Atorvastatin krka

Patient Information Leaflet

Atorvastatin Krka, 10 mg, film-coated tablets
Atorvastatin Krka, 20 mg, film-coated tablets
Atorvastatin Krka, 40 mg, film-coated tablets
atorvastatinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with 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 inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Atorvastatin Krka is and what it is used for
2. What you need to know before you take 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 Atorvastatin Krka is and what it is used for

Atorvastatin Krka belongs to a group of medicines called statins, which regulate lipid (fat) levels.
Atorvastatin Krka is used to lower lipid levels (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes are not sufficient. In patients with an increased risk of heart disease, Atorvastatin Krka may also be used to reduce this risk, even if cholesterol levels are within the normal range. While being treated with Atorvastatin Krka, you should continue to follow a cholesterol-lowering diet.

2. Important information before using Atorvastatin Krka

When not to use Atorvastatin Krka

• if the patient is allergic to atorvastatin or any other similar medicine used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had liver disease,
• if the patient has unexplained abnormal liver function test results,
• in women of childbearing potential who are not using effective contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atorvastatin Krka, discuss this with your doctor or pharmacist.
The following situations may mean that Atorvastatin Krka is not suitable for the patient:

• if the patient is taking or has taken fusidic acid (a medicine used to treat bacterial infections) orally or by injection within the previous 7 days. Concomitant use of fusidic acid with Atorvastatin Krka may lead to serious muscle problems (rhabdomyolysis),
• if the patient has severe respiratory failure,
• if the patient has previously had a haemorrhagic stroke or has small fluid-filled cavities in the brain resulting from previous strokes,
• kidney disease,
• hypothyroidism,
• history of recurrent or unexplained muscle pain or muscle problems, or such problems in family members,
• history of 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,
• patient age over 70 years,
• if the patient has or has had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may occasionally worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

If any of the above situations apply to the patient, the doctor will order a blood test before starting treatment with Atorvastatin Krka and, as necessary, during treatment to detect the risk of muscle-related adverse reactions. The risk of muscle-related adverse reactions, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 "Atorvastatin Krka and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and treat this condition.
While taking this medicine, your doctor will closely monitor patients with diabetes and patients at risk of developing diabetes. Patients at risk of developing diabetes include those with high fasting blood glucose levels, obese patients, and patients with high blood pressure.

Atorvastatin Krka and other medicines
Some medicines may alter the effect of Atorvastatin Krka or their effect may be altered by Atorvastatin Krka. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk or severity of adverse reactions, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, 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, cholestyramine,
• certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem,
• medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atorvastatin Krka, including ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (a medicine used to treat heartburn and peptic ulcer disease), phenazone (a painkiller), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: products containing St. John's wort,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily discontinued. Your doctor will inform you when it is safe to restart treatment with Atorvastatin Krka. Taking Atorvastatin Krka together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Taking Atorvastatin Krka with food, drink and alcohol
Instructions for taking Atorvastatin Krka are provided in section 3.
Warning:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities may alter the effect of Atorvastatin Krka.
Alcohol
Avoid excessive alcohol consumption while taking Atorvastatin Krka.
See section 2 "Warnings and precautions" for further details.
Pregnancy and breastfeeding
Do not take Atorvastatin Krka during pregnancy or if planning to become pregnant.
The use of Atorvastatin Krka in women of childbearing potential is contraindicated unless effective contraception is used.
Do not take Atorvastatin Krka while breastfeeding. The safety of Atorvastatin Krka during breastfeeding has not yet been established.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Atorvastatin Krka usually does not affect the ability to drive or operate machinery. However, if this medicine affects your ability to drive, do not drive. Do not use tools or machines if your ability to operate them is impaired by Atorvastatin Krka.
Atorvastatin Krka contains lactose and sodium
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Atorvastatin Krka

