Package Leaflet: Information for the User

Atorvastatina Teva-ratiopharm 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Atorvastatina Teva-ratiopharm is and what it is 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. Storage of Atorvastatina Teva-ratiopharm

6. Contents of the pack and additional information

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 lipids such as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes on their own have failed.

If you present a high risk of heart disease, Atorvastatina Teva-ratiopharm may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

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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 any liver disease.
• if you have or have had abnormal results in liver function blood tests.
• 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
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult 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 within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Atorvastatina Teva-ratiopharm may cause severe muscle problems (rhabdomyolysis)
• if you have had a previous stroke with brain bleeding, or have small fluid accumulations 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 medicines 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
• 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)

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 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 persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

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

Other medicines and atorvastatina Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

• Medicines used to modify the functioning of your immune system, for example ciclosporin.
• Certain antibiotics or antifungal medicines, for example erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines 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, Medicines to regulate your heart rhythm, for example digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of HIV/AIDS, for example ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc. Some medicines used to treat hepatitis C, such as telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines that are known to interact with Atorvastatina Teva-ratiopharmincluding:ezetimibe (which reduces cholesterol),warfarin(which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medicines: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will instruct you when it is safe to restart the treatment with Atorvastatina Teva-ratiopharm. Taking Atorvastatina Teva-ratiopharm in combination with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• daptomycin (a medicine used to treat skin and skin structure infections 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:

Orange juice:

Do not take more than one or two small glasses of orange juice per day because large amounts of orange juice may alter the effects of atorvastatin.

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 intend 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 breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Atorvastatina Teva-ratiopharm contains sodium

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

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

The usual initial dose of atorvastatin is 10 mg once a day in adults and children aged 10 years and above. Your doctor may increase it if necessary to 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.

Atorvastatin tablets should be swallowed whole 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 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), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication 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 the missed doses.

If you interrupt treatment with Atorvastatina Teva-ratiopharm

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

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

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

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

• 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.

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

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. 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 of Atorvastatina Teva-ratiopharm

• Frequent: may affect up to 1 in 10 people:
• nasal inflammation, sore throat, nasal bleeding
• 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
• Abnormal blood test results that may show abnormal liver function

Poco frequent: may affect up to 1 in 100 people

• 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)
• Heptatitis (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

• Visual disturbances
• Unexpected or unusual bleeding or bruising
• Bile duct obstruction (yellow discoloration of the skin and white of the eyes)
• Tendon damage
• Skin rash or ulcers in the mouth (drug reaction)
• Lesions on the skin or purple spots (signs of inflammation of blood vessels, vasculitis)

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

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

Frequency not known: cannot be estimated from available data:

• Constant muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness, which 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, eyelid drooping, difficulty swallowing, or difficulty breathing

The 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. 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 medication.

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.

Store below30°C.

Do not use Atorvastatina Teva-ratiopharm after the expiration date that appears on the packaging after“CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Atorvastatina Teva-ratiopharm

The active ingredient is atorvastatina. Each tablet contains 10 mg of atorvastatina, equivalent to 10.3625 mg of atorvastatina calcium.

The other components are:

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

Appearance of the product and contents of the package

Film-coated tablets.

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

Each package contains 28 tabletsconditioned in blister or in HDPE bottle (contains desiccant).

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.

28108 – Alcobendas (Madrid). Spain.

Responsible for manufacturing

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza. Spain.

Last review date of this leaflet: March 2025

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74043/P_74043.html