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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:meloxicam
The drug is available without a prescription
What is Aspicam Bio?
It is a preparation with general action containing a non-steroidal anti-inflammatory drug.
What does Aspicam Bio contain and how does it work?
The active substance is meloxicam
, a non-steroidal anti-inflammatory drug (NSAID) from the oxicam group. It has anti-inflammatory, analgesic and antipyretic effects. Meloxicam counteracts the synthesis of prostaglandins, substances that play a significant role in the development of inflammation. The effect of meloxicam is primarily the inhibition of cyclooxygenase, mainly cyclooxygenase-2 (COX-2), and to a small extent cyclooxygenase-1 (COX-1). These enzymes take part in the reactions leading to the formation of prostaglandins from the lipids of cell membranes. Meloxicam does not have an antimicrobial effect. It reduces the symptoms of inflammatory response (swelling, elevated temperature, pain, joint stiffness). It is well absorbed from the gastrointestinal tract. After oral administration, the maximum concentration in the blood is obtained within 5-6 hours after administration, and steady-state concentration within 3-5 days of application. Meloxicam passes into the synovial fluid, where it reaches a concentration equal to half the concentration in the plasma. Meloxicam crosses the placenta and into breast milk.
When to use Aspicam Bio?
The preparation is indicated as an anti-inflammatory and analgesic in osteoarticular and muscular pain in the course of rheumatoid and degenerative diseases of the joints.
Indicated in the short-term symptomatic treatment of exacerbations of rheumatoid diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients or other NSAIDs
The product is contraindicated if you have ever experienced allergy to Acetylsalicylic acid
(colloquially called Aspirin
) or to other nonsteroidal anti-inflammatory drugs (eg Ibuprofen
). This sensitization may have manifested in the form of hypersensitivity reactions such as eg asthma attack, bronchospasm, allergic rhinitis, nasal polyps, angioedema or skin reactions, including urticaria, rash, erythema.
The use of the preparation is contraindicated in people:
with active or recurrent gastric and / or duodenal ulcer disease, bleeding or perforation, including NSAIDs
with bleeding from the gastrointestinal tract, cerebral vessels or with other bleeding disorders
with severe liver failure
with severe renal failure and not undergoing dialysis
with severe heart failure
· In women in the third trimester of pregnancy
· In children and adolescents up to 15 years of age.
It should not be used in women who are breast-feeding.
Take special care with Aspicam Bio?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Use of the product at the lowest effective dose over the shortest possible period reduces the risk of side effects.
The use of other non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors) should be avoided.
If the symptoms persist, consult a doctor after a few days of using the product. Do not increase the recommended dose or include other NSAIDs as this increases the risk of side effects.
The preparation is not recommended for the treatment of acute attacks of pain.
If you have ever had an inflammation of the mucous membrane of the esophagus or stomach and / or stomach ulcer, please inform your doctor prescribing the prescription for this medicine. It is necessary to completely cure the above disorders before starting the preparation. If the above inflammations or ulcers have occurred in the past, the use of the preparation may contribute to their recurrence. You must remain under the doctor's supervision and report any irregularities or suspected gastrointestinal activity.
The use of non-steroidal anti-inflammatory drugs is associated with the risk of gastrointestinal haemorrhage, ulceration or perforation, which may be the cause of death and may not be preceded by warning signs. These symptoms can occur at any time during treatment, also in people without previous gastrointestinal disorders. These complications are particularly dangerous in the elderly. Always tell your doctor immediately if you have any unusual symptoms on the part of the digestive tract (especially bleeding). If there is bleeding from the gastrointestinal tract, immediate discontinuation of the preparation is necessary.
In the case of people with gastrointestinal diseases, after bleeding ulcers or perforations, the use of the preparation is possible only under medical supervision. The lowest effective doses should be used in these patients. Large doses and advanced age increase the risk of Gastrointestinal bleeding
. Your doctor may prescribe curing agents, such as proton pump inhibitors or misoprostol. Be cautious and consult a doctor immediately if any unusual symptoms occur.
Protective drugs may also be indicated in patients taking medications that increase the risk of gastrointestinal adverse reactions, including peptic ulceration or bleeding (eg corticosteroid
s with a general effect, anticoagulants, eg Warfarin
, drugs that inhibit platelet aggregation, including even small doses of acetylsalicylic acid [colloquially called aspirin], drugs from the group of selective serotonin reuptake inhibitors). Be careful.
