Sinutab 3-Way 200 mg ,30 mg Tablets.

SINUTAB u00ae 3-WAY is indicated for the relief of symptoms associated with the common cold, sinusitis, or flu, including nasal congestion, headache, fever, body aches and pain.

Adults and children over 12 years: One tablet every four to six hours. If symptoms do not respond to one tablet, a second tablet may be taken. DO NOT EXCEED SIX TABLETS IN 24 HOURS. Use the lowest effective dose for the shortest possible duration of treatment. SINUTAB u00ae 3-WAY should be taken with food or milk or after meals. For oral use only. SINUTAB u00ae 3-WAY should not be used continuously for colds for more than 7 days, or for fever for more than 3 days, without consulting a doctor. Patients should consult a medical doctor if their cold or fever persists or worsens, or if new symptoms occur. Children: Not recommended for children under 12 years of age.

SINUTAB u00ae 3-WAY is contraindicated:

• In patients with known hypersensitivity to pseudoephedrine, ibuprofen or any of the other ingredients in SINUTAB u00ae 3-WAY (see section 6.1).
• In persons receiving monoamine oxidase inhibitor treatment, including linezolid, or within 14 days of ceasing such treatment.
• In patients who have had an allergic reaction to aspirin or to other nonsteroidal anti-inflammatory analgesics e.g. asthma, swelling, shock or hives, because even though this product does not contain aspirin, or salicylates, cross-reactions may occur in patients allergic to aspirin.
• In patients with cardiovascular disease, such as ischaemic heart disease, heart failure, dysrhythmia, tachycardia, severe hypertension or uncontrolled hypertension, arteriosclerosis and aneurysms.
• In patients just before or after heart surgery.
• In patients with diabetes mellitus, hyperthyroidism, phaeochromocytoma, closed-angle glaucoma, hyperexcitability and difficulty in urination due to enlargement of the prostate.
• In patients with severe acute or chronic kidney disease/renal failure and hepatic impairment.
• In patients with a history of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs use including SINUTAB u00ae 3-WAY.
• In patients with an active or a history of recurrent ulcer, haemorrhage or perforations.
• SINUTAB u00ae 3-WAY is contraindicated in pregnant women from 20 weeks onwards and in lactating women (see sections 4.4 and 4.6).
• SINUTAB u00ae 3-WAY should not be given to children under 12 years of age.
• In patients using digoxin.

• NSAIDs may cause gastrointestinal bleeding.
• Elderly patients: The elderly have an increased frequency of adverse reactions to NSAIDs, including SINUTAB u00ae 3-WAY, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.
• The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of SINUTAB u00ae 3-WAY, in patients with a history of ulcers, and the elderly.
• When gastrointestinal bleeding or ulceration occurs in patients receiving SINUTAB u00ae 3-WAY, treatment with SINUTAB u00ae 3-WAY should be stopped.
• SINUTAB u00ae 3-WAY should be given with caution to patients:
• With a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition, may be exacerbated.
• Who are receiving anticoagulants, platelet aggregation inhibitors (such as aspirin), corticosteroids, other NSAIDs or patients who are using alcohol.
• With a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with SINUTAB u00ae 3-WAY therapy. In view of the inherent potential of SINUTAB u00ae 3-WAY to cause fluid retention, heart failure may be precipitated in some compromised patients.
• With organic heart disease, cardiac decompensation or angina of effort.
• Patients with cardiovascular disease or risk factors for cardiovascular disease are at greater risk as are associated with an increased risk of serious cardiovascular thrombotic events, myocardial infarction, Kounis syndrome (KS) and stroke. This risk may increase with dose and duration of use.
• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).
• Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.
• Ibuprofen may cause a severe allergic reaction in patients allergic to aspirin (see section 4.3). Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters with or without pyrexia or erythema. If any of these symptoms occur, patients should stop use and seek medical help right away. Serious skin reactions, some of them fatal, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis (AGEP) have been reported. SINUTAB u00ae 3-WAY should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in patients taking NSAIDs such as SINUTAB u00ae 3-WAY. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue SINUTAB u00ae 3-WAY and evaluate the patient immediately.
• AGEP may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localised on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms, such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with SINUTAB u00ae 3-WAY should be discontinued, and a doctor should be consulted (see section 4.8).
• SINUTAB u00ae 3-WAY should not be combined with other non-prescription pain relievers or any other ibuprofen-containing products. SINUTAB u00ae 3-WAY should not be used without consulting a doctor or pharmacist if a patient is presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension, or other cardiovascular disorders.
• SINUTAB u00ae 3-WAY may decrease the ability of aspirin to protect against heart attack and stroke. The use of NSAIDs, such as SINUTAB u00ae 3-WAY, around 20 weeks gestation or later in pregnancy may cause a rare but serious foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Complications of prolonged oligohydramnios include limb contractures and delayed lung maturation, which may require invasive procedures such as exchange transfusion or dialysis, in some cases.
• Use of NSAIDs, such as SINUTAB u00ae 3-WAY, 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 newborn. The onset of labour may be delayed and its duration increased (see section 4.3 and section 4.6).
• SINUTAB u00ae 3-WAY should be used with caution in patients with asthma, fluid retention or in patients taking diuretic medicine.
• Ibuprofen which is in SINUTAB u00ae 3-WAY, has been associated with vanishing bile duct syndrome. Patients should be instructed to consult a doctor if the develop a sudden onset of abdominal pain, chronic abdominal pain with a loss of appetite and/or new onset itching (see section 4.8).
• Ischaemic colitis has been associated with the use of pseudoephedrine, as in SINUTAB u00ae 3-WAY. Patients should be instructed to stop taking SINUTAB u00ae 3-WAY if abdominal pain, rectal bleeding, or other symptoms associated with ischaemic colitis develop.
• SINUTAB u00ae 3-WAY treats fever and pain which sometimes can be signs of a serious underlying condition. If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a doctor.
• NSAIDs, such as SINUTAB u00ae 3-WAY, is associated with an increased risk of renal tubular acidosis (RTA) and hypokalaemia.

