Composition: Phenylephrine HCL        10 mg

Loratadine                       2.5 mg

Therapeutic indications:

For  Symptomatic relief of allergic rhinitis, nasal congestion and nasal and eye pruritus.

Posology:

Capsule:

Adults and kids older than 12 years old; one capsule every 12 hours.Tablets:For adults and children over 12 years of age, take 1 tablet 4 times daily.Do not give to children under 12 years.

Contraindications:

Hypersensitivity to the components of the formula; MAOI (up to 14 days after having stopped the product); narrow angle glaucoma; urinary retention; Severe AHT, and hyperthyroidism; stenosis peptic ulcer and diabetes mellitus; pregnancy and lactation.

Warnings and precautions:
Sympathomimetic agents should be used with caution in patients with glaucoma, stenosis peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy and bladder neck obstruction, increased intraocular pressure and diabetes mellitus; sympathomimetic agents should be used with caution in patients treated with digital; sympathomimetic agents can stimulate the CNS and cause seizures and cardiovascular collapse associated with hypotension; in patients 60 years of age or older, sympathomimetics are also more likely to cause renal  adverse effects, caution should be exercised when administered to elderly patients; in patients with I.H. a lower dose should be administered initially, since these patients may have a slower loratadine clearance, half of the recommended dose is recommended as an initial dose; Safety and efficacy have not yet been established in children under 12 years.

Liver failure:

Caution. In patients with I.H. a lower dose should be administered initially, since these patients may have a slower clearance of loratadine, half of the recommended dose is recommended as an initial dose.

Interactions:
In controlled clinical studies, an increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin or cimetidine, but without significant clinical changes (including electrocardiographic changes).Loratadine is metabolized by CYP3A4 and CYP2D6 isozymes of cytochrome P450.
Therefore the use with other drugs that inhibit or are metabolized by these liver enzymes can lead to changes in their plasma concentrations and possibly harmful effects.When sympathomimetic agents such as phenylephrine hydrochloride are administered to patients receiving MAOI, hypertensive reactions, including hypertensive crises, may occur.
The antihypertensive effects of methyldopa, mecamylamine, reserpine and alkaloids derivatives can be reduced by sympathomimetic compounds.
Β-adrenergic blocking agents can also interact with sympathomimetics.
Lab: The administration of antihistamine agents should be discontinued approximately 4 days before performing skin test procedures since these drugs can prevent or decrease reactions that would otherwise be positive for dermal reactivity indicators.

Pregnancy:
Contraindicated.

Lactation:
Contraindicated, loratadine excreted in breast milk.

Adverse reactions:
Severe AHT, tachycardia, palpitations, nervousness, insomnia, asthenia, headache, vomiting and reflex bradycardia with the use of phenylephrine; fatigue, drowsiness, dry mouth, nausea, gastritis, rash, insomnia with the use of loratadine.Elderly patients are more susceptible to the hypertensive and bradycardic effects of phenylephrine, so they may have reduced cardiac output as a result of sinus bradycardia, increasing the risk of possible cardiac insufficiency.

Storage conditions: Store at temperature below 25 c away from light and moisture.

How supplied: 30-600 tablets ACTIFANA NEW.