Atorvastatin Bluefish 60 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Atorvastatina Bluefish 10 mg film-coated tablets EFG
Atorvastatina Bluefish 20 mg film-coated tablets EFG
Atorvastatina Bluefish 30 mg film-coated tablets
Atorvastatina Bluefish 40 mg film-coated tablets EFG
Atorvastatina Bluefish 60 mg film-coated tablets
Atorvastatina Bluefish 80 mg film-coated tablets EFG

atorvastatin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet Contents

1. What Atorvastatina Bluefish is and what it is used for

2. What you need to know before taking Atorvastatina Bluefish

3. How to take Atorvastatina Bluefish

4. Possible side effects

5. How to store Atorvastatina Bluefish

6. Contents of the pack and other information

1. What Atorvastatina Bluefish is and what it is used for

Atorvastatina Bluefish belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

This medicine is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, this medicine may also be used to reduce that risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before taking Atorvastatin Bluefish

Do not take Atorvastatin Bluefish

• If you are hypersensitive (allergic) to atorvastatin or to any similar medicine used to lower blood lipids, or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had a liver disease.
• If you have or have had unexplained abnormal results in liver function blood tests.
• If you are using the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.
• If you are a woman of childbearing age and are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine if:

• You have severe respiratory failure.
• You have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• You are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• You have previously had a stroke with bleeding into the brain, or have small accumulations of fluid in the brain due to prior strokes.
• You have kidney problems.
• You have an underactive thyroid gland (hypothyroidism).
• You have repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• You have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• You regularly drink large amounts of alcohol.
• You have a history of liver problems.
• You are over 70 years old.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with atorvastatin to assess your risk of experiencing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatin Bluefish”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines may interfere with the proper functioning of Atorvastatin Bluefish, or the effects of these medicines may be altered by Atorvastatin Bluefish. Such interactions may reduce the effect of one or both medicines. Alternatively, this combination may increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines used to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medicine used to help prevent cytomegalovirus infection.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).
• 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 restart treatment with Atorvastatin Bluefish. Taking atorvastatin together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Taking Atorvastatin Bluefish with food and drink

See section 3 for instructions on how to take Atorvastatin Bluefish. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may alter the effects of this medicine.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take atorvastatin if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take atorvastatin if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine normally does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so safely. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatin Bluefish contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Atorvastatin Bluefish contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablet; hence, it is essentially “sodium-free”.

3. How to take Atorvastatin Bluefish

Before starting treatment, your doctor will place you on a cholesterol-lowering diet, which you must continue during treatment with this medicine.

The usual starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin tablets should be swallowed with a glass of water and may be taken at any time of day, with or without food. However, try to take your tablet at the same time each day.

Always follow exactly the instructions provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide how long your treatment with atorvastatin should last.

Ask your doctor if you think that the effect of atorvastatin is too strong or too weak.

If you take more Atorvastatin Bluefish than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested. Do not forget to bring the medicine package.

If you forget to take Atorvastatin Bluefish

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

If you stop taking Atorvastatin Bluefish

If you have any further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects 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 patients

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.
• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, or rupture, muscle pain, or change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis) that can potentially be life-threatening and lead to kidney problems.

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

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

Other possible adverse effects with Atorvastatina Bluefish:

Common (may affect up to 1 in 10 patients):

• Inflammation of the nasal passages, sore throat, nosebleeds.

• Allergic reactions.

• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood.

• Headache.

• Nausea, constipation, gas, indigestion, diarrhea.

• Joint pain, muscle pain, and back pain.

• Blood test results that may indicate abnormal liver function.

Uncommon (may affect up to 1 in 100 patients):

• Anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully).
• Nightmares, insomnia.
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss.
• Blurred vision.
• Ringing in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain).
• Hepatitis (inflammation of the liver).
• Rash, skin rash and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, feeling of malaise, weakness, chest pain, swelling, especially in the ankles (edema), increased temperature.
• Urine tests positive for white blood cells.

Rare (may affect up to 1 in 1,000 patients):

• Changes in vision.
• Unexpected bleeding or bruising.
• Cholestasis (yellowing of the skin and whites of the eyes).
• Tendon injury.
• Skin rash or mouth ulcers (drug-induced lichenoid reaction).
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

Very rare (may affect up to 1 in 10,000 patients):

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

Frequency not known (cannot be estimated from available data):

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
• Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects of some statins (medicines of the same type):

• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• 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 while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Bluefish

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following {EXP}. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatina Bluefish

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

The other components are:

Tablet core: microcrystalline cellulose (E460), monohydrate lactose, calcium carbonate (E170), hydroxypropylcellulose (E463), sodium croscarmellose type A (E468), colloidal anhydrous silica (E551), magnesium stearate (E572).

Film coating: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b).

Appearance of Atorvastatina Bluefish and contents of the pack

Atorvastatina Bluefish 10 mg film-coated tablets EFG: film-coated, oval-shaped, white tablets marked with the number "10" on one side and the code "ATV" on the other. Length: 8.3 mm, width: 4.2 mm.

Atorvastatina Bluefish 20 mg film-coated tablets EFG: film-coated, oval-shaped, white tablets marked with the number "20" on one side and the code "ATV" on the other. Length: 10.6 mm, width: 5.3 mm.

Atorvastatina Bluefish 30 mg film-coated tablets: film-coated, oval-shaped, white tablets marked with the number "30" on one side and the code "ATV" on the other. Length: 12.2 mm, width: 6.1 mm.

Atorvastatina Bluefish 40 mg film-coated tablets EFG: film-coated, oval-shaped, white tablets marked with the number "40" on one side and the code "ATV" on the other. Length: 13.3 mm, width: 6.7 mm.

Atorvastatina Bluefish 60 mg film-coated tablets: film-coated, oval-shaped, white tablets marked with the number "60" on one side and the code "ATV" on the other. Length: 15.3 mm, width: 7.6 mm.

Atorvastatina Bluefish 80 mg film-coated tablets EFG: film-coated, oval-shaped, white tablets marked with the number "80" on one side and the code "ATV" on the other. Length: 16.8 mm, width: 8.3 mm.

PA/Alu/PVC – Alu Blister packs: 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 200 (10x20) and 500 film-coated tablets.

PVC/PVDC – Alu Blister packs: 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 200 (10x20) and 500 film-coated tablets.

Only certain 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.
47,600 – 04100 Latina (LT)
Italy

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U
P.O. Box 36007
28320 Las Rozas, Madrid, Branch Office 36
Spain

This medicine is authorized in the Member States of the European Economic Area (EEA) under the following names:

Date of the latest review of this leaflet: October 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/