Atorvastatin Krka 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatina Krka 40 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Atorvastatine Krka is used to lower 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, Atorvastatine Krka may also be used to reduce this risk even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. Before taking Atorvastatine Krka

Do not take Atorvastatine Krka

• if you are allergic to atorvastatin or to 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 potential and you are not using 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

Talk to your doctor or pharmacist before starting to take Atorvastatine Krka.

Atorvastatine Krka may not be suitable for you for the following reasons:

• if you have severe respiratory failure

• 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 atorvastatin may cause serious muscle problems (rhabdomyolysis)

• if you have previously had a stroke with bleeding into the brain, or have small fluid-filled pockets 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 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 causing generalized muscle weakness, which in some cases affects the muscles used for breathing), or ocular myasthenia (a disease causing weakness in the eye muscles), as statins may worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatine Krka to assess your 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 concomitantly (see section 2 “Other medicines and Atorvastatine Krka”).

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 of developing diabetes. This risk increases if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatine Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how Atorvastatine Krka works, or the effects of these medicines may be altered by Atorvastatine Krka. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, e.g. cyclosporine
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other lipid-regulating medicines, 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 heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine used to help prevent disease caused by cytomegalovirus
• Medicines used in the treatment of HIV/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 combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with Atorvastatine Krka include ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), 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 must stop taking this medicine. Your doctor will advise you when you can restart treatment with Atorvastatine Krka. Taking Atorvastatine Krka with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria)

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Atorvastatine Krka with food, drinks and alcohol

See section 3 for instructions on how to take Atorvastatine 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 may alter the effects of Atorvastatine 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 Atorvastatine Krka if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take Atorvastatine Krka if you are of childbearing potential unless you are using adequate contraceptive measures.

Do not take Atorvastatine Krka if you are breastfeeding.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine normally 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 do so is affected by this medicine.

Atorvastatine Krka contains lactose and sodium

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

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

3. How to take Atorvastatin Krka

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue during treatment with Atorvastatin Krka.

The usual starting dose of Atorvastatin Krka 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 Krka is 80 mg once daily.

Atorvastatin Krka 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.

Always follow exactly the instructions for use provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

If you take more Atorvastatin Krka than you should

If you accidentally take too many Atorvastatin Krka tablets (more than your usual daily dose), contact your doctor, go to the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Krka

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Krka

If you have any further questions about using this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you notice any of the following serious adverse effects or 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; 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, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle breakdown, or change in urine color to red-brown, and especially if occurring together with malaise or high temperature, which may be caused by abnormal muscle destruction (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, 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 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 illness syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatina Krka:

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

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased 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
• Blood test results that may show abnormal liver function

Uncommon adverse effects (may affect up to 1 in 100 people) 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 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, malaise, weakness, chest pain, swelling, especially in the ankles (edema), increased temperature
• Urine tests positive for white blood cells

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

• 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 adverse 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 (enlargement of the breasts in men)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Persistent muscle weakness.
• Worsening of myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

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

5. Storage of Atorvastatin Krka

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

This medicine does not require any special storage temperature.

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

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

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

6. Contents of the container and other information

Composition of Atorvastatin Krka

• The active substance 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 “Atorvastatin Krka contains lactose and sodium”), microcrystalline cellulose, sodium croscarmellose, crospovidone and magnesium stearate in the tablet core; polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the film coating.

Appearance of Atorvastatin Krka and contents of the pack

Atorvastatin Krka 40 mg film-coated tablets are white, round
(diameter = 10 mm), slightly convex and with bevelled edges.

Packaged in cardboard boxes containing blisters with 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.

Only certain pack 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

For further information about this medicinal product, please contact 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 most recent review of this leaflet: January 2025

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