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. 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.

In this leaflet: 
1. What Atorvastatin Bluefish is and what it is used for 
2. What you need to know before taking Atorvastatin Bluefish 
3. How to take Atorvastatin Bluefish 
4. Possible side effects 
5. How to store Atorvastatin Bluefish
6. Contents of the packaging and other information 

What Atorvastatin Bluefish is and what it is used for

Atorvastatin Bluefish belongs to a class of drugs called statins regulating blood lipids ( lipid s).

Atorvastatin Bluefish is used to lower blood fats called cholesterol and triglycerides when a low-fat diet and lifestyle changes are insufficient. If you have an increased risk of heart disease, Atorvastatin Bluefish can also be used to reduce this risk even if your cholesterol levels are normal. A normal cholesterol-lowering diet should be maintained during treatment.

Cholesterol is a naturally occurring substance in the body, necessary for normal growth. If there is too much cholesterol in the blood, it can be stored in the blood vessel walls, which leads to the blood vessels becoming narrower and possibly eventually blocked. This is one of the most common causes of heart disease. It is known that increased cholesterol levels increase the risk of heart disease. Other factors that can increase the risk of heart disease include high blood pressure, diabetes, weight gain, lack of exercise, smoking, or heart disease in the family.

Atorvastatin contained in Atorvastatin Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask doctors and pharmacists or other healthcare professionals if you have further questions and always follow their instructions.

What you need to know before you take Atorvastatin Bluefish

Do not take Atorvastatin Bluefish:

  • 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 have or have had diseases that affect the liver
  • if you have had unexplained abnormal liver function values
  • if you are using a combination of telaprevir and pibrentasvir to treat hepatitis C.
  • 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, pharmacist, or nurse before using Atorvastatin Bluefish

  • 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 (personally 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 you have severe breathing problems

If any of these apply to you, your doctor will need to take blood samples before and probably during treatment with Atorvastatin Bluefish, to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis (muscle breakdown), increases when certain medicines are taken together (see section 2 “Other medicines and Atorvastatin Bluefish”). Also, tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.

When taking this medicine, your doctor should check your values ​​carefully, if you have diabetes or are at risk of developing diabetes. You are more likely to develop diabetes if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Bluefish

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 Bluefish, or their effect may be affected by Atorvastatin Bluefish. This type of interaction may make one or both drugs less effective. Alternatively, an 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
  • Certain antibiotics or antifungal agents, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, and fusidic acid
  • 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
  • Certain drugs used to treat hepatitis C, e.g. telaprevir, boceprevir, and a combination of elbasvir and grazoprevir
  • Drugs used in the treatment of HIV, eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
  • Other medicines that affect or are affected by Atorvastatin Bluefish 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 Bluefish with food, drink and alcohol

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

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 Bluefish during pregnancy or if you are trying to conceive. Do not use Atorvastatin Bluefish if you are of childbearing potential and do not use a reliable contraceptive.

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

The safety of Atorvastatin Bluefish 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 Bluefish contains lactose

This medicine 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 take Atorvastatin Bluefish

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

The usual starting dose of Atorvastatin Bluefish 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 Bluefish is 80 mg daily for adults and 20 mg daily for children.

Atorvastatin Bluefish 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 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 Bluefish is too strong or too weak.

If you forget to take Atorvastatin Bluefish

If you forget to take a dose, only take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atorvastatin Bluefish

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 1000 people): –

  • The severe allergic reaction causes swelling of the face, tongue, and throat and that 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, tenderness, pain, reddish-brown discoloration of the urine, or rupture, especially if you also feel unwell or have a high fever. This may be due to an abnormal muscle breakdown. 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 syndrome (including rash, joint disease, and blood cell changes).

Other possible side effects are with Atorvastatin Bluefish:

Common side effects (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 showing liver function may be abnormal

Uncommon side effects (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 side effects (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 side effects (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 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 or fat in your blood, are overweight, or have high blood pressure. Your doctor will check your values ​​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 Bluefish

No special storage instructions.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the 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

Content declaration

  • The active substance is atorvastatin. Each tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (as atorvastatin calcium).
  • Other ingredients are Tablet core: lactose monohydrate, magnesium stearate (E470b), sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, butyl hydroxy anisole (E320), crospovidone (E1202), sodium bicarbonate (E500), and sinespum.Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), and macrogol 4000.

What the medicine looks like and the contents of the pack

10mg: A white, biconvex, cylindrical tablet with a notch on one side and the code AT1 on the other side.

20mg: A white, biconvex, cylindrical tablet with a notch on one side and the code AT2 on the other side.

40mg: A white, biconvex, cylindrical tablet with a notch on one side and the code AT4 on the other side.

80mg: A white, biconvex, oblong tablet with a notch on one side and the code AT8 on the other side.

All strengths are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

SAG Manufacturing SLU

Crta Ni, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

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

Member State Name of the medicine
Poland Atorvastatin Bluefish
Austria Atorvastatin Bluefish 10 mg / 20 mg / 40 mg / 80 mg film tablets
Iceland Atorvastatin Bluefish 10 mg / 20 mg / 40 mg / 80 mg film-coated tablets

Muhammad Nadeem

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