Ibupain ® Forte Capsules

IBUPAIN FORTE is used for mild to moderate pain caused by inflammation, with or without fever.

Do not take IBUPAIN FORTE:

• if you are hypersensitive (allergic) to ibuprofen, paracetamol or codeine or any of the other ingredients of IBUPAIN FORTE (listed in section 6).
• if you have previously had an allergic reaction to aspirin or other pain/inflammation medication.
• if you have difficulty breathing.
• if you are on medication called Monoamine Oxidase Inhibitors (MAOIs) that is used to treat depression or have taken some within the last 14 days.
• if you have diarrhoea due to inflammation in your intestines.
• if you suffer from severe liver impairment.
• if you have, or have a history of, a bleeding stomach ulcer. This can be due to previous use of pain/inflammation medication you have taken.
• if you have uncontrolled asthma or breathing difficulties.
• if you have nasal polyps due to aspirin-induced asthma.
• if you have bleeding disorders.
• if have suffer from heart failure.
• if you have severe kidney failure.
• if you are a child (0 - 18 years of age) who is being treated for pain after surgery to remove the tonsils and or adenoids, as there is an increased risk of developing serious and fatal side effects.
• if you are an ultra-rapid CYP2D6 metaboliser. This is a liver enzyme that metabolises medicines.
• if you are pregnant, due to risk of kidney dysfunction in the foetus.
• if you are breastfeeding.
• if you suffer from chronic constipation.

Warnings and precautions

This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

IBUPAIN FORTE contains codeine, which is an opioid medicine. Repeated use of IBUPAIN FORTE 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 (see section 4).

If you experience any of the following signs whilst taking IBUPAIN FORTE, 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’)

Dosages in excess of those recommended may cause severe liver damage. The side effects of IBUPAIN FORTE can be minimised by taking the lowest effective dose for the shortest duration. IBUPAIN FORTE is for short term use and is not recommended for use beyond 5 days.

The use of NSAIDs around 20 weeks or later in pregnancy, may cause kidney dysfunction in neonates.

Take special care with IBUPAIN FORTE:

• If you are suffering from or have a history of asthma or allergic diseases, this can be triggered by IBUPAIN FORTE. The use of IBUPAIN FORTE should be avoided if this is the case.
• Your conditions should be appropriately monitored if you have high blood pressure or any type of heart disease while taking IBUPAIN FORTE. Your risk of heart disease is increased if you are smoking, have diabetes (increased sugar levels in your blood), high cholesterol or high blood pressure. IBUPAIN FORTE can result in heart failure in some compromised patients.

Do not share medicines prescribed for you with any other person.

Always take IBUPAIN FORTE exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

DO NOT EXCEED THE RECOMMENDED DOSE. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see “Take special care with IBUPAIN FORTE”).

IBUPAIN FORTE is not for children under twelve years of age.

Adults, the elderly and children over 12 years: 1 to 2 capsules 6 hourly. Do not take more than 8 capsules in 24 hours. You should not take IBUPAIN FORTE for more than 5 days, and if you are not feeling better, you should see your doctor.

In patients with liver or kidney problems, or Gilbert’s syndrome (liver disorder), speak to your doctor or pharmacist, as you will need to take a lower dose and/or leave more time between doses. The elderly are at higher risk of serious side effects, and therefore should use the lowest effective dose and for the shortest possible duration. Elderly patients should also be monitored often for gastrointestinal bleeding (e.g. stomach, intestine, etc.).

If you have the impression that the effect of IBUPAIN FORTE is too strong or too weak, tell your doctor or pharmacist.

If you take more IBUPAIN FORTE than you should

Prompt treatment is essential. In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. A delay in starting treatment for paracetamol overdose may mean that treatment is given too late to be effective. Paracetamol overdose can lead to liver damage and death. Elderly subjects, young children, patients with liver disease, alcoholic patients, malnourished patients or patients taking other medicines at the same time, which have an effect on liver enzymes, are particularly at risk, after an overdose.

Symptoms of paracetamol overdosage usually occur within 24 hours and may include pallor (skin colour becoming pale), nausea, vomiting, anorexia and abdominal pain. Afterwards, your condition may improve, however, mild stomach pain may continue, which could indicate that you have liver damage.

