Consumer medicine information

Mobic

Meloxicam

BRAND INFORMATION

Brand name

Mobic

Active ingredient

Meloxicam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mobic.

Mobic®

Mobic®


 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


 1. Why am I taking Mobic?

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

 2. What should I know before I take Mobic?

Do not use Mobic 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 take Mobic? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with Mobic 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 take Mobic?

Follow the instructions provided by your doctor and pharmacist.

  • For osteoarthritis, the usual dose of Mobic is 7.5 mg once daily.
  • For rheumatoid arthritis, the usual dose of Mobic is 15 mg once daily.

Swallow Mobic whole with a full glass of water with or immediately after food.

More instructions can be found in Section 4. How do I take Mobic? in the full CMI.

 5. What should I know while taking Mobic?

Things you should do
  • Remind any doctor, dentist or pharmacist that you visit that you are taking Mobic.
  • If you are going to have surgery, tell the nurse, surgeon, or anaesthetist that you are taking Mobic as it can slow down blood clotting.
Things you should not do
  • Do not stop taking Mobic or lower the dosage without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how Mobic affects you.
  • This medicine may cause dizziness, drowsiness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
  • Keep Mobic in a cool dry place where the temperature stays below 25°C.
  • Keep it where children cannot reach it.

For more information, see Section 5. What should I know while taking Mobic? in the full CMI.

 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.


Mobic®

Active ingredient: meloxicam


 Consumer Medicine Information (CMI)

This leaflet provides important information about taking Mobic. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking Mobic.

Where to find information in this leaflet:

1. Why am I taking Mobic?
2. What should I know before I take Mobic?
3. What if I am taking other medicines?
4. How do I take Mobic?
5. What should I know while taking Mobic?
6. Are there any side effects?
7. Product details

1. Why am I taking Mobic?

Mobic contains the active ingredient meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by relieving pain, swelling, and redness.

Mobic is used to treat the symptoms of:

  • Osteoarthritis (OA) is a chronic disorder that causes damage to the cartilage and surrounding tissues and is characterized by pain, stiffness, and loss of function.
  • Rheumatoid arthritis (RA) is an inflammatory arthritis in which joints, usually including those of the hands and feet, are inflamed, resulting in swelling, pain, and often destruction of joints.

Both diseases mainly affect the joints causing pain and swelling.

Although Mobic can relieve the symptoms of pain and inflammation, it will not cure your condition.

2. What should I know before I take Mobic?

Warnings

Do not take Mobic if you are allergic to:

  • meloxicam, or any of the ingredients listed at the end of this leaflet. Always check the ingredients in section 7 to make sure that you can take this medicine.
  • Aspirin or any other non steroidal anti inflammatory drugs (NSAIDs).

Do not take Mobic if you:

  • Are under 18 years of age
  • Are pregnant or think you may be pregnant (see Pregnancy and Breastfeeding)
  • Are breastfeeding (see Pregnancy and Breastfeeding)
  • Are going to have or have just had heart bypass surgery
  • Have galactose intolerance (a rare genetic condition)
  • Have a hole in or experience bleeding from the stomach, gut or any other bleeding
  • Have uncontrolled heart failure
  • Have severe liver problems
  • Have severe, non-dialysis kidney disease
  • Have had a stroke due to a bleed in the brain
  • Have a stomach ulcer
  • Have or have had inflammation of the stomach lining
  • Have an inflammatory bowel disease such as Crohn's disease or ulcerative colitis now or in the past
  • Are taking any of these medicines:
    - fluconazole (a medicine used to treat fungal infections) or
    - certain sulfur antibiotics (e.g. sulfamethoxazole)
    - methotrexate (a medicine used to treat diseases of the immune system and some cancers).
  • Had any of the following reactions after taking aspirin or an NSAID:
    - asthma
    - nasal polyps (painless growths inside the nose or sinuses)
    - swelling of the face, lips, mouth, tongue or throat (which may cause difficulty in swallowing or breathing)
    - hives or an itchy rash.

Tell your doctor if you have:

  • any allergies to other medicines, foods, preservatives, or colours
  • a current infection
  • advanced or chronic kidney disease
  • any problems with your
    - heart or blood vessels
    - liver
    - blood pressure
  • fluid retention
  • diabetes
  • high cholesterol
  • any clotting or bleeding disorder
  • asthma.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Speak to your doctor if you intend to become pregnant or breastfeed.

Tell your doctor immediately if you become pregnant while taking Mobic.

Birth control

Tell your doctor if you are using an intrauterine device (IUD) to prevent pregnancy. NSAID medicines, like Mobic, may decrease the effectiveness of the birth control device.

