- pseudoephedrine hydrochloride
This information is intended for use by health professionals
|Active Substances||per tablet|
|Pseudoephedrine Hydrochloride||30 mg|
Adults, older people, and young persons over 12 years:Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days.
PosologyAdults, older people and young persons over 12 years:Take 1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in any 24 hour period.
Paediatric populationRobiCold Sinus Relief is contraindicated in children under the age of 12 (see section 4.3).
Renal and hepatic insufficiencyNo dose reduction is required in patients with mild to moderate renal or hepatic impairment. (see section 4.4) The lowest effective dose should be used.
Method of administrationFor oral administration only. Tablets should be taken with a glass of water.
It is considered unsafe to take Ibuprofen in combination with warfarin or heparin unless under direct medical supervision.
Not recommended combinations:
Acetylsalicylic acidConcomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).
Combinations requiring precautions:Care should be taken in patients treated with any of the following drugs as interactions have been reported.
|Combination of pseudoephedrine with:||Possible Reaction|
|Non-selective MAOIs (iproniazid):||This product should not be taken by patients who are currently or in the previous two weeks monoamine oxidase inhibitors (MAO inhibitors) have applied because the risk of a hypertensive episode as paroxysmal hypertension, hyperthermia can lead to death output is (see section 4.3).|
|Other indirectly-acting, orally or nasally administered sympathomimetics or vasoconstrictor agents, α-sympathomimetic drugs, phenylpropanolamine, phenylephrine, ephedrine, methylphenidate:||Risk of vasoconstriction and/or hypertensive crises.|
|Reversible inhibitors of monoamine oxidase A (RIMAs), linezolid, dopaminergic ergot alkaloids, vasoconstrictor ergot alkaloids:||Risk of vasoconstriction and/or hypertensive crises.|
|Volatile halogenated anaesthetics:||Perioperative acute hypertension. In scheduled surgery, discontinue treatment with (RobiCold Sinus Relief) several days before.|
|Guanethidine, reserpine and methyldopa:||Effect of pseudoephedrine may be diminished.|
|Tricyclic antidepressants:||Effect of pseudoephedrine may be diminished or enhanced.|
|Digitalis, chinidine or tricyclic antidepressants:||Increased frequency of arrhythmia.|
|Concomitant use of ibuprofen with :||Possible Reaction|
|Other NSAIDs:||The concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. The concomitant use of ibuprofen with other NSAIDs should therefore be avoided (see sections 4.3 and 4.4).|
|Digoxin:||The concomitant use of RobiCold Sinus Relief with digoxin preparations may increase serum levels of these medicinal products. A check of serum-digoxin is not as a rule required on correct use (maximum over 5 days).|
|Corticosteroids:||Corticosteroids as these may increase the risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal; ulceration or bleeding) (see section 4.3).|
|Anti-platelet agents:||Increased risk of gastrointestinal bleeding (see section 4.4).|
|Acetylsalicylic acid:||Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).|
|Anticoagulants: (e.g.: warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost)||NSAIDs as ibuprofen may enhance the effect of anti-coagulants (see section 4.4).|
|Phenytoin:||The concomitant use of RobiCold Sinus Relief with phenytoin preparations may increase serum levels of these medicinal products. A check of serum-phenytoin levels is not as a rule required on correct use (maximum over 5 days).|
|Selective serotonin reuptake inhibitors (SSRIs):||Increased risk of gastrointestinal bleeding (see section 4.4).|
|Lithium:||The concomitant use of RobiCold Sinus Relief with lithium preparations may increase serum levels of these medicinal products. A check of serum-lithium is not as a rule required on correct use (maximum over 5 days).|
|Probenecid and sulfinpyrazone:||Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of ibuprofen.|
|Diuretics, ACE inhibitors, betareceptor-blockers and angiotensin-II antagonists:||NSAIDs may reduce the effect of diuretics and other antihypertensive medicinal products. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, betareceptor-blockers or angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.|