Ibuprofen overdose may cause the following symptoms: nausea, vomiting, stomach pain, or more rarely diarrhoea. Tinnitus (ringing in the ears), headache and gastrointestinal bleeding (severe stomach pains, blood in stool) are also possible. In more serious poisoning, symptoms may include dizziness, headache, drowsiness, excitation (feeling excited), disorientation, coma and convulsions. In serious poisoning, the following may occur: metabolic acidosis (high acid levels in the body), reduced blood clotting, worsening of asthma, kidney failure and liver failure may occur.

Codeine overdose may result in nausea, vomiting, hypoxia (not enough oxygen is circulated in the body), hypotension (low blood pressure, which can cause you to feel lightheaded or dizzy), shock and constipation. You may present with a lowered level of consciousness, reduced pupil size and slower breathing.

Your doctor will determine suitable treatment for your overdose.

If you forget to take IBUPAIN FORTE

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

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

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing and breathing.
• rash or itching.
• fainting.
• yellowing of the skin and eyes, also called jaundice.
• signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools (melaena), vomiting blood (haematemesis) or dark particles that look like coffee grounds.
• serious skin reactions which may include redness, hives (red itchy bumps), blisters, pustules, peeling of the skin and bleeding in the lips, eyes, mouth, nose and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome or erythema multiforme).
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• a red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• sensitivity of the skin to sunlight especially when IBUPAIN FORTE is taken at higher dose than recommended or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). Signs and symptoms include muscle weakness and light-headedness.

These are all very serious side effects. If you have them, you may have had a serious reaction to IBUPAIN FORTE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

The following side effects were experienced frequently:

• stomach ulcers
• perforation or gastrointestinal bleeding, sometimes fatal
• indigestion
• nausea
• vomiting
• diarrhoea
• abdominal cramps and pain
• bloating
• flatulence
• constipation
• mouth ulcers
• exacerbation of bowel inflammation and Crohn’s disease
• gastritis
• pancreatitis (inflammation of the pancreas) which may present as pain in the upper part of the stomach, going into your back, a swollen and tender belly, fever
• drowsiness
• dizziness
• seizures
• addiction
• tolerance
• dependence
• headache
• vertigo (balance disturbances)
• malaise (general feeling of uneasiness)
• sleep disturbances

The following side effects were experienced less frequently:

• runny nose and meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation)
• blood disorders (lowered white blood cells that increases your risk of infections, decreased platelets and neutrophils)
• decrease in haemoglobin (seen in blood tests)
• insomnia
• anxiety
• depression
• confusional state
• hallucination
• feeling depressed or sad or extremely happy for no particular reason
• mood changes
• restlessness
• nervousness
• pins and needles in hands and feet
• inflammation of the optic nerve (in your eye)
• feeling tired
• visual disturbances
• narrowing of the pupil
• hearing impairment
• hearing sound when no external sound is present
• changes to your heartbeat
• heart failure
• swelling of hands and feet
• high blood pressure
• dizziness when getting in the upright position
• feeling cold
• facial flushing
• asthma
• wheezing or shortness of breath
• difficulty breathing
• dry mouth
• impairment of renal and liver function
• yellowing of eyes and skin
• increased liver enzymes
• biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder)
• pain and difficulty in passing urine and a less frequent need to do so
• spasm of the urinary system
• skin rash
• sensitivity of the skin to sunlight
• fatigue.

The frequency of the following side effects are unknown:

• increased sweating
• irritability
• nightmares
• increased pressure within your head (raised intracranial pressure)
• uncontrolled muscle movements
• blurred or double vision
• suppression of cough
• dull pain in the middle to upper right area of the abdomen (biliary colic)
• decreased appetite
• muscle stiffness
• severe kidney pain, with or without blood in the urine
• pain when passing urine
• too much acid in the blood/kidney

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 IBUPAIN FORTE.

Suspected side effects can also be reported directly to the HCR via https://pvi1j.solutions.iqvia.com or [email protected]

Keep in a dry place below 25 °C. Protect from light.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Do not use after the expiry date stated on the label or container.