Atorvastatin bluefish ab

Package leaflet: Information for the user

Atorvastatin Bluefish AB, 10 mg, film-coated tablets
Atorvastatin Bluefish AB, 20 mg, film-coated tablets
Atorvastatin Bluefish AB, 30 mg, film-coated tablets
Atorvastatin Bluefish AB, 40 mg, film-coated tablets
Atorvastatin Bluefish AB, 60 mg, film-coated tablets
Atorvastatin Bluefish AB, 80 mg, film-coated tablets
Atorvastatinum
Please read all of 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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

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

1. What Atorvastatin Bluefish AB is and what it is used for

Atorvastatin Bluefish AB belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Bluefish AB is used to reduce levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes alone are not effective. Atorvastatin Bluefish AB may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. What you need to know before taking Atorvastatin Bluefish AB

Do not take Atorvastatin Bluefish AB:

• if you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have unexplained abnormal liver function test results,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing potential who are not using effective contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women.

Warnings and precautions
Before starting Atorvastatin Bluefish AB, discuss this with your doctor, pharmacist or nurse if:

• you have severe respiratory failure,
• you are taking or have taken fusidic acid (a medicine used to treat bacterial infections) orally or by injection within the last 7 days. Concomitant use of fusidic acid with Atorvastatin Bluefish AB may lead to serious muscle problems (rhabdomyolysis),
• you have had a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• you have kidney problems,
• you have hypothyroidism (underactive thyroid),
• you have a history of recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in your family,
• you have experienced muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are aged over 70 years.

For patients with any of the above conditions, your doctor may order a blood test before starting treatment with Atorvastatin Bluefish AB and, where appropriate, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken concomitantly (see section 2 “Atorvastatin Bluefish AB and other medicines”). Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medicines may be needed to diagnose and treat this condition.

During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and fats, overweight, and high blood pressure may be at increased risk of developing diabetes.

Atorvastatin Bluefish AB and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may alter the effect of Atorvastatin Bluefish AB, or the effect of these medicines may be altered by Atorvastatin Bluefish AB. Such interactions may reduce the effectiveness of one or both medicines and may increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and the combination medicines elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• other medicines known to interact with Atorvastatin Bluefish AB include ezetimibe (a cholesterol-lowering medicine), warfarin (a medicine that reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (a medicine used to treat gout), and antacids (medicines for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St. John’s wort (Hypericum perforatum),
• if you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Atorvastatin Bluefish AB. Taking Atorvastatin Bluefish AB together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.

Atorvastatin Bluefish AB with food, drink and alcohol
Information on taking Atorvastatin Bluefish AB is provided in section 3. However, please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atorvastatin Bluefish AB.

Alcohol
Avoid excessive alcohol consumption while taking this medicine. Further information is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Atorvastatin Bluefish AB must not be used by women who are pregnant or planning to become pregnant.
Atorvastatin Bluefish AB must not be used by women of childbearing potential unless they are using effective contraception.
Atorvastatin Bluefish AB must not be used during breastfeeding.
The safety of Atorvastatin Bluefish AB during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine usually does not affect the ability to drive or operate machinery. However, you should not drive or operate machinery if this medicine affects your ability to do so.

Atorvastatin Bluefish AB contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Atorvastatin Bluefish AB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablet, meaning the medicine is considered "sodium-free".

3. How to take Atorvastatin Bluefish AB

Before starting treatment, your doctor will recommend a low-cholesterol diet, which should be continued during treatment with Atorvastatin Bluefish AB.

The usual starting dose of Atorvastatin Bluefish AB in adults and children aged 10 years and older is 10 mg once daily. This dose may be increased by your doctor as needed, up to the dose appropriate for you. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Atorvastatin Bluefish AB is 80 mg once daily.

Swallow the Atorvastatin Bluefish AB tablets whole with water. They can be taken at any time of day, with or without food. However, try to take the tablet at the same time each day.

Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The duration of treatment with Atorvastatin Bluefish AB will be determined by your doctor.

If you feel the effect of Atorvastatin Bluefish AB is too strong or too weak, consult your doctor.

