Axim Polibar Acb Suspension

AXIM POLIBAR ACB contains the active substance barium sulphate. AXIM POLIBAR ACB is a contrast medium for use in diagnostic X-ray visualisation of the lower gastrointestinal tract (GI)(such as your bowels/intestines). A radiographic (X-ray) examination of the lower GI is made visible on X-ray film by filling your bowel with the liquid suspension called AXIM POLIBAR ACB. Certain areas in your body can be highlighted and a clearer picture can be created.

AXIM POLIBAR ACB should not be administered to you:

• If you are hypersensitive (allergic) to barium sulphate or any of the other ingredients of AXIM POLIBAR ACB (see section 6).
• If you have an obstruction of the colon or suspect that perforation (a small hole that develops through the wall of your intestines) of the GI tract is likely to occur soon.
• If you suffer from GI bleeding or GI ischemia (blood flow through the major arteries that supply blood to your intestines slows or stops).
• If you have a megacolon or toxic megacolon (an abnormal dilation of the colon).
• If you have severe constipation or have problems with your gut movement which could lead to a build-up or blockage.
• If you have a serious disease that affects your intestines.
• If you have had infection or inflammation in your GI tract which caused a fistula to form (an abnormal connection between two body parts).
• If you are at risk of developing perforation, infection or inflammation of your intestines after undergoing biopsies or diagnostic testing.
• If you have had radiotherapy to the rectum or prostate, you should not receive AXIM POLIBAR ACB for up to six weeks afterwards.
• If you have an injury or have suffered from chemical burn of your GI tract.

Warnings and precautions

AXIM POLIBAR ACB is for diagnostic use only. AXIM POLIBAR ACB is only administered in hospitals or clinics. Tell your doctor or health care provider before you are given the rectal suspension:

• If you have any underlying conditions or disease, especially conditions affecting your digestive tract.
• If you have any known hypersensitivities.
• If you have a history of bronchial asthma (a lung disease causing difficulty in breathing) or a family history of being allergic.
• If you have atopy (a problem with your immune system that makes you more likely to develop allergic diseases) and when you have developed allergies such as hay fever and eczema (skin inflammation).
• If you have ever developed a previous allergic reaction after using contrast medicines.

You will not be expected to give yourself AXIM POLIBAR ACB. It will be given to you by a person who is qualified to do so. AXIM POLIBAR ACB will be given to you as a rectal suspension (enema) by your doctor. AXIM POLIBAR ACB will be inserted into the back passage (rectum), where it will remain throughout the procedure. Your dosage will depend on the technique used and the desired type of examination.

If you receive more AXIM POLIBAR ACB than you should

Since a health care provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage, your doctor will manage the overdosage.

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

If any of the following happens, stop receiving AXIM POLIBAR ACB and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, 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 AXIM POLIBAR ACB. 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:

• Chest pain or changes in your blood pressure such as bradycardia (slow heart rate) or tachycardia (rapid or irregular heart rate).
• Bronchospasm (where your airways go into spasm making it difficult to breathe, which may cause wheezing or coughing).
• Intestinal ischemia (when the blood flow through the major arteries that supply blood to your intestines slows or stops).
• Perforation (a small hole that develops through the wall of your bowel) or if you develop severe inflammation, ulcers or obstruction of your GI tract.

Tell your doctor if you notice any of the following:

Rare side effects:

• Abdominal pain.
• Nausea, vomiting.
• Bacteraemia (presence of bacteria in your blood).
• Intestinal abscess (a collection of pus or infected fluid that is surrounded by inflamed tissue inside the belly).
• Liver abscess (a pus-filled pocket of fluid within the liver).
• Peritoneal infection (an inflammation of the inside of your abdomen) or appendicitis (a condition in which the appendix becomes inflamed, swollen or infected, causing pain in the lower right side of your torso).
• Swelling of lymph nodes (small glands responsible for regulating your immune system).
• Low blood sugar.
• Confusion.
• Nervousness.
• Agitation.
• Dizziness.
• Headache.
• Low muscle tone.
• Swelling of your eyes.
• Ringing in ears.
• Cyanosis (a blue discolouration of the skin).
• Pale skin.
• Hypotension (low blood pressure).
• Dyspnoea (sensation of uncomfortable breathing).
• Throat tightness, throat irritation or pain.
• Cough.
• Constipation or diarrhoea.
• Swollen tongue.
• Feeling bloated.
• Inflammation of the skin.
• Excessive sweating.
• Painful urination.
• Weakness.
• Feeling ill or feverish.
• Formation of baroliths, when your stool becomes thickened and hindered with barium.

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. This includes any possible side effects not listed in this leaflet. 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 AXIM POLIBAR ACB.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. AXIM POLIBAR ACB should be used immediately following reconstitution and must not be stored. ALWAYS RESHAKE PRIOR TO USE.