| 4.3 CONTRAINDICATIONS
Deleted:
See your doctor for advice before taking this medicine if you suffer from high blood
pressure, any heart complaint, diabetes, thyroid disease, hepatic or renal disorders.
Added:
Hypersensitivity to oxymetazoline or any of the other ingredients.
Inflammation or lesions of the skin around the nostrils or nasal mucosa.
Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Children under 12 years of age.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Deleted: See your doctor if you feel worse or do not feel better after 7 days. Inform your doctor if you develop new symptoms.
Added:
Consult a doctor before taking this medicine in case of:
High blood pressure, heart disease including angina, diabetes mellitus, hyperthyroid disease, hepatic and renal disorders and prostatic hypertrophy.
Patients currently taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs in the last 14 days.
Use with caution in occlusive vascular disease
If any of the following occur, Vicks Sinex Micromist should be stopped;
o Hallucinations
o Restlessness
o .Sleep disturbances
Patients who have narrow angle glaucoma.
Patients are advised to use for a maximum of 7 consecutive days to avoid rebound effect and drug induced rhinitis.
If symptoms persist consult a doctor
Keep away from eyes
Keep out of the reach and sight of children
4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
If you are taking other medicines, you should see your doctor for advice before taking this medicine changed to
Hypertensive interactions may occur between sympathomimetic amines such as oxymetazoline and monoamine oxidase inhibitors (MAOIs) (see Section 4.4) and/or reversible inhibition of monoamine oxidase (RIMA) and Moclobemide.
Oxymetazoline may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs including adrenergic neurone blockers.
There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants are given with sympathomimetics such as oxymetazoline.
Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptine
There is an increased risk of dysrhythmias when cardiac glycosides are given with sympathomimetics such as oxymetazoline.
There is an increased risk of ergotism when ergot alkaloids (ergotamine & methysergide) are given with sympathomimetics such as oxymetazoline.
4.6 USE DURING PREGNANCY AND LACTATION
Deleted: Before using this medicine, obtain advice from your doctor if you intend to become pregnant, are pregnant or are breast-feeding.
Added:
Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known changed to No effects on ability to drive and use machines have been observed.
4.8 UNDESIRABLE EFFECTS
None known changed to
In general no severe undesirable effects are expected.
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Rare:
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Eye disorders: Eye irritation, dryness, discomfort or redness
Respiratory : Discomfort or irritation in the nose, mouth or throat; Sneezing
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Very rare:
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Cardiovascular : Tachycardia, palpitations, increased blood pressure
CNS : Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache
Gastrointestinal: Nausea
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Prolonged and/or heavy use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa), cardiovascular effects and/or CNS effects.
4.9 OVERDOSE
4.9.1 Symptoms
No information changed to
The symptoms of moderate or acute overdosage can include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, hypertension, dyspnoea, and cardiovascular failure.
CNS depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnoea or loss of consciousness is possible.
4.9.2 Treatment of overdose
No information changed to
Symptomatic treatment of the overdosage is required. In serious cases, intubation and artificial ventilation are required.
10. DATE OF (PARTIAL) REVISION OF TEXT
June 2009 changed to 21-Mar-2012
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