Asceprib IV Solution

Ibuprofen belongs to the group of medicines called nonsteroidal anti-inflammatory drugs or (NSAIDs). This medicine is used in adults for the short-term symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified and other routes of administration are not possible.

ASCEPRIB IV should not be administered to you:

• If you are hypersensitive (allergic) to Ibuprofen or any of the other ingredients of ASCEPRIB IV (listed in section 6).
• If you have heart failure
• If you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs.
• If you have active, or a history of recurrent (two or more episodes) stomach ulcer or bleeding.
• If you are pregnant.
• If you have ever suffered from shortness of breath, have had asthma, skin rash, itchy runny nose or facial swelling, when previously taking ibuprofen, acetylsalicylic acid or other similar painkiller (NSAIDs).
• If you suffer from severe kidney problems.
• If you have a condition which increases your tendency or active bleeding.
• If you are suffering from bleeding in the brain (cerebrovascular bleeding) or other active bleeding.
• If you are suffering from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• If the injection is for your child.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• When given anti-inflammatory/pain-killer medicines like ibuprofen you may have a small increased risk of heart attack or stroke, particularly when used at high doses.
• If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including mini-stroke or transient ischaemic attack (TIA)).
• If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
• If you have had or developed an ulcer, bleeding or perforation of the stomach or duodenum. In these cases, your doctor will consider of prescribing a protective medicine for the stomach.
• If you suffer from serious skin reactions such as exfoliative dermatitis (reddening and scaling of the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (severe life-threatening skin problems). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (fever, rash, swelling of the glands and facial swelling). The use of this medicine should be stopped immediately at the first appearance of skin rash, mucosal lesions, or any other signs of allergic reactions. These reactions may be life threatening.
• It is important that you are given the lowest dose that alleviates and controls pain and are not given this medicine for longer than three days.
• If you have kidney disease or liver disease, are more than 60 years old or use ibuprofen long-term, your doctor may need to carry out checks on a regular basis. Your doctor will tell you the frequency of these checks.
• If you have asthma or other breathing disorder. If you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, you are at higher risk of allergic reactions. The allergic reactions may present as asthma attacks (so-called analgesic asthma), rapid swelling (Quincke’s oedema) or a rash.
• Allergic reactions may occur with this medicine, mainly at the start of treatment. In this case, treatment should be discontinued.
• If you observe any injuries, swelling or redness of the skin, trouble breathing (asphyxiation), immediately stop the treatment with the medicine and contact your doctor or nurse.
• If you suffer from systemic lupus erythematosus (SLE), you might develop aseptic meningitis more likely than other patients. ASCEPRIB IV can mask symptoms of infection, which may lead to a delay in the start of appropriate treatment and this may worsen the outcome of the infection.

Do not share medicines prescribed for you with any other person. ASCEPRIB IV is restricted to hospital use only. The medicine will be given to you by a doctor or nurse. Your doctor will give you the lowest effective dose for the shortest time possible in order to avoid side effects. Your doctor will also make sure that you have had enough fluids in order to minimize the risk of side effects to the kidney.

Use should be limited to situations where oral administration is inappropriate. You should be switched to oral treatment as soon as this is possible. The usual dose for adults is 400 mg or 600 mg intravenously, every 6 to 8 hours as necessary. The maximum daily dose of 1 200 mg should not be exceeded. This medicine is indicated for short-term acute treatment only and should not be used for more than 3 days.

Method of administration

The solution should be administered by intravenous infusion over 30 minutes. Inspect the solution before use. It should be discarded if any particulate matter or discoloration is observed.

If you are given more ASCEPRIB IV than you should receive Since a health care provider will administer ASCEPRIB IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ASCEPRIB IV can have side effects. Not all side effects reported for ASCEPRIB IV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ASCEPRIB IV, please consult your health care provider for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reactions may occur with this medicine, mainly at the start of treatment. If you observe any injuries, swelling or redness of the skin, trouble breathing (asphyxiation), immediately stop the treatment with the medicine and contact your doctor or nurse.
• Serious skin reactions, including widespread redness and scaling of the skin, rash on the body where each mark resembles a bullseye, Stevens-Johnson syndrome a rare, serious disorder of your skin and mucous membranes. Often, it begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters.
• Perforation or gastrointestinal bleeding (vomiting blood or material that looks like coffee ground, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea. These are all very serious side effects. If you have them, you may have had a serious reaction to ASCEPRIB IV. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent Tiredness, sleeplessness, headache, dizziness
• Vertigo
• Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, peptic ulcers, gastrointestinal bleeding, inflammation of your digestive tract, which can lead to abdominal pain, severe diarrhoea, fatigue, weight loss and malnutrition.
• Skin rashes
• Pain and burning sensation in the injection area

Less frequent:

• Worsening or a “flare up” of infection-related inflammations
• Disorders of blood cell formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding
• Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis) such as stiff neck, headache, nausea, vomiting, fever or disorientation
• Respiratory tract reactivity, such as asthma, bronchospasm, shortness of breath
• Anxiety, restlessness, nervousness, irritability, confusion or disorientation and depression, agitation
• Visual disturbances, reversible reaction in the optic nerve resulting in visual loss (toxic amblyopia)
• Ringing or buzzing in the ears (tinnitus), hearing disorders
• Rapid heartbeat (palpitations), swelling (oedema), hypertension, heart failure, myocardial infarction
• Arterial hypertension
• Dyspepsia, black stools, inflammation of the stomach
• Narrowing of the oesophagus (blood vessels in gullet), complications of diverticula of the large bowel, unspecific haemorrhagic colitis, pancreatitis
• Yellowing of the skin or whites of the eyes, liver dysfunction, liver damage, acute hepatitis (inflammation of the livers)
• Stiff neck
• Reduced production of urine and, particularly in patients with high blood pressure or kidney problems, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal insufficiency, damage of kidney tissue (papillary necrosis), increased serum uric acid concentration in the blood
• Site of injection reactions such as swelling, bruising or bleeding

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. By reporting side effects, you can help provide more information on the safety of ASCEPRIB IV.

Store all medicines out of reach of children.

• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Do not use ASCEPRIB IV if you notice any particles or discoloration. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).