Ibugesic Fever And Pain 100 mg/5 ml Oral Suspension

IBUGESIC FEVER AND PAIN belongs to a class of medicine known as antirheumatics (anti-inflammatory agents). The ibuprofen in IBUGESIC FEVER AND PAIN is a non-steroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever, post-traumatic (following injury) conditions and acute attacks of gout.

Do not take IBUGESIC FEVER AND PAIN:

• if you or your child are hypersensitive (allergic) to ibuprofen or any of the other ingredients of IBUGESIC FEVER AND PAIN (listed in section 6).
• if you (or your child) have been diagnosed with heart failure.
• if you (or your child) currently have or previously had repeated stomach ulcers, bleeding, or holes of the gut, including a history of bleeding or holes of the stomach or gut due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs), e.g. aspirin, diclofenac.
• if you (or your child) have had allergic reactions to aspirin or other similar pain medicines (NSAIDs) (see Possible side effects).
• if you (or your child) are also taking lithium, for bipolar mood disorder.
• if you (or your child) have been diagnosed with polyps (growths) inside your nose due to aspirin use, with tightness of the chest or wheezing.
• if you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility).
• if you (or your child) are known to have a bleeding disorder.
• if you (or your child) have liver or kidney failure.
• if your child is younger than 1 year.

Warnings and precautions

Take special care with IBUGESIC FEVER AND PAIN: Please report to your doctor if you (or your child) have a fever that does not improve within 3 days, or pain that does not improve within 7 days (see HOW TO TAKE IBUGESIC FEVER AND PAIN). Please inform your doctor if you know that you have high blood pressure, or heart failure because IBUGESIC FEVER AND PAIN may cause fluid retention and swelling that may worsen these conditions (see Possible side effects). Do not take IBUGESIC FEVER AND PAIN if you are in heart failure (see Do not take IBUGESIC FEVER AND PAIN).

Do not share medicines prescribed for you with any other person. Always take IBUGESIC FEVER AND PAIN 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.

USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST POSSIBLE DURATION OF TREATMENT.

Take IBUGESIC FEVER AND PAIN with or after food.

Adults: The recommended dosage of IBUGESIC FEVER AND PAIN is 600 mg (6 medicine measures) 6 to 8 hourly. Do not exceed the total dose of 1 200 mg (12 medicine measures) IBUGESIC FEVER AND PAIN per day.

Children: Do not give to children under 1 year of age, as safety has not been proven (see Do not take IBUGESIC FEVER AND PAIN). The total daily dosage of IBUGESIC FEVER AND PAIN is 20 mg/kg (1 mL/kg) of body mass given in divided doses.

Pain: Initial dose of 0,25 mL IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s bodyweight. If pain is not controlled, a second dose of 0,25 mL IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s body weight may be given after 2 hours. Thereafter, 0,25 mL of IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s body weight every 4 to 6 hours. DO NOT GIVE more than 1 mL of IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s bodyweight per day (24 hours). Should the pain persist for more than 7 days, you should contact your doctor.

Fever: Give of 0,25 mL of IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s bodyweight every 4 to 6 hours. DO NOT GIVE more than 1 mL of IBUGESIC FEVER AND PAIN suspension per 1 kg of your child’s bodyweight per day (24 hours). Should the fever persist for more than 3 days contact your doctor.

Dosage for suspension:

• Age Bodyweight Daily dosage
• 1 to 2 years 7 to 12 kg 2,5 mL up to 3 to 4 times daily
• 3 to 7 years 14 to 23 kg 2,5 to 5 mL up to 3 to 4 times daily
• 8 to 12 years 25 to 40 kg 10 mL up to 3 to 4 times daily

Do not give to children weighing less than 7 kg or younger than 1 year of age.

