Meloxicam 7.5mg Tablets
Size: 210 x 543 mm
% SOVEREIGN
^ Medical
GB 724-8255-APIL
Package leaflet: Information for the user
Meloxicam 7.5 mg & 15 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Please keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Meloxicam Tablets are and what they are used for
2. What you need to know before you take Meloxicam Tablets
3. How to take Meloxicam Tablets
4. Possible side effects
5. How to store Meloxicam Tablets
6. Contents of the pack and other information
1. What Meloxicam Tablets are and what they are used for
The name of your medicine is Meloxicam 7.5 mg and 15 mg Tablets (referred to as Meloxicam Tablets in this leaflet).
Meloxicam Tablets contain the active substance meloxicam which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles and can also reduce a fever.
Meloxicam Tablets are used for
• the short-term treatment of attacks of osteoarthritis
• the long-term treatment of rheumatoid arthritis and ankylosing spondylitis (a condition affecting the spine, also known as Bechterew's disease).
2. What you need to know before you take Meloxicam Tablets
Do not take Meloxicam Tablets:
• during the last three months of pregnancy
• if you are under 16 years of age
• if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs)
• if you have had any of the following signs after taking aspirin or other NSAIDs:
• wheezing, chest tightness, breathlessness (asthma)
• nasal blockage due to swellings in the lining in your nose (nasal polyps)
• skin rashes/nettle rash (urticaria)
• sudden skin or mucosal swelling, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioneurotic oedema)
• if after previous therapy with NSAIDs you have a history of
• bleeding in your stomach or intestines
• holes (perforations) in your stomach or intestines
• if you have ulcers or a bleeding in your stomach or intestines
• if you have recent or history of stomach or intestinal ulcers or bleeding (ulceration or bleeding occurring at least twice)
• if you have severely impaired liver function
• if you have non-dialysed severe kidney failure
• if you have had recent bleeding in the brain (cerebrovascular bleeding)
• if you have any kind of bleeding disorders
• if you have severe heart failure.
If you are unsure whether any of the above apply to you, please contact your doctor.
Warnings and precautions
Medicines such as Meloxicam Tablets may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (apoplexy). Any risk is more likely with high doses and prolonged treatment.
Do not take more than the recommended dose.
Do not take Meloxicam Tablets for longer than it is prescribed for you (see section 3 “How to take Meloxicam Tablets”).
If you have heart problems, previous stroke or think that you might be at risk of these conditions, you should discuss your treatment with your doctor or pharmacist.
For example if you:
- have high blood pressure (hypertension)
- have high levels of sugar in the blood (diabetes mellitus)
- have high levels of cholesterol in the blood (hypercholesterolem ia)
- are a smoker
If you develop severe allergic reactions, you should discontinue Meloxicam Tablets at first appearance of skin rash, lesions of soft tissues (mucosal lesions), or any other sign of allergy, and contact your doctor.
Stop your treatment with Meloxicam Tablets immediately as soon as you notice bleeding (causing tar-coloured stools) or ulceration of your digestive tract (causing abdominal pain).
Meloxicam Tablets are not appropriate if you require immediate relief from acute pain.
Meloxicam Tablets may hide the symptoms of infection (e.g. fever). If you think you may have an infection you should see your doctor.
As it will be necessary to adjust the treatment, it is important to ask your doctor's advice before you take Meloxicam Tablets in case of:
- history of inflammation of the gullet (oesophagitis),
inflammation of the stomach (gastritis) or any other disease of the digestive tract, e.g. ulcerative colitis, Crohn's disease
- high blood pressure (hypertension)
- older age
- heart, liver or kidney disease
- high levels of sugar in the blood (diabetes mellitus)
- reduced blood volume (hypovolaemia) which may occur if you have a serious blood loss or burn, surgery or low fluid intake
- high potassium levels in the blood previously diagnosed by your doctor
- bronchial asthma or a previous history of it
Your doctor will need to monitor your progress whilst on treatment.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of meloxicam, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of meloxicam, you must not be re-started on meloxicam at any time.
If you develop a rash or these skin symptoms, stop taking meloxicam, seek urgent advice from a doctor and tell him that you are taking this medicine.
