Product Information
Patient Information leafletComposition:
Storage:
"Store protected from light and moisture, at a temperature not exceeding 30ºC."Unique Identification Code:
8901148258938Manufacturing License Number:
M.L. 31/UA/2013For the treatment of fever associated with cold, nasal congestion in adults.
The recommended adult dose is 1 tablet, to be taken two to three times daily or as directed by the Physician.
It is contraindicated in patients with known hypersensitivity to any of the active ingredient(s) or to any of other components, Concomitant use of other sympathomimetic decongestants cause, Phaeochromocytoma, Closed angle glaucoma, Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients who are taking tricyclic antidepressants, or beta-blocking drugs and those or who have taken within the last two weeks monoamine oxidase inhibitors.
Patients should be advised not to take other paracetamol-containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Concomitant use of other decongestants or cold and flu medicines should be avoided. Excessive intake of should be avoided while taking this product. Diphenhydramine should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, prostatic hypertrophy, urinary retention, narrow-angle glaucoma, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment. Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of a serious underlying medical illness. It May increase the effects of alcohol; therefore, alcohol should be avoided. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines.
Pregnancy- This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content.
Breast feeding- This product should not be used while breast-feeding without medical advice. Patients should be advised not to drive or operate machinery if affected by dizziness.
Fatigue, Dry mouth, sedation, drowsiness, disturbance in attention, unsteadiness, dizziness.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Overdose of caffeine may result in epigastric pain, vomiting, tachycardia or cardiac arrhythmia, CNS stimulation. Phenylephrine overdosage is likely to result in effects like those listed under adverse reactions. Diphenhydramine Overdose is expected to result in effects like the adverse effects that are ordinarily associated with the use of diphenhydramine, including drowsiness, hyperpyrexia, and anticholinergic effects, among others
