INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo IBUMAX COLD AND FLU (Film-coated tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

IBUMAX COLD AND FLU (Film-coated tablets)

COMPOSITION:
Each film-coated tablet contains 200 mg
ibuprofen and 30 mg pseudoephedrine hydrochloride.
Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry yellow, and sodium lauryl sulphate.
Contains lactose.

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants.

PHARMACOLOGICAL ACTION:
Pharmacodynamics
:
Ibuprofen is a non-steroidal anti-inflammatory compound with analgesic, antipyretic and anti-inflammatory properties.
Pseudoephedrine hydrochloride is a direct- and indirect-acting sympathomimetic agent. It is a vasoconstrictor and has nasal decongestant properties.
Pharmacokinetics:
Ibuprofen:
Absorption:
Ibuprofen is well absorbed. Bioavailability following oral administration of the racemate is more than 80%.
Distribution:
Following oral administration of a single 800 mg dose of the racemate, time to the peak serum concentration of 61,1 +5,5 micrograms/mL is 1,6 +0,3 hours. Ibuprofen is bound avidly to plasma proteins (more than 99%) with a volume of distribution of 0,15 +0,02 L/kg.
Metabolism:
Ibuprofen undergoes hepatic metabolism and 90% of an administered dose is metabolised to hydroxylate or carboxylate derivates. The half-life is approximately 2 hours.
Elimination:
The metabolites are renally excreted with less than 1% of administered ibuprofen appearing unchanged in the urine.
Pseudoephedrine:
Absorption:
Bioavailability following oral administration of pseudoephedrine is almost 100%.
Distribution:
Pseudoephedrine is not bound to plasma proteins and has a volume of distribution of 2,64 –3,51 L/kg. Time to peak serum concentration following administration of a 60 mg immediate-release tablet is 1,4 –2 hours.
Metabolism:
Pseudoephedrine has a half-life of approximately 4,3 –8 hours.
Elimination:
Approximately 43 – 96% of an administered dose is excreted in the urine. At a high urine pH (>7,0), pseudoephedrine is extensively reabsorbed; t
1/2 increases and clearance decreases.

INDICATIONS:
IBUMAX COLD AND FLU
tablets are indicated for the relief of cold and flu symptoms, including nasal congestion, headache, fever and sore throat.

CONTRAINDICATIONS:
IBUMAX COLD AND FLU
tablets are contraindicated in:
Patients with hypersensitivity to ibuprofen and pseudoephedrine, or to any of the other ingredients of IBUMAX COLD AND FLU.
Heart failure.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of termination of MAOI treatment.
Patients with hypersensitivity to NSAIDs, including patients in whom attacks of asthma, angioedema, urticaria, or rhinitis have been precipitated by aspirin.
Pregnant or lactating women (see “PREGANCY AND LACTATION”) or in children under the age of 12 years.
Patients with active or history of recurrent ulcer / haemorrhage / perforations.
Patients with a history of gastrointestinal bleeding, ulceration or perforation (PUBs) related to previous NSAIDs, including IBUMAX COLD AND FLU.

WARNINGS AND SPECIAL PRECAUTIONS:
Patients who are currently taking monoamine oxidase inhibitors (see “CONTRAINDICATIONS”) or other medicines for psychiatric or emotional conditions, depression, or hypertension should not take IBUMAX COLD AND FLU tablets without consulting their doctor or pharmacist. IBUMAX COLD AND FLU tablets should not be given to patients with hyperthyroidism, phaeochromocytoma, prostatic enlargement, cardiovascular disease such as ischaemic heart disease, dysrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms, diabetes mellitus or closedangle glaucoma.
In patients with angina pectoris, anginal pain may be precipitated.
In view of IBUMAX COLD AND FLU’s inherent potential to cause fluid retention and oedema, heart failure may be precipitated in some compromised patients. Caution is required in patients with a history of hypertension and/or heart failure.
IBUMAX COLD AND FLU tablets should be used with caution in patients receiving digoxin, guanidine, or tricyclic antidepressants or in patients undergoing anaesthesia with halogenated anaesthetics (see “INTERACTIONS”).
The elderly have an increased frequency of adverse reactions to NSAIDs, including IBUMAX COLD AND FLU, especially gastrointestinal bleeding, ulceration and perforation (PUBs), which may be fatal.
The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of IBUMAX COLD AND FLU, in patients with a history of ulcers, and the elderly.
When gastrointestinal bleeding or ulceration occurs in patients receiving IBUMAX COLD AND FLU, treatment with IBUMAX COLD AND FLU should be stopped.
IBUMAX COLD AND FLU should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
IBUMAX COLD AND FLU should be discontinued at the first sign of skin rash, mucosal lesions, or any other sign of hypersensitivity.
IBUMAX COLD AND FLU contains lactose. Its use is not recommended in patients with galactose intolerance, the Lapp lactase deficiency or glucose or galactose malabsorption syndrome.
Effects on the ability to drive and use machinery:
IBUMAX COLD AND FLU
may exert a mild to moderate influence on a patient’s ability to drive or operate machinery. IBUMAX COLD AND FLU may cause dizziness, double or blurred vision, changes in colour perception or other visual disturbances. Patients should be advised to refrain from driving a car and operating machinery until they know how IBUMAX COLD AND FLU affects them.

