10 mg, 20 mg, 40 mg film-coated tablets 
atorvastatin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read about it.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atorvastatin Krka is and what it is used for 
2. What you need to know before you use Atorvastatin Krka 
3. How to use 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 lipids(fats).

Atorvastatin Krka is used in the treatment of high blood fats, so-called cholesterol, and triglycerides when the effect of a changed diet and lifestyle is insufficient. If you have an increased risk of heart disease, Atorvastatin Krka can also be used to reduce this risk even if your cholesterol levels are normal. During treatment with Atorvastatin Krka, you should continue with a low cholesterol diet.

Atorvastatin contained in Atorvastatin Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Atorvastatin Krka

Do not use 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 diseases that affect the liver
  • if you have had unexplained abnormal liver function values
  • if you are a woman of childbearing potential and do not use contraception
  • if you are pregnant or trying to become pregnant
  • if you are breast-feeding
  • if you are using a combination of telaprevir and pibrentasvir to treat hepatitis C.

Warnings and cautions

Talk to your doctor or pharmacist before taking Atorvastatin Krka.

In the following situations, Atorvastatin Krka may be inappropriate for you:

  • if you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain from a previous stroke
  • if you have kidney problems
  • if you have underactive thyroid function (hypothyroidism)
  • if you have had repeated and unexplained muscle pain or muscle problems in person or in the family. Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
  • if you have a history of muscle problems with other lipid-lowering medicines (eg other statins or fibrates)
  • if you regularly drink large amounts of alcohol
  • if you have had liver disease
  • if you are over 70 years old

Talk to your doctor or pharmacist before taking Atorvastatin Krka

  • if you have severe breathing problems

If any of these apply to you, your doctor will need to take blood samples before and probably during treatment with Atorvastatin Krka to assess the risk of muscle-related side effects . The risk of muscle-related side effects such as rhabdomyolysis is known to increase when certain medicines are taken together (see section 2 “Other medicines and Atorvastatin Krka”).

During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to get diabetes if you have high blood sugar and high blood fat levels, are overweight, and have high blood pressure.

Other medicines and Atorvastatin Krka

Some medicines may affect the effect of Atorvastatin Krka or their effect may be affected by Atorvastatin Krka. This type of interaction may make one or both drugs less effective. Alternatively, the interaction may increase the risk of, or severity of side effects, which include the severe condition of muscle breakdown, rhabdomyolysis, as described in section 4:

  • Drugs that affect the immune system, such as cyclosporine
  • Certain antibiotics or antifungal agents, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, and fusidic acid
  • Other lipid-lowering drugs, such as gemfibrozil, other fibrates and colestipol
  • Some calcium channel blockers for angina and hypertension, such as amlodipine and diltiazem
  • Drugs to regulate the heart rhythm, eg digoxin, verapamil, amiodarone
  • Drugs used in the treatment of HIV , eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir, etc.
  • Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination of elbasvir and grazoprevir
  • Other medicines that affect or are affected by Atorvastatin Krka include ezetimibe (which lowers cholesterol ), warfarin (blood thinners), birth control pills, stiripentol (antispasmodic for epilepsy ), cimetidine (used for heartburn and stomach ulcers ), phenazone (painkillers), colchicine used for gout ) and antacids (medicines for digestive problems that contain aluminum or magnesium ) 
  • Over-the-counter medicines: St. John’s wort

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

Atorvastatin Krka with food, drink, and alcohol

See section 3 for instructions on how to use Atorvastatin Krka. Note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day as large amounts of grapefruit juice may affect the effect of Atorvastatin Krka

Alcohol

Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and Precautions” for more information.

Pregnancy, breastfeeding, and fertility

Do not use Atorvastatin Krka during pregnancy or if you are trying to conceive. Do not use Atorvastatin Krka if you are of childbearing potential and do not use a reliable contraceptive.

Do not use Atorvastatin Krka if you are breast-feeding.

The safety of Atorvastatin Krka during pregnancy and lactation has not yet been established. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, you should not drive if you notice that your ability is affected. Do not use any tools or machines if your ability to use them is affected by this medicine.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Atorvastatin Krka contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is next to “sodium-free”.

