10 mg, 20 mg, 40 mg film-coated tablets
atorvastatin
1. What Atorbir is and what it is used for
Atorbir belongs to a class of drugs called statins and regulating blood lipids ( lipid s).
Atorbir is used in the treatment of high blood fats, so-called cholesterol, and triglycerides when the effect of a change in lifestyle and diet is insufficient. If you have an increased risk of heart disease, Atorbir can also be used to reduce this risk, even if your cholesterol levels are normal. During treatment with Atorbir, you should continue with a low cholesterol diet.
Atorvastatin contained in Atorbir 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.
2. What you need to know before you take Atorbir
Do not take Atorbir:
- 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 a reliable contraceptive
- if you are pregnant or trying to become pregnant
- if you are breast-feeding
- if you are using a combination of glekaprevir and pibrentasvir to treat hepatitis C.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Atorbir:
- if you have severe breathing problems
- if you are taking or during the last 7 days have taken a medicine called fusidic acid (a drug against a bacterial infection) by mouth or injection. The combination of fusidic acid and Atorbir can lead to severe muscle problems ( rhabdomyolysis )
- 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 hypothyroidism (hypothyroidism)
- if you have had repeated or unexplained muscle pain or muscle problems in person or in the family
- if you have previously had muscle problems during treatment with other lipid-lowering drugs (eg other statins or fibrates)
- if you regularly drink large amounts of alcohol
- if you have or have had any liver disease
- if you are over 70 years old
If any of these apply to you, your doctor will need to take blood samples before and probably during treatment with Atorbir to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken together (see section 2 “Other medicines and Atorbir”).
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
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 Atorbir
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the effect of Atorbir, or their effect may be affected by Atorbir. This type of interaction may make one or both drugs less effective. Alternatively, the interaction may increase the risk or severity of side effects, including 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
- Other lipid-lowering drugs, such as gemfibrozil, other fibrates, and colestipol
- Some calcium channel blockers against angina or high blood pressure, eg amlodipine, diltiazem, and medicines to regulate heart rhythm, eg digoxin, verapamil, amiodarone
- Drugs used in the treatment of HIV, eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir and ritonavir, letermovir, etc.
- Certain drugs used to treat hepatitis C, e.g. telaprevir, boceprevir, and a combination of elbasvir and grazoprevir
- Other medicines that affect or are affected by Atorbir are 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
- If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to pause this medicine. Your doctor will tell you when it is safe to start taking Atorbir again. Concomitant intake of Atorbir and fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
Atorbir with food, drink, and alcohol
See section 3 for instructions on how to use Atorbir. 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 can affect Atorbir’s effect.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and Precautions” for more information.
Pregnancy and breastfeeding
Do not use Atorbir during pregnancy or if you are trying to get pregnant. Do not use Atorbir if you are of childbearing potential and do not use a reliable contraceptive.
Do not use Atorbir if you are breast-feeding.
The safety of Atorbir 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 a car if you notice that your driving 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 sharpened attention. 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.
Atorbir 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.
10 mg film-coated tablets:
This medicine contains 4.68 mg sodium (the main ingredient in table salt/table salt) per film-coated tablet. This corresponds to 0.23% of the maximum recommended daily sodium intake for adults.
20 mg film-coated tablets:
This medicine contains 9.35 mg sodium (the main ingredient in table salt/table salt) per film-coated tablet. This corresponds to 0.47% of the maximum recommended daily sodium intake for adults.
40 mg film-coated tablets:
This medicine contains 18.70 mg sodium (the main ingredient in table salt/table salt) per film-coated tablet. This corresponds to 0.94% of the maximum recommended daily intake of sodium for adults.
3. How to take Atorbir
Before starting treatment, your doctor will put you on a low-cholesterol diet, which you will then continue with atorbir.
The usual starting dose of Atorbir is 10 mg once daily in adults and children 10 years of age or older. Dose one can be increased gradually as needed by your doctor until you reach the dose you need. Dose one will be adjusted by the doctor at intervals of 4 weeks or more. The maximum dose of Atorbir is 80 mg daily.
