ATORVASTATIN DAVURGAMA 10 mg FILM-COATED TABLETS

Introduction

Prospective: Information for the User

Atorvastatin Davurgama 10 mg film-coated tablets EFG

Atorvastatin Davurgama 20 mg film-coated tablets EFG

Atorvastatin Davurgama 30 mg film-coated tablets

Atorvastatin Davurgama 40 mg film-coated tablets EFG

Atorvastatin Davurgama 60 mg film-coated tablets

Atorvastatin Davurgama 80 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What is Atorvastatin Davurgama and what is it used for
2. What you need to know before taking Atorvastatin Davurgama
3. How to take Atorvastatin Davurgama
4. Possible adverse effects
5. Storage of Atorvastatin Davurgama
6. Package contents and additional information

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

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

Atorvastatin Davurgama is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have failed on their own. If you are at high risk of heart disease, Atorvastatin Davurgama 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 taking Atorvastatin Davurgama

Do not take Atorvastatin Davurgama

• if you are allergic to atorvastatin or any of the other components of this medication listed in section 6.
• if you have or have had any 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 breastfeeding.
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take atorvastatin:

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) orally or by injection. The combination of fusidic acid and this medication can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled blisters 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 medications (e.g., with another statin or fibrates)
• if you have or have had myasthenia (a disease that causes general muscle weakness, which in some cases affects the muscles used for breathing), or ocular myasthenia (a disease that causes eye muscle weakness), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4)
• 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 this medication to predict the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 "Other medications and Atorvastatin Davurgama").

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

While taking this medication, your doctor will monitor you for diabetes or the 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 medications and Atorvastatin Davurgama

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

There are some medications that can change the effect of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction can decrease the effect of one or both medications. Alternatively, it could increase the risk or severity of adverse effects, including a serious condition that causes muscle deterioration known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, e.g., cyclosporine
• Certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medications 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; medications to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus

• Medications used in the treatment of AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• 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 ulcer), phenazone (a pain reliever), colchicine (used for gout), and antacids (products for indigestion that contain aluminum or magnesium)
• Over-the-counter medications: St. John's Wort
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication temporarily. Your doctor will indicate when it is safe to restart treatment with this medication. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood)

Taking Atorvastatin Davurgama with food and drinks

See section 3 for instructions on how to take atorvastatin. 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 atorvastatin.

Alcohol

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

Pregnancy and breastfeeding

DO NOT take atorvastatin if you are pregnant, think you may be pregnant, or plan to become pregnant.

DO NOT take atorvastatin if you are of childbearing age unless you take adequate contraceptive measures.

DO NOT take atorvastatin if you are breastfeeding your child.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

The safety of atorvastatin during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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 machines if this medication affects your ability to operate them.

Atorvastatin Davurgama contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Atorvastatin Davurgama

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The initial dose of atorvastatin is usually 10 mg once a day in adults and children from 10 years old. 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.

The tablets of Atorvastatin Davurgama 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.

Atorvastatin Davurgama 20 mg, 40 mg, and 80 mg

The tablet can be divided into equal doses.

Your doctor will decide the duration of treatment with Atorvastatin Davurgama

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

If you take more Atorvastatin Davurgama than you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), consult your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Davurgama

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 missed doses.

If you interrupt treatment with Atorvastatin Davurgama

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse 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 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.

• Weakness, sensitivity, pain, or muscle rupture, or brownish-red 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 adverse effects with Atorvastatin Davurgama

Frequent: may affect up to 1 in 10 people

• 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
• 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, 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 discomfort, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

Frequency not known: cannot be estimated from available data:

• constant muscle weakness.

• severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• ocular myasthenia (a disease that causes eye muscle weakness).

Consult 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 (medications 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 medication.

Reporting adverse effects

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

5. Storage of Atorvastatin Davurgama

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Davurgama

• The active ingredient is atorvastatin.

Each tablet contains 10 mg of atorvastatin (as atorvastatin calcium).

Each tablet contains 20 mg of atorvastatin (as atorvastatin calcium).

Each tablet contains 30 mg of atorvastatin (as atorvastatin calcium).

Each tablet contains 40 mg of atorvastatin (as atorvastatin calcium).

Each tablet contains 60 mg of atorvastatin (as atorvastatin calcium).

Each tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

• The other components are:

Tablet core: microcrystalline cellulose (E 460), calcium carbonate (E 170), maltose, sodium croscarmellose (E 466), polysorbate 80 (E 433), and aluminum and magnesium metasilicate and magnesium stearate (E 470b).

Coating: hypromellose (E 464), hydroxypropylcellulose (E 463), triethyl citrate (E 1505), polysorbate 80 (E 433), and titanium dioxide (E 171)

Appearance ofAtorvastatina Davurgamaand Container Content

Atorvastatina Davurgama 10 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face engraved with "10" and the other face smooth. Dimensions: Approx. 8 mm x 4 mm.

Atorvastatina Davurgama 20 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face engraved with "20" and a score on the other face. Dimensions: Approx. 10 mm x 6 mm.

Atorvastatina Davurgama 30 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face with the inscription "30" in relief and the other face smooth. Dimensions: Approx. 12 mm x 6 mm.

Atorvastatina Davurgama 40 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face engraved with "40" and a score on the other face. Dimensions: Approx. 13 mm x 7 mm.

Atorvastatina Davurgama 60 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face engraved with "60" and smooth on the other. Dimensions: Approx. 14 mm x 8 mm.

Atorvastatina Davurgama 80 mg are film-coated tablets, white to off-white, elliptical, biconvex, with one face engraved with "80" and a score on the other face. Dimensions: Approx. 16 mm x 9 mm.

Atorvastatina Davurgama 10 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, 100, 250, or 500 tablets.

Atorvastatina Davurgama 20 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, 100, 250, 500, or 1,000 tablets.

Atorvastatina Davurgama 30 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, or 100 tablets.

Atorvastatina Davurgama 40 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, 100, 250, or 500 tablets.

Atorvastatina Davurgama 60 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, or 100 tablets.

Atorvastatina Davurgama 80 mg is presented in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 105 tablets, in single-dose precut blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1, or 105x1 tablets, and in bottles of 28, 30, 50, 90, 100, or 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11. Edificio Albatros B – 1st floor

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: August 2024

Detailed information about this medicinal product 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 medicinal product 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