ATORVASTATIN KRKA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Atorvastatina Krka 40 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

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

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

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 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. Before taking Atorvastatina Krka

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 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 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 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 atorvastatin can cause serious muscle problems (rhabdomyolysis)

• if you have had a previous 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, 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 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 general muscle weakness that, in some cases, affects the muscles used for breathing), or ocular myasthenia (a disease that causes weakness in the eye muscles), as statins can worsen the disease or cause myasthenia to appear (see section 4).

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with Atorvastatina Krka 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 Krka").

Also, inform your doctor or pharmacist if you have constant muscle weakness. Tests and additional medications 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 sugars and fats in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatina Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that can affect the proper functioning of Atorvastatina Krka or the effects of these medicines may be altered by Atorvastatina Krka. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, 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 you from contracting the disease caused by cytomegalovirus
• Medicines used in the treatment of AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, combinations of tipranavir/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 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 peptic ulcer), 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 have to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart treatment with Atorvastatina Krka. The use of Atorvastatina Krka with fusidic acid can 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 with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of Atorvastatina Krka.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy and breast-feeding

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

Do not take Atorvastatina Krka if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatina Krka if you are breast-feeding your child.

The safety of Atorvastatina Krka 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 your ability to use 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 an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Atorvastatina Krka

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

The initial normal dose of Atorvastatina Krka 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 Atorvastatina Krka is 80 mg once a day.

The tablets of Atorvastatina Krka should be swallowed whole with a glass of water and can be taken at any time of day with or without food. However, try to take your tablet at the same time every day.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 tablets of Atorvastatina Krka (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 forgotten doses.

If you stop taking Atorvastatina Krka

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 skin disease with severe scaling 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, muscle rupture, or change in urine color to reddish-brown, and especially if it occurs at the same time, a feeling of discomfort or high temperature, which can be caused by abnormal destruction of the muscles (rhabdomyolysis). The abnormal destruction of the muscles may 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 bleeding or bruising problems or unexpected or unusual bleeding, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like 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:

• inflammation of the nasal passages, sore throat, nosebleeds
• allergic reactions
• increases in 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

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

• loss of appetite, weight gain, decreased 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 side effects (may affect up to 1 in 1,000 people) include:

• vision changes
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• 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 (breast enlargement in men)

Side effects of unknown frequency (cannot be estimated from the available data):

• constant muscle weakness.
• severe myasthenia (a disease that causes general 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 your arms or legs that worsens after 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 such as persistent cough and/or difficulty breathing or fever
• diabetes. This is more likely if you have high levels of sugars 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 side effects

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

5. Storage of Atorvastatina Krka

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

This medicine does not require any special storage temperature.

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

Do not use this medicine after the expiry date that appears on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorvastatina Krka

• The active ingredient is atorvastatin. Each tablet contains 40 mg of atorvastatin as atorvastatin calcium.
• The other components (excipients) are: sodium hydroxide, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate (see section 2 "Atorvastatina Krka contains lactose and sodium"), microcrystalline cellulose, sodium croscarmellose, 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 Package Contents

The film-coated tablets of Atorvastatina Krka 40 mg are white, round

(diameter = 10 mm), slightly convex, and with a beveled edge.

They are presented in cardboard 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

Manufacturer

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

You can request more information about this medication 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

Date of the last revision of this leaflet:January 2025

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