Due to the possibility of exacerbation of the disease, the preparation can be used only under strict medical supervision and with caution in patients with ulcerative colitis or Leśniowski and Crohn's disease.
Particular care should be taken if the product is used in people with hypertension, congestive heart failure, fluid retention, and edema (the use of NSAIDs may cause fluid retention and edema). Patients should remain under medical supervision. Monitoring of cardiac and renal function is recommended.
Prolonged use of NSAIDs at high doses may increase the risk of a heart attack or stroke. Particular caution and close medical supervision is required when using the product in hypertensive patients with congestive heart failure, with ischemic heart disease, peripheral artery disease or cerebrovascular disease, and in patients with risk factors for cardiovascular disease (diabetes, smoking, hyperlipidemia). If you belong to any of the above groups, consult a physician before using the preparation.
The preparation, like other NSAIDs, may cause severe skin reactions, sometimes leading to death, such as Stevens and Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis. These reactions are very rare and usually appear in 1.month of application. In the event of the first symptoms of skin lesions (rash, mucosal lesions) or any symptoms of hypersensitivity, the preparation should be discontinued immediately and a physician should be consulted. If severe skin reactions associated with the use of meloxicam occur, it must not be re-used.
The use of the preparation may be associated with an increase in liver enzymes and changes in other parameters characterizing liver function. These changes are usually transient. In the event of their occurrence, immediately consult a physician who may recommend discontinuation of the preparation.
The preparation should be used with caution by people with reduced blood flow through the kidneys and with reduced circulating blood volume. Renal impairment may occur in these patients, which usually disappear after discontinuation of the preparation. The group of increased risk of these disorders includes patients with congestive heart failure, cirrhosis, nephrotic syndrome, renal failure, lupus nephropathy, diuretics or antihypertensive agents, significantly dehydrated and after major surgery as well as in the elderly. In these patients, close monitoring of renal function and urine output during the use period is recommended.
The use of non-steroidal anti-inflammatory drugs (NSAIDs) can cause sodium retention, potassium and water and cause edema or worsening of hypertension and cardiac dysfunction. Close medical supervision and clinical control from the start of treatment is required if the drug is used by patients with hypertension or heart failure. It is possible to reduce the effectiveness of antihypertensive therapy.
If you are diabetic and you are taking medicines that may increase the amount of potassium in your blood, regular monitoring of potassium is recommended because of the risk of hyperkalemia.
In patients who are weak and / or low in weight, side effects may be more severe; patients in this group should remain under strict medical supervision. Increased caution is also required for elderly people with an increased risk of renal, hepatic or cardiac dysfunction. In elderly patients, the risk of side effects (especially gastrointestinal bleeding, which can cause death) is increased.
The preparation, like other NSAIDs, can mask the symptoms of infection. If you suspect an infection, consult your doctor, as appropriate treatment may be necessary. The preparation does not have an antimicrobial effect.
The use of the preparation may cause fertility problems in women and is not recommended in women who are planning to become pregnant.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of Glucose
-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
There are no studies on the effect of the preparation on the ability to drive and use machines / machines. However, the preparation may cause side effects such as blurred vision, drowsiness, dizziness, tiredness or other central nervous system disorders, and if they occur, do not drive or operate machinery / equipment or perform other activities that require increased concentration.
Dosage of Aspicam Bio
The preparation is in the form of tablets. It is intended for oral use. Use the preparation as recommended. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Dosage is determined individually, usually 1 tablet (7.5 mg) per day.
You should not use the preparation for more than 7 days without consulting your doctor.
In patients undergoing dialysis with severe renal impairment, the dose should not exceed 7.5 mg daily.
In patients with severe renal dysfunction who are not subjected to hemodialysis and in patients with severe hepatic impairment, the use of the preparation is contraindicated.
Do not use the preparation in children and adolescents up to 15 years of age.
The preparation is intended for oral use. The tablets should be taken with a meal, washed down with water or other liquid.
Can Aspicam Bio be used during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, consult your doctor before using this product (see the warnings in the section "Take special care with the preparation?").
The use of the preparation is contraindicated in women in the third trimester of pregnancy. Do not use the preparation in the first and second trimester of pregnancy. The use of the preparation in the first and second trimester of pregnancy, and in women planning pregnancy, is allowed only at the express request of the doctor in cases when considering the ratio of expected benefits for the mother to possible risk to the fetus he considers the use of the preparation absolutely necessary (only the shortest effective dose). Only a doctor can assess the benefit / risk ratio in your case.
