Naproxen Bluefish 250 mg, Naproxen bluefish 500 mg, Naproxen Tablets
What Naproxen Bluefish Is And What It Is Used For
Naproxen Bluefish is an anti-inflammatory, analgesic, and antipyretic drug. Naproxen Bluefish belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These work by reducing the formation of so-called prostaglandins that cause pain and swelling in the body.
Adults and adolescents from 12 years (over 50 kg):
Naproxen Bluefish is used for temporary, mild to moderate pain conditions, e.g. headache, toothache, muscle and joint pain, back pain. Period pain.
Adults from 18 years:
Naproxen Bluefish can also be used in acute migraine attacks in adults.
Naproxen contained in Naproxen Bluefish may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What You Need To Know Before You Take Naproxen Bluefish
Do Not Take Naproxen Bluefish
- If you are allergic to naproxen or any of the other ingredients of Naproxen Bluefish English (listed in section 6)
- If you have previously had allergic reactions such as
- Asthma
- Runny nose or rash when you have taken painkillers containing acetylsalicylic acid or other pain/inflammation medicines in the NSAID group
- If you have an increased tendency to bleed
- If you have or have had recurrent stomach ulcers or duodenal ulcers
- If you have had stomach ulcers or duodenal ulcers during treatment with naproxen or similar preparations
- If you have severe liver or kidney disease
- If you have severe heart failure
- During the last three months of pregnancy
Warnings And Cautions
| Do not use different types of painkillers at the same time without a doctor’s prescription |
The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. In general, higher doses than recommended can lead to serious risks. This also means that the combination of several NSAIDs at the same dose should be avoided.
Talk to your doctor before using Naproxen Bluefish if you have or have had any of the following conditions:
- Inflammatory bowel diseases such as
- Ulcerative colitis
- Crohn’s disease
- Diseases with an increased tendency to bleed
- SLE
- Connective tissue disease
- Asthma
- Impaired renal function or liver function
- Heart failure
- High blood pressure
- Gastric ulcer or duodenal ulcer
Elderly people should be aware of the increased risk of side effects that exist in old age.
Especially at the beginning of treatment, patients who have previously had gastrointestinal problems, especially elderly patients, should consult a doctor in case of abdominal symptoms.
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Naproxen Bluefish and consult a doctor if you get a rash or damage to the mucous membranes. See also section 4.
For chickenpox, Naproxen Bluefish English should not be used. Naproxen may temporarily make it difficult for you to get pregnant during use. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant.
Medicines such as Naproxen Bluefish may cause a small increased risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time (see section 3. How to take Naproxen Bluefish).
Talk to your doctor or pharmacist about your treatment if you have heart problems, if you have had a stroke before, or if you think you have an increased risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
Children And Young People
Naproxen Bluefish should not be used in children under 12 years of age without a doctor’s prescription.
Naproxen Bluefish should not be used in adolescents over 12 years of age weighing less than 50 kg without a doctor’s prescription.
Other Medicines And Naproxen Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not use different types of painkillers at the same time without a doctor’s prescription.
Naproxen Bluefish may affect or be affected by certain medicines, e.g. medicines for:
- Blood clots eg
- Ticlopidine
- Warfarin
- Clopidogrel
- Acetylsalicylic acid
- Manic depressive illness
- Lithium
- Tumor and immune system disorder
- Methotrexate
- High blood pressure and heart failure
- So-called beta-receptor blocking drugs
- ACE inhibitors
- Angiotensin -II- antagonists
- Diuretics
- Rejection of organs after transplantation
- Immunosuppressive drugs, eg
- Cyclosporine
- Tacrolimus
- Immunosuppressive drugs, eg
- Gout
- Probenecid
- Depression (so-called SSRIs )
- Anti- inflammatory and analgesic drugs
- Other NSAIDs
- Acetylsalicylic acid
- Corticosteroids
Naproxen Bluefish With Food And Drink
The effect is not reduced but can be delayed slightly if Naproxen Bluefish is taken with food.
Pregnancy, Breastfeeding And Fertility
If you are pregnant or breastfeeding, 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 use Naproxen Bluefish during the last three months of pregnancy. Intake of Naproxen Bluefish should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Naproxen passes into breast milk but is unlikely to affect the breastfeeding baby. Consult a physician if you need more than temporary use during breastfeeding.
Naproxen may temporarily make it difficult for you to get pregnant during use. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant.
Driving And Using Machines
Naproxen Bluefish can cause side effects (such as dizziness) that impair your ability to react. You should therefore know how the treatment affects you before performing anything that requires sharpened attention (eg driving a car or performing precision work).
