MELBEK 7.5 mg. 10 tablets
The active substance in MELBEK is meloxicam, which belongs to the group of nonsteroidal anti-inflammatory products of the oxicam group (belonging to the class of the enolic acid).
MELBEK tablet is a non-steroidal anti-inflammatory drug (NSAID) that is indicated for the symptomatic treatment of:
painful osteoarthritis (degenerative changes in articular cartilage and bones).
ankylosing spondylitis (ankylosing spondylitis)
2. BEFORE YOU TAKE MELBEK
Do not take MELBEK
- If you are allergic (hypersensitive) to meloxicam or any of the other ingredients of MELBEK. An allergic reaction may be recognized as a: rash, itching, redness of the skin or difficulty breathing.
- If you know that you are sensitive to acetylsalicylate (aspirin) or other NSAIDs, because it may cause a cross reaction.
- MELBEK should not be applied even in patients with exacerbations of asthma, nasal polyps, edema, which can affect the face, extremities, lips, tongue, throat (angioedema), or hives (rash with itching) to all kinds of NSAIDs and in the following cases:
Active peptic ulcer
Severe heart failure
Severe hepatic insufficiency
Severe renal failure without dialysis
Children and adolescents under the age of 15
Pregnant and lactating mothers
Bleeding, regardless of what type (gastrointestinal, brain, etc.).
Take special care with MELBEK
- As with all NSAIDs, if you had complaints from the upper gastrointestinal tract (digestive disorders - oesophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach), gastric ulcer or duodenal) or being treated with anticoagulants preparations (anticoagulants) are required to have under special surveillance. If a peptic ulcer or bleeding from the gastrointestinal tract, MELBEK intake should be stopped.
- Before treatment with MELBEK tell your doctor if you have:
congestive heart failure (heart disease, which can result in fatigue, shortness of breath, swelling of the ankles, etc.).
clinically overt renal insufficiency as caution during treatment.
- If you are taking diuretics (water resources) or have hypovolemia (decreased blood volume) should be carefully monitor renal function and volume of diuresis in the early stages of treatment with NSAIDs.
- If you suffer from kidney failure, your doctor will assess whether there is a need for a change in dosage.
- In rare cases, the administration of NSAIDs may lead to the onset and development of renal diseases, as well as increased liver values.
- Drugs such as MELBEK may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
- If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Use in children and adolescents
MELBEK tablets not be used in children and adolescents under 15 years of age.
Use in elderly patients
For adult patients must be given multiple organ failure.
The drug should only be taken by adults, as the dose for children has not been established.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
High doses of NSAIDs including salicylates: Concomitant use of two NSAIDs can cause a synergistic effect with a risk of gastrointestinal ulceration and increased bleeding.
Oral anticoagulants, ticlopidine, heparin, thrombolytics: Increased risk of bleeding. When co-administration is required, the effect of anticoagulants should be closely monitored.
Lithium (for mental disorders, depression): Concomitant use can increase the plasma level of lithium. Upon initiation of treatment with MELBEK and during dose adjustment as well as discontinuation of the drug plasma concentration of lithium should be monitored.
Metotreksat (used in malignancies, and also in psoriasis or rheumatoid arthritis): MELBEK, like other NSAIDs, may increase the hematologic toxicity of methotrexate. In these cases it is advisable precise monitoring of blood counts.
Contraception: NSAIDs can reduce the efficacy of intrauterine contraceptives (intrauterine spirals).
Diuretics: Risk of acute renal failure in dehydrated patients taking NSAIDs. Co-administration of diuretics MELBEK requires strict monitoring of renal function.
Antihypertensive drugs (lowering high blood pressure - beta-blockers, ACE inhibitors, vasodilators, diuretics): The efficacy of these drugs may be reduced.
Cholestyramine (to lower cholesterol) associated molecule of meloxicam in the gastrointestinal tract and thus increasing the purification of meloxicam.
NSAIDs increase the nephrotoxicity of ciclosporin (used after transplant immune diseases). In cases of co-administration, must strictly monitor the indicators of renal function.
Concurrent use of peripheral vasodilators (drugs affecting the cardiovascular system), such as pentoxifylline, can be expected to an increased risk of bleeding.
These medications do not interfere with MELBEK in pharmacokinetic aspect: antacids (against acids), cimetidine, digoxin (heart failure), furosemide (diuretic). It should be borne in mind its interaction with oral antidiabetic agents.
