Etiflam Film-Coated Tablets

ETIFLAM belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Medicines belonging to this class are used in the treatment of pain, fever, and inflammation. ETIFLAM film-coated tablets are used in the treatment of:

• Rheumatoid arthritis (joint diseases)
• Ankylosing spondylitis (spinal joint disease)
• Acute gouty arthritis, limited to a maximum of 8 days.
• Short-term relief of acute pain, treatment limited to a maximum period of 8 days.
• Primary dysmenorrhea (painful menstruation)
• Moderate to severe acute post-operative pain associated with dental surgery

Do not take ETIFLAM if you:

• are allergic to etoricoxib or any other ingredients of ETIFLAM
• have stomach / gut ulcers or any other complications of the gut such as stomach / intestinal bleeding, signs include tarry or black stools, vomiting blood, diarrhoea and/or abdominal (stomach) pain.
• have severe liver or kidney disease.
• have previously experienced allergic reactions (signs include facial swelling, rash, asthma, or flu-like symptoms such as postnasal drip, persistent stuffiness, facial pain, headache, or runny nose) to NSAIDs such as aspirin.
• are pregnant or breastfeeding.
• are younger than 16 years of age (parents, guardians or other care givers must not give ETIFLAM to children under 16 years of age)
• have uncontrolled high blood pressure.
• have inflammatory bowel syndrome (a condition characterised by food intolerance, alternating constipation and diarrhoea, abdominal cramping and constant gas and bloating)
• suffered from heart attack, stroke, or any other heart problems.
• are having heart bypass surgery.

Warnings and precautions

Take special care with ETIFLAM if you have

• Allergic reactions
• Serious skin reaction which can be fatal can occur. If you have a history of allergies, you might be at risk of serious skin reactions. Discontinue treatment if you suspect any development of skin reactions such as rashes, itchiness, or any other form of allergies. Other forms of allergies can be indicated by mouth ulcers, sneezing, swelling of the mouth, throat, tongue, or eyes and breathing or swallowing difficulties.
• Heart problems
• Tell your doctor if you are a smoker or are suffering from high blood pressure, diabetes or have been told you have too much fat in your blood as you may be at a high risk of developing heart disease whilst on ETIFLAM therapy. If you already have high blood pressure, ETIFLAM can worsen your condition. Discontinue treatment and tell your doctor immediately if you suspect that your health has worsened.
• If you have a history of heart attacks or strokes, ETIFLAM and other NSAIDs can aggravate your heart condition or cause new heart problems for you. Please ensure that your doctor is made aware of your heart condition before you start treatment with ETIFLAM.
• Long treatment periods at high doses can make you more prone to heart problems. You should not take ETIFLAM for periods longer than those prescribed by your doctor.
• Gut complications
• ETIFLAM can cause upper gastrointestinal (mouth, oesophagus / swallowing tube and stomach sections of your gut) complications such as perforations, ulcers, or bleeding (PUBs), some of which may be fatal. You are at high risk of experiencing these side effects if you are using other NSAIDs such as aspirin concurrently with ETIFLAM, or if you are suffering from pre-existing stomach problems (indicated by ulcers, diarrhoea or tarry / black stools and abdominal pain). Tell your doctor if you are taking other NSAIDs like aspirin or know or suspect that you have stomach complications.
• Others
• Tell your doctor if you have kidney or liver ailments as ETIFLAM can exacerbate your kidney or liver condition. If you are elderly (above 65 years of age), your ETIFLAM treatment can put you at risk of kidney or liver failure.
• Let your doctor know if you have dehydration (loss of body water indicated by fatigue, dizziness, and increased thirst due to exercise, high temperatures or some illnesses) as you need to have acceptable levels of water in your body before treatment with ETIFLAM can commence.
• Risk of renal impairment and low potassium levels are associated with non-steroidal anti-inflammatory medicine (NSAID) usage.

Other medicines and ETIFLAM

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take ETIFLAM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

• Rheumatoid arthritis (RA): 90 mg once per day
• Ankylosing spondylitis (AS): 90 mg once per day
• Short-term relief of acute pain: 90 or 120 mg once per day for a maximum of 8 days treatment period
• Acute gouty arthritis: 120 mg once per day for a maximum of 8 days treatment period.
• Dysmenorrhoea (painful menstruation): 120 mg once per day
• Post-operative dental pain: 90 mg once per day.

DO NOT EXCEED THE RECOMMENDED DOSES. Your doctor will tell you how long your treatment will last. If you have the impression that the effect of ETIFLAM is too strong or too weak, tell your doctor or pharmacist.

If you take more ETIFLAM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ETIFLAM

Do not take a double dose to make up for forgotten individual missed doses.

ETIFLAM can have side effects. Not all side effects reported for ETIFLAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ETIFLAM, please consult your health care provider professional for advice. If any of the following happens, stop taking ETIFLAM and tell your doctor immediately or go to the casualty department at your nearest hospital.

Less frequent side effects:

• Allergic reaction - swollen face, hives, skin itchiness and/or skin rash
• Stroke
• Heart attack

Side effects with unknown frequencies:

• Anaphylactic shock (allergic reaction indicated by swollen mouth / throat accompanied by difficulty in breathing or swallowing, collapsing and unconsciousness)
• Steven-Johnson syndrome / toxic epidermal necrolysis (life-threatening skin diseases indicated by painful red blisters followed by skin peeling, flu-like symptoms may also develop)
• Jaundice (yellowing of the skin and eyes)
• Liver disease / failure (symptoms may include lower abdominal pain accompanied by vomiting and nausea and disorientation)
• Kidney disease / failure or injury (you may experience severe back pain).

These are all very serious side effects. If you have them, you may have had a serious reaction to ETIFLAM. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following.

Frequent side effects:

• High blood pressure (may be indicated by nosebleeds and shortness of breath)
• Alveolar osteitis (dull, aches or throbbing pain around the tooth area or socket), pain may extend to other parts of the head area.

Less frequent side effects:

• Upper respiratory tract infection, symptoms may include mouth or stomach ulcers and heartburn.
• Gastroenteritis (you may suffer from vomiting and diarrhoea)
• Urinary tract infection, symptoms may include a burning sensation when passing urine, cloudy urine, and lower back / abdominal pain.
• Aseptic meningitis (may be indicated by a stiff neck, headache and being nauseous)
• Chest pain
• Congestive cardiac failure (shortness of breath with exertion, fatigue, feeling faint)
• Pink eye with swollen eyelids
• Palpitations (rapid and irregular heartbeats)
• Coughing
• Breathlessness.

Side effects with unknown frequencies:

• Irregular and abnormal heart rates
• Wheezing, tightness of the chest and dry cough.

These are serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following.

Frequent side effects:

• Nausea
• Bloatedness
• Heartburn
• Flatulence (gas)
• Skin discolouration
• Dizziness
• Headache
• Fatigue
• Flu-like illness.

Less frequent side effects:

• Oral ulcers
• Constipation
• Dry mouth
• Vomiting
• Abnormal intestinal movements
• Nosebleeds
• Swollen limbs (fluid retention)
• Decreased or increased appetite
• Weight gain
• Flushing
• Decreased vision.
• Muscular cramps or spasms

Side effects with unknown frequencies:

• Being pale and feeling exhausted
• Confusion
• Hallucinations, depression
• Restlessness.
• Drowsiness
• Weird taste
• Blurred vision
• Photosensitivity.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of ETIFLAM.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package. Keep well closed.