Pseudoephedrine hydrochloride:

• Should be avoided or used with caution in patients undergoing anaesthesia with halogenated anaesthetics as they may induce ventricular fibrillation.
• An increased risk of dysrhythmias may occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
• There is an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin.
• Reserpine and methyldopa diminish the effects of pseudoephedrine hydrochloride.
• Aluminium hydroxide-containing preparations may increase the absorption rate of pseudoephedrine hydrochloride.
• Reversal of the action of antihypertensive medicines may occur and therefore special care is advisable in patients receiving antihypertensive therapy.
• Concurrent use of pseudoephedrine with either monoamine oxidase inhibitors (MAOI) or sympathomimetic amines may result in an acute hypertensive crises (see section 4.3).

Ibuprofen:

• Enhances the effect of oral anticoagulants (such as warfarin), phenytoin and sulphonylurea antidiabetics and increases the plasma concentrations of lithium, methotrexate and cardiac glycosides and may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels during concomitant use with cardiac glycosides.
• The risk of nephrotoxicity may be increased if given with ACE-inhibitors, ciclosporin, tacrolimus or diuretics. There may also be an increased risk of hyperkalaemia with ACE-inhibitors and potassium-sparing diuretics.
• The antihypertensive effects of some antihypertensive medicines, including ACE-inhibitors, beta-blockers and diuretics, may be reduced.
• Convulsions may occur due to an interaction with quinolones.
• The concomitant use of more than one nonsteroidal anti-inflammatory drug (NSAID), including aspirin, should be avoided because of the increased risk of adverse effects. Ibuprofen may inhibit the antiplatelet effects of aspirin when taken concomitantly.
• The risk of gastrointestinal perforation, ulceration or bleeding is increased when used with corticosteroids, alcohol, bisphosphonates or oxpentifylline.
• There may be an increased risk of haemotoxicity during concomitant use of zidovudine and ibuprofen.
• Ritonavir may increase the plasma concentrations of nonsteroidal anti-inflammatory medicines (NSAIDs).
• It is recommended that ibuprofen should be avoided for 8 to 12 days after mifepristone use.
• Antiplatelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

Pregnancy

SINUTAB u00ae 3-WAY is contraindicated from 20 weeks or later in pregnancy. The use of NSAIDs, such as SINUTAB u00ae 3-WAY, around 20 weeks gestation or later in pregnancy may cause a rare but serious foetal renal dysfunction leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal renal impairment. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. Complications of prolonged oligohydramnios include limb contractures and delayed lung maturation, which may require invasive procedures such as exchange transfusion or dialysis, in some cases. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, SINUTAB u00ae 3-WAY should not be given unless clearly necessary. If SINUTAB u00ae 3-WAY is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to SINUTAB u00ae 3-WAY for several days from gestational week 20 onward. SINUTAB u00ae 3-WAY should be discontinued if oligohydramnios or ductus arteriosus constriction are found. Regular use of nonsteroidal anti-inflammatory medicines (NSAIDs) during the third trimester of pregnancy, may result in premature constriction/closure of the foetal ductus arteriosus in utero, renal dysfunction (see above), and possibly, in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased. The bleeding time may be prolonged and an anti-aggregating effect may occur even at low doses.

