10 mg, 20 mg, 40 mg, 80 mg film-coated tablets 
atorvastatin

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

Save this information, you may need to read it again.

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.

This leaflet contains information about: 
1. What Atorvastatin Mylan is and what it is used for 
2. What you need to know before taking Atorvastatin Mylan 
3. How to take Atorvastatin Mylan 
4. Possible side effects 
5. How to store Atorvastatin Mylan 
6. Package contents and other information

What Atorvastatin Mylan is and what it is used for

Atorvastatin Mylan belongs to a group of medicines called statins that regulate lipids(fats). Atorvastatin Mylan is used to treat high blood fats, so-called cholesterol, and triglycerides when the effects of an altered lifestyle and a low-fat diet are insufficient. If you have an increased risk of heart disease, Atorvastatin Mylan can also be used to reduce this risk even if your cholesterol levels are normal.

During treatment with Atorvastatin Mylan, you should continue with a low cholesterol diet.

Atorvastatin contained in Atorvastatin Mylan 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 you take Atorvastatin Mylan

Do not take Atorvastatin Mylan

  • if you are allergic to atorvastatin or any of the other products used to lower blood fats or any of the other ingredients of this medicine (listed in section 6)
  • if you are using a combination of telaprevir and pibrentasvir to treat hepatitis C.
  • if you are allergic to peanuts or soy, as it contains soy lecithin
  • 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

Warnings and cautions

Talk to your doctor or pharmacist before taking Atorvastatin Mylan:

  • if you have severe breathing problems
  • if you have had a previous stroke or TIA attack (a disturbance in the blood circulation that passes) or 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 repeated or unexplained muscle pain or if you or someone in your family has had muscle problems
  • if you have a history of muscle problems with other lipid-lowering drugs (eg other statins or fibrates)
  • if you regularly drink large amounts of alcohol
  • if you have or have had liver disease
  • if you are over 70 years old
  • if you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infection) orally or as an injection within the last 7 days. The combination of fusidic acid and Atorvastatin Mylan can lead to serious muscle problems ( rhabdomyolysis ).

If any of these apply to you, your doctor will need to take blood samples before and possibly during treatment with Atorvastatin Mylan 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 Mylan”).

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.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.

Other medicines and Atorvastatin Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Some medicines may affect the effect of atorvastatin, or their effect may be affected by atorvastatin. 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, e.g. cyclosporine
  • Some antibiotics or remedies for fungal infections, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole , posaconazole, rifampicin
  • Other lipid-lowering drugs, e.g. gemfibrozil, other fibrates, and colestipol, niacin
  • 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, delavirdine, efavirenz, saquinavir, a combination of tipranavir / ritonavir, nelfinavir, fosamprenavir etc.
  • Certain drugs used to treat liver problems, such as hepatitis C, e.g. telaprevir, boceprevir, and a combination of elbasvir and grazoprevir.
  • Other medicines that affect or are affected by Atorvastatin Mylan 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
  • If you need to take fusidic acid by mouth for the treatment of a bacterial infection, you should temporarily stop using this medicine. Your doctor will tell you when it is safe to start using Atorvastatin Mylan again. Ingestion of Atorvastatin Mylan with fusidic acid may in rare cases lead to muscle weakness, tenderness or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.

Atorvastatin Mylan with drink and alcohol

Grapefruit juice :

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may affect the effect of Atorvastatin Mylan.

Alcohol :

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

Pregnancy and breastfeeding

Do not take Atorvastatin Mylan if you are pregnant or trying to become pregnant. Do not use Atorvastatin Mylan if you are of childbearing potential and do not use a reliable contraceptive.

Do not take Atorvastatin Mylan if you are breast-feeding.

The safety of Atorvastatin Mylan during pregnancy and lactation has not yet been established. Ask your doctor or pharmacist for advice before taking this 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 Mylan 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 tablet, ie essentially ‘sodium-free’.

How to take Atorvastatin Mylan

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 then continue with during treatment with Atorvastatin Mylan.

The recommended starting dose of Atorvastatin Mylan 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 Mylan is 80 mg daily.

Atorvastatin Mylan 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.

