Atorvastatin Davurgama 20 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Atorvastatina Davurgama belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatina Davurgama is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina Davurgama may also be used to reduce this risk, even if your cholesterol levels are normal. You should continue to follow a standard low-cholesterol diet during treatment.

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 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 liver function blood tests.
• 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 breastfeeding.
• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before taking atorvastatin:

• if you have severe respiratory insufficiency.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled sacs 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, or personal or family history of muscle disorders.
• if you have previously experienced 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 causing general muscle weakness, which in some cases affects the muscles used for breathing), or ocular myasthenia (a disease causing eye muscle weakness), as statins may sometimes worsen the condition or trigger the onset of myasthenia (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 of age.

In any of these cases, your doctor may advise you to have blood tests before and possibly during treatment with this medicine to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatin Davurgama”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Davurgama

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

Some medicines may alter the effect of atorvastatin, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a serious condition causing muscle damage known as rhabdomyolysis, described in section 4:

• Medicines used to modify the function of your immune system, for example cyclosporine.
• Certain antibiotics or antifungal medicines, for example erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used to regulate lipid levels, for example gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used to treat angina or high blood pressure, for example amlodipine, diltiazem; medicines to regulate your heart rhythm, for example digoxin, verapamil, amiodarone.
• Letermovir, a medicine used to prevent cytomegalovirus infections.
• Medicines used in the treatment of 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 combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin include: ezetimibe (cholesterol-lowering agent), warfarin (anticoagulant), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium 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 temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment. Taking atorvastatin together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
  • Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

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 drink more than one or two small glasses of grapefruit juice per day, as large amounts may interfere with 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 plan 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 breastfeeding.

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machines if this medicine impairs your ability to use them safely.

Atorvastatin 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 instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with this medicine.

The usual starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatina Davurgama tablets should be swallowed whole with a glass of water and may be taken at any time of 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 may be divided into equal doses.

Your doctor will decide the duration of treatment with Atorvastatina Davurgama

Ask your doctor if you think that 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

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

If you notice any of the following adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.

• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.

• Muscle weakness, tenderness, pain, or muscle breakdown, or brownish-red discoloration of the urine, and especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, 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 problems with unexpected or unusual bleeding or bruising, this may indicate 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 Atorvastatina Davurgama

Common: may affect up to 1 in 10 people

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, monitor your blood sugar levels), increased blood creatine kinase
• 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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing 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 body temperature
• Urine tests positive for white blood cells

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

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (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 blood vessel inflammation, 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, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts in men)

Frequency not known: cannot be estimated from the available data:

• Persistent muscle weakness.

• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening arm or leg weakness after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects reported with 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 fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Davurgama

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Davurgama

• The active substance is atorvastatin.

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

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

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

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

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

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

• The other components are:

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

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

Appearance of Atorvastatin Davurgama and contents of the pack

Atorvastatin Davurgama 10 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with "10" engraved on one side and the other side smooth. Dimensions: approx. 8 mm x 4 mm.

Atorvastatin Davurgama 20 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with "20" engraved on one side and a score line on the other side. Dimensions: approx. 10 mm x 6 mm.

Atorvastatin Davurgama 30 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with the inscription "30" in relief on one side and the other side smooth. Dimensions: approx. 12 mm x 6 mm.

Atorvastatin Davurgama 40 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with "40" engraved on one side and a score line on the other side. Dimensions: approx. 13 mm x 7 mm.

Atorvastatin Davurgama 60 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with "60" engraved on one side and the other side smooth. Dimensions: approx. 14 mm x 8 mm.

Atorvastatin Davurgama 80 mg are film-coated tablets, white to off-white in colour, elliptical, biconvex, with "80" engraved on one side and a score line on the other side. Dimensions: approx. 16 mm x 9 mm.

Atorvastatin Davurgama 10 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 120, 250 or 500 tablets.

Atorvastatin Davurgama 20 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 120, 250, 500 or 1,000 tablets.

Atorvastatin Davurgama 30 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90 or 100 tablets.

Atorvastatin Davurgama 40 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 120, 250 or 500 tablets.

Atorvastatin Davurgama 60 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90 or 100 tablets.

Atorvastatin Davurgama 80 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in single-dose perforated blister packs of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 120 or 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ 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 most recent revision of this leaflet: August 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima