10 mg, 20 mg, 40 mg film-coated tablet
Atorvastatin
What Atorvastatin Actavis is and what it is used for
Atorvastatin Actavis belongs to a group of medicines called statins, which regulate lipids (fats).
Atorvastatin Actavis is used to treat high blood fats, cholesterol, and triglycerides when the effects of lifestyle changes and diet are insufficient. If you have an increased risk of heart disease, Atorvastatin Actavis can also be used to reduce this risk, even if your cholesterol levels are normal.
During treatment with Atorvastatin Actavis, you should continue with a low cholesterol diet.
Atorvastatin contained in Atorvastatin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Atorvastatin Actavis
Do not use Atorvastatin Actavis
- 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 Actavis.
- 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 Atorvastatin Actavis 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 Atorvastatin Actavis 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 Atorvastatin Actavis”).
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
When you are treated with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You will probably be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Other medicines and Atorvastatin Actavis
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 Atorvastatin Actavis, or their effect may be affected by Atorvastatin Actavis. 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
- Some antibiotics or antifungal agents, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, and rifampicin
- If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume treatment with Atorvastatin Actavis. Taking Atorvastatin Actavis with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
- Other lipid-lowering drugs, such as gemfibrozil, other fibrates, and colestipol
- Some calcium channel blockers for angina or high blood pressure, such as amlodipine, diltiazem, and medicines to regulate heart rhythm, such as digoxin, verapamil, amiodarone
- Drugs used in the treatment of HIV, eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir and ritonavir, 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 Atorvastatin Actavis 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
Atorvastatin Actavis with food, drink, and alcohol
See section 3 for instructions on how to use Atorvastatin Actavis. 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 Actavis.
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 Atorvastatin Actavis during pregnancy or if you are trying to get pregnant. Do not use Atorvastatin Actavis if you are of childbearing potential and do not use a reliable contraceptive.
Do not use Atorvastatin Actavis if you are breast-feeding.
The safety of Atorvastatin Actavis 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 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.
Atorvastatin Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’. it is next to “sodium-free”.
How to use Atorvastatin Actavis
Before starting treatment, your doctor will put you on a low-cholesterol diet, which you will then continue with during treatment with Atorvastatin Actavis.
The usual starting dose of Atorvastatin Actavis is 10 mg 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 Atorvastatin Actavis is 80 mg daily.
Atorvastatin Actavis 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 the tablet at the same time each day.
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 Atorvastatin Actavis is too strong or too weak.
If you forget to use Atorvastatin Actavis
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 Actavis
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 are or symptoms, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:
Rare (may affect up to 1 in 1000 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 (may affect up to 1 in 10,000 users):
- Lupus-like disease (including rash, joint problems, and effects on blood cells ).
- 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.
Other possible side effects are with Atorvastatin Actavis:
Common (may affect up to 1 in 10 users):
- 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 (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 (may affect up to 1 in 1000 people):
- visual disturbances
- unexpected bleeding or bruising
- bile stasis (yellowing of the skin and whites of the eyes)
- senskada
Very rare (may affect up to 1 in 10,000 users):
- 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 and women).
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
- Respiratory problems including persistent cough and / or shortness of breath 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 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 Actavis
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Shelf life after the first opening of a tablet can is 100 days.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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 (atorvastatin calcium trihydrate). One 10 mg, 20 mg or 40 mg film-coated tablet contains 10 mg, 20 mg or 40 mg of atorvastatin.
- Other ingredients are Tablet core: mannitol, microcrystalline cellulose, crospovidone, sodium carbonate, povidone, methionine, magnesium stearateTablet coating: Hypromellose 6 cP, macrogol 6000, titanium dioxide (E 171). Talc.
What the medicine looks like and contents of the pack
Tablet, film-coated.
10 mg: White, oval, biconvex, 4.9 x 9.1 mm film-coated tablet marked with “10” on one side and “A” on the other.
20 mg: White, oval, biconvex, 6.2 x 11.5 mm film-coated tablet marked with “20” on one side and “A” on the other.
40 mg: White, oval, biconvex, 7.8 x 14.5 mm film-coated tablet marked with “40” on one side and “A” on the other.
Pack sizes :
Blister packs:
Atorvastatin Actavis 10 mg film-coated tablet: 10, 20, 28, 30, 50, 90, 98, 100 tablets.
Atorvastatin Actavis 20 mg film-coated tablet: 10, 20, 28, 30, 50, 90, 98, 100 tablets.
Atorvastatin Actavis 40 mg film-coated tablet: 10, 20, 28, 30, 50, 90, 98, 100 tablets.
Tablet jar:
Atorvastatin Actavis 10 mg film-coated tablet: 30, 100, 200, 250, 500 tablets.
Atorvastatin Actavis 20 mg film-coated tablet: 30, 100, 250, 500 tablets.
Atorvastatin Actavis 40 mg film-coated tablet: 30, 100, 250, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd., Malta
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis Group PTC ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjörður
Iceland
Balkanpharma-Dupnitsa AD
3 Samakovsko Shosse Str.
Dupnitsa, 2600
Bulgaria