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Before starting treatment with Atorvastatin Krka, your doctor will recommend a low-cholesterol diet, which
should also be followed during treatment with Atorvastatin Krka.
The recommended starting dose for adults and for children aged 10 years or older is 10 mg once daily.
If necessary, your doctor may increase the dose to the level appropriate for the individual patient.
Your doctor will adjust the dose every four weeks or less frequently. The maximum dose of Atorvastatin Krka
is 80 mg once daily for adults and 20 mg once daily for children.
The tablets should be swallowed whole with water. The tablets may be taken at any time of day,
independent of meals. However, it is recommended to take the tablets at the same time each day.
The duration of treatment with Atorvastatin Krka is determined by your doctor.
If you feel that the effect of Atorvastatin Krka is too strong or too weak, you should contact your doctor.
Taking more than the recommended dose of Atorvastatin Krka
If you accidentally take too many Atorvastatin Krka tablets (more than the usual daily dose),
contact your doctor or go to the nearest hospital immediately.
Missing a dose of Atorvastatin Krka
If you forget to take a dose, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
Stopping Atorvastatin Krka
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects or symptoms occur,
stop taking Atorvastatin Krka immediately and contact your doctor or
go to the nearest hospital emergency department.

Rare adverse effects (may occur in up to 1 in 1,000 patients):

• Severe allergic reaction with swelling of the face, tongue and throat, which may cause difficulty in breathing.
• A serious condition characterized by severe skin peeling and swelling, skin blisters, mouth sores, conjunctival, genital lesions, 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 red-brown discoloration of urine, particularly if accompanied by malaise or high fever. These symptoms may be due to rhabdomyolysis (breakdown of striated muscles). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin, may be life-threatening, and can lead to kidney problems.

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• If unexpected or unusual bleeding or bruising occurs, this may indicate impaired liver function. In such cases, contact your doctor immediately.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects of Atorvastatin Krka:
Common adverse effects (may occur in up to 1 in 10 patients):

• Nasal mucosal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (patients with diabetes should carefully monitor their blood glucose levels), increased creatine kinase activity in blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon adverse effects (may occur in up to 1 in 100 patients):

• Loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should carefully monitor their blood glucose levels)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensation of pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash associated with itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially around the ankles
• Elevated body temperature
• Presence of white blood cells in urine analysis

Rare adverse effects (may occur in up to 1 in 1,000 patients):

• Vision disturbances
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage
• Rash which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• Allergic reaction, symptoms of which may include sudden wheezing, chest pain or tightness, swelling of eyelids, face, lips, mouth, tongue or throat, difficulty breathing, fainting
• Hearing loss
• Gynaecomastia (breast enlargement in men)

Unknown frequency (cannot be estimated from 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 weakness of eye muscles). If the patient experiences worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, consult a doctor.

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

• Sexual dysfunction
• 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 fasting blood glucose levels, obese patients, and patients with high blood pressure. Your doctor will closely monitor you while taking this medicine.

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps 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.
Store in the original packaging to protect from light and moisture.
No special precautions for storage temperature are required for this medicinal product.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin Krka contains

• The active substance is atorvastatin.
  10 mg, film-coated tablets Each film-coated tablet contains 10 mg of atorvastatin in the form of atorvastatin calcium.
  20 mg, film-coated tablets Each film-coated tablet contains 20 mg of atorvastatin in the form of atorvastatin calcium.
  40 mg, film-coated tablets Each film-coated tablet contains 40 mg of atorvastatin in the form of atorvastatin calcium.
• Other components (excipients) are: sodium hydroxide, sodium lauryl sulfate, hydroxypropylcellulose, lactose monohydrate (see section 2 "Atorvastatin Krka contains lactose and sodium"), microcrystalline cellulose, sodium croscarmellose, crospovidone, magnesium stearate in the tablet core; polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000 and talc in the tablet coating.

What Atorvastatin Krka looks like and contents of the pack
10 mg, film-coated tablets: white, round, slightly biconvex film-coated tablets with bevelled edges,
6 mm in diameter
20 mg, film-coated tablets: white, round, slightly biconvex film-coated tablets with bevelled edges,
8 mm in diameter
40 mg, film-coated tablets: white, round, slightly biconvex film-coated tablets with bevelled edges,
10 mm in diameter
Packaging: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets in blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia