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
atorvastatinum
This medicine is contraindicated during pregnancy.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Atorvastatin Krka is and what it is 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 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 have not been effective. In patients with 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, a cholesterol-lowering diet should be continued.

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 pregnancy,
• in breastfeeding women,
• if the patient is 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.
Below are situations in which Atorvastatin Krka may not be suitable for the patient:

• if the patient has severe respiratory impairment,
• if the patient is taking or has taken orally or by injection fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Atorvastatin Krka may lead to serious muscle problems (rhabdomyolysis),
• if the patient has previously had a stroke with bleeding into the brain or if small fluid-filled cavities have developed in the brain following previous strokes,
• kidney problems,
• hypothyroidism,
• a history of recurrent or unexplained muscle pain or muscle problems, or such problems in family members,
• 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 general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes 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 effects. The risk of muscle-related adverse effects, 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 additional medicines may be necessary to diagnose and treat this condition.
During treatment, the doctor will closely monitor the patient for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, overweight, and 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 currently taking or have recently taken, as well as any medicines you plan to take.
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 effects, including severe muscle damage called rhabdomyolysis, described in section 4:

• medicines affecting the 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, cholestyramine,
• certain calcium channel blockers used to treat angina or hypertension, 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 (used to treat heartburn and peptic ulcer disease), phenazone (a painkiller), colchicine (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 for a bacterial infection, Atorvastatin Krka should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Atorvastatin Krka. Concomitant use of Atorvastatin Krka 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).

Atorvastatin Krka with food, drink and alcohol
Instructions for taking Atorvastatin Krka are provided in section 3.
Caution:
Grapefruit juice
Do not consume 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.
Further information is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Do not take Atorvastatin Krka during pregnancy or if planning pregnancy.
The use of Atorvastatin Krka in women of childbearing potential is contraindicated if they do not use effective methods of contraception.
Do not take Atorvastatin Krka while breastfeeding. The safety of Atorvastatin Krka during breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking 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 the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Atorvastatin Krka

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a 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 usual 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 one appropriate for the individual patient. Dose adjustments will be made by the doctor 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, with or without food. However, it is recommended to take the tablets at the same time each 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 Atorvastatin Krka than recommended
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 reactions

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

Rare adverse reactions (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 breathing.
• Severe illness characterized by extensive skin peeling and swelling, skin blisters, mouth sores, eye conjunctiva, genital organs, and fever. Skin rash with pink-red patches, especially on the palms of the hands or soles of the feet, sometimes with blisters.
• Muscle weakness, tenderness, muscle pain, muscle rupture or red-brown discoloration of urine, particularly if these occur together with malaise or high fever. These symptoms may be due to muscle damage (rhabdomyolysis). Breakdown of striated muscles may not always resolve even after the patient stops taking atorvastatin, and may be life-threatening and lead to kidney problems.

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

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

Other possible adverse reactions of Atorvastatin Krka:

Common adverse reactions (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 blood creatine kinase activity
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon adverse reactions (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 sensation 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 of the ankles, elevated body temperature
• Presence of white blood cells in urine analysis

Rare adverse reactions (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 mouth ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare adverse reactions (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 the 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)

Please consult your doctor if you experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Possible adverse reactions 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 during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions 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.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
EXP. The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation ,,Lot”.
Store in the original packaging to protect from moisture.
No special temperature storage precautions are required.
Medicines must not be disposed of via the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the
environment.

6. Contents of the pack and other information

What Atorvastatin Krka contains

• The active substance is atorvastatin.
  30 mg, film-coated tablets Each film-coated tablet contains 30 mg of atorvastatin in the form of atorvastatin calcium.
  60 mg, film-coated tablets Each 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, hydroxypropylcellulose (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 biconvex film-coated tablets with bevelled 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, capsule-shaped film-coated tablets, 18 mm x 9 mm in size.

Pack sizes: 14, 30, 60 or 90 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

For further information on the product names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500.