INTERACTIONS:
Ibuprofen
:
- NSAIDs: use of two or more NSAIDs together, including aspirin, should be avoided as it could result in an increase in side-effects.
- Corticosteroids: there is an increased risk of gastrointestinal ulceration or bleeding when ibuprofen, such as contained in IBUMAX COLD AND FLU, is used together with corticosteroids.
- Anticoagulants (warfarin): ibuprofen may enhance the effects of anticoagulants, such as warfarin, and phenylbutazone.
- Lithium, methotrexate, and digoxin: ibuprofen may cause an increase in plasma concentrations of these medicines.
- Antiplatelet agents, such as clopidogrel, and selective serotonin reuptake inhibitors (SSRIs): there is an increased risk of gastrointestinal bleeding when ibuprofen is administered together with these agents.
- The serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, sibutramine, bisphosphonates, erlotinib, pentoxyfilline: the risk of gastrointestinal bleeding is increased when ibuprofen is used together with these medicines.
- Zidovudine: there may be an increased risk of haematotoxicity if zidovudine is used with ibuprofen.
- Ritonavir: ritonavir may increase the plasma concentration of ibuprofen.
Pseudoephedrine:
- Because of the potential for pseudoephedrine to cause a hypertensive crisis in patients receiving MAOIs, including the reversible inhibitors of monoamine oxidase type-A (RIMA), the use of IBUMAX COLD AND FLU together with phenelzine or with moclobemide is contraindicated (see “CONTRAINDICATIONS”).
- An increased risk of dysrhythmias may occur if pseudoephedrine is given to patients receiving digoxin, quinidine or tricyclic antidepressants and there is an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin.
- Aluminium hydroxide mixture may increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate.
General:
Reversal of the action of antihypertensive agents may occur and special care is therefore advisable in patients receiving concomitant antihypertensive therapy.
Interactions with alpha- and beta-receptor blocking medicines may be complex.
Interactions are possible with reserpine, tricyclic antidepressants, digoxin and alpha-methyldopa (see above).
IBUMAX COLD AND FLU tablets should be used with caution in patients receiving digoxin, guanidine, or tricyclic antidepressants or in patients undergoing anaesthesia with halogenated anaesthetics (see “WARNINGS AND SPECIAL PRECAUTIONS”).

PREGNANCY AND LACTATION:
IBUMAX COLD AND FLU
should not be used by pregnant or lactating women (see “CONTRAINDICATIONS”).
Use of non-steroidal anti-inflammatory drugs (NSAIDs), such as IBUMAX COLD AND FLU, during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
Always take the lowest possible dose for the shortest possible duration of treatment.
Take one to two tablets every 4 to 6 hours. Do not take more than 6 tablets in any 24-hour period. Always take IBUMAX COLD AND FLU with food or milk.
Advise patients to consult their doctor if symptoms persist beyond 3 days.

