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

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
  • 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, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Atorvastatin Accord is and what it is used for 
2. What you need to know before you use Atorvastatin Accord 
3. How to use Atorvastatin Accord 
4. Possible side effects 
5. How to store Atorvastatin Accord 
6. Contents of the pack and other information 

1. What Atorvastatin Accord is and what it is used for

Atorvastatin Accord belongs to a group of medicines called statins, which regulate lipids (fats).

Atorvastatin Accord is used in the treatment of high blood fats, so-called cholesteroland triglycerides , when the effect of changes in lifestyle and diet is insufficient. If you have an increased risk of heart disease, Atorvastatin Accord can also be used to reduce this risk, even if your cholesterol levels are normal.

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

Atorvastatin contained in the Atorvastatin Accord 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 using Atorvastatin Accord

Do not use Atorvastatin Accord

  • 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
  • about duammar
  • 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 Atorvastatin Accord.

  • 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 bacterial infection) by mouth or injection . The combination of fusidic acid and Atorvastatin Accord 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 repeated or unexplained muscle pain or muscle problems in person or in the family
  • if you have a history of muscle problems with other lipid-lowering medicines (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 Accord 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 Accord”).

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 Atorvastatin Accord

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 Accord, or their effect may be affected by Atorvastatin Accord. 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 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 a combination of elbasvir and grazoprevir
  • Other medicines that affect or are affected by Atorvastatin Accord 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 pause this medicine. Your doctor will tell you when it is safe to start taking Atorvastatin Accord again. Concomitant intake of Atorvastatin Accord and fusidic acid may in rare cases lead to muscle weakness, tenderness or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.

Atorvastatin Accord with food, drink and alcohol

See section 3 for instructions on how to use Atorvastatin Accord.

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 Atorvastatin Accord 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 Atorvastatin Accord during pregnancy or if you are trying to conceive.

Do not use Atorvastatin Accord if you are of childbearing potential and do not use a reliable contraceptive.

Do not use Atorvastatin Accord if you are breast-feeding.

The safety of Atorvastatin Accord 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 Accord 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.

How to use Atorvastatin Accord

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you will then continue with during treatment with Atorvastatin Accord.

The usual starting dose of Atorvastatin Accord 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 Atorvastatin Accord is 80 mg once daily.

Atorvastatin Accord 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 duration of treatment with Atorvastatin Accord is determined by your doctor.

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

If you use more Atorvastatin Accord than you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to use Atorvastatin Accord

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 Accord

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 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, 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.

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 (including rash, joint pain and effects on blood cells ).

Other possible side effects are of Atorvastatin Accord

Common: 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
  • 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 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  (may occur 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.

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 Accord

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the outer carton and blister 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

Contents of Atorvastatin Accord

  • The active substance is atorvastatin.

Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

  • Other ingredients are:

Tablet core: calcium carbonate , lactose monohydrate , microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, polysorbate 80 and magnesium stearate.

Film coating: Hypromellose 2910 (E464), macrogol 8000, titanium dioxide (E171) and talc.

What the medicine looks like and contents of the pack

Atorvastatin Accord 10 mg film-coated tablet: White to off-white, round, biconvex film-coated tablets approximately 5.6 mm in diameter, imprinted with FUI on one side and smooth on the other.

Atorvastatin Accord 20 mg film-coated tablet: White to off-white, round, biconvex film-coated tablets approximately 7.1 mm in diameter, imprinted with FU2 on one side and smooth on the other.

Atorvastatin Accord 40 mg film-coated tablet: White to off-white, round, biconvex film-coated tablets approximately 9.6 mm in diameter, embossed with FU3 on one side and smooth on the other.

Atorvastatin Accord 80 mg film-coated tablet: White to off-white, round, biconvex film-coated tablets approximately 12.1 mm in diameter, embossed with FU4 on one side and smooth on the other.

Atorvastatin Accord will be available in OPA / Al / PVC-Al blister packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets. Hospital packs of 50, 84, 100, 200 (10 x 20) or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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