Acetylsalicylic Acid Bluefish
Package leaflet: Information for the patient
Acetylsalicylic acid Bluefish 75 mg tablets
Acetylsalicylic acid Bluefish 160 mg tablets
Acetylsalicylic acid
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist or nurse.
- 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Acetylsalicylic acid Bluefish is and what it is used for
2. What you need to know before you take Acetylsalicylic acid Bluefish
3. How to take Acetylsalicylic acid Bluefish
4. Possible side effects
5. How to store Acetylsalicylic acid Bluefish
6. Contents of the pack and other information
1. What Acetylsalicylic acid Bluefish is and what it is used for
Acetylsalicylic acid Bluefish contains the active substance acetylsalicylic acid.
Acetylsalicylic acid Bluefishis aso-calledblood thinner agent, which reduces the risk ofblood clottingby preventing theblood plateletsclump together.
Acetylsalicylic acid Bluefish is used by patients who have severe angina in the heart (unstable angina pectoris) or who has a history of cardiac or cerebral infarction (stroke). Acetylsalicylic acid Bluefish helps reduce the risk of relapse of a new infarction, by preventing clots forming in the heart and the brain's blood vessels.
2. What you need to know before you take Acetylsalicylic acid Bluefish
Do not take Acetylsalicylic acid Bluefish:
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If you are allergic to acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6).
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If you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
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If you have asthma.
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If you suffer from stomach ulcers.
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If you have problems of your blood not clotting properly.
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If you have liver cirrhosis
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If you have severe heart failure.
The daily dose ofAcetylsalicylic acid Bluefishmust not exceed 100mgduringlast 3 months of pregnancy(see Pregnancy and breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Acetylsalicylic acid Bluefish
Informyour doctor before treatmentwithAcetylsalicylic acid Bluefishbegin:
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If you are treated with drugs that prevent the formation of blood clots or diuretic
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If you have gastrointestinal disease
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If you have heart failure
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If you have kidney or liver disease.
People withasthma, chronic lung disease, hay fever ornasal polypshavean increased risk ofhypersensitivity reactions during treatment with NSAIDs such as acetylicsalicylic acid. This reaction might include asthmatic attack, swelling of the face, mouth, throat and difficulties to swallow or breathe (angioedema) and urticaria.
Other medicines and Acetylsalicylic acid Bluefish
Tell your doctor or pharmacist if you are taking, have recently takenor might take any other medicines.
The effect ofthe treatment can beaffectedifAcetylsalicylic acid Bluefishis taken simultaneously with certainother drugsagainst:
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blood clots (e.g. warfarin)
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organ rejection after transplantation (cyclosporine, tacrolimus)
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high blood pressure (e.g. diuretics and ACE inhibitors)
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pain and inflammation (e.g. corticosteroids and NSAIDs)
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gout (probenecid)
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cancer and rheumatoid arthritis (methotrexate)
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heart rhythm disturbances (digoxin)
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manic depressive illness (lithium)
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epilepsy (phenytoin and valproic acid)
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Type II diabetes (sulfonylureas)
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dyslipidemia (nicotinic acid)
Acetylsalicylic acid Bluefishwithfood, drink and alcohol
Acetylsalicylic acid Bluefishin combination with alcoholcanincrease the risk ofbleeding in thegastrointestinal tract.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant womenshould not takeacetylsalicylic acidduring pregnancyunlessadvised bya doctor. The daily doseshould not exceed100mgduring thelast 3 months of pregnancy(seesectionDo nottake Acetylsalicylic acid Bluefish). Regular orhigh dosesof this druglate in the pregnancycan cause serious complicationsfor mother and child.
Acetylsalicylic
acidis excreted
inhuman milk, but is
unlikely to affectnursing
infants. Yet,
speakwitha
doctoratmore thanoccasional
useofAcetylsalicylic acid Bluefishduring lactation.
Acetylsalicylic acid
Bluefishcan, asmany
anti-inflammatory drugs
(NSAIDs), make it more difficult to become pregnantandis therefore not
recommendedin women trying to
get pregnant.
Driving and using machines
Acetylsalicylic acid Bluefishhas no known effectson the abilityto drive anduse machines.
3. How to take Acetylsalicylic acid Bluefish
Always take this medicineexactly as your doctoror pharmacist has told you. Check with your doctor orpharmacist ifyou are not sure.
The dose should
bedetermined by the
doctorwho adjust it individually
for you.
Adults
Heart attack:
- The recommended dose is 150-500 mg.
Prevention of cardiovascular problems after a heart attack:
- The recommended dose is 75 mg once daily.
Prevention of cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain):
- The recommended dose is 75 mg once daily.
Prevention of strokes:
- The recommended dose is 75 mg once daily.
If you take more Acetylsalicylic acid Bluefish than you should
If youtake toomuch medicine, or if achild has takenmedicine by accident, contact your doctor or hospitalfor the assessment ofrisk and advice.
Symptoms of overdose might include dizziness, hearing disturbances, anxiety, irritability, hallucinations, tremor, increased breathing, thirst, flushing and sweating.
If you forget to take Acetylsalicylic acid Bluefish
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Acetylsalicylic acid Bluefish
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
Indigestion, increased risk of bleeding.
Uncommon
(may affect up to 1 in 100
people):
Hypersensitivity reactions such asurticaria, allergicrhinitis and asthma.
Rare side
effects(may affect up to 1 in 1000 people):
Bleeding inthe gastrointestinal tract, brain hemorrhage. Renal effects. Severe skin reactions.
People with known
allergy or asthmaare at
increasedrisk of
hypersensitivity reactions.
Smallloss of
bloodmay inrare
caseslead to
anemia.
Dizziness
andtinnituscanbe a symptom
ofoverdose.
If you
getside effects,
talkwithyour doctor or pharmacist. This includes any
possibleside effects
notlisted in this
leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Acetylsalicylic acid Bluefish
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton. 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 protect the environment.
6. Contents of the pack and other information
What Acetylsalicylic acid Bluefish contains
The active substance is acetylsalicylic acid. Each tablet contains 75 mg/ 160 mg of acetylsalicylic acid.
The other ingredients are: magnesium oxide heavy, cellulose microcrystallin, maize starch, gelatin, silica colloidal anhydrous, talc and stearic acid.
What Acetylsalicylic acid Bluefish looks like and contents of the pack
75 mg:
White to off-white, clear to mottled, 6.5 mm, round, biconvex, uncoated tablets plain on both sides.
160 mg:
White to off-white, clear to mottled, 8.5 mm, round, biconvex, uncoated tablets with break line on onside and plain on other side.
The tablets are packed in HDPE bottles with a polypropylene (PP) screw cap and silica gel dessicant.
75 mg: 50, 100, 105 and 500 tablets
160 mg: 50, 100 and 105 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Name of the Member State |
Name of the medicinal product |
|
Sweden |
Acetysalicylic acid Bluefish |
|
Iceland |
Acetylsalicylic acid Bluefish 75 mg/ 160 mg töflur |
This leaflet was last revised in 2016-06-30
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