SIDE-EFFECTS:
IBUPROFEN
:
Infections and infestations:
Frequency unknown: Urinary tract infection.
Immune system disorders:
Less frequent: Anaphylaxis or anaphylactoid reactions, angiitis (vasculitis) (see “Vascular disorders”), angioedema, bronchospastic allergic reactions, hepatotoxicity and aseptic meningitis due to hypersensitivity reactions (see “Nervous system disorders” and “Hepatobiliary disorders”), allergic rhinitis, serum sickness-like reaction, systemic lupus erythematosus-like syndrome.
Frequency unknown: Hypersensitivity reactions including fever, asthma, rashes (see “Skin and subcutaneous tissue disorders”), laryngeal oedema due to an allergic reaction, Loeffler syndrome (eosinophilic pneumonitis).
Blood and lymphatic system disorders:
Less frequent: Agranulocytosis (granulocytopenia), anaemia, aplastic anaemia (pancytopenia), eosinophilia, haemolytic anaemia, leukopenia (neutropenia), thrombocytopenia with or without purpura.
Frequency unknown: Pure white-cell aplasia, bone marrow depression, disseminated intravascular coagulation, ecchymosis / bruising, hypocoagulability, petechiae.
Metabolism and nutrition disorders:
Less frequent: Fluid retention / oedema, hyperkalaemia, decreased appetite or loss of appetite.
Frequency unknown: Hyponatraemia, continuing thirst, unexplained weight loss.
Psychiatric disorders:
Less frequent: Hallucinations, depression, nervousness or irritability.
Frequency unknown: Disorientation, feeling of depersonalisation, psychotic reaction, anxiety.
Nervous system disorders:
Frequent: Dizziness.
Less frequent: Confusion, aseptic meningitis (see “Immune system disorders”), peripheral neuropathy, drowsiness, trouble in sleeping.
Frequency unknown: Convulsions, dysarthria, headache (including severe headaches especially in the morning), forgetfulness, migraine, syncope, trembling or twitching, unusual weakness with no other signs or symptoms.
Eye disorders:
Less frequent: Toxic amblyopia, visual disturbances such as blurred or double vision, conjunctivitis, dry, irritated or swollen eyes, scotomata.
Frequency unknown: Changes in visual colour perception, corneal opacity, retinal or macular disturbances, corneal deposits, eye pain, palpebral oedema, retinal haemorrhage, photophobia.
Ear and labyrinth disorders:
Less frequent: Decreased hearing or any change in hearing, tinnitus (ringing or buzzing in ears).
Frequency unknown: Vertigo / light-headedness.
Cardiac disorders:
Less frequent: Dysrhythmias, congestive heart failure or exacerbation thereof, tachycardia.
Frequency unknown: Angina pectoris or exacerbation of chest pain, pericarditis.
Vascular disorders:
Less frequent: Increased blood pressure (may reach hypertensive levels), flushing or hot flushes.
Respiratory, thoracic and mediastinal disorders:
Less frequent: Shortness of breath or troubled breathing, unexplained nosebleeds.
Frequency unknown: Bronchospasm in patients with asthma, haemoptysis, pulmonary oedema.
Gastrointestinal disorders:
Frequent: Mild to moderate abdominal cramps, pain or discomfort, mild to moderate epigastric pain or discomfort, heartburn, nausea.
Less frequent: Gastrointestinal bleeding or haemorrhage, gastrointestinal perforation, gastrointestinal ulceration, including oesophageal, gastric or peptic ulceration, multiple gastrointestinal ulcerations, and perforation of pre-existing sigmoid lesions, e.g. diverticula, carcinoma, gastritis, gingival ulceration, aphthous stomatitis, pancreatitis, bloated feeling or gas, constipation, diarrhoea, indigestion, vomiting, irritation, dryness or soreness of the mouth.
Frequency unknown: Peptic ulcer, dyspepsia, colitis or exacerbation thereof, enterocolitis, regional enteritis or exacerbation thereof, abdominal distension, dysphagia, oesophagitis, gastroenteritis, glossitis, swelling of the lips and tongue, bitter taste or other taste change.
Hepatobiliary disorders:
Less frequent: Toxic hepatitis or jaundice.
Frequency unknown: Hepatitis, liver failure, cholestatic hepatitis or jaundice, raised liver transaminase values in patients with chronic hepatitis C infection. Hepatotoxicity due to hypersensitivity reactions (see “Immune system disorders”).
Skin and subcutaneous tissue disorders:
Less frequent: Bullous eruptions / blisters, hives, and itching due to an allergic reaction (see “Immune system disorders”), erythema multiforme, Stevens-Johnson syndrome (often associated with hepatotoxicity), toxic epidermal necrolysis, photosensitive or photo-allergic dermatologic reaction.
Frequency unknown: Bullous leukocytoclastic vasculitis, eczema, exfoliative dermatitis, desquamation, erythema or other skin discolouration, erythema nodosum, photosensitivity reactions resembling porphyria cutanea tarda and epidermolysis bullosa, loosening or splitting of fingernails or other nail disorder, increased sweating.
Musculoskeletal, connective tissue and bone disorders:
Frequency unknown: Muscle cramps or pain, muscle weakness.
Renal and urinary disorders:
Less frequent: Renal impairment or failure, renal papillary or tubular necrosis, haematuria, cystitis, polyuria.
Frequency unknown: Nephrotoxicity such as interstitial nephritis, nephrotic syndrome, cystitis, glomerulitis or glomerulonephritis, nephrosis, oliguria / anuria, increase in serum creatinine concentration, acute flank pain, reversible renal dysfunction, bladder pain, crystalluria, renal calculi, or uretheral obstruction, urethritis, dysuria, frequent urge to urinate, incontinence, proteinuria, strong-smelling urine.
Reproductive system and breast disorders:
Less frequent: Unexplained, unexpected, and/or unusual heavy menstrual bleeding.
General disorders:
Frequency unknown: Chest pain, fever with or without chills, lymphadenopathy, general feeling of discomfort or illness.