Children and adolescents

The safety and effectiveness in adolescents or children younger than 18 years have not been established.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Mobic and affect how it works. These include:

  • other non-steroidal anti-inflammatory drugs (NSAIDs): aspirin, celecoxib, diclofenac, etoricoxib, ibuprofen, indometacin, ketoprofen, mefenamic acid, naproxen, piroxicam, rofecoxib, salicylates, or sulindac.
  • warfarin or heparin, medicines used to thin the blood
  • furosemide, other diuretics or medicines used to treat high blood pressure
  • Amiodarone or quinidine, two medicines used to treat fast, slow or irregular heart beats
  • Ciclosporin, a medicine used to treat inflammatory conditions suppress the immune system
  • Ketoconazole and itraconazole, medicines used to treat fungal infections
  • Erythromycin, a commonly used broad-spectrum antibiotic
  • Lithium, a tablet used to treat mood disorders
  • Cortisone, dexamethasone, prednisolone, prednisone, or any other steroid medicine used to treat inflammatory conditions (e.g. skin rashes or asthma)
  • Pemetrexed, a medicine injected into a vein that is used to treat some lung cancers
  • Sulfonylureas, oral medicines used to treat diabetes
  • citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline, medicines used to treat depression and anxiety (called SSRIs).

Medicines that may reduce the effect of Mobic include:

  • Cholestyramine, a medicine used for lowering blood fats (cholesterol).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Mobic.

4. How do I take Mobic?

How much to take

The dose depends on your condition and any medicines that you are taking.

Follow the instructions provided by your doctor and pharmacist and take Mobic until your doctor tells you to stop.

Osteoarthritis (OA)

The usual starting dose for osteoarthritis is 7.5 mg, taken as a single dose each day. Depending on your response, your doctor may increase the single daily dose to 15 mg.

Rheumatoid arthritis (RA)

The usual dose for rheumatoid arthritis is 15 mg taken as a single dose each day. If needed, your doctor may reduce the single daily dose to 7.5 mg.

Ask your doctor for more information if you have been advised to take a different dose.

Patients with kidney problems undergoing dialysis should not take more than 7.5 mg each day.

Do not exceed the maximum recommended daily dose of 15 mg.

How to take Mobic

Swallow Mobic whole with a full glass of water with or immediately after food. This may help reduce the risk of getting an upset stomach.

When to take Mobic

Take Mobic once a day, at about the same time each day. Taking it at the same time each day will help you remember when to take it.

If you forget to take Mobic

If you miss taking your dose at the usual time, and it is 2-3 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you have taken too much Mobic

If you think that you have taken too much Mobic, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

The symptoms of an overdose may include:

  • nausea and/or vomiting
  • headache
  • drowsiness and/or dizziness
  • blurred vision
  • fits or seizures
  • fainting, feeling weak, light-headed, tired, confused and having blurred vision (signs of low blood pressure)
  • difficulty in breathing
  • being unaware of what happens to you or around you
  • changes in amount of urine, fluid retention, confusion, and/or nausea.
5. What should I know while taking Mobic?

Things you should do

If you are going to have surgery, tell the nurse, surgeon, or anaesthetist that you are taking Mobic. Mobic can slow down blood clotting and put you at risk of bleeding.

Keep your medical appointments so that your progress can be monitored.

Your doctor may want to perform tests now and then to detect any side effects, such as anaemia.

Tell any healthcare professionals who treat you that you are taking this medicine.

Continue taking Mobic for as long as your doctor tells you.

Talk to your doctor or pharmacist if you do not feel any better after several days of taking Mobic.

Things you should not do

Do not stop taking your medicine or lower the dosage without speaking to your doctor first.

Things to be careful of

Tell your doctor if you get an infection while using Mobic. Mobic may hide some of the signs of an infection, such as pain, fever, redness and swelling. You may think, mistakenly, that you have improved or that the infection is not serious.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Mobic affects you.

Mobic may cause dizziness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Looking after your medicine

Store Mobic in a cool dry place where the temperature stays below 25°C.

Store Mobic away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

Return Mobic to your pharmacist for safe disposal if:

