Patient Information Leaflet: Product Information

Atorvastatina Krka 20 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Atorvastatina Krka

3. How to take Atorvastatina Krka

4. Possible side effects

5. Storage of Atorvastatina Krka

6. Contents of the pack and additional information

Atorvastatina Krka belongs to a group of medicines known as statins, which are

medicines that regulate lipids (fats).

Atorvastatina Krka 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 Krka may 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 Krka

• 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 abnormal results in liver function blood tests
• 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

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

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

• if you have severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis)

• if you have had a previous stroke with brain bleeding, or have small fluid-filled 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 medicines to reduce lipids (e.g. 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 causes generalized muscle weakness that, in some cases, affects the muscles used for breathing), or myasthenic eye (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4)

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

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

While taking this medicine, your doctor will monitor 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, being overweight, and high blood pressure.

Other medicines and Atorvastatina Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. There are some medicines that may affect the proper functioning of Atorvastatina Krka or the effects of these medicines may be modified by Atorvastatina Krka. 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, cholestyramine
• 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.
• Letermovir, a medicine that helps prevent you from contracting the disease caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, combinations of tipranavir/ritonavir etc.
• Other 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 Atorvastatina Krka include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (products for indigestion that contain aluminum 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 stop taking this medicine. Your doctor will tell you when you can restart the treatment with Atorvastatina Krka. The use of Atorvastatina Krka with fusidic acid may cause 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 taking, have taken recently, or may need to take other medicines, including those purchased without a prescription.

Taking Atorvastatina Krka with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Krka. 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 Krka.

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 Atorvastatina Krka if you are pregnant, think you may be pregnant, or are trying to become pregnant.

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Normally, this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if your ability to operate them is affected by this medicine.

Atorvastatina Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

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

The usual initial dose of Atorvastatina Krka is 10 mg once a day in adults and children aged 10 years and above. 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 Krka is 80 mg once a day.

Atorvastatina Krka 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 this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

If you take more Atorvastatina Krka than you should

If you accidentally take too many Atorvastatina Krka 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 indicating the medication and the amount ingested.

If you forget to take Atorvastatina Krka

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 Krka

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, this medicine can cause side effects, although not everyone will experience them.

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

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that may make it difficult to breathe.
• 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 may form blisters.
• Weakness, sensitivity, pain, muscle rupture, or change in urine color to brown-red, and especially, if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction (rhabdomyolysis). Abnormal muscle destruction does not always disappear, even after stopping atorvastatin, and this can be fatal and cause kidney problems.

Very rare(may affect up to 1 in 10,000 people):

• If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like disease syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Krka:

Frequent side effects (may affect up to 1 in 10 people) include:

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased 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

Infrequent side effects(may affect up to 1 in 100 people)include:

• loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, 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)
• 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 in the blood

Rare side effects(may affect up to 1 in 1,000 people)include:

• vision changes
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and eyes)
• tendon damage
• 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(may affect up to 1 in 10,000 people)include:

• allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

Side effects of unknown frequency (cannot be estimated from 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 weakness in 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.

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. This is more likely if you have high blood sugar and fat levels in your blood, if you are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light and moisture.

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.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Atorvastatina Krka

• The active ingredient is atorvastatina. Each tablet contains 20 mg of atorvastatina as atorvastatina calcium.
• The other components (excipients) are: sodium hydroxide, lauril sulfato of sodium, hydroxypropyl cellulose, lactose monohydrate (see section 2 "Atorvastatina Krka contains lactose and sodium"), microcrystalline cellulose, croscarmellose sodium, crospovidone, and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the film coating.

Appearance of Atorvastatina Krka and contents of the packaging

The film-coated tablets of Atorvastatina Krka 20 mg are white, round (diameter = 8 mm), slightly convex, and with a beveled edge.

They are presented in carton boxes containing blisters with 10, 14, 28, 30, 50, 56, 84, 90, 98, and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for Manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last review date of this leaflet: January 2025

"Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”