Atorvastatina pensa 80 mg comprimidos recubiertos con pelicula efg

PATIENT INFORMATION LEAFLET

Atorvastatina pensa 80mg film-coated tablets

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you experience is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before taking Atorvastatina Pensa

3. How to take Atorvastatina Pensa

4. Possible side effects

5. Storage of Atorvastatina Pensa

6. Additional information

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

Atorvastatina Pensa 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 Pensamay also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not takeAtorvastatina Pensa

• If you are allergic (hypersensitive) to atorvastatin or to any other medicine similar to atorvastatin used to reduce blood lipids or to any of the other components of this medicine – see more details in Section 6.
• If you have or have had any liver disease.
• If you have or have had abnormal results in blood tests for liver function.
• 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina Pensa.

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used for the treatment of bacterial infection) by mouth or by injection. The combination of fusidic acid and Atorvastatina Pensa may produce severe muscle problems (rhabdomyolysis).
• If you have had a previous stroke with bleeding in the brain, or have small fluid embolisms 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 previously during 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 courses with generalized muscle weakness that, in some cases, affects the muscles used to breathe) 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).

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.

Consult your doctor or pharmacist before taking Atorvastatina Pensa if you:

• Have severe respiratory failure.

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with Atorvastatina Pensa to predict the risk of experiencing adverse effects related to muscle. It is known that the risk of experiencing adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of other medicines”).

While you are taking this medicine, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, being overweight, and high blood pressure.

Other medicines and Atorvastatina Pensa

Inform your doctor or pharmacist if you are using, have used recently, or may have to take any other medicine.

There are some medicines that may affect the proper functioning of Atorvastatina Pensa or the effects of these medicines may be modified by Atorvastatina Pensa. 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, colestipol.
• 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.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with Atorvastatina Pensa, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion that contain aluminum or magnesium).

• Over-the-counter medicines: St. John's Wort.
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will instruct you when you can restart the treatment with Atorvastatina Pensa. The use of Atorvastatina Pensa with fusidic acid may produce muscle weakness, sensitivity, 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).

Inform your doctor or pharmacist if you are using or have used recently other medicines, even those purchased without a prescription.

Taking Atorvastatina Pensa with food and drinks

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

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of Atorvastatina Pensa.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Be especially careful with Atorvastatina Pensa”.

Pregnancy and breastfeeding

Do not take Atorvastatina Pensa if you are pregnant, think you may be pregnant, or if you are trying to become pregnant.

Do not take Atorvastatina Pensa if you are fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina Pensa if you are breastfeeding your child.

The safety of Atorvastatina Pensa during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Do not drive if this medicine affects your ability to drive. Do not handle tools or machinery if this medicine affects your ability to handle them.

Important information about some of the components of Atorvastatina Pensa:

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

The usual initial dose of Atorvastatina Pensa is 10 mg once a day in adults and children aged 10 years and older. 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 Atorvastatina Pensa is 80 mg once a day for adults and 20 mg once a day for children.

Atorvastatina Pensa 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 Atorvastatina Pensa given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the duration of treatment with Atorvastatina Pensa

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

If you take more Atorvastatina Pensa than you should

If you accidentally take too many Atorvastatina Pensa 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.

If you forget to take Atorvastatina Pensa

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 Pensa

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

Like all medicines, Atorvastatina Pensa can cause side effects, although not everyone will experience them.

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

Rare: affect between 1 and 10 of every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing difficult.

• 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 can form blisters.

• Muscle weakness, pain on palpation, pain or rupture or change in color of the urine to brown-red, and especially if you have discomfort or high fever, it may be due to an abnormal rupture of the muscles that can be fatal and cause kidney problems.

Very rare: affect less than 1 of every 10,000 patients:

• Syndrome similar to lupus (which includes skin rash, joint disorders, and effects on blood cells).
• If you experience problems with unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.

Frequency not known:

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, 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, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Other possible side effects with Atorvastatina Pensa:

Frequent side effects (affect between 1 and 10 of every 100 patients) include:

• inflammationof the nasal passages, sore throat, nasal bleeding
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increasedcreatine kinasein blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function.

Rare side effects (affect between 1 and 10 of every 1,000 patients) include:

• anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• 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 side effects (affect between 1 and 10 of every 10,000 patients) include:

• vision changes
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and eyes)
• tendon injury
• skin rash or ulcers in the mouth (drug reaction)
• skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

Very rare side effects (affect less than 1 of every 10,000 patients) include:

• 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
• hearing loss
• gynecomastia (enlargement of the breasts in men and women).

Possible side effects of some statins (medicines of the same type):

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• 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.

If you consider that any of the side effects you are experiencing are serious or if you appreciate any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medication.

Keep out of reach and sight of children.

Do not store at a temperature above30°C.

Store in the original packaging.

Do not use Atorvastatina Pensa after the expiration date that appears on the blister and 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. Dispose of the packaging and medicines you no longer need at theSIGREcollection point of thepharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina Pensa

- The active ingredient is atorvastatina.

Each film-coated tablet contains 80 mg of atorvastatina (as atorvastatina calcium).

The other components (excipients) are: lactose monohydrate (lactose), magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E-460), anhydrous colloidal silica, butylhydroxyanisole (E-320), crospovidone, sodium hydrogen carbonate, saccharose, sorbitan triesterate, magnesium stearate of macrogol 40, dimethicone, and 2-Bromo-2-Nitropropano-1,3-diol.

The coating of Atorvastatina Pensa contains lactose monohydrate (lactose), hypromellose (E-464), titanium dioxide (E-171), and macrogol 4000.

Appearance of Atorvastatina Pensa and contents of the package

The film-coated tablets of Atorvastatina Pensa 80 mg are oblong, biconvex, scored, breakable, white in color, and marked with the code “AT8”.

Atorvastatina Pensa 80 mg is presented in blister packs containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 – Industrial Park Areta

31620 Huarte – Pamplona (Navarra)

Spain

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat.08950 Barcelona

Spain

Or

SAG Manufacturing , S.L.U.

N-I Highway, Km. 36

San Agustin de Guadalix, 28750 Madrid

Spain

Last review date of this leaflet:August 2024

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