Children and adolescents
Meloxicam Tablets are not for use in children and adolescents under 16 years of age.
Other medicines and Meloxicam Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any medicines obtained without a prescription.
This is especially important if you are taking any of the following:
• other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, ibuprofen or naproxen
• any medicine used to treat heart problems or high blood pressure e.g. “water tablets” such as bendroflumethiazide, furosemide or digoxin, beta-blockers such as atenolol or for high cholesterol e.g. colestyramine
• medicines to treat kidney disease
• medicines which prevent blood clotting such as warfarin
• medicines which break down blood clots (e.g. heparin)
• tacrolimus or ciclosporin, used to prevent and treat the rejection of an organ transplant and also used in immune diseases
• corticosteroids (such as prednisolone, cortisol or cortisone) used to treat inflammation or allergic reactions
• selective serotonin reuptake inhibitors (SSRI's) which are antidepressant medicines (e.g. citalopram, fluoxetine and sertraline), and lithium, used to treat mood disorders
• methotrexate, used to treat some types of cancer, or for psoriasis or rheumatoid arthritis
• mifipristone, used to induce abortions
• zidovudine, used in the treatment of HIV infection
• quinolones, a type of antibiotic
• if you are a woman who uses a coil (intrauterine contraceptive device (IUD))
Laboratory Tests
Tell the doctor if you are due to have a liver or kidney function test. This is important because taking meloxicam can affect the results.
Meloxicam Tablets with food and drink
Meloxicam Tablets should be swallowed whole with water, or another drink, during a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you become pregnant while taking Meloxicam Tablets, please notify your doctor.
During the first 6 months of pregnancy your doctor may prescribe Meloxicam Tablets for you if he/she considers it to be necessary.
During the last three months of pregnancy, do not use this product, because Meloxicam Tablets can have serious effects on your child, in particular cardiopulmonary and renal effects, even with only one administration.
Breast-feeding
This product is not recommended during breast feeding. Fertility
Meloxicam Tablets 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.
Driving and using machines
Do not drive or operate machines until you know how the tablets affect you. They may make you feel light headed, dizzy or drowsy, and may cause blurred vision. If they affect you in any way do not drive or operate machinery.
Meloxicam Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Meloxicam Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or the pharmacist if you are not sure.
Meloxicam Tablets should be taken by mouth, with a drink of water or other liquid and with food. If you need to take two tablets they must be taken together as a single dose. The score line is not intended for breaking the tablets.
Dose
Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may experience.
Adults
Depending on your condition, the recommended dose is 7.5 mg or 15 mg taken daily.
Do not take exceed the recommended maximum dose of 15 mg a day.
If any of the statements listed under the heading "Warnings and precautions" apply to you, your doctor may restrict your dose to 7.5 mg (one tablet) once a day.
Attacks of osteoarthritis:
The recommended dose is 7.5 mg a day. Your doctor may increase your dose to 15 mg a day if necessary.
Rheumatoid arthritis and ankylosing spondylitis:
The recommended 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 treatment of rheumatoid arthritis and ankylosing spondylitis in these patients is 7.5 mg a day.
Do not exceed the recommended maximum dose of 15 mg a day.
Patients with kidney impairment:
The maximum recommended dose for treatment in dialysis patients with severe kidney failure is 7.5 mg a day.
Use in children and adolescents
Meloxicam Tablets should not be taken by children and adolescents under 16 years of age.
If you feel that the effect of Meloxicam Tablets is too strong or too weak, or if after several days you do not feel any improvement in your condition you should talk to your doctor.
If you take more Meloxicam Tablets than you should
If you realize you have taken more Meloxicam Tablets than your doctor has recommended (or if someone else has taken some of your Meloxicam Tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Symptoms following acute NSAID overdose are usually limited to:
- lack of energy (lethargy)
- drowsiness
- feeling sick (nausea) and being sick (vomiting)
- pain in the area of the stomach (epigastric pain)
These symptoms generally get better when you stop taking Meloxicam Tablets. You may suffer from bleeding of the stomach or intestines (gastrointestinal bleeding).