|Potassium sparing diuretics:||The concomitant administration of RobiCold Sinus Relief and potassium-sparing diuretics may lead to hyperkalaemia (check of serum potassium is recommended).|
|Methotrexate:||The administration of RobiCold Sinus Relief within 24 hours before or after administration of methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic effect.|
|Ciclosporin:||The risk of a kidney-damaging effect due to ciclosporin is increased through the concomitant administration of certain nonsteroidal antiinflammatory drugs. This effect also cannot be ruled out for a combination of ciclosporin with ibuprofen.|
|Tacrolimus:||The risk of nephrotoxicity is increased if the two medicinal products are administered concomitantly.|
|Zidovudine:||There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.|
|Sulfonylureas:||Clinical investigations have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although interactions between ibuprofen and sulfonylureas have not been described to date, a check of blood-glucose values is recommended as a precaution on concomitant intake.|
|Quinolone antibiotics:||Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.|
|Heparins; Gingko biloba:||Increased risk of bleeding.|
|Mifepristone:||NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone|
|Antacids:||Certain antacids may increase the gastrointestinal absorption of Ibuprofen. This is considered to be of clinical relevance particularly during long-term use of Ibuprofen.|
|Aminoglycosides:||Reduction in renal function in susceptible individuals decreased elimination of aminoglycosides and increased plasma concentrations.|
Pregnancy:Ibuprofen:Whilst no teratogenic effect has been demonstrated in animal experiments, use of ibuprofen during pregnancy should be avoided.During the third trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both mother and child (see Section 4.3).Pseudoephedrine:Data on pregnancy outcomes after maternal exposure to pseudoephedrine are limited. Two analyses of health maintenance organisation pharmacy data identified 9 malformed infants among 902 first-trimester pseudoephedrine exposures suggesting no specific association with birth defects overall. However the related compounds epinephrine, ephedrine and phenylephrine have been associated with haemorrhages and cardiovascular and limb malformations in animal models. The vasoconstrictive effects of these drugs may indicate that their use in early pregnancy might increase the risk of vascular disruption defects.
FertilityThere is some evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving and who are undergoing investigation of infertility, withdrawal of the product should be considered.
Lactation:Ibuprofen: In limited studies, ibuprofen appears in the breast milk in very low concentrations, and is unlikely to affect the breast fed infant adversely.Pseudoephedrine:Pseudoephedrine is excreted in breast milk in small quantities, but the effect of this on breast-fed infants is not known. It is estimated that 0.4% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in breast milk over 24 hours.In summary, the use of this product is contraindicated during pregnancy and breastfeeding.
|<Very common (≥1/10)>|
|<Common (≥1/100 to <1/10)>|
|<Uncommon (≥1/1000 to <1/100)>|
|<Rare (≥1/10000 to <1/1000)>|
|<Very rare (<1/10000)>|
|<not known (cannot be estimated from the available data)>|
|Infections and infestations||Ibuprofen||Very rare||Exacerbation of infectious inflammations (e.g. necrotizing fasciitis), Aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever or disorientation in patients with pre-existent autoimmune diseases (SLE, mixed connective tissue disease)|
|Blood and lymphatic system disorders||Ibuprofen||Very rare||Haematopoietic disorders (e.g. anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis)|
|Immune system disorders||Ibuprofen||Uncommon||Hypersensitivity reactions with urticaria, pruritus and asthma attacks (with drop in blood pressure)|
|Ibuprofen and pseudoephedrine hydrochloride||Very rare||Severe generalised hypersensitivity reactions, signs may be facial oedema, angioedema, dyspnoea, tachycardia, drop in blood pressure, anaphylactic shock|
|Psychiatric disorders||Ibuprofen||Very rare||Psychotic reactions, depression|
