Ibugesic Forte 200 mg/250 mg/10 mg Capsules

IBUGESIC FORTE capsules is a pain-relieving combination containing the following active substances: ibuprofen, paracetamol and codeine. Ibuprofen reduces pain, fever and swelling. Paracetamol reduces pain and fever. Codeine is metabolised to morphine, which in turn, exerts a pain-relieving effect. IBUGESIC FORTE is indicated for the relief of mild to moderate pain of inflammatory origin (due to swelling) with or without fever.

Do not take IBUGESIC FORTE:

• if you are hypersensitive (allergic) to ibuprofen, paracetamol, codeine phosphate or to any of the other ingredients of IBUGESIC FORTE (listed in section 6)
• if you find it difficult to breathe, take breaths that are slower and shallower than normal
• together with a medicine classified as Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping such treatment (ask your doctor or pharmacist if you are unsure)
• if you have diarrhoea associated with an infection
• if you have severe liver impairment
• if you have burning stomach pain, feel bloated, nausea or if you have bleeding in your digestive system (ask your doctor or pharmacist if you are unsure)
• if you are sensitive to aspirin or other nonsteroidal anti-inflammatory medicines
• if you have uncontrolled asthma or sudden difficulty in breathing
• if you have small growths inside the nose associated with difficulty in breathing in the presence of aspirin
• if you have a bleeding disorders

if you are pregnant, do not use NSAIDs, including IBUGESIC FORTE at 20 weeks or later in your pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby

if you have heart failure

if you have had a bleeding stomach ulcer after taking a non-steroidal anti-inflammatory medicine (NSAID) (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

if you have a stomach ulcer, perforation or bleeding from the ulcer, or have had an ulcer in the past.

Warnings and precautions

Take special care with IBUGESIC FORTE:

• if you have a sudden onset of stomach pain or condition as the diagnosis or clinical course may be masked by using IBUGESIC FORTE
• if your heart beats too fast, too slow or irregularly as IBUGESIC FORTE may worsen this
• if you have seizures or history thereof as IBUGESIC FORTE can bring on an attack
• if you have a history of alcoholism, drug abuse or dependence as IBUGESIC FORTE contains codeine which may predispose patients to drug dependence DEPENDENCE MAY DEVELOP WITH PROLONGED USE OF HIGH DOSES
• if you have gallbladder disease or gallstones as this may cause sudden attacks of tummy pain (ask your doctor or pharmacist if you are uncertain)
• if you had undergone recent surgery to the digestive tract
• if you have a head injury as this may increase the risk of interfering with your breathing
• IBUGESIC FORTE may also cause drowsiness and affect your eyes (pupillary changes), this may obscure the clinical course of your head injury.
• if you have liver problems as IBUGESIC FORTE is broken down by the liver
• if you have kidney problems as IBUGESIC FORTE may interfere with the body’s ability to let out urine, as a result, this may lead to the accumulation of waste products which may lead to more adverse effects.
• if your thyroid gland is not able to produce enough thyroid hormone as this may increase your risk of difficulty breathing, low heart rate and loss of consciousness.
• if your body produces low levels of cortisol, symptoms may include tiredness, light-headedness and body aches (ask your doctor or pharmacist if you are uncertain)
• if you have a condition called inflammatory or obstructive bowel disorder, as this makes it difficult to pass stool or gas and IBUGESIC FORTE can worsen it
• if you have an enlarged prostate gland, narrowing of the tube that carries urine out of the body or have had recent urinary tract surgery
• if you fall in the older population group as these patients are more likely to develop liver and kidney problems, and if stomach ulcers with bleeding occurs, it is more likely to cause serious consequences, in which case the dosage should be reduced or stopped
• if you are diabetic, as it may give false blood glucose test results
• if undergoing surgery shortly, as it may possibly increase bleeding
• if you are anaemic, as it may worsen it
• if you have high blood pressure, as it may worsen it
• if you are concerned that you have an infection because IBUGESIC FORTE may mask symptoms of the occurrence or worsening of infection
• if you frequently consume alcohol as alcohol may increase your risk of liver damage.

If any of these applies to you, tell your doctor or nurse before you take IBUGESIC FORTE.

