When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Benzalkonium chloride solution (50%) 0.04
Topical application as a nasal spray.
Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours unless otherwise
advised by your doctor.
Not to be used for children under 12 years of age. In Section 4.3 Use in patients with a hypersensitive to the active ingredient or any of the excipients Use in patients with hypertension, acute ischaemic heart disease, thyrotoxicosis, glaucoma or urinary retention Use in patients who are currently receiving or have received within 2 weeks, monoamine oxidase inhibitors Use in patients who are currently receiving other sympathomimetic drugs has been replaced with: Hypersensitivity to oxymetazoline or any of the other ingredients. Where there is inflammation or lesions of the skin around the nostrils or nasal mucosa. Not to be used for children under 12 years of age. In Section 4.4 1. Use with great care in patients suffering from angina and digitalized patients. 2. This product should be given with care to patients with prostatic enlargement, as it may increase difficulty in micturition. 3. Use with caution in diabetic patients as this product may cause an increase in blood sugar level. 4. Prolonged use may cause rebound congestion and drug induced rhinitis. Contains Benzalkonium chloride irritant, may cause skin reactions. has been replaced with: Patients are advised to consult their doctor before taking this medicine if they: Have high blood pressure, heart disease including angina, diabetes, thyroid disease, hepatic or renal disorders. Are currently taking (or have taken during the last two weeks) monoamine oxidase inhibitors (MAOIs). Have narrow angle glaucoma. Sympathomimetic-containing products should be used with great care in patients receiving phenothiazines or tricyclic antidepressants. Sympathomimetic-containing products should be used with caution in patients receiving digitalis, beta-adrenergic blockers, methyldopa or other anti-hypertensive agents. The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes ie. orally and topically (nasal, aural and eye preparations). Patients are advised to use for a maximum of 7 consecutive days to avoid rebound effect and drug induced rhinitis. Section 4.5 This product may alter the effects of guanethidine, reserpine, methyldopa and tricyclic anti-depressants. has been replaced with: Patients are advised to consult their doctor before using this product if they are taking other medicines. Hypertensive interactions may occur between sympathomimetic amines such as oxymetazoline and monoamine oxidase inhibitors (MAOIs) (see Section 4.4). Oxymetazoline may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs (see Section 4.4). There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants are given with sympathomimetics. Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptine. Section 4.6
Use in patients with a hypersensitive to the active ingredient or any of the excipients
Use in patients with hypertension, acute ischaemic heart disease, thyrotoxicosis, glaucoma or urinary retention
Use in patients who are currently receiving or have received within 2 weeks, monoamine oxidase inhibitors
Use in patients who are currently receiving other sympathomimetic drugs
has been replaced with:
Hypersensitivity to oxymetazoline or any of the other ingredients.
Where there is inflammation or lesions of the skin around the nostrils or nasal mucosa.
Not to be used for children under 12 years of age.
In Section 4.4 1. Use with great care in patients suffering from angina and digitalized patients. 2. This product should be given with care to patients with prostatic enlargement, as it may increase difficulty in micturition. 3. Use with caution in diabetic patients as this product may cause an increase in blood sugar level. 4. Prolonged use may cause rebound congestion and drug induced rhinitis. Contains Benzalkonium chloride irritant, may cause skin reactions. has been replaced with:
Patients are advised to consult their doctor before taking this medicine if they:
Have high blood pressure, heart disease including angina, diabetes, thyroid disease, hepatic or renal disorders.
Are currently taking (or have taken during the last two weeks) monoamine oxidase inhibitors (MAOIs).
Have narrow angle glaucoma.
Sympathomimetic-containing products should be used with great care in patients receiving phenothiazines or tricyclic antidepressants.
Sympathomimetic-containing products should be used with caution in patients receiving digitalis, beta-adrenergic blockers, methyldopa or other anti-hypertensive agents.
The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes ie. orally and topically (nasal, aural and eye preparations).
Patients are advised to use for a maximum of 7 consecutive days to avoid rebound effect and drug induced rhinitis. Section 4.5 This product may alter the effects of guanethidine, reserpine, methyldopa and tricyclic anti-depressants. has been replaced with:
Patients are advised to consult their doctor before using this product if they are taking other medicines.
Hypertensive interactions may occur between sympathomimetic amines such as oxymetazoline and monoamine oxidase inhibitors (MAOIs) (see Section 4.4).
Oxymetazoline may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs (see Section 4.4).
There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants are given with sympathomimetics.
Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptine.
Section 4.6
This product should not be used in pregnancy unless considered essential by the physician has been replaced with Before using this medicine obtain advice from your doctor if you are pregnant or are breast-feeding. Section 4.8 Occasional use may very rarely cause local irritation and dryness of the mouth and throat, prolonged use may cause rebound congestion and rhinitis medicamentosa has been replaced with In general no severe undesirable effects are expected. Rare (<1/1000): Eye disorders: Eye irritation, discomfort or redness Respiratory : Discomfort or irritation in the nose, mouth or throat Very rare Cardiovascular : Tachycardia, palpitations, increased blood (<1/10,000): pressure CNS : Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache Gastrointestinal: Nausea Frequent or prolonged use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa). Section 4.9 Oxymetazoline hydrochloride is an a-adrenergic imidazoline derivative, providing localised nasal vasoconstriction has been replaced with Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, oedema of the lungs, dyspnoea, psychic disturbance. The inhibition of functions of the central nervous system such as somnolence, lowering of the body temperature, bradycardia, shock-like hypotension, apnoea and loss of consciousness is also possible. A nonselective alpha-lytic such as phentolamine may be administered to depress the increased blood pressure. Intubation and artificial respiration may be necessary in serious cases. Further treatment is supportive and symptomatic Section 10 November 2006 changed to November 2009
In general no severe undesirable effects are expected.
Rare (<1/1000): Eye disorders: Eye irritation, discomfort or redness
Respiratory : Discomfort or irritation in the nose, mouth or throat
Very rare Cardiovascular : Tachycardia, palpitations, increased blood
(<1/10,000): pressure
CNS : Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache
Gastrointestinal: Nausea
Frequent or prolonged use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa). Section 4.9 Oxymetazoline hydrochloride is an a-adrenergic imidazoline derivative, providing localised nasal vasoconstriction has been replaced with
Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, oedema of the lungs, dyspnoea, psychic disturbance. The inhibition of functions of the central nervous system such as somnolence, lowering of the body temperature, bradycardia, shock-like
hypotension, apnoea and loss of consciousness is also possible. A nonselective alpha-lytic such as phentolamine may be administered to depress the increased blood pressure. Intubation and artificial respiration may be necessary in serious cases.
Further treatment is supportive and symptomatic
Section 10 November 2006 changed to November 2009