Flamaryx 7,5 mg/15 mg Tablets

FLAMARYX contains the active ingredient meloxicam belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

FLAMARYX is used to treat pain or inflammation caused by arthritis. It may be used for osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), or ankylosing spondylitis (arthritis that mainly affects the spine). FLAMARYX is also used to treat sciatica (low back pain combined with pain through the buttock and down one leg).

Do not take FLAMARYX:

• If you have ever had an unusual or allergic reaction (hypersensitivity) to meloxicam as in FLAMARYX or any ingredients of the product.
• If you have ever suffered from asthma, hives, nasal polyps (nasal obstruction due to swellings in the lining in your nose) along with a runny nose, angioedema (painless swelling under your skin) when taking aspirin or other non-steroidal anti-inflammatory medicines.
• If you have recently undergone heart surgery (for narrowed or blocked arteries), since FLAMARYX should not be used to treat pain after such an operation.
• If you have or have ever had an ulcer/sore in your stomach or intestines, or perforation or bleeding.
• If you have ever suffered from gastrointestinal bleeding (bleeding in the stomach or intestines) or holes in the stomach or intestine.
• If you have been diagnosed with Crohn’s disease or ulcerative colitis (an inflammatory bowel disease with symptoms such as abdominal pain and cramping, bloody diarrhoea, rectal pain or bleeding, weight loss and fatigue).
• If you have a history of gastrointestinal bleeding or perforation (PUBs) related to previous NSAIDs.
• If you have serious liver disease.
• If you have serious kidney disease and are not undergoing dialysis.
• If you suffer from any kind of established bleeding disorder, bleeding in your stomach or intestines, or recent cerebrovascular bleeding (bleeding in your brain).
• If you have heart failure or ischaemic heart disease (not enough blood flowing to/from your heart with symptoms such as shortness of breath, fatigue and swelling in your legs, ankles and feet) and/or a condition that affects the blood vessels and blood supply to your brain (stroke) or peripheral arterial disease (a condition in which narrowed arteries reduce blood flow to your arms or legs).
• If you are pregnant, planning to become pregnant or if you are breastfeeding (see Pregnancy and breastfeeding).
• If you or your child are younger than 12 years of age.
• If you have been told by your doctor that you have an intolerance to some sugars, as FLAMARYX contains lactose (as monohydrate) (see Important information about some of the ingredients of FLAMARYX).

• Take this medication only as directed by your doctor.

• Do not take more or less of it or take it more often than prescribed by your doctor.

• The tablets should be swallowed with water, during a meal.

• If you need to take two tablets, they must be taken together as one single dose.

The usual recommended doses are given below:

Adults:

• Acute sciatica: 7,5 mg (one tablet) once a day. If there is no improvement, this may be increased to 15 mg once a day.
• Ankylosing spondylitis: 15 mg once a day. Your doctor may reduce your dose to 7,5 mg a day depending on your response to the treatment.
• Osteoarthritis: 7,5 mg (one tablet) once a day. This may be increased to 15 mg once a day.
• Rheumatoid arthritis: 15 mg once a day. This may be reduced to 7,5 mg (one tablet) once a day.

FLAMARYX can have side effects. Not all side effects reported for FLAMARYX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLAMARYX, please consult your health care provider for advice.

If any of the following happens, stop taking FLAMARYX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, eyes, lips, tongue, or throat which may cause difficulty in swallowing or breathing or wheezing
• bronchospasm or asthma (tightening of your chest causing difficulty/noisy breathing, shortness of breath or coughing), especially if you are allergic to aspirin or other NSAIDs.
• hives (skin rash) or itching
• fainting
• stroke (sudden numbness/weakness in your face, arm or leg, especially on one side of your body)
• heart attack (chest pain, weakness, shortness of breath).

Store all medicines out of the reach of children. Store at or below 25 °C (room temperature). Do not remove tablets from the blister until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).