Austifen Side Effects

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Answer the side-effect intent for austifen without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Austifen?

Austifen contains the active ingredient Ibuprofen.

• Active ingredient — Ibuprofen
• Registration number — 42/3.1/0058; 42/3.1/0059; 42/3.1/0060
• Registration holder — Austell Pharmaceuticals (Pty) Ltd

It is approved for:

• rheumatoid arthritis (chronic disease of the system, mainly inflammation of joints)
• idiopathic juvenile arthritis (Still’s disease) of children
• ankylosing spondylitis (inflammation of one or more of the vertebrae)
• osteo-arthritis (a non-inflammatory change to a less active form of joints)
• arthritis due to gout
• non-articular (non-joint) rheumatism including fibrositis (inflammation with pain and stiffness)
• non-rheumatic inflammatory conditions such as frozen shoulder (capsulitis), bursitis (inflammation of sac like cavity filled with a liquid in the tissues), tendonitis (inflammation of the tendons), tenosynovitis (inflammation of the membranes of the tendon) and low back pain
• relief of mild to moderate pain such as painful menstruation, dental, after prevention of tearing during delivery and pain after childbirth
• soft tissue injuries such as sprains and strains
• fever

Common side effects of Austifen

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• burning, indigestion, nausea or vomiting
• feeling extremely tired
• constipation, flatulence (passing wind), stomach cramps, diarrhoea
• painful mouth ulcers
• headache, dizziness

Less frequent side effects

• runny nose
• depression
• hot flushes, increase in blood pressure
• having difficulty falling off to sleep or maintaining sleep, feeling anxious
• swelling of the limbs
• tingling sensation in the skin; sensitivity of the skin to light; itchiness of skin, blood spots on skin
• feeling nervous, sleepy or drowsy

Frequency not known side effects

• abnormal liver function tests (noticed on a blood test)
• AUSTIFEN, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood
• This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are allergic to ibuprofen or any of the ingredients of AUSTIFEN
• if you are suffering from (or have suffered from) stomach ulcer disease, perforations or gastrointestinal bleeding
• if you are sensitive to aspirin or another nonsteroidal anti-inflammatory medicine
• if you have a history of severe allergic reactions such as wheezing or swelling of the face or throat after taking ibuprofen, aspirin or other anti-inflammatory medicines
• if you suffer from heart disease including heart failure
• if you have had nasal polyps with breathing difficulties when taking aspirin
• if you are pregnant or in labour
• if you have severe liver or kidney problems
• if you are pregnant, do not use AUSTIFEN at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause harm in your unborn baby. If you are uncertain whether any of these apply to you, please discuss this with your doctor or pharmacist before taking AUSTIFEN

Use with care, and tell your doctor, if

• if you have or have had high blood pressure (hypertension) or other heart problems such as a heart attack or any kind of stroke
• if you have bowel problems (including ulcerative colitis, Crohn’s disease, gastro-oesophageal reflux disease)
• if you suffer from a bleeding disorder
• if you are taking medicine to thin your blood
• if you have or have had asthma or bronchospasm
• if you have anaemia
• if you have systemic lupus erythematosus (SLE), this is an immune condition which causes joint pain and changes to the skin
• if you are taking medicine which “thins” the blood such as warfarin, or any other non-steroidal anti-inflammatory medicines
• if you have not been drinking fluids or has lost fluids due to continuous vomiting or diarrhoea, especially if you are between the ages of 12 -18 years or are an older person
• if you have an infection
• if you develop a problem with your vision
• if you develop a rash and swollen glands. The use of painkillers for a long period of time has in some patients been linked to headaches, a condition called medication overuse headache (MOH). If you have frequent or daily headaches despite (or because of) the regular use of pain killers, you should not treat your headache with increased doses of AUSTIFEN. Tell your doctor if you have been having headaches while taking AUSTIFEN. Taking AUSTIFEN while you are pregnant may cause kidney problems in your unborn baby and this can lead to low levels of the amniotic fluid that surrounds your baby. This fluid provides a protective cushion for the baby and helps the unborn babies’ lungs, digestive system, and muscles develop. Complications can occur when the amniotic fluid is low. Use of AUSTIFEN in the last trimester can also cause problems with the baby’s heart/ blood pressure. Repeated use of AUSTIFEN may result in you becoming accustomed to it (needing to take higher doses). Repeated use of AUSTIFEN may also lead to dependence, abuse and addiction, which may result in life-threatening overdose. If you are taking AUSTIFEN for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal. If you experience any of the following signs whilst taking AUSTIFEN, talk to your doctor or pharmacist as it could be an indication that you are dependent or addicted
• You need to take this medicine for longer than advised
• You need to take more than the recommended dose
• You are using this medicine for reasons other than medical reasons, for instance, ‘to stay calm’ or to ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of this medicine
• When you stop taking this medicine you feel unwell, and you feel better once taking this medicine again (‘withdrawal effects’). Children and adolescents AUSTIFEN tablets are not recommended for children under the age of 12 years

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking AUSTIFEN
• Pregnancy AUSTIFEN is not for use in pregnancy and during labour
• Do not use AUSTIFEN at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because this medicine may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid that surrounds the baby
• This fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles to develop
• Complications can occur with low levels of this fluid
• Additionally, do not use AUSTIFEN at 30 weeks or later in pregnancy since it can cause a passage in the baby’s heart to close prematurely, possibly leading to heart or lung damage, or even death

Interactions and medicines to check

The approved leaflet names these interactions.

• anti-coagulants (like warfarin) to prevent blood clots
• anti -hypertensives (medicines for high blood pressure) or diuretics “water tablets”
• digoxin (medicine used to treat heart conditions), lithium (medicine used to treat bipolar disorder), corticosteroid tablets (medicine used to suppress the immune system), methotrexate (medicine used in the treatment of cancer or some types of arthritis), clopidogrel, and ticlopidine (medicines used to “thin” the blood), oxpentifylline (medicine used in the treatment of blood vessel disorders) or ciclosporin (medicine used to suppress the immune system)
• antidiabetic medicines (medicine used to treat high blood sugar levels)
• anti-depressants, like sertraline, paroxetine and those falling under the class of selective serotonin reuptake inhibitors (SSRIs)
• any other anti-inflammatory pain killers including aspirin or ibuprofen preparations, such as those you can buy without a prescription
• mifepristone (medicine used for abortions)
• antibiotic medicines such as ciprofloxacin or moxifloxacin or amikacin
• ginkgo biloba (herbal medicine)
• zidovudine (medicine used for HIV)
• tacrolimus (medicine used to suppress the immune system)
• fluconazole or voriconazole (antifungal medicines). Consult your doctor, pharmacist or other healthcare professional as these medicines may interact with AUSTIFEN. AUSTIFEN with food, drink and alcohol AUSTIFEN may cause some side effects including dizziness, drowsiness and stomach problems such as bleeding in the stomach. Drinking excessive alcohol with AUSTIFEN might make these side effects worse. To minimize gastrointestinal side-effects or if gastrointestinal disturbances occur, AUSTIFEN should be given with food or milk

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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