Atorvastatin Krka

Leaflet attached to the packaging: patient information

Atorvastatin Krka, 10 mg, film-coated tablets

Atorvastatin Krka, 20 mg, film-coated tablets

Atorvastatin Krka, 40 mg, film-coated tablets

Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Atorvastatin Krka and what is it used for
• 2. Important information before taking Atorvastatin Krka
• 3. How to take Atorvastatin Krka
• 4. Possible side effects
• 5. How to store Atorvastatin Krka
• 6. Contents of the packaging and other information

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

Atorvastatin Krka belongs to a group of medicines called statins, which regulate lipid levels (fats).
Atorvastatin Krka is used to lower lipid levels (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes are not effective. In patients with increased risk of heart disease, Atorvastatin Krka may also be used to reduce this risk, even if cholesterol levels are normal. During treatment with Atorvastatin Krka, a cholesterol-lowering diet should be continued.

2. Important information before taking Atorvastatin Krka

When not to take Atorvastatin Krka

• in women of childbearing age who are not using effective contraception,
• in pregnant or breastfeeding women,

Warnings and precautions

Before starting treatment with Atorvastatin Krka, the patient should discuss it with their doctor or pharmacist.
The following situations may make Atorvastatin Krka unsuitable for the patient:

• kidney disease,
• hypothyroidism,
• repeated or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• regular consumption of large amounts of alcohol,
• history of liver disease,
• age over 70 years,

If any of these situations apply to the patient, the doctor will order a blood test before starting treatment with Atorvastatin Krka and, if necessary, during treatment to detect the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, increases when taking certain medicines (see section 2 "Atorvastatin Krka and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment with this medicine, the doctor will closely monitor patients with diabetes and patients at risk of developing diabetes. Patients at risk of developing diabetes are those with high blood sugar levels, obese patients, and patients with high blood pressure.

Atorvastatin Krka and other medicines

Some medicines may change the effect of Atorvastatin Krka or their effect may be changed by Atorvastatin Krka. This type of interaction can reduce the effectiveness of one or both medicines. It can also increase the risk or severity of side effects, including serious muscle damage called rhabdomyolysis, described in section 4:

• medicines that affect the immune system, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem,
• medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atorvastatin Krka, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (a medicine used to treat heartburn and ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: medicines containing St. John's Wort,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking Atorvastatin Krka with food, drink, and alcohol

Recommendations for taking Atorvastatin Krka are presented in section 3.
Note:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts can change the effect of Atorvastatin Krka.
Alcohol
Avoid excessive alcohol consumption while taking Atorvastatin Krka.
See section 2 "Warnings and precautions" for more information.

Pregnancy and breastfeeding

Do not take Atorvastatin Krka during pregnancy or if planning to become pregnant.
Taking Atorvastatin Krka is contraindicated in women of childbearing age who do not use effective contraception.
Do not take Atorvastatin Krka while breastfeeding. The safety of taking Atorvastatin Krka during breastfeeding has not been established yet.
If the patient is pregnant, breastfeeding, or planning to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

Atorvastatin Krka usually does not affect the ability to drive or operate machinery. However, if the medicine affects the ability to drive, the patient should not drive. The patient should not use tools or machinery if their ability to operate them is impaired by Atorvastatin Krka.

Atorvastatin Krka contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Atorvastatin Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
Before starting treatment with Atorvastatin Krka, the doctor will recommend a low-cholesterol diet, which should also be followed during treatment with Atorvastatin Krka.
The recommended initial dose for adults and children aged 10 years or older is 10 mg once daily.
If necessary, the doctor may increase the dose to the one that is suitable for the patient. The doctor will adjust the dose every four weeks or less often. The maximum dose of Atorvastatin Krka for adults is 80 mg once daily, for children 20 mg once daily.
Tablets should be swallowed whole with water. Tablets can be taken at any time of day, with or without food. However, it is recommended to take the tablets at the same time every day.

The doctor determines the duration of treatment with Atorvastatin Krka.

If the patient feels that the effect of Atorvastatin Krka is too strong or too weak, they should contact their doctor.

Taking a higher dose of Atorvastatin Krka than recommended

If the patient has accidentally taken more tablets of Atorvastatin Krka than the usual daily dose, they should contact their doctor or go to the nearest hospital.

Missing a dose of Atorvastatin Krka

If the patient has forgotten to take a dose, they should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Krka

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Krka can cause side effects, although not everybody gets them.

If any of the following side effects occur or if the patient experiences any symptoms, they should stop taking Atorvastatin Krka and contact their doctor or go to the nearest hospital immediately.

Rare side effects (may affect up to 1 in 1000 people):

• Severe allergic reaction with swelling of the face, tongue, and throat, which can cause breathing difficulties.
• Severe condition characterized by intense skin peeling and swelling, blisters on the skin, in the mouth, on the eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, sometimes with blisters.
• Muscle weakness, hypersensitivity, muscle pain, muscle rupture, or brownish discoloration of urine, especially if they occur together with malaise or high fever. These symptoms may be caused by the breakdown of striated muscles (rhabdomyolysis). Rhabdomyolysis may not always resolve, even if the patient stops taking atorvastatin, and can be life-threatening and cause kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate abnormal liver function. In this case, the patient should contact their doctor immediately.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Krka:

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

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (patients with diabetes should closely monitor their blood sugar levels), increased creatine kinase activity in the blood
• headache
• nausea, constipation, flatulence, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• abnormal liver function test results

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

• loss of appetite (loss of appetite), weight gain, low blood sugar levels (patients with diabetes should closely monitor their blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensation of pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and (or) head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, itchy skin rash, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles
• increased body temperature
• presence of white blood cells in the urine

Rare side effects (may affect up to 1 in 1000 people):

• vision disorders
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon damage
• skin rash, which may occur on the skin, or ulcers in the mouth (drug-induced lichenoid reaction)
• purple skin changes (symptoms of vasculitis)

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

• allergic reaction, which may include sudden, wheezing breathing and pain or pressure in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, fainting
• hearing loss
• gynecomastia (breast enlargement in men)

Unknown frequency (cannot be estimated from the available data):

• persistent muscle weakness
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease causing muscle weakness in the eyes) The patient should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

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

• sexual function disorders
• depression
• breathing problems, including persistent cough and (or) shortness of breath or fever
• diabetes. The development of diabetes is more likely in patients with high blood sugar levels, obese patients, and patients with high blood pressure. The doctor will closely monitor the patient while taking this medicine.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Atorvastatin Krka

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
No special precautions for storage temperature are required.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atorvastatin Krka contains

• The active substance of the medicine is atorvastatin. 10 mg, film-coated tabletsEach film-coated tablet contains 10 mg of atorvastatin in the form of atorvastatin calcium. 20 mg, film-coated tabletsEach film-coated tablet contains 20 mg of atorvastatin in the form of atorvastatin calcium. 40 mg, film-coated tabletsEach film-coated tablet contains 40 mg of atorvastatin in the form of atorvastatin calcium.
• Other ingredients (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, magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, and talc in the tablet coating.

What Atorvastatin Krka looks like and what the packaging contains

10 mg, film-coated tablets: white, round, slightly convex film-coated tablets with beveled edges, 6 mm in diameter
20 mg, film-coated tablets: white, round, slightly convex film-coated tablets with beveled edges, 8 mm in diameter
40 mg, film-coated tablets: white, round, slightly convex film-coated tablets with beveled edges, 10 mm in diameter
Packaging:10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets in blisters, in a carton

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: 15.01.2025