The treatment time is determined by your doctor:

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

If you forget to take Atorvastatin Mylan

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 Atorvastatin Mylan

Contact your doctor or pharmacist if you have any further questions on the use of this medicine or wish to end 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:

Less common side effects are (may affect up to 1 in 100 people)

  • ­ pancreatitis ( inflammation of the pancreas that causes severe abdominal pain that radiates to the back)
  • ­ hepatitis (inflammation of the liver)

Rare side effects are (may affect up to 1 in 1000 people):

  • severe allergic reaction – symptoms may include sudden wheezing and chest pain or shortness of breath, swelling of eyelids, face, lips, mouth, tongue and throat, severe difficulty breathing, collapse.
  • the severe condition with severe peeling 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, 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.
  • blockage in the bile ducts (bile stasis) that can cause yellowing of the skin and whites of the eyes, pain in the right upper abdomen, loss of appetite.

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

  • if you get pain in the right upper abdomen, bloated stomach, and yellowing of the skin and whites of the eyes, 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 the blood cells ).

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

  • muscle weakness that is persistent.

Other possible side effects are with Atorvastatin Mylan:

Common side effects are (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, muscle spasm
  • blood test results that show that your liver function may be abnormal

Less common side effects are (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
  • 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 are (may affect up to 1 in 1000 people):

  • visual disturbances
  • unexpected bleeding or bruising
  • senskada

Very rare side effects are (may affect up to1 in 10 000 people):

  • hearing loss
  • gynecomastia (breast augmentation in men).

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 Atorvastatin Mylan

Keep this medicine out of the sight and reach of children.

OPA / AI / PVC / AI blisters and cans: Store in the original package in order to protect from light and moisture.

PVC / Aclar blister: Store in the original package in order to protect from light, store blister in the outer carton or inner carton (if multipack is used) to protect from light.

Do not use this medicine after the expiry date which is stated on the carton, can label and blister after EXP. The expiration date is the last day of the specified month.

Use within 3 months after opening the jar.

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 (as atorvastatin calcium trihydrate). Each film-coated tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin as atorvastatin calcium trihydrate.
  • The other ingredients of Atorvastatin Mylan are colloidal anhydrous silica, sodium carbonate, microcrystalline cellulose, L- arginine, lactose, croscarmellose sodium, hydroxypropyl cellulose (E463), and magnesium stearate. The film coating contains polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415), and macrogol. See section 2 “Do not take Atorvastatin Mylan” and “Atorvastatin Mylan contains lactose and sodium”.

What the medicine looks like and the contents of the pack

The film-coated tablets are oval and white. The 10 mg tablet is labeled “10” on one side, the 20 mg tablet is labeled “20”, the 40 mg tablet is labeled “40” and the 80 mg tablet is labeled “80”. The 20 mg, 40 mg, and 80 mg tablets have a break notch on one side to facilitate tablet division and to facilitate swallowing. The switch is not intended to divide the tablet into two equal doses.

Atorvastatin Mylan is available in plastic jars of 10, 14, 28. 30, 50, 56, 60, 90, 100, 200, 250 and 500 tablets.

Atorvastatin Mylan is also available in blisters of 10, 14, 28. 30, 50, 56, 60, 84, 90, 98, and 100 tablets and calendar blisters of 28 tablets and a multipack of 98 tablets containing 2 cartons of 49 tablets each.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Tel: 08-555 227 50

Fax: 08-555 227 51

Email: inform@mylan.se

Manufacturer

McDermott Laboratories Limited t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

or

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.

This medicinal product is authorized under the European Economic Area under the names :

Belgium, Netherlands: Atorvastatin Mylan

Czech Republic, Denmark, Ireland, Norway, Slovakia, Atorvastatin Mylan

Slovenia: Atorvastatin Mylan 10, 20, 40 mg film-free tablets

Bulgaria: Atorgen

Cyprus: Atorvastatin / Generics

Greece: Atorvastatin / Mylan

Portugal, Spain: Atorvastatina Mylan

Poland: ATORVAGEN

United Kingdom: Atorvastatin [10/20/40/80] mg Film-coated Tablets

Muhammad Nadeem

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