  • your doctor tells you to stop taking it or
  • the pack has expired or
  • the packaging is torn/shows signs of tampering.
6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
General problems:
  • Flu-like symptoms: runny or blocked nose, cough, sore mouth or throat, discomfort when swallowing
  • fatigue
  • fluid retention in lower body
  • swelling of hands, ankles or feet
  • allergic reaction.
Gut and digestion:
  • indigestion (stomach upset) including heartburn/reflux, feeling sick (nausea), vomiting, burping or passing more wind than usual, cramps, pain, constipation, loose stools (diarrhoea).
Nervous system:
  • headache
  • dizziness
  • spinning sensation
  • trouble sleeping
  • drowsiness.
Skin:
  • itching or flaking
  • excessive sweating that's not related to heat or exercise
  • irritation of the moist internal linings of the body such as the mucous membranes (e.g. lips, mouth, throat, nasal passages, eyelids, intestines or genitals).
Breathing:
  • cough
  • shortness of breath, chest tightness.
Nutrition:
  • dehydration
  • increased appetite.
Muscle and bone:
  • back pain
  • pain or swelling in or near a joint
  • muscle spasms
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • pain in extremity.
Infections:
  • runny or stuffy nose, sneezing, or swelling of the lining of the nose
  • swelling of the air-filled spaces in your forehead, cheeks or nasal passages.
Urine:
  • blood in the urine.
Blood:
  • increased blood pressure (BP) over several days (if self-checked at home with a suitable BP machine).
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Gut and bowel:
  • bleeding from the back passage, black sticky stools or bloody diarrhoea
  • severe pain or tenderness in the stomach
  • vomiting of blood or material that looks like coffee grounds.
Liver:
  • yellowing of the skin or the whites of the eyes
  • pain in the abdomen
  • loss of appetite.
Kidney and bladder:
  • any pain or difficulty when urinating
  • any change in the amount or colour of urine.
Eyes:
  • blurred vision or difficulty seeing.
Lungs:
  • sharp chest pain, usually worse when you inhale or cough.
Heart:
  • fast or irregular heartbeat
  • chest pain
  • swollen ankles or legs (oedema of the lower limbs).
Severe allergic reaction:
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.
Severe skin and soft tissue reactions:
  • sudden unexplained bruising or blood spots under the skin that were not caused by an injury
  • itching, blistering or peeling of the skin, which can be potentially life-threatening
  • rashes which may be caused by sunlight, can blister, and may take on the appearance of a severe burn
  • swelling of skin or mucosa, such as swelling around the eyes, face and lips, mouth or throat, possibly making breathing difficult.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very serious side effectsWhat to do
Signs of a stroke
  • weakness or numbness or paralysis of the face, arm or leg on either or both sides of the body
  • slurred speech
  • difficulty speaking or understanding
  • loss of vision, sudden blurring or decreased vision in one or both eyes
  • Headache, usually severe and fast onset or unexplained change in the pattern of headaches.
Call an ambulance (dial 000) at once if you experience these side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects experienced, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Mobic tablets contain

Active (main) ingredientmeloxicam
Other (inactive) ingredients
  • colloidal anhydrous silica
  • crospovidone
  • magnesium stearate (vegetable sourced)
  • microcrystalline cellulose
  • povidone
  • sodium citrate dihydrate
Potential allergenlactose (as monohydrate)

What Mobic capsules contain

Active (main) ingredientmeloxicam
Other (inactive) ingredients
  • gelatin
  • indigo carmine CI73015
  • iron oxide yellow CI77492
  • maize starch
  • magnesium stearate (vegetable sourced)
  • purified water
  • sodium citrate dihydrate
  • titanium dioxide
Potential allergenlactose (as monohydrate)

Do not take this medicine if you are allergic to any of these ingredients.

Mobic does not contain gluten.

What Mobic looks like

7.5 mg tablet

Pastel yellow round tablet, marked 59D on one side with break bar, and the Boehringer Ingelheim company logo on the reverse side (Aust R 77694).

7.5 mg capsule

Opaque pale green hard gelatin capsule containing a fine yellow powder (Aust R 77698).

15 mg tablet

Pastel yellow round tablet, marked 77C on one side with break bar, and Boehringer Ingelheim company logo on the other (Aust R 77695).

15 mg capsule

Opaque hard gelatin capsule, with a pale yellow body and pale green cap, containing a fine yellow powder (Aust R 77699).

Mobic tablets and capsules are packed in blister cartons containing 30, 10*, 20*, 60* (tablets only), and 100* tablets or capsules.

*Some pack sizes are not available in Australia.

Who distributes Mobic

Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
78 Waterloo Road
North Ryde NSW 2113
Website: www.boehringer-ingelheim.com.au

®Registered trademark

© Copyright 2023

This leaflet was prepared in November 2023.

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Mobic

Active ingredient

Meloxicam

Schedule

S4

 

1 Name of Medicine

Meloxicam.

2 Qualitative and Quantitative Composition

Mobic is available as tablets and capsules.
Each Mobic 7.5 mg tablet contains meloxicam 7.5 mg.
Each Mobic 15 mg tablet contains meloxicam 15 mg.
Each Mobic 7.5 mg capsule contains meloxicam 7.5 mg.
Each Mobic 15 mg capsule contains meloxicam 15 mg.
Excipients with known effect. Each Mobic 7.5 mg tablet contains 23.5 mg lactose monohydrate.
Each Mobic 15 mg tablet contains 20 mg lactose monohydrate.
Each Mobic 7.5 mg capsule contains 123 mg lactose monohydrate.
Each Mobic 15 mg capsule contains 112 mg lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets 7.5 mg. Pastel-yellow, round tablets, marked 59D on one side with break bar, and company logo on the other.
Tablets 15 mg. Pastel-yellow, round tablets, marked 77C on one side with break bar, and company logo on the other.
Capsules 7.5 mg. Oblong, hard gelatin capsule with pale green opaque cap and body, containing a fine yellow granulate.
Capsules 15 mg. Oblong, hard gelatin capsule with pale green opaque cap and yellow opaque body, containing a fine yellow granulate.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
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.

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 pastel yellow solid 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. Mobic is available as tablets and capsules.
Chemical structure. Chemical names: 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.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMELOXI.gif 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/MOBICST.gif