ATORVASTATIN DAVURGAMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina Davurgama 10 mg film-coated tablets EFG

Atorvastatina Davurgama 20 mg film-coated tablets EFG

Atorvastatina Davurgama 30 mg film-coated tablets

Atorvastatina Davurgama 40 mg film-coated tablets EFG

Atorvastatina Davurgama 60 mg film-coated tablets

Atorvastatina Davurgama 80 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 Atorvastatina Davurgama and what is it used for
2. What you need to know before you take Atorvastatina Davurgama
3. How to take Atorvastatina Davurgama
4. Possible side effects
5. Storage of Atorvastatina Davurgama
6. Contents of the pack and other information

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

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

Atorvastatina Davurgama 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 are at high risk of heart disease, Atorvastatina Davurgama 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 Davurgama

Do not take Atorvastatina Davurgama

• 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 unexplained abnormal results in blood tests for liver function.
• if you are a woman of childbearing age and are not using adequate contraceptive measures
• if you are pregnant or trying to become pregnant
• if you are breast-feeding.
• if you are using 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 medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and this medicine 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 medicines (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 medicine 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 Davurgama").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication 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 Davurgama

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

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

• Medicines used to modify the functioning of your immune system, e.g. ciclosporin
• 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 to regulate 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.
• Certain 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 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 to treat 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 this medicine. 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 medicine used to treat skin and skin structure infections with complications and bacteria present in the blood)

Taking Atorvastatina 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 too much 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.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Consult your doctor or pharmacist before using 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 Davurgama contains sodium

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

3. How to take Atorvastatina Davurgama

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 medicine.

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.

The tablets of Atorvastatina Davurgama 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 at the same time every day.

Atorvastatina 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 Atorvastatina Davurgama

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

If you take more Atorvastatina 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atorvastatina 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 stop taking Atorvastatina Davurgama

If you have any other questions about the use of this medicine or want 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 disease with severe peeling 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 breakdown or brownish-red discoloration of the urine, and especially if you 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 Davurgama

Common: 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 (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 pain or tightness in the chest, 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 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 eye muscle weakness).

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.

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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Storage of Atorvastatina Davurgama

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 pack after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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:

Core of the tablet: 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 notch 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 notch 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 notch 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 Street, 11. Albatros B Building – 1st floor

28108 Alcobendas,

Madrid, Spain.

Manufacturer

Teva Pharma, S.L.U.

Malpica Industrial Estate, C Street 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