- Approval Id
- 7933b5c6fab3bf46
- Drug Approval Emc Name
- Sudafed Sinus-Ease 0.1% Nasal Spray
- Drug Name
- Sudafed Sinus-Ease 0.1% Nasal Spray
- Company Name
- McNeil Products Ltd
- Company Address
- 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, UK
- Company Medical Info Direct Line
- 0808 238 9999 (freephone)
- Company Medical Info Email
- consumer-gb@kenvue.com
- Atc Code
- R01AA07
- Legal Category
- General Sales List
- Authorisation Holder
- McNeil Products Limited
50 – 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Authorisation Number
- PL 15513/0074
- Authorisation Date
- 21/April/1999
- Instruction Authorisation Holder
- McNeil Products Limited
50 – 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Instruction Authorisation Number
- PL 15513/0074
- Instruction Authorisation Date
- 21/April/1999
- Instruction Composition
- This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.
Excipients with known effect:
Benzalkonium chloride 0.196 mg/ml
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Aqueous solution
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults and children 12 years and over:\*\*
One spray to be expressed into each nostril 2-3 times daily, as necessary.
Maximum daily dose: 3 sprays in 24 hours.
Use for more than seven consecutive days is not recommended, [See section 4.4].
\*\*Children under 12 years:\*\*
Do not give to children under 12 years of age.
\*\*The Elderly\*\*
Experience has indicated that normal adult dosage is appropriate, [See section 5.2].
\*\*Hepatic/renal dysfunction\*\*
Normal adult dosage is appropriate, [See section 5.2].
\*\*Method of administration\*\*
Nasal4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Children under 12 years of age.
This product is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks.
This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.4.4 Special warnings and precautions for use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
This medicine is intended for short term use only. Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.
This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (see section 4.8).
This medicine contains 1.96 mg benzalkonium chloride in each 10 ml, and 2.94 mg benzalkonium chloride in each 15 ml, which is equivalent to 0.196 mg/ml of product. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Long-term use may cause oedema of the nasal mucosa.4.5 Interaction with other medicinal products and other forms of interaction
Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.
\*\*Lactation\*\*
It is not known whether xylometazoline or its metabolites are excreted in human milk. This product should not be used during lactation unless the potential benefit to the mother outweighs the possible risks to the nursing infant.4.7 Effects on ability to drive and use machines
It is not known if xylometazoline has an effect on the ability to drive and use machines.4.8 Undesirable effects
Adverse Drug Reactions (ADRs) identified during clinical trials and post-marketing experience with xylometazoline are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.
| | | |
| --- | --- | --- |
| \*\*System Organ Class (SOC)\*\* | \*\*Frequency\*\* | \*\*Adverse Drug Reaction\*\* \*\*(Preferred Term)\*\* |
| \*\*Nervous System Disorders\*\* | Rare Not known | Headache Burning sensation mucosal |
| \*\*Respiratory, Thoracic and Mediastinal Disorders\*\* | Uncommon | Epistaxis |
| Not known | Nasal discomfort Nasal dryness Nasal pruritus Rhinalgia Sneezing |
| \*\*Gastrointestinal Disorders\*\* | Rare | Nausea |
| \*\*General Disorders and Administration Site Conditions\*\* | Not known | Rebound effect |
\*\*Reporting of suspected adverse reactions:\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.
\*\*Management\*\*
Treatment of overdose should be supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain; ATC code: R01AA07It acts directly on α-adrenoreceptors but does not act on ß-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.5.2 Pharmacokinetic properties
\*\*Absorption, Distribution, Biotransformation and Elimination\*\*
Little information is available concerning the absorption, distribution, Biotransformation and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.
\*\*Pharmacokinetics in\*\* \*\*Renal/Hepatic Impairment\*\*
There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.
\*\*Pharmacokinetics in the Elderly\*\*
There have been no specific clinical studies of this product or xylometazoline in the elderly.5.3 Preclinical safety data
\*\*Mutagenicity\*\*
There is insufficient information available to determine whether xylometazoline has mutagenic potential.
\*\*Carcinogenicity\*\*
There is insufficient information available to determine whether xylometazoline has carcinogenic potential.
\*\*Teratogenicity\*\*
There is insufficient information available to determine whether xylometazoline has teratogenic potential.
