COXFLAM: Uses,Side Effects,Warnings,Precautions

COXFLAM is a non-steroidal anti-inflammatory medicine (NSAID) used to relieve pain and inflammation in conditions that affect the joints, spine and surrounding tissues. It is intended for symptomatic relief, which means it helps with pain, swelling and fever, but it does not cure the underlying illness. COXFLAM is a Schedule S3 medicine, so it is supplied under a healthcare professional’s guidance. The tablets contain lactose.

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What it is and what it is used for

COXFLAM contains meloxicam, an NSAID in the group of medicines known as antirheumatics (anti-inflammatory agents). It helps reduce pain, inflammation and fever.

It is used for the symptomatic relief of:

• Osteoarthritis
• Rheumatoid arthritis
• Acute sciatica (pain affecting the hip nerve)
• Ankylosing spondylitis (a form of spinal arthritis)

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How it works

COXFLAM is an anti-inflammatory pain reliever. In everyday terms, it helps to turn down the body’s inflammation signals, easing pain, swelling and fever associated with joint and musculoskeletal problems.

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Who should NOT use this medicine

Do not take COXFLAM if:

• You are allergic to meloxicam or any of the ingredients in the tablets.
• You have ever had an allergic reaction to aspirin or any other anti-inflammatory medicines (NSAIDs).
• You are pregnant.
• You have ever developed wheezing, nasal polyps with runny nose, skin swelling or urticaria (nettle rash) when taking aspirin or other anti-inflammatory medicines.
• You currently have, or have a history of, a stomach or intestinal ulcer, or active inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis).
• You have any bleeding disorder or have previously had gastrointestinal bleeding (stomach bleeding) or cerebrovascular bleeding (bleeding in the brain).
• You have serious liver disease.
• You have serious kidney disease and are not on dialysis.
• You have severe heart failure.
• You have been diagnosed with ischaemic heart disease (reduced blood flow to the heart), or peripheral arterial disease (narrowing of blood vessels causing poor circulation).
• You are scheduled for coronary artery bypass graft (CABG) surgery and have pain before the surgery.
• You are under 12 years of age.

Note: COXFLAM contains lactose. If you’ve been told you have a sugar intolerance, speak to your doctor before using it.

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Warnings and precautions (Read before use)

Speak to your doctor or pharmacist before taking COXFLAM if any of the following apply to you:

• Digestive tract conditions: current or past oesophagitis (gullet inflammation), gastritis (stomach inflammation), ulcerative colitis, Crohn’s disease, angiodysplasia, or hiatus hernia.
• Cardiovascular risks or conditions: high blood pressure, heart disease, pre-existing heart failure, high blood cholesterol, smoking, or being elderly. Fluid retention has been reported.
• Kidney or liver problems: any degree of renal or hepatic disease.
• Diabetes.
• Recent allergic issues: such as urticaria, skin rash from aspirin, or allergic rhinitis (hay fever).
• Low blood volume (hypovolaemia): after blood loss, burns, surgery or poor fluid intake.
• Current medicines such as diuretics (“water tablets”), ACE-inhibitors, angiotensin II receptor antagonists (ARBs/sartans)—these taken together with COXFLAM can increase the risk of kidney problems (overt renal decompensation).
• Infections: COXFLAM can mask signs of infection like fever and inflammation.
• Electrolyte concerns: if you have been told you have high potassium levels. Your doctor may monitor you.
• NSAID-related risks noted in general use: renal impairment and low potassium have also been associated with NSAIDs.

Driving and using machines
The effect of COXFLAM on driving has not been studied. If you feel dizzy, drowsy, light-headed or develop visual disturbances, do not drive or operate machinery until you know how it affects you.

Alcohol
Do not drink alcohol while taking COXFLAM because bleeding risk increases when alcohol and this medicine are used together.

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Pregnancy, planning pregnancy, and breastfeeding

• Pregnancy: Do not take COXFLAM if you are pregnant.
• Breastfeeding: It is not known if COXFLAM passes into breast milk, but other medicines in the same class do. Therefore, use during breastfeeding is not advised.
• Fertility: COXFLAM may reduce female fertility and is not recommended if you are trying to conceive. Women who have trouble conceiving or are undergoing investigations for infertility should not take COXFLAM.
• Planning pregnancy or unsure: Not specified in the source. Speak to your doctor or pharmacist before use.