It should not be used in women who are breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
It is not recommended to use the preparation with:
· Acetylsalicylic acid (in painkillers) or other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors (increased risk of side effects, especially ulcers and gastrointestinal bleeding)
· Diuretics, e.g. Furosemide
and antihypertensive agents, including angiotensin converting enzyme inhibitors, angiotensin antagonists (possible reduction in their effectiveness, increased risk of renal dysfunction and development of acute renal failure
, especially in dehydrated or elderly patients; hydration of the patient and control of renal function)
· Oral anticoagulants, such as warfarin (possible increase in their effect and an increased risk of haemorrhage, if the parallel use of these preparations can not be avoided, the blood coagulation parameters should be closely monitored)
· Drugs that inhibit platelet aggregation, such as ticlopidine, Clopidogrel
(increased risk of bleeding)
· Thrombolytic drugs (increased risk of bleeding)
· Corticosteroids or serotonin reuptake inhibitors (increased risk of side effects, especially gastrointestinal bleeding)
· Drugs from the group of beta blockers (possible reduction of their effectiveness)
· Cyclosporine and tacrolimus (increased risk of renal damaging effects, kidney function should be monitored, especially in elderly patients)
· Lithium (possible increase in lithium concentration and intensification of its toxic effects, if it is necessary to use it in parallel, it is recommended to check the concentration of lithium in the blood)
methotrexate at doses higher than 15 mg per week (possible increase in Methotrexate
concentration and intensification of its toxic effects, sometimes severe intoxication, also in the case of methotrexate in doses lower than 15 mg per week it is possible to increase its toxicity to the hematopoietic system; blood count and renal function, special care should be taken in people with impaired renal function, and also if the interval between taking the drug and methotrexate does not exceed 3 days)
cholestyramine (cholestyramine significantly accelerates the excretion of meloxicam).
Women with intrauterine inserts should consult a physician before using meloxicam.
What side effects can occur?
Like all medicines, Aspicam Bio can cause side effects, although they will not occur in all patients who use this medicine.Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The most common are gastrointestinal side effects, which include: nausea, vomiting, indigestion, abdominal pain, bloating, diarrhea, constipation, gastritis, oral or esophagitis, gastrointestinal bleeding (including tarry stools, bloody vomiting) and gastrointestinal ulceration, sometimes with bleeding and perforation (including fatal outcome, especially in the elderly), colitis, exacerbation of colitis, exacerbation of Leśniowski and Crohn's disease, increased liver enzymes, rarely hepatitis . Possible: headache and dizziness, fatigue, drowsiness, mood disorders, insomnia, nightmares, confusion, nervousness, blurred vision (including blurred vision), tinnitus. Possible: heart failure, palpitations, edema, hypertension, haematological abnormalities, including anemia, agranulocytosis, leukopenia, thrombocytopenia (if you experience symptoms such as fever, sore throat, flu-like symptoms, superficial ulceration of the oral mucosa, fatigue, bleeding from the nose, bruising, ecchymosis or purpura should immediately consult a doctor, because they may be the first signs of hematological disorders). Possible impaired renal function, sodium and water retention, renal failure, increased urea and creatinine in the blood. Hypersensitivity reactions (rash, urticaria, pruritus, photosensitivity) and Anaphylactic reactions
, including life-threatening anaphylactic shock, angioneurotic edema
(swelling of the face, larynx, tongue, throat that may impede breathing), bronchospasm, asthma attack and severe skin reactions: toxic epidermal necrolysis, Stevens and Johnson syndrome, erythema multiforme. Long-term use of meloxicam in high doses may increase the risk of heart attack or stroke.
Other preparations on the Polish market containing meloxicam
Aglan (solution for injection)
Aglan 15 (tablets)
Mel (orodispersible tablets)
Mel Forte (orodispersible tablets)
Melobax 15 (tablets)
Meloxicam Adamed (tablets)
Meloxicamum 123ratio (tablets)
MeloxiLEK 15 (tablets)
Meloxilek Activ 7.5 (tablets)
Movalis (solution for injection)
Opokan forte (tablets)
INJ Opokan (solution for injection)
Trosicam (orodispersible tablets)