\*\*Fertility\*\*
No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of this product on fertility.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Benzalkonium chloride solution
Disodium edetate
Sodium dihydrogen phosphate dihydrate
Sodium monohydrogen phosphate dihydrate
Sodium chloride
Sorbitol solution, 70% (Non crystalline)
Purified water6.2 Incompatibilities
Not applicable6.3 Shelf life
Unopened: 3 years.
Opened: 20 weeks after first opening, discard the bottle even if there is solution remaining.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Amber glass bottle of either 10 ml or 15 ml nominal fill volume.
The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.
Excipients with known effect:
Benzalkonium chloride 0.196 mg/ml
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Aqueous solution
## Clinical Particulars
4.1 Therapeutic indications
This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults and children 12 years and over:\*\*
One spray to be expressed into each nostril 2-3 times daily, as necessary.
Maximum daily dose: 3 sprays in 24 hours.
Use for more than seven consecutive days is not recommended, [See section 4.4].
\*\*Children under 12 years:\*\*
Do not give to children under 12 years of age.
\*\*The Elderly\*\*
Experience has indicated that normal adult dosage is appropriate, [See section 5.2].
\*\*Hepatic/renal dysfunction\*\*
Normal adult dosage is appropriate, [See section 5.2].
\*\*Method of administration\*\*
Nasal4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Children under 12 years of age.
This product is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks.
This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.4.4 Special warnings and precautions for use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
This medicine is intended for short term use only. Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.
This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (see section 4.8).
This medicine contains 1.96 mg benzalkonium chloride in each 10 ml, and 2.94 mg benzalkonium chloride in each 15 ml, which is equivalent to 0.196 mg/ml of product. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Long-term use may cause oedema of the nasal mucosa.4.5 Interaction with other medicinal products and other forms of interaction
Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.
\*\*Lactation\*\*
It is not known whether xylometazoline or its metabolites are excreted in human milk. This product should not be used during lactation unless the potential benefit to the mother outweighs the possible risks to the nursing infant.4.7 Effects on ability to drive and use machines
It is not known if xylometazoline has an effect on the ability to drive and use machines.4.8 Undesirable effects
Adverse Drug Reactions (ADRs) identified during clinical trials and post-marketing experience with xylometazoline are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.
| | | |
| --- | --- | --- |
| \*\*System Organ Class (SOC)\*\* | \*\*Frequency\*\* | \*\*Adverse Drug Reaction\*\* \*\*(Preferred Term)\*\* |
| \*\*Nervous System Disorders\*\* | Rare Not known | Headache Burning sensation mucosal |
| \*\*Respiratory, Thoracic and Mediastinal Disorders\*\* | Uncommon | Epistaxis |
| Not known | Nasal discomfort Nasal dryness Nasal pruritus Rhinalgia Sneezing |
| \*\*Gastrointestinal Disorders\*\* | Rare | Nausea |
| \*\*General Disorders and Administration Site Conditions\*\* | Not known | Rebound effect |
\*\*Reporting of suspected adverse reactions:\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.
\*\*Management\*\*
Treatment of overdose should be supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain; ATC code: R01AA07It acts directly on α-adrenoreceptors but does not act on ß-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.5.2 Pharmacokinetic properties
\*\*Absorption, Distribution, Biotransformation and Elimination\*\*
Little information is available concerning the absorption, distribution, Biotransformation and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.
\*\*Pharmacokinetics in\*\* \*\*Renal/Hepatic Impairment\*\*
There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.
\*\*Pharmacokinetics in the Elderly\*\*
There have been no specific clinical studies of this product or xylometazoline in the elderly.5.3 Preclinical safety data
\*\*Mutagenicity\*\*
There is insufficient information available to determine whether xylometazoline has mutagenic potential.
\*\*Carcinogenicity\*\*
There is insufficient information available to determine whether xylometazoline has carcinogenic potential.
\*\*Teratogenicity\*\*
There is insufficient information available to determine whether xylometazoline has teratogenic potential.
\*\*Fertility\*\*
No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of this product on fertility.
## Pharmaceutical Particulars
6.1 List of excipients
Benzalkonium chloride solution
Disodium edetate
Sodium dihydrogen phosphate dihydrate
Sodium monohydrogen phosphate dihydrate
Sodium chloride
Sorbitol solution, 70% (Non crystalline)
Purified water6.2 Incompatibilities
Not applicable6.3 Shelf life
Unopened: 3 years.
Opened: 20 weeks after first opening, discard the bottle even if there is solution remaining.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Amber glass bottle of either 10 ml or 15 ml nominal fill volume.
The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
