Bluefish Pharma

Tablet 75 mg
(Not provided)(White to off-white, clear to semi-clear, 6.5 mm round biconvex uncoated tablet, smooth on both sides.)

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, 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.

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 Acetylsalicylic acid Bluefish to be stored 
6. Contents of the packaging 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 Bluefish is a so-called blood thinner, which reduces the risk of blood clots by preventing platelets from clotting.

Acetylsalicylic acid Bluefish is used by patients who have severe angina in the heart ( unstable angina pectoris) or who have previously suffered a heart attack or stroke. Acetylsalicylic acid Bluefish helps reduce the risk of recurrence in a new infarction, by preventing clots from forming in the blood vessels of the heart and brain.

Acetylsalicylic acid contained in Acetylsalicylic acid Bluefish 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 Acetylsalicylic acid Bluefish

Do not take Acetylsalicylic acid Bluefish:

  • if you are allergic to the active substance or any of the other ingredients of this medicine, see section 6.
  • if you are allergic to medicines with pain-relieving and anti-inflammatory effects, so-called non-steroidal anti-inflammatory drugs ( NSAIDs )
  • if you have allergic symptoms (eg difficulty breathing, nasal congestion, and runny nose, rash) when taking acetylsalicylic acid or similar anti-inflammatory drugs.
  • if you suffer from stomach ulcers
  • if you have problems with the blood not clotting properly
  • if you have cirrhosis of the liver
  • if you have severe heart failure.

The daily dose of Acetylsalicylic acid Bluefish should not exceed 100 mg during the last three months of pregnancy (see section Pregnancy and lactation).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Acetylsalicylic acid Bluefish.

Tell your doctor before starting treatment with Acetylsalicylic acid Bluefish:

  • if you are being treated with medicines that prevent the formation of blood clots or are diuretic
  • if you have gastrointestinal disease
  • if you have heart failure
  • if you have kidney or liver disease.

People with asthma, chronic lung disease, hay fever or nasal polyps have an increased risk of hypersensitivity reactions when treated with NSAIDs such as acetylsalicylic acid. Such a reaction may include asthma attacks, swelling of the face, mouth, or throat, difficulty swallowing or difficulty breathing ( angioedema ), and hives.

Other medicines and Acetylsalicylic acid Bluefish

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

The effect of the treatment can be affected if Acetylsalicylic acid Bluefish is taken at the same time as certain other medicines for:

  • blood clots (eg warfarin )
  • organ rejection after transplantation (cyclosporine, tacrolimus)
  • high blood pressure (eg diuretics and ACE inhibitors )
  • pain and inflammation (eg corticosteroids and NSAIDs )
  • gout (probenecid)
  • cancer and rheumatoid arthritis (methotrexate)
  • arrhythmias in the heart ( digoxin )
  • manic depressive illness (lithium)
  • epilepsy ( phenytoin and valproic acid )
  • type 2 diabetes (sulphonylurea)
  • high blood fats ( nicotinic acid ).

Metamizole (a substance that reduces pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation ( blood cells that attach together and form a blood clot) when taken at the same time. Therefore, this combination should be used with caution in patients taking a low dose of acetylsalicylic acid for cardiac protection.

Acetylsalicylic acid Bluefish with food, drink, and alcohol

Acetylsalicylic acid Bluefish in combination with alcohol may increase the risk of gastrointestinal bleeding.

Pregnancy and breastfeeding

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 women should not take acetylsalicylic acid during pregnancy unless directed to do so by a doctor. The daily dose should not exceed 100 mg during the last three months of pregnancy (see section Do not take Acetylsalicylic acid Bluefish). Regular or high doses of this drug during late pregnancy can cause serious complications for both mother and baby.

Acetylsalicylic acid passes into breast milk but is unlikely to affect breastfed infants. However, talk to your doctor if you use Acetylsalicylic acid Bluefish more than occasionally during breast-feeding.

Acetylsalicylic acid Bluefish, like many anti-inflammatory drugs (so-called NSAIDs ), can make it more difficult to get pregnant and is therefore not recommended for women trying to conceive.

Driving and using machines

Acetylsalicylic acid Bluefish has no known effects on the ability to drive and use machines.

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.

3. How to take Acetylsalicylic acid Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one should be determined by the doctor who adapts it individually for you.

Adults

Myocardial infarction:

  • 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 with stable or unstable angina Pectoris (a type of chest pain):

  • The recommended dose is 75 mg once daily.

Stroke prevention:

The recommended dose is 75 mg once daily.

Symptoms of overdose may include dizziness, hearing loss, anxiety, irritability, hallucinations, tremors, faster breathing, thirst, redness, 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 product, ask your doctor, 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): 

Stomach upset, increased risk of bleeding.

Uncommon (may affect up to 1 in 100 people): Hypersensitivity reactions such as hives, allergic rhinitis, and asthma.

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

Bleeding in the gastrointestinal tract, cerebral hemorrhage. Kidney impact. Severe skin reactions.

People with known allergies or asthma are at increased risk of hypersensitivity reactions. Minor blood loss can in some cases lead to anemia.

Dizziness and tinnitus can be symptoms of overdose.

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 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. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton 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 acetylsalicylic acid. One tablet contains 75 mg or 160 mg of acetylsalicylic acid.

The other ingredients are magnesium oxide, microcrystalline cellulose, corn starch, gelatin, anhydrous colloidal silica, talc, and stearic acid.

What the medicine looks like and the contents of the pack

75 mg:

White to off-white, clear to semi-clear, 6.5 mm, round, biconvex, uncoated tablet, smooth on both sides.

160 mg:

White to off-white, clear to semi-clear, 8.5 mm, round, biconvex, uncoated tablet with a scoreline on one side and smooth on the other side.

The tablets are packaged in HDPE jars with polypropylene (PP) screw caps and silica gel desiccants.

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

Bluefish Pharmaceuticals AB

PO Box 49013

100 28 Stockholm

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

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

Name of Member State Name of the medicine
Sweden Acetylsalicylic acid Bluefish
Iceland Acetylsalicylic acid Bluefish 75 mg / 160 mg tablets

Muhammad Nadeem

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