PSEUDOEPHEDRINE:
Metabolism and nutrition disorders:
Frequency unknown: Altered metabolism, including disturbances of glucose metabolism.
Psychiatric disorders:
Frequent: Anxiety, restlessness.
Less frequent: Hallucinations, particularly in children.
Nervous system disorders:
Frequent: Insomnia.
Less frequent: Convulsions.
Cardiac disorders:
Frequent: Tachycardia.
Respiratory, thoracic and mediastinal disorders:
Frequency unknown: Dyspnoea.
Gastrointestinal disorders:
Frequency unknown: Ischaemic colitis, hypersalivation.
Skin and subcutaneous tissue disorders:
Less frequent: Skin rash.
Frequency unknown: Sweating.
Renal and urinary disorders:
Less frequent: Urinary retention.
Frequency unknown: Difficulty in micturition.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Epigastric pain, nausea, vomiting, headache, anxiety, thirst, irritability, restlessness, sinus tachycardia, fever, dilated pupils, sweating, hallucinations, blurred vision, tremors, muscular weakness, hypertension, supraventricular and ventricular dysrhythmia, coma, convulsions and respiratory depression. Gastric lavage will remove any unabsorbed IBUMAX COLD AND FLU if recently taken and electrolytes may be corrected by intravenous infusions, if necessary.

IDENTIFICATION:
Orange to yellow, smooth, film-coated, round, biconcave tablet.

PRESENTATION:
Carton containing 12, 20 or 24 blister-packed tablets.

STORAGE INSTRUCTIONS:
Keep the blisters in the outer carton until required for use.
Store at or below 25ºC.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
40/5.8/0218

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap, Mispel Street,
Bellville, 7530, RSA.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
09 April 2014

CM530A/SA 7567 Pro-Print

Information for the Patient about IBUMAX COLD AND FLU TABLETS

SCHEDULING STATUS: S2
PROPRIETARY NAME (AND DOSAGE FORM):
IBUMAX COLD AND FLU (Film-coated tablets)

Read all of this leaflet carefully because it contains important information for you. IBUMAX COLD AND FLU is available without a doctor’s prescription for you to treat a mild illness. Nevertheless you still need to use IBUMAX COLD AND FLU carefully to get the best results from it.
•        Keep this leaflet, you may need to read it again.
•        Ask your pharmacist if you need more information or advice.
•        You must see a doctor if your symptoms worsen or do not improve after 3 days.

WHAT IBUMAX COLD AND FLU CONTAINS:
Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride.
Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry yellow, and sodium lauryl sulphate.
Contains lactose.

WHAT IBUMAX COLD AND FLU IS USED FOR:
IBUMAX COLD AND FLU
tablets are used for the relief of cold and flu symptoms, including blocked nose, headache, fever and sore throat.