Elderly: If you are 65 years of age or older you may be at increased risk of serious adverse reactions. If IBUGESIC FEVER AND PAIN is considered necessary, the lowest effective dose should be used and for the shortest possible duration. You should be monitored regularly during therapy by your doctor for bleeding of the stomach or gut. If your kidney or liver function is impaired, the dosage should be assessed on an individual basis. Please ask your doctor or pharmacist for advice.

If you have the impression that the effect of IBUGESIC FEVER AND PAIN is too strong or too weak for you, please discuss this with your doctor or pharmacist.

If you take more IBUGESIC FEVER AND PAIN than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. You may experience any of the following side effects (see Possible side effects): Nausea, vomiting, stomach pain, lethargy, drowsiness, headache, ringing in the ears, dizziness, convulsions/seizures and loss of consciousness, involuntary eye movement, decreased body temperature, bleeding of the stomach or gut, coma, difficult breathing, loose stools, disorientation, excitation, fainting, low blood pressure, increased or decreased heart rate, kidney failure and liver damage.

If you forget to take IBUGESIC FEVER AND PAIN If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

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

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

• Allergic reactions, including fever, hives or itching, wheezing, laboured breathing, swelling of the lips, tongue, face or whole body, and skin rash (see Take special care with IBUGESIC FEVER AND PAIN).
• Swelling of the hands, feet or legs, inability to lie flat due to shortness of breath, or coughing with the production of pink sputum (see Take special care with IBUGESIC FEVER AND PAIN).
• Any skin rash with blisters. These are all very serious side effects. If you have them, you may have had a serious reaction to IBUGESIC FEVER AND PAIN. 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:

• Sore throat, unusual bleeding, pinpoint red spots on the skin, easy bruising, bleeding from the gums or blood in the urine, pale skin, shortness of breath upon exertion, unusual tiredness or weakness, as these symptoms may be due to abnormal blood cell and platelet counts.
• Vomiting of blood or a substance resembling coffee grounds, severe, incapacitating stomach pain, or passing of black, foul-smelling, tarry stools (see Take special care with IBUGESIC FEVER AND PAIN).
• Ulcers inside the mouth or on the lips (see Take special care with IBUGESIC FEVER AND PAIN).
• Yellow discolouration of the skin or whites of the eyes with pain over the liver area.
• Cloudy, dark or discoloured urine, reduced frequency or increased frequency of urination, difficulty passing urine, or pain over the bladder or kidneys.
• Vision loss, distorted vision, blurred vision, changes in visual colour perception or visual impairment.
• Headache, neck stiffness, nausea and vomiting, sensitivity to light, confusion, drowsiness or fever (see Take special care with IBUGESIC FEVER AND PAIN).
• Confusion. 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:

• Nausea, vomiting, or stomach cramps and pain.
• Stomach discomfort, loose stools, gas, constipation, or indigestion.

Less frequent side effects:

• Pins and needles.
• Rapid heart rate.
• Impaired hearing or feeling that you or your environment is moving or spinning.
• Skin rash in sun-exposed areas.
• Stuffy nose, runny nose, and post-nasal drip.
• Nervousness, depression, sleeplessness, and anxiety.
• Dizziness, headache, drowsiness or sleepiness.
• Ringing in the ears.
• Flushing/redness of the skin.
• Feeling ill or unwell, fatigue.

Side effects with unknown frequency:

• Increased blood pressure (see Take special care with IBUGESIC FEVER AND PAIN).
• Temporary burning in the mouth or throat.
• Renal tubular acidosis (damage to your kidneys which affects them removing acids properly from your blood into the urine), with symptoms such as weakness, feeling tired, muscle cramps, confusion, constipation, irregular heartbeat, tingling or numbness, increased urination, fast breathing, kidney stones, or muscle weakness.
• Very low levels of potassium in your blood (see section 2). Signs and symptoms include muscle weakness and light-headedness.

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 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 FEVER AND PAIN.

Store at or below 25 °C. Protect from light. Shake well before use. Keep well closed. Do not refrigerate. Store all medicines out of reach of children. Store in the original container. Keep the container in the outer carton. 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).