Atorvastatin Bluefish Ab

Leaflet attached to the packaging: 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

Atorvastatin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvastatin Bluefish AB and what is it used for
• 2. Important information 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 is Atorvastatin Bluefish AB and what is it 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 the levels of lipids, known as cholesterol and triglycerides, in the blood when a low-fat diet and changes in lifestyle are not effective on their own. Atorvastatin Bluefish AB can also be used to reduce the risk of heart disease, even if your cholesterol levels are normal. During treatment, you should continue with a standard low-cholesterol diet.

2. Important information before taking Atorvastatin Bluefish AB

When not to take Atorvastatin Bluefish AB

• if you are allergic (hypersensitive) to atorvastatin or any other similar medicine used to lower blood lipid levels or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have had unexplained, abnormal liver function tests,
• if you are taking glecaprevir with pibrentasvir to treat hepatitis C virus infection,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant or breast-feeding women,
• in nursing mothers.

Warnings and precautions

Before starting treatment with Atorvastatin Bluefish AB, you should discuss this with your doctor, pharmacist, or nurse.

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic used to treat bacterial infections) by mouth or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Bluefish AB can cause serious muscle problems (rhabdomyolysis),
• if 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,
• if you have kidney problems,
• if you have hypothyroidism (underactive thyroid),
• if you have had repeated or unexplained muscle pain, muscle weakness, or muscle problems in the past, or similar problems in your family,
• if you have had muscle problems while taking other medicines to lower lipid levels (e.g., other statins or fibrates),
• if you regularly drink large amounts of alcohol,
• if you have had liver disease in the past,
• if you are over 70 years old.

In patients who are at risk, your doctor will order a blood test before starting treatment with Atorvastatin Bluefish AB and possibly 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 at the same time (see section 2 "Atorvastatin Bluefish AB and other medicines").
Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and additional medications may be necessary.
During treatment with Atorvastatin Bluefish AB, your doctor will closely monitor you for the development of diabetes or an increased risk of diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Bluefish AB and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines can change the effect of Atorvastatin Bluefish AB or the effect of these medicines on the body may be changed by Atorvastatin Bluefish AB. This type of interaction can reduce the effectiveness of one or both medicines or increase the risk of serious side effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• letermovir, a medicine used to prevent disease caused by cytomegalovirus,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• other medicines that are known to interact with Atorvastatin Bluefish AB, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Atorvastatin Bluefish AB. Your doctor will tell you when you can safely restart treatment with Atorvastatin Bluefish AB. Taking Atorvastatin Bluefish AB with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Atorvastatin Bluefish AB with food, drink, and alcohol

Information on the use of Atorvastatin Bluefish AB can be found in section 3. However, you should pay attention to the following information:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atorvastatin Bluefish AB.
Alcohol
You should avoid excessive alcohol consumption while taking Atorvastatin Bluefish AB.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Taking Atorvastatin Bluefish AB during pregnancy or breast-feeding is contraindicated.
Taking Atorvastatin Bluefish AB in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Atorvastatin Bluefish AB during breast-feeding is contraindicated.
The safety of Atorvastatin Bluefish AB during pregnancy and breast-feeding has not been established. Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

Atorvastatin Bluefish AB is unlikely to affect your ability to drive or use machines. However, you should not drive if the medicine affects your ability to do so. You should not use any tools or machines if taking the medicine affects your ability to use them.

Atorvastatin Bluefish AB contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the 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, which means it is essentially "sodium-free".

3. How to take Atorvastatin Bluefish AB

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Bluefish AB.
The usual starting dose of Atorvastatin Bluefish AB in adults and children over 10 years old is 10 mg once daily. This dose may be increased if necessary by your doctor, up to a dose suitable for you. Your doctor will adjust the dose of Atorvastatin Bluefish AB at intervals of at least 4 weeks. The maximum dose of Atorvastatin Bluefish AB is 80 mg once daily.
Atorvastatin Bluefish AB tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.
This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

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

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

Taking more than the recommended dose of Atorvastatin Bluefish AB

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

Missing a dose of Atorvastatin Bluefish AB

If you forget to take a dose, you should simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Atorvastatin Bluefish AB

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Bluefish AB can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, you should stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.

Rarely, the following may occur in up to 1 in 1,000 people:

• A severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• A severe skin condition characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. A skin rash with reddish-purple spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. If this is accompanied by a feeling of being unwell or a high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always go away, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.

Very rarely, the following may occur in up to 1 in 10,000 people:

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.
• A condition similar to lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Bluefish AB:

Common side effects (may affect up to 1 in 10 people) include:

• nasal inflammation, 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, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

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

• 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 the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles
• presence of white blood cells in the urine

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

• vision disorders
• unexpected bleeding or bruising (bruises)
• jaundice (yellowing of the skin and whites of the eyes)
• tendon rupture

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

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive growth of breast tissue in men)

Side effects with unknown frequency (frequency cannot be estimated from available data):

• persistent muscle weakness

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

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the risk of developing this condition is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Atorvastatin Bluefish AB

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Bluefish AB contains

• The active substance of the medicine is atorvastatin.
• Each film-coated tablet contains 10 mg of atorvastatin (in the form of calcium trihydrate).
• Each film-coated tablet contains 20 mg of atorvastatin (in the form of calcium trihydrate).
• Each film-coated tablet contains 30 mg of atorvastatin (in the form of calcium trihydrate).
• Each film-coated tablet contains 40 mg of atorvastatin (in the form of calcium trihydrate).
• Each film-coated tablet contains 60 mg of atorvastatin (in the form of calcium trihydrate).
• Each film-coated tablet contains 80 mg of atorvastatin (in the form of calcium trihydrate).

Other ingredients are:
Core:microcrystalline cellulose, lactose monohydrate, calcium carbonate, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, magnesium stearate
Coating (Opadry YS 1-7040):hypromellose (E 464), macrogol 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, 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, 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, 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, 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, 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, 16.8 mm in length and 8.3 mm in width.
Blister pack with PA/Aluminum/PVC/Aluminum foil containing 30 or 90 film-coated tablets, in a cardboard box.
Blister pack with PVC/PVDC/Aluminum foil containing 30, 60, or 90 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area 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
Date of last revision of the leaflet:October 2021