Severe poisoning may result in a serious drug reaction (see section 4.):
- high blood pressure (hypertension)
- acute kidney (renal) failure
- liver (hepatic) dysfunction
- reduction/flattening or standstill of breathing (respiratory depression)
- loss of consciousness (coma)
- seizures (convulsions)
- collapse of the blood circulation (cardiovascular collapse)
- standstill of the heart (cardiac arrest)
- immediate allergic (hypersensitivity) reactions, including:
- fainting
- shortness of breath
- skin reactions
If you forget to take Meloxicam Tablets
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Serious side effects
Stop taking Meloxicam Tablets and consult a doctor or your nearest hospital immediately if you notice:
Uncommon (may affect up to 1 in 100 people)
• 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
Rare (may affect up to 1 in 1000 people)
• Ringing in the ears (tinnitus)
• Feeling your heart beat (palpitations)
• Inflammation of the gullet (oesophagitis)
• Inflammation of the large bowel (colitis)
• Decreased number of white blood cells (leucocytopenia) and decreased number of blood platelets (thrombocytopenia). These side effects may lead to increased risk of infection and symptoms such as unexplained bruising or bleeding
Very rare (may affect up to 1 in 10,000 people)
• Skin reactions, such as itching (pruritus), blistering or peeling of the skin, which can be severe (Steven-Johnson Syndrome and 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.
• Inflammation of the liver (hepatitis). This can cause symptoms such as:
- yellowing of the skin or the whites of the eyes (jaundice)
- pain in the abdomen
- loss of appetite
• Acute kidney failure (e.g. changes in urine output, particularly a reduction in amount passed, swelling due to fluid retention (oedema), nausea and vomiting, abdominal pains and feeling generally unwell, dehydration with thirst, later symptoms can include confusion and drowsiness).
(agranulocytosis), especially in patients who take Meloxicam Tablets 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
• 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.
Other side effects of Meloxicam Tablets
Very common (may affect more than 1 in 10 people)
• indigestion (dyspepsia)
• feeling sick (nausea) and being sick (vomiting)
• abdominal pain
• constipation
• flatulence
• loose stools (diarrhoea)
Common (may affect up to 1 in 10 people)
• headache
Uncommon (may affect 1 up to 1 in 100 people)
• dizziness (light-headedness), vertigo or drowsiness (somnolence)
• an increase in blood pressure (hypertension) and hot flushes
• increased sodium and water retention
• Increased potassium levels (hyperkalaemia), which can lead to symptoms such as changes to your heartbeat (arrhythmias), and muscle weakness
• soreness or inflammation of the mouth (stomatitis), or inflammation of the stomach (gastritis)
• 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)
• anaemia (low number of red blood cells) which may make you feel tired or breathless
• eructation (burping)
Rare (may affect 1 up to 1 in 1000 people)
• mood disorders and nightmares.
• changes in vision, for example blurred vision and conjuctivitis. If affected by visual disturbances tell your doctor immediately.
• nettle rash (urticaria)
• abnormal blood count, including:
• abnormal differential blood count
Not known: frequency cannot be estimated from the available data
• confusion
• disorientation
• rashes caused by exposure to sunlight (photosensitivity reactions)
Side effects caused by non-steroidal anti-inflammatory medicines (NSAIDs), but not yet seen after taking Meloxicam Tablets
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) Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Meloxicam Tablets
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date printed on the carton and the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package. 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.
6. Contents of the pack and other information
What Meloxicam Tablets contain
Each Meloxicam Tablet contains 7.5 mg or 15 mg of the active ingredient meloxicam.
The other ingredients are maize starch, pregelatinised starch, anhydrous colloidal silica, sodium citrate, lactose monohydrate, microcrystalline cellulose and magnesium stearate.
What Meloxicam Tablets look like and the contents of the pack
Meloxicam 7.5mg and 15mg Tablets are yellow, round, flat, uncoated tablets with bevelled edges. They are scored on one side and plain on the other side.
They are available in blister packs containing 10, 30 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Medical
Not known: frequency cannot be estimated from the available data
• heart failure (cardiac failure) has been reported in association with NSAID
• complete loss of specific types of white blood cells
I SOVEREIGN
Marketing Authorisation Holder
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK.
Manufacturer
Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK.
This leaflet was last revised in August 2016