BEFORE YOU TAKE IBUMAX COLD AND FLU:
Do NOT take IBUMAX COLD AND FLU if:
You are hypersensitive or allergic to ibuprofen, pseudoephedrine or any of the other components of IBUMAX COLD AND FLU.
You have been diagnosed with heart failure.
You are taking antidepressants of the type called monoamine oxidase inhibitors (MAOIs), such as phenelzine or moclobemide, or have taken MAOIs within the past 14 days (see “Taking other medicines with IBUMAX COLD AND FLU”).
You are hypersensitive or allergic to other non-steroidal anti-inflammatory medicines, including aspirin, or if you experienced asthma, swelling of the face, lips, or tongue, hives, or runny nose after taking aspirin.
You are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).
You are younger than 12 years.
You have recently or previously been diagnosed with stomach or gut ulcers, bleeding or perforations.
You have a history of bleeding from the gut or ulcers or perforations of the gut due to the previous use of non-steroidal anti-inflammatory medicines, including IBUMAX COLD AND FLU.

Take special care with IBUMAX COLD AND FLU:
Speak to your doctor or pharmacist if you are presently taking monoamine oxidase inhibitors (see “Do NOT take IBUMAX COLD AND FLU if”) or other medicines for depression, psychiatric or emotional conditions, or for high blood pressure before you take IBUMAX COLD AND FLU.

If you have an overactive thyroid gland, heart disease such as angina (chest pain due to inadequate blood supply to the heart muscle often brought on by exertion) or previously had a heart attack, if you have an abnormal heart rhythm or fast heartbeat, abnormal blood vessels with calcification of your arteries, balloon-like dilations of your blood vessels, diabetes mellitus or closed-angle glaucoma (raised pressure inside your eye that may cause blindness), you should not take IBUMAX COLD AND FLU. Please discuss this with your doctor or pharmacist if you are unsure.

If you have previously been diagnosed with angina, taking IBUMAX COLD AND FLU may cause an anginal attack.

Elderly patients have an increased risk of developing side-effects due to IBUMAX COLD AND FLU, especially bleeding from the stomach or gut, stomach ulcers, or perforation of ulcers, which may be fatal (see “POSSIBLE SIDE-EFFECTS”). The risk of developing these side-effects is higher with increasing doses and in patients who previously had ulcers. If you vomit blood or a substance resembling coffee grounds, if there is blood in your stool or if your stool is black, tarry and foul-smelling, immediately stop taking IBUMAX COLD AND FLU and report to your doctor as a matter of urgency.

Do not take IBUMAX COLD AND FLU if you have a disease / disorder of the gut, such as inflammation of the small or large bowel, heartburn or reflux.

If you develop a skin rash (especially if blisters are present), ulcers inside the mouth or on the lips, or if you have swelling of the lips, face or tongue, shortness of breath or tightness of the chest, immediately stop taking IBUMAX COLD AND FLU and report to your doctor as a matter of urgency (see “POSSIBLE SIDE-EFFECTS”).

Taking IBUMAX COLD AND FLUwith food and drink:
Always take IBUMAX COLD AND FLU with food or milk.

Pregnancy and breastfeeding:
Do not take IBUMAX COLD AND FLU if you are pregnant or breastfeeding your baby (see “Do NOT take IBUMAX COLD AND FLU if”). It may harm your baby and may delay the onset of labour or increase the duration of labour.

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking IBUMAX COLD AND FLU.

Driving and using machinery:
IBUMAX COLD AND FLU
may cause dizziness, double or blurred vision, changes in colour perception or other visual disturbances that may influence your ability to drive or operate machinery. Do not drive a car or operate machinery or perform any other hazardous tasks until you know how IBUMAX COLD AND FLU affects you.

Important information about some of the ingredients in IBUMAX COLD AND FLU:
IBUMAX COLD AND FLU
contains lactose. If you are lactose intolerant, please speak to your doctor or pharmacist before taking IBUMAX COLD AND FLU. If you suffer from hereditary galactose intolerance or glucose or galactose malabsorption, you should not take IBUMAX COLD AND FLU. You should also not take IBUMAX COLD AND FLU if you suffer from the rare Lapp lactase deficiency. Please discuss this with your doctor if you are unsure.

