ATORVASTATIN BLUEFISH 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin Bluefish 10 mg film-coated tablets EFG

Atorvastatin Bluefish 20 mg film-coated tablets EFG

Atorvastatin Bluefish 30 mg film-coated tablets

Atorvastatin Bluefish 40 mg film-coated tablets EFG

Atorvastatin Bluefish 60 mg film-coated tablets

Atorvastatin Bluefish 80 mg film-coated tablets EFG

Atorvastatin

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Atorvastatin Bluefish and what is it used for
2. What you need to know before you take Atorvastatin Bluefish
3. How to take Atorvastatin Bluefish
4. Possible side effects
5. Storage of Atorvastatin Bluefish

1. Contents of the pack and further information

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

Atorvastatin Bluefish belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).

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

2. What you need to know before you take Atorvastatin Bluefish

Do not take Atorvastatin Bluefish

• If you are hypersensitive (allergic) to atorvastatin or to any other 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 any liver disease.
• If you have or have had unexplained abnormal results in blood tests for liver function.
• If you use the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.
• If you are a woman of childbearing age and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.

Warnings and precautions

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

• You have severe respiratory failure.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis).
• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• If you have had muscle problems in the past while taking other medicines to lower lipids (e.g., another statin or fibrates).
• If you regularly drink large amounts of alcohol.
• If you have a history of liver problems. If you are over 70 years old.

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with atorvastatin to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side 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 constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

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

Other medicines and Atorvastatin Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. There are some medicines that can affect the proper functioning of Atorvastatin Bluefish or the effects of these medicines may be altered by Atorvastatin Bluefish. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, e.g., cyclosporine.

• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Certain medicines used to treat hepatitis C, e.g., telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medicine that helps prevent cytomegalovirus infection.
• Medicines used to treat AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used for gout), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a medical prescription: St. John's Wort.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatin Bluefish. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatin Bluefish with food and drinks

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

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of this medicine.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

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

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

Do not take atorvastatin if you are breast-feeding your child.

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

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if this medicine affects your ability to use them.

Atorvastatin Bluefish contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them 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; this is essentially "sodium-free".

3. How to take Atorvastatin Bluefish

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should also follow during treatment with this medicine.

The initial dose of atorvastatin is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary, up to the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day.

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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with atorvastatin.

Ask your doctor if you think 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Do not forget to take the medicine package with you.

If you forget to take Atorvastatin Bluefish

If you forget to take a dose, take the next scheduled dose at the correct 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 on the use of this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Rare: may affect up to 1 in 1000 patients

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.
• Weakness, sensitivity, or muscle rupture, pain or change in urine color to reddish-brown, and especially if it occurs at the same time, feeling unwell or high temperature that can be caused by abnormal muscle destruction (rhabdomyolysis) that can be potentially fatal and lead to kidney problems.

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

• If you experience bleeding or bruising problems or unexpected or unusual bleeding, this may suggest 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 side effects with Atorvastatin Bluefish:

Frequent (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), increase in creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.

• Pain in the joints, pain in the muscles, and back pain.

• Blood test results that may show 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, you should continue to carefully monitor your blood sugar levels).
• Nightmares, insomnia.
• Dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss.
• Blurred vision.
• Ringing in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain).
• Hepatitis (inflammation of the liver).
• Rash, skin rash, and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature.
• Positive urine tests for white blood cells.

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

• Vision disturbances.
• Unexpected bleeding or bruising.
• Jaundice (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 inflammation of the blood vessels, vasculitis).

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

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

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

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Talk to your doctor if you experience weakness in your arms or legs that worsens 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. It is more likely if you have high levels of sugars 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date that appears on the blister pack and on the carton after {CAD}. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition ofAtorvastatin Bluefish

• The active ingredient 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:

Core of the tablet:microcrystalline cellulose (E460), lactose monohydrate, calcium carbonate (E170), hydroxypropylcellulose (E463), sodium croscarmellose type A (E468), hydrophobic colloidal silica (E551), magnesium stearate (E572).

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

Appearance of Atorvastatin Bluefish and container contents

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

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

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

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

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

Atorvastatin Bluefish 80 mg film-coated tablets EFG: film-coated tablets, oblong, white in color and 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 some 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

You can requestmore information about this medicinal product by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: October 2024

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