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Interactions

Always tell your healthcare professional about all medicines you use, including complementary or traditional products. The following may interact with COXFLAM:

• Other anti-inflammatory medicines, including aspirin
• Anticoagulants (blood thinners) such as warfarin
• Thrombolytics (medicines that break down blood clots)
• Medicines for high blood pressure (including ACE-inhibitors and ARBs/sartans)
• Corticosteroids
• Ciclosporin
• Diuretics (“water tablets”)—your doctor may monitor kidney function
• Lithium
• Potassium supplements
• Selective serotonin re-uptake inhibitors (SSRIs) used for depression
• Methotrexate
• Cholestyramine
• Intra-uterine contraceptive device (IUD)—ask your doctor or pharmacist if unsure
• Alcohol (see above)

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How to take (Step-by-step)

General directions

1. Follow your doctor’s instructions exactly. If unsure, check with your doctor or pharmacist.
2. Use the lowest effective dose for the shortest possible time.
3. Swallow the tablet with a full glass of water, with or after a meal.
4. Do not share your medicine with anyone else.
5. In severe conditions, noticeable improvement may require 1 to 2 weeks of continuous use.

Recommended doses

• Adults
  • Rheumatoid arthritis: 15 mg once daily. The dose may be reduced to 7,5 mg daily according to response.
  • Osteoarthritis: 7,5 mg once daily; in severe cases, 15 mg once daily.
  • Ankylosing spondylitis: 15 mg once daily.
  • Acute sciatica: 7,5 mg once daily; may be increased to 15 mg once daily depending on response.
• Elderly: Start at 7,5 mg once daily with careful monitoring.
• Dialysis patients: Do not exceed 7,5 mg daily.
• Children under 12 years: Contraindicated—do not use.
• Maximum recommended dose for all adults: 15 mg meloxicam once daily.

Missed dose

• Take it as soon as you remember.
• If it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed tablet.
• Do not exceed 15 mg per day (one 15 mg tablet or two 7,5 mg tablets).

Overdose

• Contact your doctor or pharmacist immediately.
• If they are not available, contact the nearest hospital or poison control centre.
• See also the Warnings and Possible side effects sections.

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Dosing table

Patient group / Condition	Usual dose	When to adjust	Maximum daily dose
Adults – Rheumatoid arthritis	15 mg once daily	May reduce to 7,5 mg daily according to response	15 mg
Adults – Osteoarthritis	7,5 mg once daily	In severe cases, increase to 15 mg once daily	15 mg
Adults – Ankylosing spondylitis	15 mg once daily	—	15 mg
Adults – Acute sciatica	7,5 mg once daily	May increase to 15 mg once daily according to response	15 mg
Elderly	Start 7,5 mg once daily	Monitor carefully	15 mg (unless otherwise advised)
Dialysis patients	Do not exceed 7,5 mg once daily	—	7,5 mg
Children < 12 years	Contraindicated	—	—

Note: Always follow the dose your doctor has prescribed for you.

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Possible side effects

COXFLAM can cause side effects, although not everyone gets them. If your general health worsens or you experience any unexpected symptoms, speak to your healthcare provider.

Serious—seek urgent help and stop taking COXFLAM

Skin and allergic reactions :

• Allergic reactions with skin rash and blistering that can be life-threatening
• Painful, red areas that spread quickly, raw or peeling skin, with fever or discomfort; may involve eyes, mouth, throat and genitals

Stomach, intestine and bleeding risks (less frequent or frequency unknown):

• Severe abdominal pain, chills, fever, nausea and vomiting
• Gastrointestinal bleeding: black or tarry stools, vomit like coffee grounds, bright red blood in vomit, dark/bright red blood mixed with stool, cramps, dizziness or faintness, fatigue, paleness, shortness of breath, weakness
• Peptic ulcers, melaena (dark sticky faeces), haematemesis (vomiting blood)
• Inflammation of the colon (colitis), oesophagus (oesophagitis), stomach lining (gastritis), or mouth (stomatitis)

Liver and blood (less frequent or frequency unknown):

• Hepatitis signs: fatigue, flu-like symptoms, dark urine, pale stools, abdominal pain, loss of appetite, unexplained weight loss, yellow skin/eyes (jaundice)
• Abnormal liver tests
• Anaemia: shortness of breath, dizziness, headache, cold hands/feet, pale skin, chest pain
• Bleeding or bruising easily, pinpoint red spots, bleeding gums, pale skin, tiredness, fever and chills—may indicate abnormal blood cell or platelet counts
• Increased vulnerability to infection due to a decreased white blood cell count

Kidney and electrolytes (less frequent or frequency unknown):

• Urinary problems, including being temporarily unable to pass urine
• Kidney failure
• High potassium levels; sodium and water retention
• Risk of renal impairment and low potassium have also been reported with NSAIDs

Heart and circulation (frequency unknown):

• Peripheral oedema (swelling of legs/arms)
• Aggravated high blood pressure or increased blood pressure
• Irregular or fast heartbeat (dysrhythmia, tachycardia)
• Heart failure (shortness of breath, difficulty breathing, generalised swelling, tiredness)
• Myocardial infarction (heart attack)
• Cerebrovascular incidents (strokes)

Nervous system and other (less frequent or frequency unknown):

• Disorientation, confusion
• Severe allergic skin reactions such as urticaria (intensely itchy weals) or photosensitivity reactions

If you experience any of the above, stop taking COXFLAM and seek medical attention immediately.

