10 mg, 20 mg, 40 mg, 80 mg film-coated tablets
atorvastatin
What Lipitor is and what it is used for
Lipitor belongs to a group of medicines called statins, which regulate lipids (fats).
Lipitor is used in the treatment of elevated 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, Lipitor can also be used to reduce this risk, even if your cholesterol levels are normal.
During treatment with Lipitor, you should continue with a low cholesterol diet.
Atorvastatin contained in Lipitor may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Lipitor
Do not use Lipitor
- 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 glekaprevir and pibrentasvir to treat hepatitis C.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Lipitor
- if you have severe breathing problems
- if you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infection) orally or as an injection in the last 7 days . The combination of fusidic acid and Lipitor can lead to severe muscle problems ( rhabdomyolysis )
- if you have previously had a stroke with bleeding in the brain, or have small pockets of fluid in the brain from previous strokes
- if you have kidney problems
- if you have hypothyroidism (hypothyroidism)
- if you have had recurrent or unexplained muscle pain or muscle problems in person or in your 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 Lipitor 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 Lipitor”).
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 Lipitor
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 Lipitor, or their effect may be affected by Lipitor. This type of interaction may make one or both drugs less effective. Alternatively, 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, e.g. cyclosporine
- Some antibiotics or remedies for fungal infections, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole , itraconazole, voriconazole, fluconazole , posaconazole, rifampicin and fusidic acid
- Other lipid-lowering drugs, e.g. gemfibrozil, other fibrates and colestipol
- Some calcium channel blockers for angina or high blood pressure , e.g. amlodipine, diltiazem and drugs to regulate heart rhythm e.g. digoxin , verapamil, amiodarone
- Letermovir, a medicine that helps you avoid getting sick from cytomegalovirus
- Drugs used in the treatment of HIV , e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir etc.
- Certain drugs used to treat hepatitis C, e.g. telaprevir, boceprevir and combination of elbasvir and grazoprevir and combination of ledipasvir and sofosbuvir
- Other medicines that affect or are affected by Lipitor 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 and containing 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 temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking Lipitor again. Concomitant intake of Lipitor and fusidic acid may in rare cases lead to muscle weakness, tenderness or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
Lipitor with food, drink and alcohol
See section 3 for instructions on how to use Lipitor. 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 Lipitor’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 Lipitor during pregnancy or if you are trying to get pregnant. Do not use Lipitor if you are of childbearing potential and do not use a reliable contraceptive.
Do not use Lipitor if you are breastfeeding.
The safety of Lipitor 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 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.
Lipitor contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lipitor contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
Lipitor contains benzoic acid
10 mg tablets
This medicine contains 0.00004 mg benzoic acid per tablet.
20 mg tablets
This medicine contains 0.00008 mg benzoic acid per tablet.
40 mg tablets
This medicine contains 0.00016 mg benzoic acid per tablet.
80 mg tablets
This medicine contains 0.00032 mg benzoic acid per tablet.
How to use Lipitor
Before starting treatment, your doctor will put you on a low-cholesterol diet, which you will then continue with during treatment with Lipitor.
The usual starting dose of Lipitor 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 Lipitor is 80 mg once daily.
Lipitor 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 Lipitor is too strong or too weak.
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
- Severe allergic reaction that causes swelling of the face, tongue and throat, which can lead to great difficulty breathing.
- 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, tenderness, pain, 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 ). The 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 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 disease picture (including rash, joint problems and effects on blood cells ).
Other possible side effects are from Lipitor
Common: may affect up to 1 in 10 users
- inflammation of the nasal mucosa, sore 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, upper and lower abdominal pain, 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
- bile stasis (yellowing of the skin and whites of the eyes)
- senskada
Very rare: 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 high blood fat levels, are overweight and have high blood pressure . Your doctor will check you while you are taking this medicine.
How to store Lipitor
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 label and outer carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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.
Contents of the pack and other information
Content declaration
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
Other ingredients are:
calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hypromellose and magnesium stearate.
The film coating of Lipitor contains hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, stearate emulsifier (polyethylene glycol sorbitan tristearate, polyethoxylated stearate, glycerides), thickeners (methylcellulose, xanthene gum acid), bicanthosuccinic acid (E), cyanuric acid.
What the medicine looks like and contents of the pack
Lipitor 10 mg film-coated tablets are white 5.6 mm in diameter with a round shape. They are marked 10 on one side and “ATV” on the other side.
Lipitor 20 mg film-coated tablets are white 7.1 mm in diameter with a round shape. They are marked 20 on one side and “ATV” on the other side.
Lipitor 40 mg film-coated tablets are white 9.5 mm in diameter with a round shape. They are marked 40 on one side and “ATV” on the other side.
Lipitor 80 mg film-coated tablets are white 11.9 mm in diameter with a round shape. They are marked 80 on one side and “ATV” on the other side.
The blister pack consists of a molded film of polyamide / aluminum foil / polyvinyl chloride with a backing consisting of aluminum foil / vinyl heat-sealed coating.
The jar consists of HDPE, contains desiccant and has a child-resistant closure.
Lipitor is available in blisters of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets, hospital packs of 50, 84, 100, 200 (10×20) or 500 film-coated tablets and jar of 90 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Operating office Freiburg
Mooswaldallee 1
79090 Freiburg
Germany