ATORVASTATIN OPKO 40 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Atorvastatin OPKO 40 mg film-coated tablets EFG

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Atorvastatin OPKO and what is it used for
2. What you need to know before you take Atorvastatin OPKO
3. How to take Atorvastatin OPKO
4. Possible side effects
5. Storage of Atorvastatin OPKO
6. Contents of the pack and other information

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

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating medicines.

Atorvastatin is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood when changes in diet and exercise have not been enough on their own. If you are at high risk of heart disease, Atorvastatin can also be used to reduce this risk even if your cholesterol levels are normal. You should maintain a standard cholesterol-lowering diet during treatment.

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

Do not take Atorvastatin OPKO

• If you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• If you have or have had any liver disease
• If you have had any unusual results from blood tests for liver function for which no reason has been found
• If you are a woman able to have children and are not using adequate contraceptive measures
• If you are pregnant or trying to become pregnant
• If you are breast-feeding
• If you are taking a combination of glecaprevir/pibrentasvir to treat hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before taking atorvastatin:

• If you have severe respiratory failure
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis)
• If you have had a stroke with bleeding in the brain, or have small fluid-filled areas in the brain as a result of previous strokes
• If you have kidney problems
• If you have an underactive thyroid gland (hypothyroidism)
• If you have had muscle problems or repeated, unexplained muscle aches
• If you have had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates)
• If you regularly drink large amounts of alcohol
• If you have a history of liver disease
• If you are over 70 years old
• If you have had myasthenia (a disease that causes muscle weakness that can affect the muscles used for breathing) or myasthenic syndrome (a condition that causes weakness of the eye muscles), as statins can sometimes worsen the condition or trigger myasthenia (see section 4).

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during treatment with atorvastatin to predict your 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).

Also, inform your doctor or pharmacist if you have constant muscle weakness. You may need further tests and treatment to diagnose and treat it.

While you are on this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin OPKO

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are some medicines that may change the effect of atorvastatin or whose effect may be altered by atorvastatin. This type of interaction could make one or both medicines less effective. Another possibility is that it could increase the risk or severity of side effects, including the important muscle damage known as rhabdomyolysis, which is described in section 4:

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

• Certain antibiotics or antifungals, 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 for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with atorvastatin are ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for gastric acidity and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), antacids (indigestion products 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 will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to stop taking atorvastatin. Taking atorvastatin with fusidic acid can, in rare cases, cause muscle weakness, pain on palpation, or muscle pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Using Atorvastatin OPKO with food and drink

See section 3 for instructions on how to take Atorvastatin OPKO. Note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can change the effects of atorvastatin.

Alcohol

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

Pregnancy, breast-feeding, and fertility

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 are using adequate contraceptive measures.

Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin during pregnancy and breast-feeding has not yet been established.

Driving and using machines

Generally, 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 any tools or machines if your ability to use them is affected by this medicine.

Atorvastatin OPKO contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Atorvastatin OPKO

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment, your doctor will give you a cholesterol-lowering diet that you should also follow during treatment with atorvastatin.

The usual starting dose of atorvastatin is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase this dose if necessary, until you are taking the amount 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 whole with water and can be taken at any time of day, with or without food. However, try to take the tablet at the same time each day.

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 OPKO than you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatin OPKO

If you forget to take a dose, simply 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 OPKO

If you have any further questions on the use of this medicine, 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, stop taking the tablets and inform your doctor immediately or go to the casualty department of your nearest hospital.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.
• Severe disease with peeling and severe swelling of the skin, blistering of the skin, mouth, eyes, and genitals, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can develop blisters.
• Muscle weakness, pain on palpation, or muscle pain, and particularly if you also have discomfort or fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after stopping atorvastatin, and can be potentially fatal and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this could be a sign of liver disease. You should consult your doctor as soon as possible.
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Frequency not known:

• Severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing).
• Myasthenic syndrome (a condition that causes weakness of the eye muscles).

Tell 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.

Other possible side effects with Atorvastatin OPKO

Common: may affect up to 1 in 10 people

• nose inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (if you have diabetes, keep a close eye on your blood sugar levels), increased creatine kinase in the blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results showing that your liver function may be affected

Uncommon: may affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood sugar levels (if you have diabetes, keep a close eye on your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, change in taste, memory loss
• blurred vision
• ringing in the ears 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, swelling especially in the ankles (edema), increased temperature
• urine tests positive for white blood cells

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

• vision changes
• unexpected or unusual bleeding or bruising
• jaundice (yellowing of the skin and the whites of the eyes)
• tendon injury

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

• allergic reaction: symptoms can include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, fainting
• hearing loss
• gynecomastia (breast enlargement in men).

Not known: frequency cannot be estimated from the available data:

• constant muscle weakness.

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

• sexual difficulties
• depression
• breathing problems, including persistent coughing and/or difficulty breathing or fever
• diabetes. This is more likely if you have high levels of sugar and fat in your 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 or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin OPKO

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for safe disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin OPKO

• The active substance is atorvastatin calcium. Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are: calcium carbonate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, magnesium stearate, hypromellose, macrogol, titanium dioxide, talc.

Appearance of the product and pack contents

Film-coated tablet, oval, and white to off-white, with "40" engraved on one side and "AT" on the other, with a size of 15.60 x 8.20 mm

Alu/Alu blisters contain 28 film-coated tablets

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

OPKO Health Spain, S.L.U

Plaza Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Date of last revision of this leaflet: November 2023

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