Atorvastatin Krka

Package leaflet: Information for the patient

Atorvastatina Krka 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Atorvastatin
Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 Atorvastatina Krka is and what it is used for

Atorvastatina Krka belongs to a group of medicines called statins, which regulate lipid (fat) levels.
Atorvastatina Krka is used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have not been successful. If you are at increased risk of heart disease, Atorvastatina Krka may also be used to reduce this risk even if your cholesterol levels are normal. A standard cholesterol-lowering diet should be continued during treatment.

2. What you should know before taking Atorvastatin Krka

Do not take Atorvastatin Krka:

• If you are allergic to atorvastatin or to medicines similar to those used to reduce blood fats, or to any of the excipients of this medicine (listed in section 6).
• If you have or have had liver disease.
• If you have had inexplicably abnormal blood test results for liver function.
• If you are a woman of childbearing age and are not using a reliable method of contraception.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatin Krka
Atorvastatin Krka may not be suitable for you for the following reasons:

• If you have previously had a stroke with brain hemorrhage, or if you have small fluid-filled pockets in the brain following previous strokes. 1 of 6
• If you have kidney problems.
• If your thyroid gland is underactive (hypothyroidism).
• If you suffer from recurrent or unexplained muscle pain, or if you or a family member has ever had muscle problems.
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines known as "statins" or "fibrates").
• If you regularly consume large amounts of alcohol.
• If you have a history of liver disease.
• If you are over 70 years old.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Atorvastatin Krka can lead to serious muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking Atorvastatin Krka

• If you suffer from severe respiratory failure.

If any of these conditions apply to you, your doctor may need to perform blood tests before and probably during treatment with Atorvastatin Krka, to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatin Krka”).
Inform your doctor or pharmacist also if you have persistent muscle weakness. Additional tests and treatments may be necessary to diagnose and treat it.
Other medicines and Atorvastatin Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the effect of Atorvastatin Krka, or their effects can be altered by Atorvastatin Krka. This type of interaction may make one or both medicines less effective. Alternatively, it could also increase the risk or severity of adverse effects, including a serious condition of muscle breakdown known as rhabdomyolysis described in section 4:

• Medicines used to modify the activity of the immune system, e.g. cyclosporine.
• Some antibiotic and 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.
• Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem.
• Medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medicines used for the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atorvastatin Krka, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (dyspepsia products 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 will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume treatment with Atorvastatin Krka. Taking Atorvastatin Krka with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). 2 of 6

See further information about rhabdomyolysis in section 4.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
While taking this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. If you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure, you are likely at risk of developing diabetes.
Atorvastatin Krka with food, drinks and alcohol
See section 3 for instructions on how to take Atorvastatin Krka. Please keep the following in mind:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may cause changes in the effects of Atorvastatin Krka.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. See section 2 “Warnings and precautions” for further information.
Pregnancy and breastfeeding
Do not take Atorvastatin Krka if you are pregnant or trying to become pregnant.
Do not take Atorvastatin Krka if you are of childbearing age unless you are using reliable contraception.
Do not take Atorvastatin Krka while breastfeeding.
The safety of Atorvastatin Krka during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine usually does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to do so. Do not use any tools or machinery if your ability to use them is affected by this medicine.
Atorvastatin Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 prescribe a low-cholesterol diet, which you must follow both before and during treatment with Atorvastatin Krka.
The recommended starting dose of Atorvastatin Krka is 10 mg once daily in adults and children over 10 years of age. If necessary, your doctor may increase this dose gradually until the appropriate dose for you is reached. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Krka is 80 mg once daily in adults and 20 mg once daily in children.
Atorvastatin Krka tablets must be swallowed whole with a glass of water and can be taken at any time of day, regardless of meals. However, try to take your tablet at the same time each day.
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Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Krka will be determined by your doctor.
Contact 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 or go to the nearest hospital immediately.
If you forget to take Atorvastatin Krka
If you forget to take a dose, simply take the next dose at the correct time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Atorvastatin Krka
If you have any further questions about the use of this medicine or wish to stop treatment, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects or symptoms, stop taking the tablets immediately and contact your doctor right away 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 lead to severe breathing difficulties.
• Severe illness with extensive peeling and swelling of the skin, blistering of the skin, mouth, eyes and genitals, and fever. Skin rash with red spots, particularly on the palms of the hands and soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain, or red-brown discoloration of the urine, especially if accompanied by malaise and high temperature. This may be due to abnormal muscle damage (rhabdomyolysis). Abnormal muscle damage does not always resolve even after stopping atorvastatin, and may be life-threatening and lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You must consult your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Other possible side effects with Atorvastatina Krka:
Common side effects (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased creatine phosphokinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain 4 of 6
• Changes in blood test parameters indicating abnormal liver function

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

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels closely)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and fingertips, reduced sensitivity to pain or pressure, altered 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 eruption and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, particularly of the ankles (oedema), high temperature
• Positive urine test for white blood cells

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

• Visual disturbance
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon injury

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

• Allergic reaction – symptoms may include shortness of breath and chest pain and tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

Not known: frequency cannot be estimated from the available data

• Persistent muscle weakness

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

• Sexual difficulties
• Depression
• Respiratory problems including cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatina Krka

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
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Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the pack and on the blister after
EXP. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atorvastatina Krka contains:

• The active substance is atorvastatin. Each film-coated tablet of Atorvastatina Krka 10 mg, 20 mg or 40 mg contains 10 mg, 20 mg or 40 mg of atorvastatin as atorvastatin calcium, respectively.
• The other ingredients are: sodium hydroxide, sodium lauryl sulfate, hydroxypropylcellulose, monohydrate lactose (see section 2 “Atorvastatina Krka contains lactose and sodium”), microcrystalline cellulose, sodium croscarmellose, crospovidone, magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the coating film.

Description of the appearance of Atorvastatina Krka and pack contents
The 10 mg film-coated tablets are white, round (diameter = 6 mm), slightly convex, with bevelled edges.
The 20 mg film-coated tablets are white, round (diameter = 8 mm), slightly convex, with bevelled edges.
The 40 mg film-coated tablets are white, round (diameter = 10 mm), slightly convex, with bevelled edges.
Pack sizes in blisters of 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets are available in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy
This medicinal product has been authorised in the European Economic Area Member States under the following names:

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