Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Not to be used by patients taking monoaminoxidase inhibitors (MAOI’s) or for two weeks after stopping the MAOI drug.
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption 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 localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Snip should be discontinued and appropriate measures taken if needed.
Care is advised in the administration of Snip to patients with renal or hepatic impairment, cardiac or peripheral vascular disease, hypertension, hyperthyroidism, prostatic hypertrophy, diabetes mellitus or glaucoma, breathing difficulties such as emphysema or chronic bronchitis, epilepsy or thyrotoxicosis.
Do not exceed the stated dose.
Chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and operate machinery.
Anginal pain may be precipitated in angina pectoris.
Patients should be advised not to take other paracetamol-containing products or sympathomimetic agents concurrently.
Patients should be advised to consult their doctor if their cold or flu symptoms persist.
Keep all medicines safely away from children.
The co-administration of Snip with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants), or with monoamine oxidase inhibitors (MAOI’s) (or within two weeks of stopping MAOI’s) which interfere with the catabolism of sympathomimetic agents, may occasionally cause a rise in blood pressure and may lead to hypertensive crisis in the case of MAOI’s.
Because of its pseudoephedrine content, this product may partially reverse the hypotensive action of drugs, which interfere with sympathetic activity including alpha- and beta- adrenergic blocking agents and methyldopa.
Drowsiness caused by Chlorpheniramine can be exacerbated by concomitant use of alcohol, sedatives and tranquilizers. Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of Snip with increased risk of bleeding; occasional doses have no significant effect.
Absorption of paracetamol is increased by drugs, which increase gastric emptying e.g. metoclopramide and domperidone and decreased by drugs which decrease gastric emptying e.g. tricyclic antidepressants, narcotic analgesics. The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol and anticonvulsants.
Patients should avoid alcohol while taking Snip.
Do not use Snip if pregnant or breast-feeding without medical advice.
Chlorpheniramine can cause drowsiness; if affected patients should not drive or operate machinery.
The frequencies of the adverse reactions are defined as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Adverse effects of Snip are rare but a variety of allergic cutaneous reactions, with or without systemic features, have been reported.
Very rare: There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causality related to Snip.
Rare: Hallucinations have been reported rarely.
Not known: nervousness
Not known: dizziness, insomnia, agitation and restlessness have also been reported but these are usually mild, drowsiness.
Not known: Ischaemic optic neuropathy.
Not known: tachycardia.
Not known: hypertension.
Not known: Ischaemic colitis, dry mouth.
Rare: Hypersensitivity including skin rash, angioedema have also been reported rarely.
Very rare: Very rare cases of serious skin reactions have been reported.
Not known: Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).
Not known: Urinary retention can occur in those patients with prostatic enlargement.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
Not applicable.
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