Use of MELBEK with food and drink
The tablets are taken with water or other liquid during meals.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Before taking MELBEK is important to tell your doctor if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed.
Do not take MELBEK if you attempt to get pregnant because MELBEK and all medicines from the group of NSAIDs may adversely affect fertility.
There are no data on the safety during pregnancy in humans. MELBEK tablets should not be administered during pregnancy.
Safety MELBEK tablets during lactation has not been studied and its use in lactating mothers should be avoided.
Driving and using machines
No studies on the effects on ability to drive and use machines.
In case of dizziness or blurred sight do not drive or use any tools or machines.
Important information about some of the ingredients of MELBEK
MELBEK contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE MELBEK
Always take MELBEK just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Rheumatoid arthritis: 15 mg daily. Can be applied 7,5 mg per day depending on the response.
Osteoarthritis: 7,5 mg daily. If necessary can be applied 15 mg daily.
Ankylosing spondylitis: 15 mg daily.
In patients with a high risk of side effects, treatment should always start with 7,5 mg daily.
If you suffer from highly advanced renal failure, the daily dose should not exceed 7,5 mg per day.
In painful conditions, the dose is adjusted by a physician. The maximum daily dose of MELBEK is 15 mg per day.
If you take more dose MELBEK
If you take more dose MELBEK immediately visit the nearest hospital and take your medicine or its container with you or contact your doctor.
Do not exceed the recommended dose and duration of treatment.
If you forget to take MELBEK
If you forget to take MELBEK, take the tablet as soon as you remember unless it is very close to the next dose. If this happens, skip the intake and take the next tablet as you follow the prescribed treatment.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking MELBEK
Do not stop treatment before you have completed the full course of treatment even though you feel better. You may not have cured completely and some of the symptoms to recur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, MELBEK can cause side effects, although not everybody gets them.
Rarely following adverse reactions possibly related to the administration of meloxicam:
Rare cases of allergic reactions that cause difficulty in breathing or dizziness
Indigestion, flatulence, nausea, vomiting, abdominal pain, constipation, diarrhea (often 1%)
Inflammation of the esophagus, duodenal ulcer, occult (hidden) or manifest bleeding (0.1 ~ 1.0%)
Colitis (inflammation of the colon, causing abdominal pain, and diarrhea / constipation) - (less than 1%)
Blood and lymphatic system:
Anemia (decreased numbers of red blood cells which can lead to pallor, weakness, or shortness of breath) - (more often than 1%)
Change in blood counts, reduction in the number of white blood cells, which increases the likelihood of infection, reducing the number of blood platelets, which increases the risk of bleeding or bruising - (0.1 ~ 1.0%). Co-administration of drugs affecting the bone marrow, in particular methotrexate, is a predisposing factor for the development of a deficiency of one or several types of blood cells.
Skin and subcutaneous tissue disorders:
Itching, peeling of skin - (more often than 1%)
Inflammation of the mucous membranes of the oral cavity, urticaria - (0.1 ~ 1.0%)
Photosensitivity - may become more sensitive to sunlight; Avoid sun exposure during treatment - (less than 1%)
Respiratory, thoracic and mediastinal (occurring in the middle of the chest cavity) disorders:
Other NSAIDs, including aspirin, and meloxicam., Can cause acute asthma attack (less than 1%)
Nervous system disorders:
Headache (more often than 1%)
Dizziness, ringing in the ears, blurred eyes (0.1 ~ 1.0%)
Cardiac and vascular disorders:
Drugs such as MELBEK may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
There are reports of edema, hypertension (high blood pressure) and heart failure (heart disease, which can result in fatigue, shortness of breath, swelling of the ankles and the like.), The use of NSAIDs.
Renal and urinary:
Impaired kidney function, increased levels of creatinine and / or urea (0.1 ~ 1.0%)
If any of the side effects gets serious, or you notice other effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MELBEK
Keep out of reach of children.
Store in the original container.
Do not use MELBEK after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. ADDITIONAL INFORMATION
- Active substance is meloxicam. Each tablet contains 7,5 mg of meloxicam.
- The other ingredients are crospovidone, povidone, microcrystalline cellulose, sodium citrate, lactose anhydrous, silica colloidal anhydrous, magnesium stearate
MELBEK looks like and contents of the pack?
The tablets are round, light yellow, scored on one side.
10 tablets in a blister pack.
One or three blisters are placed in a cardboard box.