Taking other medicines with IBUMAX COLD AND FLU:
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Do not take IBUMAX COLD AND FLU in combination with the following medicines:
Monoamine oxidase inhibitors, such as phenelzine or moclobemide, for the treatment of depression, since this may cause a severe increase in blood pressure resulting in a stroke or kidney damage (see “Do NOT take IBUMAX COLD AND FLU if”).
Other non-steroidal anti-inflammatory medicines, such as aspirin or diclofenac, since this may result in an increase in side-effects.
Corticosteroids for the treatment of inflammation in conditions such as asthma or arthritis, since it may increase your risk of developing bleeding from the gut or stomach ulcers.
Blood thinning medicines, such as warfarin, since this may increase your risk of bleeding.
Lithium for bipolar mood disorder, since the ibuprofen in IBUMAX COLD AND FLU may increase lithium plasma concentrations, thus increasing your risk of developing side-effects due to lithium toxicity.
Methotrexate for cancer or to suppress the immune system, since the ibuprofen in IBUMAX COLD AND FLU may increase methotrexate plasma concentrations, thus increasing your risk of developing side-effects due to methotrexate.
Digoxin for the treatment of heart failure or abnormal heart rhythms or quinidine for the treatment of abnormal heart rhythms, since IBUMAX COLD AND FLU in combination with these medicines may increase your risk of developing abnormal heart rhythms.
Medicines, such as clopidogrel, that influence platelet function or antidepressants known as selective serotonin reuptake inhibitors (SSRIs), since this may increase your risk of bleeding from the gut. Please speak to your pharmacist if you are unsure.
Venlafaxine for depression, sibutramine for weight loss, bisphosphonates (such as alendronate) for osteoporosis, or erlotinib for cancer, since combining IBUMAX COLD AND FLU with these medicines may increase your risk of developing bleeding from the gut.
Zidovudine for the treatment of HIV, since this may result in low blood cell counts.
Ritonavir for the treatment of HIV, since this may result in increased blood concentrations of ibuprofen, thus increasing your risk of developing side-effects due to the ibuprofen in IBUMAX COLD AND FLU.
Tricyclic antidepressants for the treatment of depression, since this may increase your risk of developing abnormal heart rhythms. Please speak to your pharmacist if you are unsure.
Medicines containing ergot derivatives for the treatment of migraine, because this may cause an increase in blood pressure. Please speak to your pharmacist if you are unsure.
Antacids containing aluminium hydroxide, since this may increase the absorption of the pseudoephedrine in IBUMAX COLD AND FLU, while kaolin (for the treatment of loose stools) may decrease its absorption rate.
Blood pressure lowering medicines, because IBUMAX COLD AND FLU may make these medicines less effective. Please speak to your pharmacist if you are unsure.

HOW TO TAKE IBUMAX COLD AND FLU:
Always take IBUMAX COLD AND FLU exactly as you have been instructed. You should check with your pharmacist if you are unsure.
Adults and children over 12 years:
Always take the lowest possible dose for the shortest possible duration of treatment.
Take one to two tablets every 4 to 6 hours. Do not take more than 6 tablets in any 24-hour period.
Always take IBUMAX COLD AND FLU with food or milk.
If symptoms persist beyond 3 days, consult your doctor.

If you take more IBUMAX COLD AND FLU than you should:
If you take more IBUMAX COLD AND FLU tablets than you should, you may develop upper stomach pain, nausea, vomiting, headache, thirst, anxiety, restlessness, irritability, fever, rapid heart rate, sweating, dilated pupils, blurred vision, hallucinations (hear or see things that are not real), muscle weakness, tremors, high blood pressure, abnormal heart rhythms, convulsions (seizures), coma and depression of your lung function.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
Do this even if you do not experience any discomfort or signs of intoxication. If you go to the doctor or hospital, take the box of IBUMAX COLD AND FLU tablets with you.

If you forget to take IBUMAX COLD AND FLU:
If you forget to take IBUMAX COLD AND FLU, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule of 1 to 2 tablets every 4 to 6 hours.
Stop taking IBUMAX COLD AND FLU once your symptoms have cleared.

POSSIBLE SIDE-EFFECTS:
IBUMAX COLD AND FLU
can have side-effects.
Not all side-effects reported for IBUMAX COLD AND FLU are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IBUMAX COLD AND FLU, please consult your doctor, pharmacist or other healthcare professional for advice.

