1. WHAT OXIMAL IS AND WHAT IT IS USED FOR
□ The name of your medicine is OXIMAL. The active ingredient is Meloxicam. This belongs to a group of medicines known as
Non Steroidal Anti-Inflammatory agent which reduce the inflammation and pain in the joints and muscle.
This medicine is used for:
□ Short term treatment of acute attacks of osteoarthritis
□ Long term treatment of pain and stiffness in joint (rheumatoid arthritis) or backbone (ankylosing spondylitis).

Do not take OXIMAL:
□ If you are pregnant or breastfeeding
□ If you are allergic to OXIMAL or any other ingredients (see section 6)
□ If you are allergic (hypersensitive) to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs)
□ If you have developed signs of asthma (wheezing), nasal polyps (nasal obstruction) along with runny nose, swelling of the skin
or rash when taking aspirin or other anti-inflammatory medicines.
□ If you have peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach or have had two or more episodes
of peptic ulcers, stomach bleeding or perforation
□ Have severe liver disease
□ Have severe kidney failure and are not receiving dialysis.
□ Have gastrointestinal bleeding (bleeding in the stomach or gut) or cerebrovascular bleeding (bleeding in the brain) or have a
bleeding disorder.
□ Suffer from severe uncontrolled heart failure
Take special care with OXIMAL:
□ If you use other non-steroidal anti-inflammatory medicines (NSAIDs) or any medication which may cause bleeding or ulcers in
the stomach.
□ If you have a history of gastrointestinal disease e.g. inflammation of the stomach (gastritis) or gullet(osteophgitis),ulcer,
ulcerative colitis, Crohn’s disease
□ If you are elderly
□ If you have high blood pressure or any liver, kidney or heart problems.
□ If you have or have had bronchial asthma
□ If you are trying to become pregnant or undergoing investigation of fertility
□ If you suffer from lupus or any other disease.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicine, including medicines
obtained without prescription.
□ Other non steroidal anti-inflammatory drugs e.g. aspirin, ibuprofen or naproxen □ Medicines which prevent blood clotting such
as warfarin □ Medicines which break down blood clots (thrombolytics) □ Corticosteroids □ Certain medicines used to treat
depression (SSRI) □ Any diuretics (water tablet) medicine e.g. bendroflumethiazide, furosemide or acetazolamide □ ACE
inhibitors e.g. captopril or ramipril □ Angiotensin II antagonists e.g. candesartan or losartan □ Any other drugs used to treat
high blood pressure (e.g. beta-blocker such as acebutolol or oxprenolol) □ Cyclosporine □ Intra-uterine contraceptive device
(IUD), commonly called the coil
□ Lithium which used to treat depression □ Methotrexate, used to treat some types of cancer or psoriasis or rheumatoid
arthritis
□ Colestyramine, used to reduce cholesterol □ Cardiac glycoside (e.g. digoxin) □ Certain antibiotics □ Zidovudine (anti HIV
medicine)
□ Mifepristone (a type of steroid) □ Tacrolimus.
Tell your doctor about any other medicines you are taking even those obtained without prescription.
Taking OXIMAL with food and drink:
□ Take OXIMAL with or after food
□ Swallow with water
Pregnancy and breastfeeding:
Pregnancy: □ OXIMAL should not be used during pregnancy □ If you are planning to become pregnant, if you think or know
you are pregnant you should talk to your doctor for advice □ OXIMAL may make it more difficult to become pregnant. You
should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant
Breast-feeding: OXIMAL should not be given to breast-feeding mothers.
Driving and using machines: These tablets may make you feel light headed, dizzy or drowsy and may cause blurred vision. If
they affect you in this way DO NOT drive or operate machinery.
Important information about one of the ingredients of OXIMAL: These tablets contain lactose. If you have been told by your
doctor that you have intolerance to some sugar. Contact your doctor before taking this medicinal product

Follow your doctor’s instructions about when and how to take your medicine and always read the label.
Warnings:
□ Medicines such as OXIMAL 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 or 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 or high cholesterol or are smoker) you should discuss your treatment with your doctor or pharmacist.
Adult and adolescents (over the age of 16):
□ Depending on the type of condition you have, the usual recommended dosage is 7.5 mg or 15 mg take once daily with food.
