Oflaect Injection

OFLAECT INJECTION belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). OFLAECT INJECTION is used to relieve moderate pain after you had surgery. OFLAECT INJECTION will not be given to you for chronic painful conditions.

OFLAECT INJECTION should not be administered to you:

• if you are hypersensitive (allergic) to ketorolac tromethamine, other NSAIDs or any of the other ingredients of OFLAECT INJECTION (listed in section 6).
• if you have had a hypersensitivity reaction to ibuprofen, aspirin or other NSAIDs.
• if you are taking other NSAIDs such as oxpentifylline (to treat circulatory disease).
• if you are taking medicines used to treat gout such as probenecid.
• if you are taking medicines to treat nervous disorders such as lithium salts.
• if you have previously had or have peptic ulcers (ulcer in your stomach or duodenum), bleeding in your stomach or perforation.
• if you have bleeding from a damaged blood vessel in the brain.
• if you have problems with bleeding or blood clotting disorders.
• if you are taking medicines to thin the blood (such as warfarin or low-dose heparin).
• if you suffer from kidney failure.
• if you suffer from liver failure.
• if you suffer from heart failure.
• if you are dehydrated or have lost a lot of blood.
• if you are pregnant or breastfeeding your baby.
• if you are a child under 16 years of age.

OFLAECT INJECTION should not be given to you:

• During labour and delivery when pregnant.
• Before undergoing an operation, or during the operation.
• As an epidural or intrathecal injection (via your spine).

Warnings and precautions

Tell your doctor or health care provider before being given OFLAECT INJECTION:

• if you have stomach problems, inflammatory bowel disease (e.g. ulcerative colitis or Crohn’s disease) or are passing black tarry stools or blood.
• if you have problems with your kidneys or liver.
• if you have nasal polyps, allergic swellings (of the skin, around the mouth, eyes, nose or the genitals) or constriction of the airways making breathing difficult.
• if you have asthma or a history of asthma.
• if you have ever had heart failure, high blood pressure or swelling of the hands, feet, ankles or lower legs.
• if you have problems with bleeding or blood clotting disorders.
• if you have lost a large amount of blood or had a blood transfusion recently.
• if you are dehydrated or recently suffered from diarrhoea or vomiting.
• if you are 65 years of age or older.
• If you develop a skin rash, fever, swelling of lymph nodes and and an increase of eosinophils (a type of white blood cells). This is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
• If you have systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis.
• if you have skin rash or itching after administration of OFLAECT INJECTION, your doctor will stop giving you OFLAECT INJECTION immediately.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself OFLAECT INJECTION. It will be given to you by a person who is qualified to do so. OFLAECT INJECTION will be given to you by injection into a muscle (such as into your arm) or into a vein. The usual dose is between 10 mg and 30 mg. The dose may be lowered if you are an elderly person older than 65 years of age. If you have the impression that the effect of OFLAECT INJECTION is too strong or too weak, tell your doctor or pharmacist.

If you receive more OFLAECT INJECTION than you should Since your health care provider will administer OFLAECT INJECTION, he/she will control the dosage. However, in the event of an overdosage your doctor will manage the overdosage.

If you missed a dose of OFLAECT INJECTION Since health care provider will administer OFLAECT INJECTION, it is unlikely that the dose will be missed.

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

• ‘swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing’,
• ‘rash or itching’,
• ‘fainting’

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to OFLAECT INJECTION. 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:

• Less frequent:
• Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds.
• Bleeding from your anus, seen as passing black sticky stools or bloody diarrhoea.
• Ulcers or holes forming in your stomach or gut. This may be seen as upset stomach with stomach pain, fever, feeling or being sick.
• Problems with your pancreas, seen as severe stomach pain which spreads to your back.
• Yellowing of your skin or the whites of your eyes (jaundice), feeling tired, loss of appetite.
• Difficulty breathing, including shortness of breath, wheezing or coughing.
• A severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes.
• Problems passing urine with a feeling of fullness and a need to empty your bladder, but then difficulty in emptying it.
• Feeling depressed, seeing and hearing things that are not really there (hallucinations), seizures (fits).

Frequency unknown:

• Changes in the way your heart beats, chest pain which may spread to your neck and shoulders and down your left arm.
• Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion. These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

• Frequent:
• Inflammation and bleeding in the small blood vessels under the skin, appearing as blood spots on the skin.
• High blood pressure.
• Drowsiness, dizziness, headache.
• Sweating.
• Nausea and vomiting, diarrhoea, stomach pain, constipation, wind, indigestion, sore mouth.
• Weight gain.
• Swelling of your hands, legs and feet.
• Pain where the injection was given.

Less frequent:

• Blood problems, like anaemia, not enough platelets or changes to the number of white blood cells.
• Bleeding from your wound after an operation.
• Low blood pressure.
• Skin rashes, hives, itching, pimples.
• Feeling thirsty.
• Problems with your vision.
• Ringing in the ears (tinnitus), loss of hearing.
• Fever.

Frequency unknown:

• Feeling anxious, nervous, having difficulty sleeping, changes in your pattern of dreaming.
• Pins and needles or numbness of your hands and feet.
• Feeling off balance.
• Muscle spasms or pains.
• Weakness or lack of energy.
• Dry mouth, changes in your sense of taste.
• Redness of the face and neck (flushing), or pale skin.
• Anaemia (not enough platelets or changes to the number of white blood cells).
• Oedema, systemic allergic reaction, asthma and nasal polyps.
• Without appetite.
• Confusion and stimulation.
• Visual disturbances, inflammation of the optic nerves.
• Shortness of breath (cardiac failure).
• Swelling up with blood or other fluids (as with congestion), Blood loss.
• Female infertility.
• Nosebleed.
• Heartburn, stomach ache, feeling sick or being sick.
• Viral meningitis (as distinct from bacterial meningitis).

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 or pharmacist. 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. or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of OFLAECT INJECTION.

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Protect from light and moisture.
• Keep the vial in the outer carton until required for use.
• Do not store in a bathroom.
• There are no special storage instructions for OFLAECT INJECTION.
• Do not use after the expiry date stated on the label / carton / vial.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• For single use only. Discard any unused contents.