If you experience any of the following side-effects, you must stop taking IBUMAX COLD AND FLU and report to your doctor immediately:
Those that occur less frequently:
o Swelling of the lips, tongue, or face, skin rash with itching or hives, tightness of the chest or shortness of breath, fever, nausea and vomiting, wheezing, coughing or hoarseness (see “Take special care with IBUMAX COLD AND FLU”).
o Fever, chills, sore throat, coughing with sputum production, pain in the flank, ulcers that will not heal, blood in the urine, bleeding from the gums, pin point red spots on the skin or easy bruising.
o Vomiting of blood or a substance resembling coffee grounds, or blood per rectum or passing foul-smelling, tarry black stools (see “Take special care with IBUMAX COLD AND FLU”).
o Severe stomach pain accompanied by loss of appetite, nausea and vomiting, generally feeling unwell, fever and chills, and distension of the stomach (see “Take special care with IBUMAX COLD AND FLU”).
o Yellow discolouration of the white of the eyes or skin (jaundice), nausea and vomiting, loss of appetite, fever and pain over the liver area.
o Any skin rash with blisters (see “Take special care with IBUMAX COLD AND FLU”).
o Swelling of the feet, ankles, legs or hands accompanied by severe tiredness, shortness of breath, and/or inability to lie flat due to shortness of breath.
o Inability to pass urine, fluid retention, lower back or flank pain or passing cloudy or dark urine.
o Hearing or seeing things that are not real.
o Headache with neck stiffness and nausea or vomiting.
o Loss of vision, blurred vision, or double vision.
o Decreased hearing or any change in hearing.

Those that occur with unknown frequency:
o Chest pain.
o Coughing blood.
o Convulsions (seizures).
o Eye pain.
o Leaking of urine.
Stop taking IBUMAX COLD AND FLU and report to your doctor as soon as possible if you develop any of the following side-effects:
Those that occur less frequently:
o Palpitations, high blood pressure.
o Confusion.
o Pins and needles in the arms or legs or abnormal sensation.
o Teary, red, dry, irritated or swollen eyes.
o Unexplained nose bleeds.
o Heartburn or reflux that is progressively getting worse, ulcers on the gums, or vomiting.
o Hives or itching or any other skin rash, including a skin rash over areas exposed to the sun.
Those that occur with unknown frequency:
o You feel as if your thoughts and feelings are unreal or do not belong to you.
o Difficulty with pronouncing words.
o Migraine or severe headaches, fainting spells, trembling or twitching, or unusual weakness.
o Changes in colour perception (e.g. all objects appear to have a red or bluish tint).
o Loose stools (diarrhoea).
o Difficulty in swallowing, swelling of the tongue, painful tongue or inflammation of the tongue.
o Peeling of the skin.
o Muscle weakness.

Side-effects that you should report to your doctor if they continue or become bothersome include:
Those that occur frequently:
o Dizziness.
Those that occur less frequently:
o Decreased appetite or loss of appetite, thirst, or unexplained weight loss.
o Depression, nervousness or irritability, trouble sleeping or inability to sleep, drowsiness, anxiety or restlessness.
o Ringing or buzzing in the ears, light-headedness or a sensation of motion when one is keeping still.
o Flushing or hot flashes.
Those that occur with unknown frequency:
o Feeling disorientated or forgetfulness.
o Bitter taste or other taste change.
o Loosening or splitting of the nails or other nail changes.
o Increased sweating or strong-smelling urine.
o Muscle cramps or pain.
o Unexplained, unexpected and/or unusual heavy menstrual bleeding.
o Swelling of the lymph glands.
o General feeling of discomfort or illness.
o Excessive production of saliva.
Please report any other side-effects you think may be due to IBUMAX COLD AND FLU, especially if not mentioned in this leaflet.

STORAGE AND DISPOSING OF IBUMAX COLD AND FLU:
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
Keep the blisters in the outer carton until required for use.
Store at or below 25°C.
Do not use IBUMAX COLD AND FLU tablets after the expiry date stated on the packaging material.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF IBUMAX COLD AND FLU:
Carton containing 12, 20 or 24 blister packed tablets.

IDENTIFICATION OF IBUMAX COLD AND FLU:
Orange to yellow, smooth, film-coated, round, biconcave tablet.

REGISTRATION NUMBER:
40/5.8/0218

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap, Mispel Street,
Bellville, 7530, RSA.

DATE OF PUBLICATION OF THIS PATIENT INFORMATION LEAFLET:
09 April 2014

CM530A/SA 7567 Pro-Print
New addition to this site: November 2016
Source:
http://www.cipla.co.za/wp-content/uploads/2014/05/Ibumax-PI.pdf

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