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.
Naproxen Bluefish 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.
Naproxen Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How To Take Naproxen Bluefish
Naproxen Bluefish uses
- Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The tablet can be divided into two equal doses.
- Temporary mild to moderate pain conditions
- Adults and adolescents from 12 years (over 50 kg):
- 1 tablet (250 mg) as needed, but not more than 2 tablets (500 mg) per day. Contact a doctor if symptoms worsen or do not improve within 5 days in case of pain.
- In case of acute migraine attacks
- Adults from 18 years:
- 3 tablets in case of signs of incipient seizure, then 1 tablet if necessary, but not more than 5 tablets per day. Contact a doctor if Naproxen Bluefish has not helped with your migraine within 3 days.
- Naproxen bluefish english must be taken at the first sign of a migraine.
- Adolescents from 12 years (over 50 kg):
- If you think you have a migraine headache, consult a doctor.
- Higher doses than those recommended can lead to serious risks.
If You Take More Naproxen Bluefish Than You Should
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Naproxen Bluefish
Do not take a double dose to make up for a forgotten tablet.
Possible Naproxen Bluefish Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Naproxen Bluefish and contact a doctor immediately or see your nearest emergency department if you experience the following symptoms:
- Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic shock )
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Hives
- Difficulty breathing (Angioedema)
- Extremely severe and serious skin side effects ( Stevens-Johnson syndrome , toxic epidermal necrolysis ) which may consist of rash with or without blisters
- Redness of the skin
- Sores or swelling in the mouth, throat, eyes, nose and around the genitals as well as fever and flu-like symptoms may also occur.
The skin rash can develop into severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) with life-threatening consequences.
Fever in combination with severe general deterioration or fever in combination with sore throat / throat / mouth or difficulty urinating, which is a sign of infection . Because Naproxen Bluefish can in rare cases lead to a weakened defense of infection due to lack of white blood cells ( agranulocytosis ), infection can become serious. Therefore, it is important that in these situations you also inform about your medication.
These side effects are rare (may affect up to 1 in 1,000 people).
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
- Stomach pain
- Heartburn
- Nausea
- Diarrhea
- Constipation
- Inflammation of the mouth
- Skin rash
- Superficial sores on the skin
- Drowsiness
- Headache
- Dizziness
- Thirst
- Sweating
- Tinnitus
- Visual disturbances
- Fluid accumulation in the body
- Palpitation
Uncommon naproxen bluefish side effects (may affect up to 1 in 100 people):
- Shortness of breath
- Asthma
- Hives
- Skin changes (increased pigmentation or blisters) due to increased sensitivity to light
- Stomach bleeding
- Intestinal bleeding
- Gastric ulcer
- Inflammation and ulcers in the mouth
- Inflammation of the lining of the stomach
- Fever
- Hair loss
- Liver effects
- Kidney impact
- Hearing loss
- Difficulty sleeping
- Difficulty concentrating
Rare naproxen bluefish side effects (may affect up to 1 in 1,000 people):
- Cramps
- Muscle weakness
- Blood count changes
- “Broken stomach ulcer”, inflammation of the colon, vomiting, blood in the stool, inflammation of the esophagus, inflammation of the pancreas, vomiting of blood, gas formation
- Diverse redness of the skin usually on the hands and feet
- Pneumonia
- Inflammation of the liver
- Blood in the urine
- Mental disorders that can affect learning, memory, perception and problem solving.
- Depression
- Nightmares
- Muscle aches
- Mild anxiety
- Meningitis
- Vascular inflammation
- Heart failure
- High blood pressure
- Fluid accumulation in the lungs
- Elevated levels of potassium in the blood
- Exacerbation of colitis and Crohn’s disease
- A few isolated cases of elevated liver enzyme levels are known.
- Naproxen prolongs the bleeding time.
- Severe skin infections are associated with chickenpox.
Medicines such as Naproxen Bluefish English may cause a small increased risk of heart attack or stroke.
How To Store Naproxen Bluefish English
- 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 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.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is naproxen. 1 tablet contains 250 mg.
- The other ingredients are
- Lactose monohydrate
- Corn starch
- Gelatin
- Talc
- Magnesium stearate
- Sodium starch glycolate
What The Medicine Looks Like And Contents Of The Pack
- The tablets are white, round, convex with a scoreline, diameter of 11 mm.
- Pack sizes: 10 tablets and 20 tablets (pressure packs).
Marketing Authorization Holder And Manufacturer
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm, Sweden