Package Insert: Information for the User

Atorvastatina Bluefish 10 mg Film-Coated Tablets

Atorvastatina Bluefish 20 mg Film-Coated Tablets

Atorvastatina Bluefish 30 mg Tablets

Atorvastatina Bluefish 40 mg Film-Coated Tablets

Atorvastatina Bluefish 60 mg Tablets

Atorvastatina Bluefish 80 mg Film-Coated Tablets

atorvastatina

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

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

This medicineis used to reduce 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 a high risk of heart disease, this medicine may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Bluefish

• If you are hypersensitive (allergic) to atorvastatin or to any other medication used to reduce blood lipids or to any of the other components of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal results in blood tests for liver function.
• If you are using the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication if:

• You have severe respiratory insufficiency.
• 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you are taking or have taken in the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).
• If you have had a previous stroke with cerebral bleeding, or have small fluid embolisms in the brain due to previous strokes.
• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have had muscle problems during previous treatment with other medications to reduce lipids (for example, with 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 instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Other medications and Atorvastatina Bluefish”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, overweight, and high blood pressure.

Other medications and Atorvastatina Bluefish

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including medications obtained without a prescription. There are some medications that may affect the proper functioning of Atorvastatina Bluefish or the effects of these medications may be modified by Atorvastatina Bluefish. This type of interaction may reduce the effect of one or both medications. Alternatively, this concomitant use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in Section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.

• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers, used in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Some medications used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medication that helps prevent citomegalovirus infection.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medications 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 ulcers), phenazone (a pain reliever), colchicine (used for treating gout), and antacids (products for indigestion that contain aluminum or magnesium).
• Over-the-counter medications: St. John's Wort.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteremia).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will instruct you when it is safe to restart treatment with Atorvastatina Bluefish. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatina Bluefish with food and drinks

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

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of this medication.

Alcohol

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

Pregnancy and lactation

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

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and lactation has not been demonstrated. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to handle them.

Atorvastatina Bluefish contains lactose

If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

Atorvastatina Bluefish contains sodium

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

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

The usual initial dose of atorvastatinis 10 mg once a day in adults and children aged 10 years or older. 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 atorvastatinis 80 mg once a day.

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

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in 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 atorvastatinis too strong or too weak.

If you take more Atorvastatina Bluefish than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Do not forget to bring the packaging of the medication.

If you forgot to take Atorvastatina Bluefish

If you forgot to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atorvastatina Bluefish

If you have any other questions about the use of this medication or want to interrupt your treatment, ask your doctor or pharmacist.

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

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

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

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

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

• If you experience unexpected or unusual bleeding or bruising, 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 withAtorvastatina Bluefish:

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

• Inflammation of the nasal passages, sore throat, nasal bleeding.
• Allergic reactions.
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.

• Joint pain, muscle pain, and back pain.

• Abnormal results from blood tests that may show abnormal liver function.

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, 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):

• Visual disturbances.
• Unexpected or unusual bleeding or bruising.
• Jaundice (yellowing of the skin and eyes).
• Tendon damage.
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction).
• Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis).

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or oppression, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Loss of hearing.
• Gynecomastia (breast enlargement in men and women).

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

• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or eyelid drooping, 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 blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAtorvastatina 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), hydroxypropyl cellulose (E463), croscarmellose sodium type A (E468), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating of the film:hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b).

Appearance of Atorvastatina Bluefish and packaging content

Atorvastatina Bluefish 10 mg film-coated tablets: film-coated tablets, oblong, white, 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: film-coated tablets, oblong, white, 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 tablets, oblong, white, 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: film-coated tablets, oblong, white, 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 tablets, oblong, white, 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: film-coated tablets, oblong, white, 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 packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB
P.O. Box 49013

100 28 Stockholm

Sweden

Responsible 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 medicinal product, please contact the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Sucursal 36

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:October 2024

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/