7.5 mg, 15 mg meloxicam tablets

What Meloxicam Bluefish is and what it is used for

Meloxicam Bluefish is an anti-inflammatory drug with analgesic and antipyretic properties. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ).

Meloxicam Bluefish is used for:

  • short-term treatment of symptoms of worsening of joint wear and tear ( osteoarthritis )
  • long-term treatment of symptoms of rheumatoid arthritis ( rheumatoid arthritis , chronic inflammatory joint disease) or ankylosing spondylitis ( chronic inflammation of the spine).

Meloxicam contained in Meloxicam Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Meloxicam Bluefish

Do not use Meloxicam Bluefish

  • if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic (hypersensitive) to any other agent with a similar anti- inflammatory effect (eg acetylsalicylic acid ). You should not use Meloxicam Bluefish if you have previously had symptoms of asthma , nasal polyps, swelling of the skin or mucous membranes ( edema ) or hives ( urticaria ) after treatment with acetylsalicylic acid or other anti- inflammatory drugs
  • if you are a child or adolescent under 16 years of age
  • if you have stomach ulcers or if you usually get recurrent stomach ulcers
  • if you have severe hepatic impairment
  • if you have severe renal impairment that is not dialysis treated
  • if you have gastrointestinal bleeding, cerebral haemorrhage or other bleeding disorders
  • if you have severe heart failure
  • during the last three months of a pregnancy, or during any part of the pregnancy without consulting a doctor. See the section Pregnancy.

Warnings and cautions

Talk to your doctor or pharmacist before using Meloxicam Bluefish

  • if you have previously had inflammation of the esophagus ( esophagitis ), inflammation of the lining of the stomach ( gastritis ) and / or stomach ulcers
  • if you have or have had any gastrointestinal disease ( ulcerative colitis , Crohn’s disease )
  • if you have or have had asthma
  • if you have heart disease or high blood pressure
  • if you have impaired kidney or liver function
  • if you are being treated with diuretics ( diuretics )
  • if you suffer from blood loss

If you are taking oral corticosteroids, blood thinners such as warfarin, selective serotonin reuptake inhibitors e.g. fluoxetine, or drugs that affect blood coagulation such as acetylsalicylic acid increase the risk of stomach ulcers and bleeding.

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 (especially in gastrointestinal bleeding).

Skin reactions

Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with the use of meloxicam. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso.

Additional signs to pay attention to are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes).

The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas of skin detachment.

The risk of serious skin reactions is greatest during the first weeks of treatment.

If you have had Stevens-Johnson syndrome or toxic epidermal necrolysis while using meloxicam contained in Meloxicam Bluefish, you should never use meloxicam-containing medicines again.

If you get a rash or signs of these skin reactions, stop taking Meloxicam Bluefish immediately, contact your doctor immediately and tell them that you are taking this medicine.

Like other NSAIDs, Meloxicam Bluefish can mask the symptoms of an ongoing infection.

For painkillers, it generally applies that higher doses than recommended can lead to serious risks. Therefore, do not exceed the recommended daily dose and do not use other types of painkillers at the same time without a doctor’s prescription.

Meloxicam Bluefish, as well as other medicines that inhibit cyclooxygenase/prostaglandin synthesis, may make it difficult for you to get pregnant. Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant.

Medicines such as Meloxicam Bluefish may cause a slight increase in the 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.

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 (for example, if you have high blood pressure, diabetes, high cholesterol or if you smoke).

Other medicines and Meloxicam Bluefish

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

The following medicines may affect or be affected by Meloxicam Bluefish:

  • Other similar anti- inflammatory drugs (so-called NSAIDs , salicylates including acetylsalicylic acid ). Concomitant intake may increase the risk of stomach ulcers and bleeding.
  • Diuretics ( diuretics ).
  • Drugs that affect blood coagulation (blood thinners). Concomitant intake may increase the risk of bleeding.
  • Some antihypertensive agents. Concomitant treatment can reduce the blood pressure lowering effect and in some cases also increase the risk of kidney effects.
  • Ciclosporin (so-called immunosuppressive drug, which inhibits the body’s immune system).Concomitant intake increases the risk of kidney effects.
  • Cortisone drugs (for inflammation ). The risk of gastrointestinal side effects increases.
  • Intrauterine contraceptives (IUDs ) . The effect of these can be reduced.
  • Lithium (used in certain mental illnesses). The effect of lithium may increase.
  • Methotrexate (used in rheumatoid arthritis , among others ).
  • Cholestyramine (for elevated levels of blood fats).
  • Selective serotonin reuptake inhibitors (for depression)

Meloxicam Bluefish with food and drink

Meloxicam Bluefish should be swallowed with liquid at mealtime.

Pregnancy and breastfeeding

Pregnant women should not use Meloxicam Bluefish during the last three months of pregnancy. Intake of Meloxicam 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.

Although there is no specific experience with meloxicam, NSAIDs are known to pass into breast milk. Meloxicam Bluefish is therefore not recommended for breastfeeding women.