How to use Atorvastatin Krka

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

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

The usual starting dose of Atorvastatin Krka is 10 mg daily in adults and children 10 years of age or older. Dose one can be increased gradually by your doctor until you reach the dose you need. Dose one can be adjusted by the doctor at intervals of 4 weeks or more. The maximum dose of Atorvastatin Krka is 80 mg daily for adults and 20 mg daily for children.

The treatment time is determined by your doctor.

Talk to your doctor if you think the effect of Atorvastatin Krka is too strong or too weak.

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

If you forget to use Atorvastatin Krka

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

If you stop using Atorvastatin Krka

Contact your doctor or pharmacist if you have any further questions on the use of this medicine or wish to discontinue your treatment.

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 and contact your doctor immediately or go to the emergency department at the nearest hospital:

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

  • The severe allergic reaction causes swelling of the face, tongue, and throat, which can lead to great difficulty breathing.
  • The severe condition with severe scaling and swelling of the skin, blisters on the skin, mouth, eyes, and genitals, and fever. Skin rash with pink-red spots, especially on palms or soles of the feet, which may rupture.
  • Muscle weakness, soreness, pain, muscle strain or reddish-brown discoloration of the urine, especially if you also feel unwell or have a high fever. This may be due to an abnormal muscle breakdown ( rhabdomyolysis ). Abnormal muscle breakdown does not always go away despite stopping treatment with atorvastatin and can be life-threatening and lead to kidney problems.

Very rare side effects (affects less than 1 user in 10,000):

  • If you have problems with unexpected or unusual bleeding or bruising, this may be due to a liver effect. You should then contact your doctor as soon as possible.
  • lupus-like syndrome (including rash, joint problems, and effects on blood cells).

Other possible side effects are with Atorvastatin Krka:

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

  • inflammation of the nasal mucosa, pain in the throat, nosebleeds
  • allergic reactions
  • increase in blood sugar levels (if you have diabetes you should carefully monitor your blood sugar levels), increased creatine kinase in the blood
  • headache
  • nausea, constipation, gas, indigestion, diarrhea
  • joint pain, muscle aches, and back pain
  • blood test results that show that your liver function may be abnormal

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

  • anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you have diabetes, you should carefully monitor your blood sugar levels)
  • nightmares, insomnia
  • dizziness, numbness or tingling in fingers and toes, decreased sensation of pain or touch, changes in taste experience, memory loss
  • dimsyn
  • ringing in the ears and/or head
  • vomiting, belching, pain in the upper and lower abdomen, pancreatitis ( inflammation of the pancreas leading to abdominal pain)
  • hepatitis (inflammation of the liver)
  • rash, rash and itching, hives, hair loss
  • neck pain, muscle fatigue
  • fatigue, malaise, weakness, chest pain, swelling especially in the ankles ( edema ), elevated temperature
  • white blood cells in the urine

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

  1. visual disturbances
  2. unexpected bleeding or bruising
  3. bile stasis (yellowing of the skin and whites of the eyes)
  4. senskada

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

  • an allergic reaction – symptoms may include sudden wheezing and chest pain or shortness of breath, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
  • hearing loss
  • gynecomastia (breast augmentation in men).

Has been reported (occurs in an unknown number of users):

  • muscle weakness that is persistent

Possible side effects reported for certain statins (medicines of the same type):

  • sexual difficulties
  • Depression
  • difficulty breathing including persistent cough and/or shortness of breath or fever
  • diabetes. This is more likely if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure. Your doctor will check you while you are taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Moisture sensitive.

No special temperature instructions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is atorvastatin. Each Atorvastatin Krka tablet contains 10 mg, 20 mg, or 40 mg of atorvastatin as atorvastatin calcium
  • The other ingredients are calcium carbonate, lactose monohydrate, calcium lauryl sulphate , hydroxypropyl cellulose, lactose monohydrate , microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate in the tablet core and polyvinyl alcohol, macrogol 171 titanium dioxide.

What the medicine looks like and the contents of the pack

The 10 mg film-coated tablets are white, round, slightly biconvex, with beveled edges, diameter 6 mm.

The 20 mg film-coated tablets are white, round, slightly biconvex, with beveled edges, diameter 8 mm.

The 40 mg film-coated tablets are white, round, slightly biconvex, with beveled edges, diameter 10 mm.

This medicine is available in pack sizes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets in blister packs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

KRKA, dd, Novo Mesto, Šmarješka Cesta 6, 8501 Novo Mesto, Slovenia

Muhammad Nadeem

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