□ If you need to take two tablets they must be taken together as a single dose.
Infants and children:
□ OXIMAL tablets should not be used in children under the age of 16.
Acute attack of osteoarthritis:
□ The usual dose is 7.5 mg a day. Your doctor may increase your dose to 15 mg a day if necessary.
Pain and stiffness in joint (Rheumatoid Arthritis) or backbone (Anklosing spondylitis):
□ The usual dose is 15 mg a day .your doctor may reduce your dose to 7.5 mg a day if necessary. Elderly patients and Patients
with increased risk of side effects:
□ The recommended dose for long term treatment of pain and stiffness in joint and backbone in the elderly is 7.5 mg a day.
□ Patient with increased risk of side effects should start treatment with 7.5 mg a day.
Patients with kidney problems:
□ OXIMAL tablets are not recommended for use in patients with severe kidney failure who are not receiving dialysis.
□ The maximum recommended dose for treatment in dialysis patients with severe kidney failure is 7.5 mg a day
□ Patients with mild to moderate kidney problems should use the normal dose.
Do not exceed the recommended maximum dose of 15 mg daily.
If after several days taking OXIMAL you feel no improvement talk to your doctor.
If you take more OXIMAL than you should:
If you take more tablets than you should tell your doctor immediately or go to the nearest hospital. Bring this leaflet or the carton
pack with you.
Symptoms of overdose include lack of energy, drowsiness, nausea, vomiting and stomach pain.
If you forget to take OXIMAL:
Take your tablet as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as normal.
Do not take a double dose to make up for the forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking OXIMAL and consult a doctor or your nearest hospital immediately if you notice:
Any allergic (hypersensitivity) reactions, which may appear in the form of:
□ skin reactions, such as itching (pruritus), blistering or peeling of the skin, which can be potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal necrolysis), lesions of soft tissues (mucosal lesions) or erythema multiforme.
Erythema multiforme is a serious allergic skin reaction causing spots, red welts or purple or blistered areas. It can also affect the
mouth, eyes and other moist body surfaces.
□ Swelling of skin or mucosa, such as swelling around the eyes, face and lips, mouth or throat, possibly making breathing
difficult, swollen ankles or legs (oedema of the lower limbs)
□ Shortness of breath or asthma attack
□ Inflammation of the liver (hepatitis). This can cause symptoms such as: - Yellowing of the skin or the eyeballs (jaundice)
- Pain in the abdomen - Loss of appetite
Any side effects of the digestive tract, especially:
□ Bleeding (causing tar-coloured stools)
□ Ulceration of your digestive tract (causing abdominal pain)
Bleeding of the digestive tract (gastrointestinal bleeding), formation of ulcers or formation of a hole in the digestive tract
(perforation) may sometimes be severe and potentially fatal, especially in elderly.
If you have previously suffered from any symptoms of the digestive tract due to long term use of NSAIDs, seek medical advice
immediately, especially if you are elderly. Your doctor may monitor your progress whilst on treatment.
If affected by visual disturbances do not drive or operate machinery.
General side effects of non-steroidal antiinflammatory medicines (NSAIDs):
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of occlusion of
arterial vessels (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high
doses and in long term treatment.
Fluid retention (oedema), high blood pressure (hypertension) and heart failure (cardiac failure) have been reported in
association with NSAID treatment.
The most commonly-observed side effects affect the digestive tract (gastrointestinal events): □ Ulcers of the stomach and upper
part of the small bowels (peptic/gastroduodenal ulcers) □ A hole in the wall of the bowels (perforation) or bleeding of the
digestive tract (sometimes fatal, particularly in the elderly)
The following side effects have been reported after NSAID administration: □ Feeling sick (nausea) and being sick (vomiting)
□ Loose stools (diarrhoea) □ Flatulence □ Constipation □ Indigestion (dyspepsia) □ Abdominal pain □ Tar-coloured stool due to
bleeding in the digestive tract (melaena) □ Vomiting of blood (haematemesis) □ Inflammation with building of ulcers in the
mouth (ulcerative stomatitis) □ Worsening of inflammation of the digestive tract (e.g. exacerbation of colitis or Crohn’s disease)
Less frequently, inflammation of the stomach (gastritis) has been observed.