Common side effects

• Indigestion (dyspepsia)
• Nausea
• Diarrhoea
• Vomiting
• Constipation
• Gas (flatulence)
• Abdominal pain
• Headache

Less common or frequency unknown (tell your doctor if troublesome)

• Asthma in people allergic to aspirin or other NSAIDs
• Altered mood, nightmares, insomnia
• Dizziness, sleepiness
• Palpitations, flushing
• Blurred vision, conjunctivitis
• Allergic reactions (non-severe)
• Swelling (including legs)
• Belching (eructation)
• Itchy skin (pruritus)

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Storage and disposal

• Store at or below 30 °C.
• Keep the blister in the outer carton until use.
• Keep out of reach of children.
• Do not use after the expiry date on the packaging.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or toilets.

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What the medicine contains

Active ingredient: meloxicam

• COXFLAM 7,5: each tablet contains 7,5 mg meloxicam and lactose monohydrate 43 mg (contains sugar)
• COXFLAM 15: each tablet contains 15 mg meloxicam and lactose monohydrate 86 mg (contains sugar)

Other ingredients

• Both strengths: colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, sodium citrate dihydrate
• Only in COXFLAM 7,5: colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, povidone
• Only in COXFLAM 15: pregelatinised starch

Composition snapshot

Tablet	Meloxicam per tablet	Lactose per tablet	Selected excipients only in this strength
COXFLAM 7,5	7,5 mg	43 mg	Colloidal silicon dioxide; Low-substituted hydroxypropyl cellulose; Povidone
COXFLAM 15	15 mg	86 mg	Pregelatinised starch

Allergen/sugar note: Contains lactose. If you have been told you are intolerant to some sugars, consult your doctor before use.

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Pack information and appearance

• COXFLAM 7,5: yellow, circular, flat, bevelled, uncoated tablet with a central break-line on one side and plain on the other. Supplied in aluminium foil/amber PVC/PVDC blister strips of 10 tablets, packed in cartons of 10’s, 30’s or 100’s.
• COXFLAM 15: yellow, circular, flat, bevelled, uncoated tablet with a central break-line on one side and ‘15’ embossed on the other. Supplied in aluminium foil/amber PVC/PVDC blister strips of 10 tablets, packed in cartons of 10’s, 20’s, 30’s or 50’s.

Holder of certificate of registration:
CIPLA MEDPRO (PTY) LTD

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Practical FAQs

1) Can I take COXFLAM during pregnancy?
No. Do not take COXFLAM if you are pregnant.

2) Can I use COXFLAM while breastfeeding?
Use during breastfeeding is not advised. It is unknown if COXFLAM passes into breast milk, but other medicines in the same class do.

3) I’m trying to fall pregnant. Is COXFLAM suitable?
COXFLAM may reduce female fertility and is not recommended if you are trying to conceive. Women who have difficulty conceiving or are being investigated for infertility should not take COXFLAM.

4) Can children take COXFLAM?
No. It is contraindicated in children under 12 years.

5) How should I take my tablets? With food or on an empty stomach?
Take each dose with a full glass of water, with or after a meal.

6) Can I drink alcohol while taking COXFLAM?
No. Do not consume alcohol with COXFLAM because it increases the risk of bleeding.

7) What if I miss a dose?
Take it as soon as you remember. If it’s almost time for the next dose, skip the missed dose. Do not double the dose.

8) When will I start to feel better?
In severe conditions, noticeable improvement may require 1 to 2 weeks of continuous use.

9) What is the maximum amount I can take in a day?
Do not exceed 15 mg of meloxicam per day (one 15 mg tablet or two 7,5 mg tablets).

10) Does COXFLAM contain sugar or lactose?
Yes. Each 7,5 mg tablet contains 43 mg lactose, and each 15 mg tablet contains 86 mg lactose. If you have a sugar intolerance, consult your doctor.

11) Can I drive after taking it?
The effect on driving hasn’t been studied. If you feel dizzy, drowsy, light-headed or have visual disturbances, avoid driving or using machines.

12) Can I take COXFLAM with my other medicines?
Some medicines interact with COXFLAM, including other anti-inflammatories, warfarin, thrombolytics, blood pressure medicines, corticosteroids, ciclosporin, diuretics, lithium, potassium supplements, SSRIs, methotrexate, cholestyramine, and even an IUD may be relevant—speak to your doctor or pharmacist before combining.