Patient Information Leaflet

Atorvastatina Tarbis10Film-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 are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What isAtorvastatina Tarbisand what it is used for

2. Before takingAtorvastatina Tarbis

3. How to takeAtorvastatina Tarbis

4. Possible side effects

5. Storage ofAtorvastatina Tarbis

6. Additional information

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

Atorvastatina Tarbis 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 have a high risk of heart disease,Atorvastatina Tarbismay also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Tarbis

• If you are allergic (hypersensitive) to atorvastatin or to any other medicine 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.

Be especially careful with Atorvastatina Tarbis

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

For the following reasons Atorvastatina Tarbis may not be suitable for you:

• If you have or have had myasthenia (a disease that runs with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenia ocular (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).
• 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 during previous treatment with other lipid-lowering medicines (for example, with another statin or fibrates).
• 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 oral or injection route. The combination of fusidic acid and Atorvastatina Tarbis may cause severe muscle problems (rhabdomyolysis).
• If you regularly drink large amounts of alcohol.
• If you have a history of liver problems.
• If you are over 70 years old.

Talk to your doctor or pharmacist before taking Atorvastatina Tarbis

• 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 Tarbis to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering 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”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

While you are 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 sugars and fats in your blood, overweight and high blood pressure.

Use of Atorvastatina with other medicines

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

There are some medicines that can affect the proper functioning of Atorvastatina Tarbis or the effects of these medicines may be modified by Atorvastatina Tarbis. 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.
• If you have to take fusidic acid orally to treat a bacterial infection, you will have to stop using this medicine. Your doctor will instruct you when you can restart the treatment with Atorvastatina Tarbis. The use of Atorvastatina Tarbis with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, 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 Tarbis include ezetimiba (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (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

Taking of Atorvastatina with food and drinks

See section 3 for instructions on how to take Atorvastatina Tarbis. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day because in large quantities orange juice can alter the effects of Atorvastatina Tarbis.

Alcohol

Avoid drinking a lot of alcohol while taking this medicine. See details in Section 2 “Be especially careful with Atorvastatina Tarbis”.

Pregnancy and breastfeeding

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

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

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

Atorvastatina Tarbis has not been shown to be safe during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

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

The usual initial dose of Atorvastatina Tarbis 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 Tarbis is 80 mg once a day for adults and 20 mg once a day for children.

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

Your doctor will decide the duration of treatment with Atorvastatina Tarbis.

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

If you take more Atorvastatina Tarbis than you should

If you accidentally take too many Atorvastatina Tarbis 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 Tarbis

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 Tarbis

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, Atorvastatina Tarbis 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, muscle pain or rupture, or a change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to an abnormal muscle rupture that can be fatal and cause kidney problems.

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

• 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.

Other possible side effects with Atorvastatina Tarbis:

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

• inflammation of the nasal passages, 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 results from blood tests that may show abnormal liver function

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

• 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)
• skin 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 damage

Very rare side effects (affect fewer 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)

Lupus-like disease (including rash, joint disorders, and effects on blood cells).

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

• Sexual difficulties
• Depression
• Respiratory problems such as 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.
• Constant muscle weakness
• Myasthenia gravis (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 your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting 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 Pharmacovigilance of Medicines for Human Use:a. 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

Do not use Atorvastatina Tarbis 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 the SIGRE collection point of the pharmacy. If in doubt, ask 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 Tarbis

- The active ingredient is atorvastatina.

Cada tablet coated with a film contains 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components (excipients) are: microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, magnesium stearate

The coating of Atorvastatina Tarbis contains hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E-171).

Appearance of Atorvastatina Tarbis and contents of the package

The film-coated tablets of Atorvastatina Tarbis 10mg areelliptical, concave, and white in color.

Atorvastatina Tarbis 10mg is presented in boxes with blisters containing 28 film-coated tablets and in clinical packs containing 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona. Spain

Responsible for manufacturing:

TEVA PHARMA, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza. Spain

Last review date of this leaflet: April 2023

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