RobiCold Sinus Relief 200mg, 30mg Tablets
- Revised
- February 2016
- Source updated
- 18 Feb 2016
- MA number
- PL 00165/0391
- Legal status
- Pharmacy
Indications
Concepts (40)
+Angioedema (deep swelling)Contraindicated
• Use in children under 12 years of age. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or NSAIDs. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulcera
Source SmPC ↗+Bleeding riskContraindicated
eroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or NSAIDs. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or th
Source SmPC ↗+BreastfeedingContraindicated
receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+Heart conditionsContraindicated
s, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+Hormone disordersContraindicated
ntestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease. • Patients with history of haemorrhagic stroke. • Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension, coronary artery disease, angina pectoris, tachyca
Source SmPC ↗+Stomach and gutContraindicated
eroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or NSAIDs. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or th
Source SmPC ↗+Heart rhythm blockContraindicated
r more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease. • Patients with history of haemorrhagic stroke. • Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension, coronary artery disease, angina pectoris, tachycardia or haemorrhagic diathesis. • Patients taking other NSAIDs including cyclooxygenase-2 selective inhibitors, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or
Source SmPC ↗+Liver conditionsContraindicated
s, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+Allergy to the medicineContraindicated
• Use in children under 12 years of age. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urtic
Source SmPC ↗+BlockageContraindicated
eroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or NSAIDs. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or th
Source SmPC ↗+Eye conditionsContraindicated
ntestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease. • Patients with history of haemorrhagic stroke. • Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension, coronary artery disease, angina pectoris, tachyca
Source SmPC ↗+ChildrenContraindicated
• Use in children under 12 years of age. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a
Source SmPC ↗+PregnancyContraindicated
receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+Kidney conditionsContraindicated
s, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+Breathing conditionsContraindicated
• Use in children under 12 years of age. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or NSAIDs. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulcera
Source SmPC ↗+ThyroidContraindicated
ntestinal bleeding or perforation, related to previous NSAIDs therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease. • Patients with history of haemorrhagic stroke. • Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension, coronary artery disease, angina pectoris, tachyca
Source SmPC ↗+UnclassifiedContraindicated
rhagic stroke. • Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension, coronary artery disease, angina pectoris, tachycardia or haemorrhagic diathesis. • Patients taking other NSAIDs including cyclooxygenase-2 selective inhibitors, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure
Source SmPC ↗+Gap needed after another medicineContraindicated
ardia or haemorrhagic diathesis. • Patients taking other NSAIDs including cyclooxygenase-2 selective inhibitors, pain-relievers or decongestants. • Patients receiving tricyclic antidepressants. • Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors. • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). • During pregnancy and breast-feeding. (see section 4.6).
Source SmPC ↗+AlcoholWarning
upon withdrawal of treatment. • Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. • Consumption of alcohol should be avoided during treatment. • Pseudoephedrine hydrochloride may cause a positive reaction in tests conducted during anti-doping checks.
Source SmPC ↗+Taken with other medicinesWarning
• The use of RobiCold Sinus Relief with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.3 and 4.5). • Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). • If symptoms get worse
Source SmPC ↗+Older peopleWarning
ast more than 3 days or patients experience any other symptoms not related to the original condition, treatment should be stopped unless directed otherwise by a doctor or healthcare professional. • Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2) • Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without w
Source SmPC ↗+Intolerance to an ingredientWarning
mited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment. • Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. • Consumption of alcohol should be avoided during treatment. • Pseudoephedrine hydrochloride may cause a positive reaction in tests conducted during anti-doping checks.
Source SmPC ↗+FertilityWarning
adolescents or young persons, between the age of 12 and 17 years. • Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. • The use of NSAIDs may impair female fertility (see section 4.6). There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment. • Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. • Consumption of alcohol should
Source SmPC ↗+InfectionWarning
he majority of cases within the first month of treatment. RobiCold Sinus Relief should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. • Systemic Lupus Erythematosus and mixed connective tissue disease – increase risk of aseptic meningitis (see section 4.8). • As NSAIDs can interfere with platelet function, they should be used with caution in patients with intra-cranial haemorrhage and bleeding diathesis. • Patients suffering from asthma, hypertension,
Source SmPC ↗+LactoseWarning
mited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment. • Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. • Consumption of alcohol should be avoided during treatment. • Pseudoephedrine hydrochloride may cause a positive reaction in tests conducted during anti-doping checks.
Source SmPC ↗+Serotonin effectsWarning
on 4.5) • Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. • Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). • When GI bleeding or ulceration occurs in patients receiving RobiCold Sinus Relief, the treatment should be withdrawn. • NSAIDs should be given with care to patients with a history of gastrointest
Source SmPC ↗+Blood clotsWarning
effects). • In patients with cardiac or renal dysfunction, caution is required since the use of NSAIDs may result in deterioration in renal function. • Cardiovascular and cerebrovascular effects: Clinical studies suggest that use of some NSAIDs (ibuprofen) particularly at a high dose (2400 mg/day) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treat
Source SmPC ↗+Blood vessel conditionsWarning
ple myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus a
Source SmPC ↗+Salt and mineral balanceInteraction
ay 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.
+Heart rhythm (QT interval)Interaction
sk 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
Source SmPC ↗+Benzyl alcoholExcipient
rmellose sodium Colloidal anhydrous silica Sodium laurilsulfate Stearic acid Tablet Coating: Sucrose Microcrystalline cellulose Carnauba wax (yellow) Opalux Butterscotch AS-3739: Sucrose Titanium Dioxide (E 171) Iron Oxide Yellow (E 172) Iron Oxide Red (E 172) Povidone Methyl Parahydroxybenzoate (E 218) Propyl Parahydroxybenzoate (E 216) Opaglos GS-2-0310: Industrial Methylated Spirit Pharmaceutical shellac Povidone Acetylated monoglyceride Opacode S-1-27794 black printing ink: Shellac glaze Iron Oxide black (E 172)
Source SmPC ↗+Propylene glycolExcipient
Opaglos GS-2-0310: Industrial Methylated Spirit Pharmaceutical shellac Povidone Acetylated monoglyceride Opacode S-1-27794 black printing ink: Shellac glaze Iron Oxide black (E 172) Propylene glycol Or Opacode S-1-17823 black printing ink: Shellac glaze Iron Oxide Black (E172) Propylene glycol Ammonium hydroxide
Source SmPC ↗+Obstructed blood flow from the heartNot in scanned sections
+DehydrationNot in scanned sections
+Enzyme deficiencyNot in scanned sections
+Acid build-up in the bloodNot in scanned sections
+Sodium and potassium contentNot in scanned sections
+Sugar alcoholsNot in scanned sections
+PorphyriaNot in scanned sections
+ShockNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
3 years
§6.4 — Special precautions for storage
Do not store above 25°C.