Driving and using machines

Meloxicam Bluefish may cause visual disturbances, fatigue, and dizziness. If any of these side effects occur, you should refrain from driving or using 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.

Meloxicam Bluefish contains lactose

Meloxicam Bluefish contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Meloxicam Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 7.5 mg and 15 mg tablets, ie essentially ‘sodium-free’.

How to take Meloxicam Bluefish

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

Dosage:

In case of worsening of joint wear ( osteoarthritis ):

The usual dose for adults is 7.5 mg once a day. In some cases, the dose may need to be increased to 15 mg per day.

In rheumatoid arthritis ( rheumatoid arthritis ) or ankylosing spondylitis:

The usual dose for adults is 15 mg once a day.

Elderly patients and patients at increased risk of side effects

The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg once daily. Patients at increased risk of side effects should start treatment with 7.5 mg per day.

Impaired renal function

For dialysis patients with severe renal insufficiency, the dose should not exceed 7.5 mg/day. No dose reduction is required for patients with mild to moderate renal impairment (eg patients with a creatinine clearance > 25 ml/min).

Meloxicam Bluefish is not recommended for patients with severe renal impairment who do not receive dialysis.

Hepatic impairment

No dose reduction is necessary for patients with mild to moderate hepatic impairment.

Use for children and adolescents

Meloxicam Bluefish 7.5 mg and 15 mg should not be used in children under 16 years of age.

Do not take more than 15 mg Meloxicam Bluefish per day.

Meloxicam Bluefish should be swallowed with liquid at mealtime.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Medicines such as meloxicam may cause a small increased risk of heart attack or stroke.

Tell your doctor immediately if you notice any side effects from the gastrointestinal tract at the start of treatment (eg stomach pain, heartburn) or if you have previously had side effects due to long-term use of NSAIDs, especially if you are older.

Stop your treatment immediately as soon as you notice itching, any change in mucous membranes (eg on the inside of the mouth), or signs of allergy.

Stop taking Meloxicam Bluefish and contact a doctor immediately if swelling of e.g.

face, tongue and/or throat and/or difficulty swallowing or hives appearing

together with difficulty breathing occurs ( angioedema ).

The following side effects have also been reported:

Very common (may affect more than 1 user in 10) :

digestive disorders, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea.

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

dizziness, headache.

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

anemia, dizziness, drowsiness, tiredness, allergic reactions, increase in blood pressure, hot flashes, bleeding in the gastrointestinal tract, from throat to rectum, inflammation of the stomach, inflammation of the oral mucosa, belching, itching, rash, hives, effects on kidney tests, sodium and water retention which can lead to itching, rash, swelling of eg bones due to fluid accumulation ( edema ), elevated levels of potassium in the blood, effects on liver values, severe allergic reactions that cause swelling of the face, lips, tongue and/or throat.

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

effects on the blood picture (eg reduced number of white blood cells and platelets ), mood changes, insomnia, nightmares, visual disturbances, among others. blurred vision, inflammation of the eyeball or eyelids, tinnitus, palpitations, asthma attacks in people who are allergic to acetylsalicylic acid or other similar anti-inflammatory drugs, stomach ulcers, inflammation of the esophagus which leads to difficulty/pain to swallow, inflammation of the colon and rash. Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported (see section 2).

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

ruptured gastric ulcer, inflammation of the gastric mucosa, inflammation of the colon or gallbladder, inflammation of the liver, dermatitis with blistering, patches with a red rash, acute renal failure, especially in patients with risk factors.

Has been reported (occurs in an unknown number of users):

severe allergic reactions that may result in shock, confusion, disorientation, abnormal photosensitivity, pancreatitis ( inflammation of the pancreas).

Meloxicam Bluefish can in very rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.

How to store Meloxicam Bluefish

Keep this medicine out of the sight and reach of children.

No special storage instructions.  

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 pack and other information

Content declaration

  • The active substance is meloxicam 7.5 mg and 15 mg respectively
  • The other ingredients are microcrystalline cellulose, pregelatinised starch , maize starch, sodium citrate, colloidal anhydrous silica, magnesium stearate and lactose monohydrate .

What the medicine looks like and contents of the pack

7.5 mg: yellow, round tablet with a beveled edge, notched on one side and flat on the other. The notch is not to divide the tablet into equal parts but only to facilitate swallowing.

15 mg: yellow, round tablet with a beveled edge, break notch on one side and flat on the other. The tablet can be divided into equal parts.

Blister (PVC / PVDC / Al)

Pack size: 10, 20, 30 and 100 tablets

Not all pack sizes may be marketed.

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

Denmark: Meloxicam Bluefish

Norway: Meloxicam Bluefish 7.5 mg tablets / Meloxicam Bluefish 15 mg tablets

Sweden: Meloxicam Bluefish 7.5 mg tablets / Meloxicam Bluefish 15 mg tablets

Muhammad Nadeem

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