Atorbir tablets or tablet parts should be swallowed with a glass of water and can be taken at any time of the day with or without food. However, try to take the tablet at the same time each day.
10 mg film-coated tablets:
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole and is not intended for dividing the tablet into equal doses.
20 mg film-coated tablets:
The tablet can be divided into two equal doses.
40 mg film-coated tablets:
The tablet can be divided into four equal doses.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The treatment time is determined by your doctor.
Talk to your doctor if you think the effect of Atorbir is too strong or too weak.
If you forget to take Atorbir
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 taking Atorbir
If you have any further questions on the use of this product or want to stop your 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 and contact your doctor immediately or go to the emergency department at the nearest hospital:
Rare (may affect up to 1 in 1,000 people):
- A severe allergic reaction that 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, possibly with blisters.
- Muscle weakness, tenderness, pain or rupture, 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 (may affect up to 1 in 10,000 people):
- If you experience problems with unexpected or unusual bleeding or bruising, fatigue, loss of appetite, abdominal pain, nausea, or yellowing of the skin or eyes (jaundice), this may be due to a liver effect. You should then contact your doctor as soon as possible.
- Lupus-like disease (including rash, joint problems, and effects on blood cells ).
Other possible side effects are with Atorbir:
Common (may affect up to 1 in 10 people):
- Inflammation of the nasal mucosa, sore throat, nosebleeds
- Allergic reactions
- Increased 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, joint swelling, muscle aches, muscle cramps, and back pain
- Blood test results that show that your liver function may be abnormal
Uncommon (may affect up to 1 in 100 people):
- 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 (may affect up to 1 in 1,000 people):
- Visual disturbances
- Unexpected bleeding or bruising
- Gallstones (yellowing of the skin and whites of the eyes)
- Late injury
Very rare (may affect up to 1 in 10,000 people):
- An allergic reaction – symptoms may include sudden wheezing and chest pain or pressure over the chest, 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 the unknown number of users):
- Muscle weakness that is persistent
Possible side effects reported for certain statins (medicines of the same type):
- Sexual difficulties
- Depression
- Respiratory problems including persistent cough and/or shortness of breath or fever
- Diabetes. This is more likely if you have high blood sugar and high 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 Atorbir
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, jar, and blister after EXP. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
HDPE cans :
Shelf life after first opening the jar: 6 months.
Storage conditions after first opening: Do not store above 25 ° C.
Medicines 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 tablet contains 10 mg of atorvastatin (as calcium trihydrate).
Each tablet contains 20 mg of atorvastatin (as calcium trihydrate).
Each tablet contains 40 mg of atorvastatin (as calcium trihydrate).
The other ingredients are sodium carbonate (anhydrous), microcrystalline cellulose, sodium starch glycolate (type A), povidone (K25), colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide, lactose monohydrate.
What the medicine looks like and the contents of the pack
10 mg film-coated tablets:
White to off-white, dot-like yellow spots possible, oval, film-coated tablet with a scoreline on both sides, to divide the tablet into halves, and marked “10” on one side.
20 mg film-coated tablets:
White to off-white, dot-like yellow spots possible, oval, film-coated tablet with a scoreline on both sides, to divide the tablet into halves, and marked “20” on one side.
40 mg film-coated tablets:
White to off-white, dot-like yellow spots possible, round, film-coated tablet with a scoreline on one side, to divide the tablet into quarters, and marked “40” on the other side.
The film-coated tablets are packed in aluminum-aluminum blisters in a carton or packed in HDPE cans with desiccant lids.
10 mg and 20 mg:
Pack sizes:
Blisters: 7, 10, 15, 20, 28, 30, 50, 90, 98 and 100 film-coated tablets.
Jars: 50, 100, and 250 film-coated tablets.
40 mg:
Pack sizes:
Blisters: 10, 15, 20, 28, 30, 50, 90, 98 and 100 film-coated tablets.
Jars: 50, 100, and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia
or
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
or
Aeropharm GmbH, Francois-Mitterand-Allee I, 07407 Rudolstadt, Germany