ATORVASTATIN TEVA-RATIOPHARM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina Teva-ratiopharm 20 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, 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:

1. What is Atorvastatina Teva-ratiopharm and what is it used for
2. What you need to know before you take Atorvastatina Teva-ratiopharm
3. How to take Atorvastatina Teva-ratiopharm
4. Possible side effects
5. Storing Atorvastatina Teva-ratiopharm
6. Contents of the pack and other information

1. What is Atorvastatina Teva-ratiopharm and what is it used for

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

Atorvastatina Teva-ratiopharm is used to reduce lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not worked.

If you are at high risk of heart disease, Atorvastatina Teva-ratiopharm can 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 Atorvastatina Teva-ratiopharm

Do not take Atorvastatina Teva-ratiopharm

• 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 a disease that affects the liver.
• if you have or have had unexplained abnormal results in blood tests for liver function.
• 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
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Atorvastatina Teva-ratiopharm:

• if you have severe respiratory failure
• 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 Atorvastatina Teva-ratiopharm can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled areas 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 previously had muscle problems during treatment with other lipid-lowering medicines (e.g. 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
• 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)

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 Atorvastatina Teva-ratiopharm").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications 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 sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatina Teva-ratiopharm

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

There are some medicines that can affect the proper functioning of Atorvastatina Teva-ratiopharm or the effects of these medicines may be altered by Atorvastatina Teva-ratiopharm. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• Medicines used to modify the functioning of your immune system, e.g. cyclosporin.
• 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 for regulating your heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc. Some medicines used in the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines that are known to interact with Atorvastatina Teva-ratiopharm 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 prescription: St. John's Wort.
• 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 Atorvastatina Teva-ratiopharm. Taking Atorvastatina Teva-ratiopharm in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatina Teva-ratiopharm with food and drinks

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

Grapefruit juice:

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can alter the effects of atorvastatin.

Alcohol:

Avoid drinking large amounts of 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 are using 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.

Ask your doctor or pharmacist for advice before taking 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.

Atorvastatina Teva-ratiopharm contains sodium

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

3. How to take Atorvastatina Teva-ratiopharm

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

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 until you reach 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.

Atorvastatina Teva-ratiopharm tablets should be swallowed whole 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 the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Teva-ratiopharm

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

If you take more Atorvastatina Teva-ratiopharm than you should

If you accidentally take too many Atorvastatina Teva-ratiopharm tablets (more than your usual daily dose), talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Take the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Teva-ratiopharm

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 Atorvastatina Teva-ratiopharm

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 notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or go to the emergency department of the 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 breathing.

• Severe skin disease with severe scaling 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.

• Muscle weakness, pain on palpation, pain, rupture, or brownish-red discoloration of the urine, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatin, and can be fatal and cause kidney problems.

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

• If you experience bleeding or bruising problems, 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 Atorvastatina Teva-ratiopharm

• Frequent: may affect up to 1 in 10 people:
• nose inflammation, 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
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite (anorexia), 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 people

• vision changes
• 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 people

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

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).
• consult your doctor if you experience weakness in the 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 including persistent cough and/or difficulty breathing or fever
• diabetes. This is more likely if you have high levels of sugar and fat 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 or pharmacist, even if it is possible side effects 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. Storing Atorvastatina Teva-ratiopharm

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

Store below 30°C.

Do not use Atorvastatina Teva-ratiopharm after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

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

6. Additional Information

Composition of Atorvastatina Teva-ratiopharm

The active ingredient is atorvastatin. Each tablet contains 20 mg of atorvastatin, equivalent to 20.725 mg of atorvastatin calcium.

The other components are:

• Microcrystalline cellulose
• Anhydrous sodium carbonate
• Maltose
• Sodium croscarmellose
• Magnesium stearate
• Hypromellose (Pharmacoat Gr. 606)
• Hydroxypropylcellulose
• Triethyl citrate
• Polysorbate 80
• Titanium dioxide (E-171)

Appearance of the product and packaging content

Film-coated tablets.

The tablets are white or almost white, elliptical, biconvex, and smooth.

Each pack contains 28 tablets packaged in blisters or in an HDPE bottle (contains desiccant).

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1ª planta.

28108 – Alcobendas (Madrid). Spain.

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza. Spain.

Date of the last revision of this prospectus: March 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74045/P_74045.html