Atorvastatin Krka

Package Leaflet: Information for the User

Atorvastatin Krka, 30 mg, film-coated tablets

Atorvastatin Krka, 60 mg, film-coated tablets

Atorvastatin Krka, 80 mg, film-coated tablets

Atorvastatin
This medicine is absolutely contraindicated in pregnancy.

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 have not worked. 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, you should continue to follow a cholesterol-lowering diet.

2. Important information before taking Atorvastatin Krka

When not to take Atorvastatin Krka

• if you are allergic to atorvastatin or any other similar medicine used to lower lipid levels in the blood, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have had unexplained, abnormal liver function tests,
• in women who are able to become pregnant and are not using effective contraception,
• in pregnant or breast-feeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Atorvastatin Krka, discuss this with your doctor or pharmacist.
The following situations may require special attention:

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Krka can cause serious muscle problems (rhabdomyolysis),
• if you have had a stroke with bleeding into the brain or have had small cavities filled with fluid in the brain after previous strokes,
• kidney problems,
• 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 you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease causing muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or cause myasthenia (see section 4).

If any of the above situations apply to you, your doctor will order a blood test before starting treatment with Atorvastatin Krka and as needed 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 other medicines (see section 2 "Atorvastatin Krka and other medicines").
Your doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be needed to diagnose and treat this condition.
During treatment with Atorvastatin Krka, your doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Krka and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
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 (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (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,
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atorvastatin Krka. Your doctor will tell you when you can safely start taking Atorvastatin Krka again. Taking Atorvastatin Krka with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Krka with food, drink, and alcohol

Instructions 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 may 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 breast-feeding

Do not take Atorvastatin Krka if you are pregnant or 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 breast-feeding. The safety of Atorvastatin Krka during breast-feeding has not been established yet.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Atorvastatin Krka usually does not affect the ability to drive or use machines. However, if this medicine affects your ability to drive, do not drive. Do not use tools or machines if your ability to use them is impaired by Atorvastatin Krka.

Atorvastatin Krka contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Atorvastatin Krka

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Before starting treatment with Atorvastatin Krka, your doctor will recommend a low-cholesterol diet, which you should follow during treatment with Atorvastatin Krka.
Usual starting dose in adults and children over 10 years is 10 mg once a day. If necessary, your doctor may increase the dose to the one that is suitable for you. Your doctor will adjust the dose every 4 weeks or less often. The maximum dose of Atorvastatin Krka in adults is 80 mg once a day, in children 20 mg once a day.
Swallow the tablets whole with water. The tablets can be taken at any time of the day, with or without food. However, it is recommended to take the tablets at the same time every day.

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

If you feel that the effect of Atorvastatin Krka is too strong or too weak, contact your doctor.

Taking more than the recommended dose of Atorvastatin Krka

If you have accidentally taken more tablets of Atorvastatin Krka than recommended (more than the usual daily dose), contact your doctor or go to the nearest hospital.

Missing a dose of Atorvastatin Krka

If you have forgotten to take a dose, take the next dose at the normal time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Krka

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects or symptoms, stop taking Atorvastatin Krka and contact your 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 difficulty breathing.
• 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 inside of the hands or soles of the feet, sometimes with blisters.
• Muscle weakness, hypersensitivity, muscle pain, muscle rupture, or reddish-brown urine, especially if they occur together with malaise or high fever. These symptoms may be caused by muscle damage (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops taking atorvastatin, and may also threaten life and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate abnormal liver function. In this case, contact your doctor immediately.
• Lupus-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 carefully 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, decreased blood sugar levels (patients with diabetes should carefully monitor their blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, decreased sensation of pain and touch, change in taste, memory loss
• blurred vision
• ringing in the ears and (or) head
• vomiting, belching, upper and lower 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 test

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 (lichenoid drug 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)
• myasthenic syndrome (a disease causing muscle weakness in the eyes) You should discuss with your doctor if you experience muscle weakness in your 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 who have high blood sugar levels when fasting, patients who are overweight, and patients with high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatin Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
Store in the original packaging to protect from moisture.
No special precautions for storage temperature are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Krka contains

• The active substance of the medicine is atorvastatin. 30 mg, film-coated tabletsEach film-coated tablet contains 30 mg of atorvastatin in the form of atorvastatin calcium. 60 mg, film-coated tabletsEach film-coated tablet contains 60 mg of atorvastatin in the form of atorvastatin calcium.

80 mg, film-coated tablets
Each film-coated tablet contains 80 mg of atorvastatin in the form of atorvastatin calcium.

• Other ingredients (excipients) are: sodium hydroxide, hydroxypropyl cellulose (E 463), lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, crospovidone (type A), magnesium stearate (E 572), and polysorbate 80 in the tablet core, and Opadry II White 85F28751: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, and talc (E 553b) in the tablet coating. See section 2 "Atorvastatin Krka contains lactose and sodium".

What Atorvastatin Krka looks like and contents of the pack

30 mg film-coated tablets: white to almost white, round, slightly convex film-coated tablets with beveled edges, 9 mm in diameter
60 mg film-coated tablets: white to almost white, oval, biconvex film-coated tablets, 16 mm x 8.5 mm in size
80 mg film-coated tablets: white to almost white, biconvex film-coated tablets in the shape of a capsule, 18 mm x 9 mm in size
Packaging:14, 30, 60, or 90 film-coated tablets in blisters in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of the medicines in other EU member states, contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500.

Date of last revision of the leaflet: 15.01.2025