organ transplant).
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics or other related medicines.

If any of the above apply to you (or if you have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina e Omega 3 SPA Società Prodotti
Antibiotics:

If you have kidney problems.
If you have liver problems.
If you have experienced repeated or unexplained muscle cramps or pain, have 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 have persistent muscle weakness.
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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).
If you have or have had heart problems.
If you experience dizziness, fatigue, palpitations, or shortness of breath, as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).
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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics”.
If you are taking or have been administered within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics can lead to serious muscle problems (rhabdomyolysis).
If you are over 70 years old.
If you have severe respiratory failure.
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If you are scheduled for or have recently undergone surgery.
If you have recently suffered trauma.
If you have uncontrolled diabetes.
If you are allergic to fish.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics. Discontinue use of Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics.
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 the blood, are overweight, and have high blood pressure.
Other medicines and Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines:

cyclosporine (used, for example, after organ transplant)
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 – please read the 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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics, or the effect of Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics 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 advise you when it is safe to resume treatment with Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics. Taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information about rhabdomyolysis, see section 4.
Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics with food and drink
Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics can be taken at any time of day, preferably with food to avoid gastrointestinal discomfort.
Pregnancy and breastfeeding
Do not take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics, you must stop immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics 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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics – this medicine does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics. If you experience dizziness, consult your doctor before driving or operating machinery.
Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotics may contain traces of soybean oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Recommended dose
The recommended dose is 4 capsules per day.
Administration of the capsules
Swallow each capsule whole. Take the capsules with food to avoid abdominal discomfort.
Take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici once daily. It can
be taken at any time of day. Try to take the capsules at the same time each day; this may help you remember to take them.
Periodic cholesterol checks
It is important to visit 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 the dose to the amount of Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici most suitable for you.
If you take more Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici 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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici.
If you forget to take Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
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 Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici
Inform your doctor if you intend to stop taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici. If you stop taking Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici, your cholesterol and triglyceride 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. Usually they are mild and disappear within a short time.

Stop taking Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici 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 that may cause difficulty swallowing;
Severe itching of the skin (with raised hives);
Reddish, flat spots, target-shaped or circular rashes 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici and contact your doctor immediately

if you have unusual muscle pains or cramps lasting longer than expected. 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.
if you experience muscle tearing
if you develop lupus-like syndrome (including skin rash, joint problems, and effects on blood cells).

Side effects associated with rosuvastatin
Common side effects (may affect up to 1 in 10 people):

Headache
Stomach pain
Constipation
Feeling unwell
Muscle pain
Feeling of weakness
Dizziness
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 side effects (may affect up to 1 in 100 people):

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 Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici.

Rare side effects (may affect up to 1 in 1,000 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). If you suspect you are having an allergic reaction, stop taking Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici and seek immediate medical help
Muscle damage in adults – as a precaution, stop taking Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici and contact your doctor immediately if you have unusual muscle cramps 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).

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

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

Side effects of unknown frequency (frequency cannot be estimated from available data) may include:

Diarrhea (passing loose stools)
Cough
Shortness of breath
Edema (swelling)
Sleep disorders, including insomnia and nightmares
Sexual problems
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 labored breathing.

Side effects associated with omega-3 ethyl esters 90
Common side effects (may affect up to 1 in 10 people):

Fast, irregular heartbeat
Stomach problems such as bloating, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching, acid reflux, feeling unwell (nausea), and vomiting

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

High blood glucose levels
Gout
Dizziness
Taste disturbances
Headache
Low blood pressure
Nosebleeds
Blood in the stool
Skin rash.

Rare side effects (may affect up to 1 in 1,000 people):

Allergic reactions
Itchy rash (urticaria)
Liver problems, possibly affecting results of certain blood tests.

Side effects of unknown frequency (frequency cannot be estimated from available data) may include:

Itching.

If any of the side effects become severe or if you notice a side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Rosuvastatin and Omega 3 SPA Società Prodotti Antibiotici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
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. Pack contents and other information

What Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici contains

The active substances are rosuvastatin and omega-3 acid ethyl esters 90.
The other components are: gelatin, glycerol (E422), hypromellose 2910, amino methacrylate copolymer (=Eudragit® E PO), magnesium oxide (E530), triethyl citrate (E1505).

May contain traces of soybean oil.
Description of the appearance of Rosuvastatina e Omega 3 SPA Società Prodotti Antibiotici and
pack contents
White, film-coated, oblong soft capsules containing pale yellow oil.
Blister packs in oPA/Al/PVC-Al in a cardboard box: 28 or 32 soft capsules.
Blister packs in PVC/Al in a sealed pouch with a cardboard carton: 28 or 30 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A.
Via Biella 8 – 20143 Milan (Italy).
Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz (Poland).