Taking more Atorvastatin Bluefish AB than prescribed
If you accidentally take too many tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

If you forget to take Atorvastatin Bluefish AB
If you forget to take a dose, simply take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Atorvastatin Bluefish AB
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions listed below, they should stop taking
the medicine immediately and contact their doctor or go to the emergency department of the
nearest hospital without delay.
Rare: may occur in up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

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

• Unexpected or unusual bleeding or bruising, which may indicate liver abnormalities. Medical advice should be sought immediately.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Atorvastatin Bluefish AB:
Common adverse reactions (may occur in up to 1 in 10 people) include:

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

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

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers, hands, or feet, reduced sensitivity to pain and touch, taste disturbances, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling (especially in the ankles), elevated temperature
• Presence of white blood cells in urine analysis

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

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive development of glandular breast tissue in males)

Adverse reactions with unknown frequency: frequency cannot be determined from available data

• Persistent muscle weakness

Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes; the likelihood of developing diabetes is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. Your doctor will perform appropriate tests during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity or the representative of the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvastatin Bluefish AB
Keep the medicine out of sight and reach of children.
No special precautions for storage are required.
Do not use this medicine after the expiry date stated on the blister or carton after:
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Atorvastatin Bluefish AB contains

• The active substance is atorvastatin.
• Each coated tablet contains 10 mg atorvastatin (as calcium trihydrate salt).
• Each coated tablet contains 20 mg atorvastatin (as calcium trihydrate salt).
• Each coated tablet contains 30 mg atorvastatin (as calcium trihydrate salt).
• Each coated tablet contains 40 mg atorvastatin (as calcium trihydrate salt).
• Each coated tablet contains 60 mg atorvastatin (as calcium trihydrate salt).
• Each coated tablet contains 80 mg atorvastatin (as calcium trihydrate salt).

Other ingredients are:
Tablet core: microcrystalline cellulose, monohydrate lactose, calcium carbonate,
hydroxypropylcellulose, sodium croscarmellose (type A), colloidal anhydrous silica, magnesium stearate
Tablet coating (Opadry YS 1-7040): hypromellose (E 464), polyethylene glycol 8000, titanium dioxide (E 171), talc

What Atorvastatin Bluefish AB looks like and contents of the pack
Atorvastatin Bluefish AB, 10 mg: White, round film-coated tablets with "10" embossed on one side and "ATV" on the other, measuring 8.3 mm in length and 4.2 mm in width.
Atorvastatin Bluefish AB, 20 mg: White, round film-coated tablets with "20" embossed on one side and "ATV" on the other, measuring 10.6 mm in length and 5.3 mm in width.
Atorvastatin Bluefish AB, 30 mg: White, round film-coated tablets with "30" embossed on one side and "ATV" on the other, measuring 12.2 mm in length and 6.1 mm in width.
Atorvastatin Bluefish AB, 40 mg: White, round film-coated tablets with "40" embossed on one side and "ATV" on the other, measuring 13.3 mm in length and 6.7 mm in width.
Atorvastatin Bluefish AB, 60 mg: White, round film-coated tablets with "60" embossed on one side and "ATV" on the other, measuring 15.3 mm in length and 7.6 mm in width.
Atorvastatin Bluefish AB, 80 mg: White, round film-coated tablets with "80" embossed on one side and "ATV" on the other, measuring 16.8 mm in length and 8.3 mm in width.

Aluminium/PA/PVC/Aluminium foil blister pack containing 30 or 90 film-coated tablets, in a cardboard carton.
PVC/PVDC/Aluminium foil blister pack containing 30, 60 or 90 film-coated tablets, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer
Haupt Pharma Latina S.R.L
Borgo San Michele S.S 156 KM. 47600
04100 Latina
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Atorvastatin Bluefish AB 10 mg, 20 mg, 40 mg, 80 mg, Filmtabletten
Spain: Atorvastatin Bluefish 10 mg, 20 mg, 40 mg, 80 mg comprimidos recubiertos con película EFG
Atorvastatin Bluefish 30 mg, 60 mg comprimidos recubiertos con película
Ireland: Atorvastatin Bluefish 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg Film-coated tablets
Poland: Atorvastatin Bluefish AB