Side effects of Meloxicam - the active substance of OXIMAL:
Very common: affects more than 1 user in 10: □ Gastrointestinal adverse events such as indigestion (dyspepsia), feeling sick
(nausea) and being sick (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhoea)
Common: affects 1 to 10 users in 100: □ Headache
Uncommon: affects 1 to 10 users in 1,000: □ Dizziness (light-headedness) □ A feeling of dizziness or spinning (vertigo)
□ Somnolence (drowsiness) □ Anaemia (reduction of the concentration of the red blood pigment haemoglobin) □ Increase in
blood pressure (hypertension) □ Flushing (temporary redness of the face and neck) □ Sodium and water retention □ Increased
potassium levels (hyperkalaemia). This can lead to symptoms such as: - changes to your heartbeat (arrythmias) - palpitations
(when you feel your heartbeat more than usual) - muscle weakness
□ Eructation □ Inflammation of the stomach (gastritis) □ Bleeding of the digestive tract □ Inflammation of the mouth (stomatitis)
□ Immediate allergic (hypersensitivity) reactions □ Itching (pruritus) □ Skin rash □ Swelling caused by fluid retention (oedema

including swollen ankles/legs (oedema of the lower limbs) □ Sudden skin or mucosal swelling, such as swelling
around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioneurotic oedema) □ Momentary
disturbance of liver function tests (e.g. raised liver enzymes like transaminases or an increase of the bile pigment bilirubin). Your
doctor can detect these using a blood test. □ Disturbance of laboratory tests investigating kidney (renal) function (e.g. raised
creatinine or urea)
Rare: affects 1 to 10 users in 10,000: □ Mood disorders □ Nightmares □ Abnormal blood count, including: - abnormal differential
blood count - decreased number of white blood cells (leucocytopenia) - decreased number of blood platelets
(thrombocytopenia) These side effects may lead to increased risk of infection and symptoms such as bruising or nosebleeds.
□ Ringing in the ear (tinnitus) □ Feeling your heartbeat (palpitations) □ Ulcers of the stomach or upper part of the small bowels
(peptic/gastroduodenal ulcers) □ Inflammation of the gullet (oesophagitis) □ Onset of asthma attacks (seen in people who are
allergic to aspirin or other NSAIDs) □ Severe blistering of the skin or peeling (Stevens Johnson syndrome and toxic epidermal
necrolysis) □ Nettle rash (urticaria) □ Visual disturbances including: - blurred vision - conjunctivitis (inflammation of the eyeball
or eyelids) □ Inflammation of the large bowel (colitis)
Very rare: affects less than 1 user in 10,000: □ Blistering reactions of the skin (bullous reactions) and erythema multiforme.
Erythema multiforme is a serious allergic skin reaction causing spots, red welts or purple or blistered areas. It can also affect
the mouth, eyes and other moist body surfaces □ Inflammation of the liver (hepatitis). This can cause symptoms such as:
- yellowing of the skin or the eyeballs (jaundice) - pain of the abdomen - loss of appetite □ Acute failure of the kidneys (renal
failure) in particular in patients with risk factors such as heart disease, diabetes or kidney disease □ A hole in the wall of the
bowels (perforation)
Not known: frequency can not be estimated from the available data:
□ Confusion □ Disorientation □ Shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) rashes caused
by exposure to sunlight (photosensitivity reactions) □ Heart failure (cardiac failure) has been reported in association with NSAID
treatment □ Complete loss of specific types of white blood cells (agranulocytosis), especially in patients who take OXIMAL
together with other drugs that are potentially inhibitory, depressant or destructive to a component of the bone marrow
(myelotoxic drugs). This can cause: - sudden fever - sore throat - infections
Side effects caused by non-steroidal antiinflammatory medicines (NSAIDs), but not yet seen after taking Meloxicam
Changes to the kidney structure resulting in acute kidney failure:
□ Very rare cases of kidney inflammation (interstitial nephritis) □ Death of some of the cells within the kidney (acute tubular or
papillary necrosis) □ Protein in the urine (nephrotic syndrome with proteinuria)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

□ Keep out of the reach and sight of children.
□ Do not store above 30 °C.
□ Do not use OXIMAL after the expiry date which is stated on the carton and on the blister, after (EXP). Date
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the environment