Mobiflex (Tenoxicam)

For oral administration.

To be taken preferably with or after food.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults

A single daily dose of 20mg Mobiflex should be taken at the same time each day. Mobiflex Tablets are for oral administration with water or other fluid.

Higher doses should be avoided as they do not usually achieve significantly greater therapeutic effect but may be associated with a higher risk of adverse events.

In acute musculoskeletal disorders treatment should not normally be required for more than 7 days, but in severe cases it may be continued up to a maximum of 14 days.

Elderly

The elderly are at increased risk of the serious consequences of adverse reactions. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. If an NSAID is considered necessary the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Children

There are insufficient data to make a recommendation for administration of Mobiflex to children.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting, wind or abdominal pain.
• Loss of appetite.
• Mouth ulcers.
• Ulceration or bleeding in the stomach or intestines.
• Sensation of spinning (vertigo).
• Sensation of ringing, or other noise in the ears (tinnitus).
• Retention of water in the body tissues, resulting in swelling (oedema).
• Increase in blood pressure.
• Blurred vision.
• Swollen eyes or eye irritation.
• Dizziness.
• Headache.
• Drowsiness.
• Difficulty sleeping (insomnia).
• Depression.
• Nervousness.
• Confusion.
• Hallucinations.
• Pins and needles sensations.
• Inflammation of the pancreas (pancreatitis).
• Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), severe skin rashes or anaphylactic shock.
• Kidney, liver or blood disorders.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

• This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.
• Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
• NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see end of factsheet). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.
• Non-steroidal anti-inflammatory drugs such as this one may be associated with a small increase in the risk of experiencing a heart attack or stroke, although tenoxicam may have a lower risk than some other NSAIDs. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have ever had a 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.
• Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
• If you have cirrhosis of the liver, heart failure or kidney disease, you are on a low sodium diet, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
• During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

Use with caution in

• Elderly people.
• History of disorders affecting the stomach or intestines.
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• Kidney disease.
• Liver disease.
• Heart failure.
• High blood pressure (hypertension).
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
• Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
• Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
• Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
• Diabetes.
• Smokers.
• People with blood clotting problems or taking anticoagulant medicines.
• History of asthma.
• History of allergies.
• Diseases affecting connective tissue, eg systemic lupus erythematosus.

Not to be used in

• People in whom aspirin or other NSAIDs, eg diclofenac, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
• People with an active peptic ulcer or a history of peptic ulcer, bleeding in the gut or severe stomach inflammation (gastritis).
• Severe heart failure.
• Mobiflex tablets are not recommended for children.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Tenoxicam should not be used in combination with painkilling doses of aspirinor any other NSAID taken by mouth, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of cyclo-oxgenase 2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding from the gut if tenoxicam is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding from the gut if tenoxicam is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin
• anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
• dabigatran
• erlotinib
• selective serotonin re-uptake inhibitors (SSRIs) antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.

Tenoxicam may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking tenoxicam with an anticoagulant medicine should be closely monitored by their doctor.

There may be an increased risk of side effects on the kidneys if tenoxicam is used with any of the following medicines:

• ACE inhibitors, eg enalapril
• angiotensin II receptor antagonists, eg losartan
• ciclosporin
• diuretics, eg furosemide
• tacrolimus.

Tenoxicam may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following:

• ACE inhibitors such as captopril
• angiotensin II receptor antagonists, eg losartan
• beta-blockers such as propranolol
• diuretics such as furosemide.

Tenoxicam may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People using tenoxicam with any of these should be closely monitored by their doctor:

• digoxin
• lithium
• methotrexate.

If this medicine is used in combination with quinolone antibiotics, such as ciprofloxacin or norfloxacin, there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Other medicines containing the same active ingredient

Tenoxicam tablets and injection are also available without a brand name, ie as the generic medicine.