Document: Atorvastatin Bluefish film-coated tablet ENG PL change

• Atorvastatin Bluefish film-coated tablet PL
• Atorvastatin Bluefish film-coated tablet ENG PL

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Package leaflet: Information for the user

Atorvastatin Bluefish 10 mg film-coated tablets

Atorvastatin Bluefish 20 mg film-coated tablets

Atorvastatin Bluefish 40 mg film-coated tablets

Atorvastatin Bluefish 80 mg film-coated tablets

Atorvastatin

Read all of this leaflet carefully before you start using this medicinebeacuse it contains important information for you

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2. What you need to know before you use Atorvastatin Bluefish

3. How to use Atorvastatin Bluefish

4. Possible side effects

Atorvastatin Bluefish belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Atorvastatin Bluefish is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and lifestyle changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin Bluefish can also be used to reduce such risk even if your cholesterol levels are normal. A standard cholesterol lowering diet should be continued during treatment.

Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if there is too much cholesterol in your blood it can be deposited in the walls of blood vessels leading to the narrowing of these vessels which may eventually become blocked. This is one of the most common causes of heart disease. It is accepted that raised cholesterol levels increase the risk of heart disease. Other factors that will increase the risk of heart disease include high blood pressure, diabetes, increased weight, lack of exercise, smoking or a family history of heart disease.

Do not use Atorvastatin Bluefish

• if you are allergic to atorvastatin or any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine (listed in section 6).

• if you have or have ever had a disease which affects the liver

• if you have had any unexplained abnormal blood tests for liver function

• if you are a woman able to have children and not using reliable contraception

• if you are pregnant or trying to become pregnant

• if you are breast-feeding.

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before using Atorvastatin Bluefish: if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes

• if you have kidney problems

• if you have an under-active thyroid gland (hypothyroidism)

• if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems

• if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)

• if you regularly drink a large amount of alcohol

• if you have a history of liver disease

• if you are older than 70 years.

• if you have severe respiratory failure.

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atorvastatin treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Taking other medicines”). Also tell your doctor or pharmacist if you have muscle weakness that is constant. Additional tests and medicine may be needed to diagnose and treat this.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Atorvastatin Bluefish

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

There are some medicines that may change the effect of Atorvastatin or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4:

• Medicines used to alter the way your immune system works, e.g. ciclosporin

• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid

• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol

• Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone

• Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.

• Other medicines known to interact with Atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller) and antacids (indigestion products containing aluminium or magnesium)

• Medicines obtained without a prescription: St John’s Wort

Atorvastatin Bluefish with food, drink and alcohol

See Section 3 for instructions on how to take Atorvastatin Bluefish. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin Bluefish.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with Atorvastatin Bluefish” for details

Pregnancy and breast-feeding

Do not take Atorvastatin Bluefish if you are pregnant, or if you are trying to become pregnant.

Do not take Atorvastatin Bluefish if you are able to become pregnant unless you use reliable contraceptive measures.

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

The safety of Atorvastatin Bluefish during pregnancy and breast-feeding has not yet been proven. 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 operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Atorvastatin Bluefish contains Lactose

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin Bluefish.

The usual starting dose of Atorvastatin Bluefish is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dosage at intervals of 4 weeks or more. The maximum dose of Atorvastatin Bluefish is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin Bluefish tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The duration of treatment with Atorvastatin Bluefish is determined by your doctor.

Please ask your doctor if you think that the effect of Atorvastatin Bluefish is too strong or too weak.

If you take more Atorvastatin Bluefish than you should

If you accidently take too many Atorvastatin Bluefish tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Atorvastatin Bluefish

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

If you stop taking Atorvastatin Bluefish

If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.

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, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Rare: may affect 1 in 1,000 people:

Very rare: may affect up to 1 in 10,000 people:

Other possible side effects with Atorvastatin Bluefish:

Common side effects (may affect up to 1 in 10 people) include:

• inflammation of the nasal passages, pain in the throat, nose bleed

• allergic reactions

• increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase

• headache

• nausea, constipation, wind, indigestion, diarrhoea

• joint pain, muscle pain and back pain

• blood test results that show your liver function can become abnormal

Uncommon side effects (may affect up to 1 in 100 people) include:

• anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)

• having nightmares, insomnia

• dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory

• blurred vision

• ringing in the ears and/or head

• vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)

• hepatitis (liver inflammation)

• rash, skin rash and itching, hives, hair loss

• neck pain, muscle fatigue

• fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature

• urine tests that are positive for white blood cells

Rare side effects (may affect up to 1 in 1,000 people) include:

• visual disturbance

• unexpected bleeding or bruising

• cholestasis (yellowing of the skin and whites of the eyes)

• tendon injury

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

• an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse

• hearing loss

• gynecomastia (breast enlargement in men and women).

Not known (frequency cannot be estimated from the available data):

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties

• Depression

• Breathing problems including persistent cough and/or shortness of breath or fever

• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atorvastatin Bluefish

This medicinal product does not require any special storage conditions.

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 carton or blister foil. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Atorvastatin Bluefish contains

• The active substance is atorvastatin. Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium).

• The other ingredients are:

Core: lactose monohydrate, magnesium stearate (E470b), sodium laurilsulphate, microcrystalline cellulose, anhydrous colloidal silica, butylhydroxyanisole (E320), crospovidone (E1202), sodium hydrogen carbonate (E500) and sinespum.

Coating: lactose monohydrate, hypromellose, titanium dioxide (E171) and macrogol 4000.

What Atorvastatin Bluefish looks like and contents of the pack

10 mg: White, biconvex, cylindrical tablet with a score line on one side and with code ‘AT1’ on the other side.

20 mg: White, biconvex, cylindrical tablet with a score line on one side and with code ‘AT2’ on the other side.

40 mg: White, biconvex, cylindrical tablet with a score line on one side and with code ‘AT4’ on the other side.

80 mg: White, biconvex, oblong tablet with a score line on one side and with code ‘AT8’ on the other side.

All strengths are available in blister packs containing 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

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturers

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

SAG Manufacturing SLU

Crta N-i, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

This medicinal product is authorized in the Member States of the EEA under the following names:

Name of the Member state	Name of the Medicinal Product
Austria	Atorvastatin Bluefish 10 mg/20 mg/40 mg/80 mg Filmtabletten
Poland	Atorvastatin Bluefish
Sweden	Atorvastatin Bluefish
Ísland	Atorvastatin Bluefish 10 mg/20 mg/40 mg/80 mg filmuhúðaðar töflur

This leaflet was last revised in 2016-04-22