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 using 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 doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvastatin Bluefish AB

When not to take Atorvastatin Bluefish AB

• if the patient is hypersensitive (allergic) 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 the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• in women who are planning to become pregnant.

Warnings and precautions

Before starting treatment with Atorvastatin Bluefish AB, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Bluefish AB can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism (underactive thyroid),
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Atorvastatin Bluefish AB and, if possible, 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").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atorvastatin Bluefish AB, the doctor will closely monitor the patient for the development of diabetes or the risk of developing 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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may affect the action of Atorvastatin Bluefish AB or the effect of these medicines on the body may be altered by Atorvastatin Bluefish AB. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe 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 for 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 a 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 known to interact with Atorvastatin Bluefish AB, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), 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 the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Bluefish AB. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin Bluefish AB. Taking Atorvastatin Bluefish AB with fusidic acid can rarely lead to 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, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can affect the action of Atorvastatin Bluefish AB.
Alcohol
Avoid excessive alcohol consumption while taking Atorvastatin Bluefish AB.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Atorvastatin Bluefish AB during pregnancy or planning to become pregnant 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 breastfeeding is contraindicated.
The safety of Atorvastatin Bluefish AB during pregnancy and breastfeeding has not been established. Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. Do not use any tools or machines if taking the medicine affects the ability to use them.

Atorvastatin Bluefish AB contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 the medicine is considered "sodium-free".

3. How to take Atorvastatin Bluefish AB

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

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

If the patient feels that the effect of Atorvastatin Bluefish AB is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atorvastatin Bluefish AB than recommended

If the patient has accidentally taken too many Atorvastatin Bluefish AB tablets (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Bluefish AB

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

Stopping treatment with Atorvastatin Bluefish AB

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the serious side effects, they should stop taking the medicine and contact their doctor or go to the emergency department of the 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 disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. A skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. If the patient also experiences malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops 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 the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult their 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 occur in up to 1 in 10 people) include:

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in patients with diabetes, 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 occur in up to 1 in 100 people) include:

• loss of appetite, weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers, 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 rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, increased temperature
• presence of white blood cells in the urine

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

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

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

• allergic reactions - 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
• gynecomastia (excessive growth of breast tissue in men)

Side effects with unknown frequency: the frequency cannot be determined from the 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 disease 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, the doctor will perform the necessary tests on the patient.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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 can help gather more information on the safety of the 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 a trihydrate calcium salt).
• Each film-coated tablet contains 20 mg of atorvastatin (in the form of a trihydrate calcium salt).
• Each film-coated tablet contains 30 mg of atorvastatin (in the form of a trihydrate calcium salt).
• Each film-coated tablet contains 40 mg of atorvastatin (in the form of a trihydrate calcium salt).
• Each film-coated tablet contains 60 mg of atorvastatin (in the form of a trihydrate calcium salt).
• Each film-coated tablet contains 80 mg of atorvastatin (in the form of a trihydrate calcium salt).

Other ingredients are:
Tablet core:microcrystalline cellulose, lactose monohydrate, calcium carbonate, hydroxypropyl cellulose, sodium croscarmellose (type A), silicon dioxide, magnesium stearate
Tablet 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