Omegastatin

Package leaflet: Information for the patient

Omegastatin 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
Generic 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, ask 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, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT OMEGASTATIN IS AND WHAT IT IS USED FOR

Omegastatin belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Omegastatin is used to reduce levels of lipids in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been successful. If you are at high risk of cardiovascular disease, Omegastatin may also be used to reduce this risk, even if cholesterol levels are normal. You must continue a standard cholesterol-lowering diet during treatment.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OMEGASTATIN

Do not take Omegastatin

• if you are allergic to atorvastatin, or to any other medicines used to lower lipid levels in the blood, or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had liver disease.
• if liver function tests have shown unexplained abnormal results.
• if you are a woman of childbearing age and are not using a reliable method of contraception.
• if you are pregnant or planning a pregnancy.
• if you are breastfeeding.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Omegastatin.
Below are reasons why Omegastatin may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders.
• if you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class).
• if you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) taken orally or by injection. The combination of fusidic acid and Omegastatin can lead to serious muscle problems (rhabdomyolysis).
• if you regularly consume large amounts of alcohol.
• if you have a history of liver disease.
• if you are over 70 years old.
• if you have or have had myasthenia (a disease characterised by generalised 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).

Check with your doctor or pharmacist before taking Omegastatin

• if you suffer from severe respiratory insufficiency.

Also inform your doctor or pharmacist if you have persistent muscle weakness.
Additional tests and medicines may be needed to diagnose and treat this condition.
If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with Omegastatin to assess the risk of muscle-related adverse effects.
It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section “Other medicines and Omegastatin”).
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 blood sugar levels, are overweight, and have high blood pressure.

Other medicines and Omegastatin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the effect of Omegastatin, or the effect of these medicines can be altered by Omegastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify how the immune system works, e.g. cyclosporine.
• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Omegastatin include ezetimibe (lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), antacids (indigestion remedies containing aluminium and magnesium).
• Over-the-counter medicines: St. John’s wort.
• 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 Omegastatin. Taking Omegastatin with fusidic acid may rarely lead to muscle aching or pain (rhabdomyolisis). For further information on rhabdomyolysis, see section 4.

Omegastatin with food, drinks and alcohol
Please consider the following information:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice can alter the effects of Omegastatin.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see the section “Warnings and precautions”.
Omegastatin tablets can be taken at any time of day, with or without food (see section 3. How to take Omegastatin).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Women of childbearing age must use an effective method of contraception.
Do not take Omegastatin if you are breastfeeding.
The safety of Omegastatin during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect the ability to drive or use machines. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to operate them is impaired by this medicine.

3. HOW TO TAKE OMEGASTATIN

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet,
and you must continue to follow this diet during treatment with Omegastatin.
The usual starting dose of Omegastatin is 10 mg once daily in adults and children aged 10 years and older.
If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dose at intervals of 4 or more weeks.
The maximum dose of Omegastatin is 80 mg once daily for adults and 20 mg once daily for children.
Omegastatin tablets should be swallowed whole with water and may be taken at any time of day, with or without food.
However, try to take the tablets at the same time each day.
The 20 mg, 40 mg, and 80 mg Omegastatin tablets may be divided into equal parts.
The duration of treatment with Omegastatin is determined by your doctor.
If you think that the effect of Omegastatin is too strong or too weak, talk to your doctor.
If you take more Omegastatin than you should
If you accidentally take too many Omegastatin tablets (more than the prescribed dose), contact your doctor or the nearest hospital for advice.
If you forget to take Omegastatin
If you miss a dose, take your next dose at the usual time. Do not take a double dose to make up for the missed tablet.
If you stop taking Omegastatin
If you have any doubts about using this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following serious adverse reactions or symptoms, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department.

Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to significant breathing difficulties.
• A serious condition associated with severe skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience muscle weakness, tenderness, pain, or muscle breakdown, or notice red-coloured urine, especially if you also feel unwell and have a high fever, this may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

Very rare: may affect up to 1 in 10,000 people:

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like illness syndrome (including skin rash, joint problems, and effects on blood cells).

Other adverse reactions that may occur with Omegastatin

Common adverse reactions (may affect up to 1 in 10 people) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Changes in liver function laboratory tests.

Uncommon adverse reactions (may affect up to 1 in 100 people) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, reduced sensation or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin eruption, and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells

Rare adverse reactions (may affect up to 1 in 1,000 people) include:

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage.

Very rare adverse reactions (may affect up to 1 in 10,000 people) include:

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breast in men and women).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data) include:

• 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 the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Possible adverse reactions reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Breathing difficulties including persistent cough and/or shortness of breath or fever
• 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.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OMEGASTATIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after
EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What Omegastatin contains
The active substance is atorvastatin.
Each 10 mg tablet contains 10 mg of atorvastatin, equivalent to 10.36 mg of atorvastatin calcium.
Each 20 mg tablet contains 20 mg of atorvastatin, equivalent to 20.73 mg of atorvastatin calcium.
Each 40 mg tablet contains 40 mg of atorvastatin, equivalent to 41.45 mg of atorvastatin calcium.
Each 80 mg tablet contains 80 mg of atorvastatin, equivalent to 82.90 mg of atorvastatin calcium.

The other components of the tablet core are microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, and magnesium stearate.

The other components of the film coating are hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80, and titanium dioxide (E171).

This medicinal product is available as film-coated tablets in strengths of 10 mg, 20 mg, 40 mg, and 80 mg.

Description of the appearance of Omegastatin and packaging contents
Omegastatin 10 mg film-coated tablets, white to off-white, elliptical, biconvex tablets with "10" engraved on one side.
Omegastatin 20 mg film-coated tablets, white to off-white, elliptical, biconvex tablets with a score line on one side and "20" engraved on the other side. The tablet can be divided into two equal halves.
Omegastatin 40 mg film-coated tablets, white to off-white, elliptical, biconvex tablets with a score line on one side and "40" engraved on the other side. The tablet can be divided into two equal halves.
Omegastatin 80 mg film-coated tablets, white to off-white, elliptical, biconvex tablets with a score line on one side and "80" engraved on the other side. The tablet can be divided into two equal halves.

Omegastatin is available in PA/Al/PVC-Al blisters containing 10 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy
Manufacturer responsible for batch release
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo n. 1 – 03012 Anagni (FR), Italy

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