Breastfeeding:

SINUTAB u00ae 3-WAY is not recommended for use in lactating women. Pseudoephedrine is distributed and concentrated in breast milk.

Fertility:

There is limited evidence that medicines, such as SINUTAB u00ae 3-WAY, which inhibit cyclo-oxygenase/prostaglandin synthesis, may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. Women who are trying to become pregnant must avoid treatment with SINUTAB u00ae 3-WAY.

Spontaneous abortion:

The risk of miscarriage may be increased with the use of NSAIDs, as in SINUTAB u00ae 3-WAY. The observation remains to be confirmed.

Patients should be advised to use caution when driving a car or operating machinery, since SINUTAB u00ae 3-WAY may cause dizziness.

The following side effects may occur with SINUTAB u00ae 3-WAY:

Psychiatric disorders

• Frequent: Nervousness and insomnia.
• Less frequent: Anxiety.

Nervous system disorders

• Frequent: Dizziness, tremor and somnolence.

Eye disorders

• Frequent: Eye disorder.

Ear and Labyrinth disorders

• Frequent: Tinnitus.

Gastrointestinal disorders

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohnu2019s disease, gastritis.

• Frequent: Dry mouth
• Frequency unknown: Pancreatitis, gastrointestinal ulcer haemorrhage/perforation, oral discomfort (local burning sensation, irritation).

General disorders and administration site conditions

• Frequent: Thirst and asthenia.

Post-marketing data

Infections and infestations

• Aseptic meningitis.

Blood and the lymphatic system disorders

• Bone marrow toxicity, eosinophilia, thrombocytopenia and anaemia.

Immune system disorders

• Hypersensitivity reactions, angioedema and anaphylactic reactions.

Psychiatric disorders

• Euphoric mood, hallucinations (including visual hallucinations) and restlessness.

Nervous system disorders

• Headache, psychomotor hyperactivity, paraesthesia and stroke, posterior reversible encephalopathy syndrome (PRES) (see section 4.4), reversible cerebral vasoconstriction syndrome (RCVS) (see section 4.4).

Eye disorders

• Visual impairment, blurred vision.

Cardiac disorders

• Palpitations, tachycardia, oedema, cardiac failure, dysrhythmia and myocardial infarction.

Vascular disorders

• Bleeding and hypertension.

Respiratory, thoracic and mediastinal disorders

• Asthmatic conditions and bronchospasm.

Hepatobiliary disorders

• Hepatotoxicity (abnormal hepatic function, hepatitis and increased transaminases), vanishing bile duct syndrome.

Skin and subcutaneous tissue disorders

• Pruritus, bullous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, rash, erythema, erythema multiforme, acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS) [see section 4.4], fixed eruption and urticaria.

Renal and urinary disorders

• Dysuria, urinary retention, nephritis, nephrotic syndrome, renal failure, renal impairment and renal papillary necrosis.

General disorders and administrative site conditions

• Jittery feeling and hypothermia.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of SINUTAB 3-WAY is important. It allows continued monitoring of the benefit/risk balance of SINUTAB 3-WAY. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. For further information, please contact the Johnson & Johnson via www.kenvuecontact.eu or call centre on 0860 410032 (landline).

Ibuprofen

The most frequently reported symptoms of acute ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms following acute overdose include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure, rhabdomyolysis, hypothermia, fulminant hepatic failure and apnoea may occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, have been reported. Onset of symptoms usually occurs within 4 hours. Serious toxicity and death have been reported in association with acute ibuprofen overdose.

Pseudoephedrine

Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension, and reflex bradycardia. Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischaemic bowel infarction. Drowsiness has been reported with overdose in children.

Treatment of overdose: Treatment is symptomatic and supportive.