|Pseudoephedrine hydrochloride||Not known||Agitation, hallucination, anxiety, abnormal behaviour, insomnia, excitability, irritability, nervousness, restlessness|
|Nervous system disorders||Ibuprofen||Uncommon||Central nervous system disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness|
|Pseudoephedrine hydrochloride||Not known||Haemorhagic stroke, ischemic stroke, convulsion, headache, insomnia, nervousness, anxiety, agitation, tremor, hallucinations.|
|Eye disorders||Ibuprofen||Uncommon||Visual disturbances|
|Ear and labyrinth disorders||Ibuprofen||Rare||Tinnitus|
|Cardiac disorders||Ibuprofen||Very rare||Palpitations, heart failure, myocardial infarction, edema, hypertention|
|Pseudoephedrine hydrochloride||Not known||Palpitations, tachycardia, chest pain, arrythmia|
|Vascular disorders||Ibuprofen||Very rare||Arterial hypertension|
|Pseudoephedrine hydrochloride||Not known||Hypertension|
|Respiratory, thoracic and mediastinal disorders||Pseudoephedrine hydrochloride||Rare||Exacerbation of asthma or hypersensitivity reaction with bronchospasm|
|Gastrointestinal disorders||Ibuprofen||Common||Dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, anorexia, minor gastrointestinal blood loss in rare cases leading to anaemia|
|Ibuprofen||Uncommon||Gastric ulcer with bleeding and/or perforation, gastritis, ulcerous stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4)|
|Ibuprofen||Very rare||Oesophagitis, pancreatitis, intestinal diaphragm-like stricture|
|Pseudoephedrine hydrochloride||Not known||Dry mouth, thirst, nausea, vomiting|
|Hepatobiliary disorders||Ibuprofen||Very rare||Hepatic dysfunction, hepatic damage, particularly in long-term therapy, hepatic failure, acute hepatitis|
|Skin and subcutaneous tissue disorders||Ibuprofen||Uncommon||Various skin rashes|
|Ibuprofen||Very rare||Bullous exanthema such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), alopecia, severe skin infections, soft-tissue complications in a varicella infection|
|Pseudoephedrine hydrochloride||Not known||Rash, urticaria, pruritus, hyperhidrosis.|
|Renal and Urinary disorders||Ibuprofen||Rare||Kidney-tissue damage (papillary necrosis) and elevated uric acid concentrations in the blood|
|Ibuprofen||Very rare||Oedemas (particularly in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal insufficiency|
|Pseudoephedrine hydrochloride||Not known||Difficulty in micturition (Urinary retention in men with urethra-prostatic disorders.)|
|Investigations||Ibuprofen||Not Known||Haematocrit decreased and haemoglobin decreased|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
SymptomsOver dosage may result in nervousness, agitation, anxiety, irritability, restlessness, dizziness, tremor, vertigo, insomnia, nausea, abdominal pain, vomiting, epigastric pain, diarrhoea, bradycardia, palpitation, tachycardia, tinnitus, headache and gastrointestinal bleeding. Hyperkalemia, metabolic acidosis, hypertension or hypotension are also possible signs of overdose. Toxicity may manifest as drowsiness, excitation, disorientation or coma. The patient may develop convulsions. Hepatic function may be abnormal. Metabolic acidosis may occur and the prothrombin time/INR may be prolonged. Acute renal failure and liver damage may occur. In asthmatics, exacerbation of asthma is possible.
ManagementDue to the rapid absorption of the two active ingredients from the gastro-intestinal tract, emetics and gastric lavage must be instituted within four hours of overdosage to be effective. Charcoal is effective only if given within one hour. Cardiac status should be monitored and the serum electrolytes measured.If there are signs of cardiac toxicity, propanolol may be administered intravenously. A slow infusion of a dilute solution of potassium chloride should be initiated in the event of a drop in the serum potassium level. Despite hypokalaemia, the patient is unlikely to be potassium depleted, therefore overload must be avoided. Continued monitoring of the serum potassium is advisable for several hours after administration of the salt. For delirium or convulsions, intravenous administration of diazepam is indicated.
|Titanium Dioxide||(E 171)|
|Iron Oxide Yellow||(E 172)|
|Iron Oxide Red||(E 172)|
|Methyl Parahydroxybenzoate||(E 218)|
|Propyl Parahydroxybenzoate||(E 216)|
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