ATORVASTATIN KRKA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Atorvastatin Krka

Do not take Atorvastatin Krka

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)

• if you have or have had any liver disease
• if you have or have had unexplained abnormal results in blood tests for liver function
• if you are a woman able to have children and are not using adequate contraceptive measures
• if you are pregnant or trying to become pregnant
• if you are breast-feeding
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before taking Atorvastatin Krka.

For the following reasons, Atorvastatin Krka may not be suitable for you:

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis)

• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have repeated or unexplained muscle pain, personal or family history of muscle problems
• if you have had muscle problems while taking other medicines to lower lipid levels (e.g. with another statin or fibrates)
• if you regularly drink large amounts of alcohol
• if you have a history of liver problems
• if you are over 70 years old
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that can affect the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to occur (see section 4).

In any of these cases, your doctor may decide to perform blood tests before and possibly during treatment with Atorvastatin Krka to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Other medicines and Atorvastatin Krka").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

While taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are some medicines that can affect the proper functioning of Atorvastatin Krka or the effects of these medicines may be altered by Atorvastatin Krka. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, e.g. ciclosporin
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem
• Medicines for regulating your heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent you from contracting the disease caused by cytomegalovirus
• Medicines used in the treatment of AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combinations, etc.
• Certain medicines used in the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines that are known to interact with Atorvastatin Krka include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminium or magnesium)
• Medicines obtained without a prescription: St. John's Wort
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart treatment with Atorvastatin Krka. The use of Atorvastatin Krka with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Taking Atorvastatin Krka with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Krka. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of Atorvastatin Krka.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Do not take Atorvastatin Krka if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not take Atorvastatin Krka if you are of childbearing age and are not using adequate contraceptive measures.

Do not take Atorvastatin Krka if you are breast-feeding your child.

The safety of Atorvastatin Krka during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if your ability to use them is affected by this medicine.

Atorvastatin Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".

3. How to take Atorvastatin Krka

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should also follow during treatment with Atorvastatin Krka.

The initial dose of Atorvastatin Krka is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you reach the dose you need.

Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Krka is 80 mg once a day.

The tablets of Atorvastatin Krka should be swallowed whole with a glass of water and can be taken at any time of day with or without food. However, try to take your tablet at the same time every day.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Ask your doctor if you think 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 tablets of Atorvastatin Krka (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatin Krka

If you forget to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Krka

If you have any further questions on the use of this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or go to the emergency department of the nearest hospital.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.
• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.
• Weakness, sensitivity, pain, muscle breakdown, or change in urine color to reddish-brown, and especially if it occurs at the same time as a feeling of discomfort or high temperature, which can be caused by abnormal muscle destruction (rhabdomyolysis). Abnormal muscle destruction does not always disappear, even after stopping atorvastatin, and this can be fatal and cause kidney problems.

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

• If you experience bleeding or bruising problems, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatin Krka:

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

• inflammation of the nasal passages, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in the blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

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

• loss of appetite, weight gain, decrease in blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, skin rash and itching, hives
• neck pain, muscle fatigue

• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature
• positive urine tests for white blood cells

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

• vision changes
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or mouth ulcers (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or throat, difficulty breathing, collapse
• hearing loss
• gynaecomastia (breast enlargement in men)

Side effects of unknown frequency (cannot be estimated from the available data):

• constant muscle weakness.
• severe myasthenia (a disease that causes generalised muscle weakness that can affect the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

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

• sexual difficulties
• depression
• respiratory problems such as persistent cough and/or difficulty breathing or fever
• diabetes. This is more likely if you have high levels of sugar and fat in your 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 effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Krka

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Atorvastatina Krka

• The active ingredient is atorvastatin. Each tablet contains 10 mg of atorvastatin as atorvastatin calcium.
• The other components (excipients) are: sodium hydroxide, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate (see section "Atorvastatina Krka contains lactose and sodium"), microcrystalline cellulose, sodium croscarmellose, crospovidone, and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the film coating.

Appearance of Atorvastatina Krka and Packaging Content

The film-coated tablets of Atorvastatina Krka 10 mg are white, round

(diameter = 6 mm), slightly convex, and with a beveled edge.

They are available in cardboard boxes containing blisters with 10, 14, 28, 30, 50, 56, 84, 90, 98, and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this leaflet:January 2025

“Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”