Always take IBUGESIC FORTE exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure. The usual dose is 1 to 2 capsules 6 hourly. Do not take more than 6 capsules in 24 hours. If no effective pain relief is achieved, the patients should be advised to seek the views of a physician. IBUGESIC FORTE is for short term use and is not recommended for use beyond 4 days. Your doctor will tell you how long your treatment with IBUGESIC FORTE will last. Do not stop treatment early. If you have the impression that the effect of IBUGESIC FORTE is too strong or too weak, tell your doctor or pharmacist.

DO NOT EXCEED THE RECOMMENDED DOSE.

If you take more IBUGESIC FORTE than you should

The following is a list of the signs and symptoms that might help you identify an overdosage:

• abdominal pain
• coma or depressed level of consciousness
• decreased urine output
• drowsiness
• gastrointestinal bleeding
• lethargy (lack of energy)
• low blood pressure
• nausea
• seizures
• shortness of breath
• slower breathing rate
• swelling of legs, ankles, or feet
• the pupils shrink (becomes smaller)
• vomiting.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. A delay in starting treatment may mean that the antidote is given too late to be effective.

If you forget to take IBUGESIC FORTE

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

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

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

• swelling of the 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 reaction to IBUGESIC FORTE. 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,
• angina,
• changes in the way your heart beats, for example, if you notice it beating faster,
• difficulty breathing,
• less urine than is normal for you,
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems,
• drug-induced hypersensitivity syndrome (DIHS) (a severe reaction usually characterised by fever, rash, and multiorgan failure).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• abdominal cramps and pain,
• bloating,
• confusion,
• constipation,
• diarrhoea,
• drowsiness,
• dyspepsia (indigestion),
• nausea,
• vomiting.

Less frequent side effects:

• abnormalities of liver function tests,
• agranulocytosis (low white blood cells), thrombocytopenia (low platelets),
• blurred vision and other eye reactions,
• bradycardia (slow heart rate), palpitations (the heart is racing, pounding, fluttering or can skip a beat), orthostatic hypotension (sudden drop in blood pressure when standing up),
• changes in myosis (excessive constriction of the pupil),
• dizziness, nervousness, depression, drowsiness, insomnia (inability to fall asleep), headache,
• dry mouth,
• pancytopenia (red blood cells, white blood cells, and platelets),
• heart failure may be precipitated in compromised patients, angina pectoris (chest pain experience on physical exertion), cardiac arrhythmias (heart beats too slow, too fast or irregular),
• hepatitis (swelling on the liver),
• impairment of renal function, acute reversible renal failure, oedema (build up of fluid results in tissue swelling),
• micturition difficulties (difficulty urinating), ureteric or biliary spasm (presence of a urinary stone that can cause an excruciating pain that can strike without warning),
• low levels of neutrophils (type of white blood cell),
• peptic ulceration (sores that develop in the lining of the stomach, lower esophagus, or small intestine), gastrointestinal bleeding, decreased appetite,
• renal failure,
• respiratory depression (difficulty breathing),
• restlessness, vertigo (dizziness), changes in mood, hypothermia (dangerously low body temperature), growing pressure inside your skull leading to headaches,
• sensitivity reactions resulting in reversible skin rash (which may be accompanied by fever and lesions or sores in the mouth) or blood disorders,
• skin rash and itchiness,
• sweating, facial flushing, urticaria (swollen pale red itchy bumps on the skin),
• tinnitus (ringing noises in the ear), hypersensitivity reactions.

Side effects with unknown frequency:

• fixed drug eruptions (FDE) (fever, malaise, nausea, diarrhoea, abdominal cramps, anorexia, and dysuria),
• low potassium levels (hypokalaemia),
• renal impairment (renal tubular acidosis),
• inflammation of the stomach.

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 “Adverse drug reaction and quality problem reporting form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problemreporting-form/ or to Cipla Medpro (Pty) Ltd. 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 IBUGESIC FORTE.

Store all medicines out of reach of children. Securitainer and amber glass bottle: Keep well closed and store at or below 25 °C. Blister strips and patient ready packs: Keep in outer carton until required for use. Store at or below 25 °C. Protect from light. Store in the original container. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).