Consumer medicine information

1. Why am I using Meloxibell?

Meloxibell tablets contains the active ingredient meloxicam. Meloxibell is used to treat the symptoms of osteoarthritis and rheumatoid arthritis. For more information, see Section 1. Why am I using Meloxibell? in the full CMI.

2. What should I know before I use Meloxibell?

Do not use Meloxibell if you have ever had an allergic reaction to meloxicam or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Meloxibell? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Meloxibell and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Meloxibell?

Follow the instructions provided by your doctor and pharmacist

• For osteoarthritis, the usual dose of Meloxibell is 7.5 mg once daily.

• For rheumatoid arthritis, the usual dose of Meloxibell is 15 mg once daily.

5. What should I know while using Meloxibell?

6. Are there any side effects?

Common side effects: aching muscles, allergic reactions, back pain, being sick, blood in the urine, burping, chest tightness, constipation, cough, cramps, dehydration, dizziness, drowsiness, excessive sweating, fatigue, feeling sick, fluid retention, flu-like symptoms, headache, heartburn, increased appetite, increased blood pressure, itching or flaking skin, joint pain, loose stools, muscle spasms/ tenderness/ weakness, pain, passing wind, reflux, runny or blocked nose, shortness of breath, sore mouth/throat, stomach upset, trouble sleeping, upper respiratory tract infections.
Serious side effects: asthma, blurred vision, heartbeat irregularities, infection, photosensitivity, rash, severe skin reactions, sharp chest pain, swelling of skin/mucous membranes/stomach/intestines/liver, ulcers, urine changes. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Meloxicam.

2 Qualitative and Quantitative Composition

Each Meloxibell tablet contains 7.5 mg or 15 mg of meloxicam.
List of excipients with known effects. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Meloxibell 7.5 mg tablets are pale yellow, circular, flat bevelled uncoated tablet with a break-line on one side and plain on the other.
Meloxibell 15 mg tablets are pale yellow, circular, flat bevelled uncoated tablet with a break-line on one side and plain on the other.

4 Clinical Particulars

4.9 Overdose

Patients should be managed with symptomatic and supportive care following an NSAID overdose. In cases of acute overdose, activated charcoal is recommended. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly.
It has been shown in a clinical trial that colestyramine accelerates the elimination of meloxicam.
The typical signs and symptoms of NSAID overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness. Rare cases of seizures, hypotension, apnoea, coma and renal failure have been reported with severe NSAID overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Meloxicam did not demonstrate genotoxic potential in assays for gene mutation in vitro and chromosomal damage in vitro and in vivo.
Carcinogenicity. Two year dietary studies showed no evidence for carcinogenic activity at meloxicam doses up to 0.8 mg/kg/day (approximately half of the highest human dose at 15 mg/day for a 50 kg person based on body surface area [BSA]) in rats and up to 8 mg/kg/day (2.2 times the highest human dose based on BSA) in mice. In rats, the highest dose used was nephrotoxic, while the highest dose used in mice was subtoxic.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Meloxicam is a pale-yellow powder with pKa values of 1.09 and 4.18 and a melting point of about 256°C. The substance is practically insoluble in water, soluble in dimethylformamide, slightly soluble in chloroform and acetone and very slightly soluble in methanol. There are no chiral centres and no polymorphs are formed under normal conditions.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMELOXI.gif Chemical Name: 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide and 2H-1,2-benzothiazine-3-carboxamide,4-hydroxy-2-methyl-N-(5 methyl-2-thiazolyl)-1,1-dioxide.
Molecular Formula: C₁₄H₁₃N₃O₄S₂.
Molecular Weight: 351.4.
CAS number. 71125-38-7.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MELBELST.gif