Lipistad 10 mg & 20 mg & 40 mg & 80 mg Atorvastatin Film Coated Tablets
What Lipistad Is And What Lipistad Used For?
Lipistad belongs to a group of medicines called statins, which regulate lipids (fats). Listed is used to treat 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, Lipistad can also reduce this risk, even if your cholesterol levels are normal.
During treatment with Lipistad, you should continue with a low cholesterol diet. Atorvastatin in Lipistad may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions.
What You Need To Know Before Using Lipistad?
Do Not Use Lipistad
- 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 fertile woman and do not use contraception
- If you are pregnant or trying to become pregnant
- If you are breast-feeding
- If you use a combination of glekaprevir and pibrentasvir to treat hepatitis C.
Warnings And Cautions:
Talk to a doctor, pharmacist, or nurse before taking Lipistad:
- If you have severe breathing problems
- If you take 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 Lipistad 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 an underactive thyroid gland (hypothyroidism)
- If you have had recurrent or unexplained muscle pain or if you or someone in your family has had muscle problems
- If you have previously had muscle problems during treatment with other lipid-lowering drugs (e.g., 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 must take blood samples before and probably during treatment with Lipistad 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 Lipistad”).
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 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 Lipistad
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines. Some medicines may affect the effect of Lipistad, or their effect may be affected by Lipistad. 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
- Certain antibiotics or agents for fungal infections, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole , itraconazole, voriconazole, fluconazole , posaconazole, rifampicin, fusidic acid
- Other lipid-lowering drugs, e.g., gemfibrozil, other fibrates and colestipol
- Certain calcium channel blockers against angina or hypertension , 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 a combination of elbasvir and grazoprevir, as well as a combination of ledipasvir and sofosbuvir
- Other medicines that affect or are affected by Lipistad 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 must temporarily stop taking this medicine. Your doctor will tell you when it is safe to start retaking Lipistad. Concomitant intake of Lipistad and fusidic acid may, in rare cases, lead to muscle weakness, tenderness or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
Lipistad With Food, Drinks And Alcohol:
See section 3 for instructions on how to use Lipistad. Note the following:
- Grapefruit juice
- Do not take more than one or two small glasses of grapefruit juice per day, as large amounts can affect Lipista’s effect.
- 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 Lipistad during pregnancy or if you are trying to conceive.
- Do not use Lipistad if you are fertile, and do not use a reliable contraceptive.
- Do not use Lipistad if you are breast-feeding.
The safety of Lipistad 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 can drive a motor vehicle or perform work requiring sharpened attention.
One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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.
Lipistad Contains Lactose And sodium:
- Lipistad contains lactose
- If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine.
- Lipistad contains sodium
- This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e., essentially ‘sodium-free.’ It is next to “sodium-free.”
How To Use Lipistad?
- Always take 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 continue with during treatment with Lipistad.
Dosage
- The usual starting dose of Lipistad is 10 mg daily in adults and children 10 years or older. Dose one can be increased gradually as needed by your doctor until you reach the dose you need. The doctor will adjust dose one at intervals of 4 weeks or more. The maximum dose of Lipistad is 80 mg once daily.
Method of administration
Lipistad tablets should be swallowed whole with water and 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.
Your doctor determines the duration of treatment with Lipistad.
Talk to your doctor if you think the effect of Lipistad is too strong or too weak.
Possible lipistad side effects
This medicine can cause side effects like all medicines, although not everybody gets them.
If you experience 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 the palms or soles of the feet, may rupture.
- Muscle weakness, soreness, pain
- Muscle strain or reddish-brown urine discoloration, especially if you feel unwell or have a high fever. This may be due to an abnormal muscle breakdown. Abnormal muscle breakdown ( rhabdomyolysis ) 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 syndrome (including rash, joint disease and effects on blood cells ).
Other possible side effects are from Lipistad
Common (may affect up to 1 in 10 people):
- 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 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):
- Persistent muscle weakness
Possible side effects reported for certain statins (medicines of the same type):
- Sexual difficulties
- Depression
- Difficulty breathing, including persistent cough and 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 Lipistad?
- Keep this medicine out of sight and reach of children.
- No special storage instructions.
- Do not use this medicine after the expiry date stated on the blister and 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 that are 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 in Lipistad are:
- Lactose monohydrate, cellulose powder, calcium carbonate, pregelatinized starch, hypromellose, croscarmellose sodium, magnesium stearate
- The film coating contains hypromellose, macrogol, titanium dioxide (E 171), talc
What The Medicine Looks Like And Contents Of The Pack?
- 10 mg tablet: White to off-white, round, biconvex film-coated tablets, diameter: 6 mm.
- Lipistad 20 mg tablet: White to off-white, round, biconvex film-coated tablets, diameter: 8 mm.
- 40 mg tablet: White to off-white, round, biconvex film-coated tablets, diameter: 10 mm.
- 80 mg tablet: White to off-white, round, biconvex film-coated tablets, diameter: 12 mm.
- OPA / AI / PVC-Al blisters containing 4, 7, 10, 14, 20, 28, 30, 50 (hospital packaging), 50, 56, 84, 90, 98, 100, 112, 120, 180 and 500 film-coated tablets .
- OPA / AI / PVC-Al blisters containing 4×1, 7×1, 10×1, 14×1, 20×1, 28×1, 30×1, 50×1 (hospital packaging), 50×1, 56×1, 84×1, 90×1, 98×1, 100×1, 112×1, 120×1, 180×1 and 500×1 film-coated tablets .
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Centrafarm Services BV
New Donk 9
4879 AC Etten-Leur
Netherlands
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
PharmaCoDane ApS.
Marielundvej 46A
2730 Herlev
Denmark
Coripharma
Reykjavikurvegur 78
220 Hafnarfjordur
Iceland
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark