Geneith GG Cold, 10 x 10 Capsules

Product Name & Strength: G. G. Cold Capsules, 10 x 10's / 20 x 1 x 10's blister packs.

Indications (Approved Uses): Indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or other respiratory allergies, and associated sinusitis. It combines a potent antihistamine and a sympathomimetic decongestant to reduce capillary permeability, relieve oedema, and produce local vasoconstriction to clear blocked nasal passages.

Contraindications (Safety Warnings): Contraindicated in individuals with a known hypersensitivity to antihistamines, sympathomimetics, or any of the constituent excipients. It is strictly contraindicated in patients suffering from severe hypertension or severe coronary artery disease, as well as premature or newborn infants. Contraindicated in nursing mothers due to the elevated risk of antihistamine intolerance in newborns. Antihistamines are contraindicated in patients concurrently receiving antihypertensive or antidepressant medications containing monoamine oxidase inhibitors (MAOIs), as these agents may prolong and intensify anticholinergic and central nervous system depressant effects. It should not be used to treat lower respiratory tract symptoms. Risk-benefit must be carefully evaluated in patients presenting with hyperthyroidism, diabetes mellitus, glaucoma, raised intra-ocular pressure, prostatic hypertrophy, urinary retention, epilepsy, bronchitis, bronchiectasis, hepatic impairment, renal impairment, or asthma, where anticholinergic drying effects may cause thickening of secretions and impair expectoration during an acute episode. It should not be used concurrently with alcohol, hypnotics, anxiolytics, vasodilators, beta-blockers, or other antihistamine-containing products, including cough and cold medicines. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision, and psychomotor impairment, which can seriously affect the ability to drive and use machinery.

Side Effects (Adverse Reactions): Very common side effects include sedation and somnolence. Common reactions include disturbance in attention, abnormal coordination, dizziness, headache, blurred vision, nausea, dry mouth, and fatigue. Adverse events recorded with an unknown frequency include haemolytic anaemia, blood dyscrasias, allergic reactions, angioedema, anaphylactic reactions, anorexia, confusion, excitation, irritability, nightmares, depression, tinnitus, palpitations, tachycardia, arrhythmias, hypotension, thickening of bronchial secretions, vomiting, abdominal pain, diarrhoea, dyspepsia, hepatitis, jaundice, exfoliative dermatitis, rash, urticaria, photosensitivity, muscle twitching, muscle weakness, and urinary retention. Overdosage can cause hallucinations, convulsions, central nervous system depression, cardiac arrhythmias, cerebral haemorrhage, pulmonary oedema, reflex bradycardia, severe hypertensive effects, or death, with children and the elderly being more susceptible to paradoxical excitation and neurological toxicity.

Nutritional Information (per capsule): Phenylephrine Hydrochloride BP 5 mg, Chlorphenamine Maleate BP 4 mg, hard gelatin capsule shell excipients.

Instructions for Use / Dosage: For oral/topical administration. For oral use. Capsules must be swallowed whole and the stated dose or frequency must not be exceeded. Adults and children over 12 years of age should take 1 capsule every 4 to 6 hours as required, up to a maximum daily dose of 6 capsules in any 24-hour period. Children aged 6 to 12 years should not exceed a maximum daily dose of 3 capsules in any 24-hour period. This product is not recommended for children under 6 years of age. For elderly patients, consideration should be given to utilising a lower daily dose as they are more likely to experience neurological anticholinergic effects and psychomotor impairment.

Regulatory Information: NAFDAC Registration Number: 04-9125. Manufactured by: Fredun Pharmaceuticals Limited, India.