- Approval Id
- f9575fc699b10a13
- Drug Approval Emc Name
- Otrivine Blocked Nose Relief, 0.1% w/v Nasal Spray, Solution
- Drug Name
- Otrivine Blocked Nose Relief, 0.1% w/v Nasal Spray, Solution
- Company Name
- Haleon UK Trading Limited
- Company Address
- The Heights, Weybridge, Surrey, KT13 0NY, UK
- Company Website
- https://www.haleon.com/
- Company Medical Info Direct Line
- 0800 783 8881
- Company Medical Info Email
- mystory.gb@haleon.com
- Company Customer Care Direct Line
- 0800 783 8881
- Legal Category
- General Sales List
- Authorisation Holder
- Haleon UK Trading Limited,
The Heights,
Weybridge,
Surrey,
KT13 0NY,
U.K.
- Authorisation Number
- PL 44673/0184
- Authorisation Date
- 1st October 1997/19TH August 2010
- Instruction Authorisation Holder
- Haleon UK Trading Limited,
The Heights,
Weybridge,
Surrey,
KT13 0NY,
U.K.
- Instruction Authorisation Number
- PL 44673/0184
- Instruction Authorisation Date
- 1st October 1997/19TH August 2010
- Instruction Composition
- Active ingredient: 0.1% \*wlv\* Xylometazoline Hydrochloride
For excipients see 6.1
- Instruction Dosage Form
- Nasal spray, solution (Nasal Spray)
A clear, colourless solution
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.4.2 Posology and method of administration
Adults and elderly: One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.
Not suitable for children under 12 years.
Route of administration: Application to the nasal passages.
Laterally actuated pump (Khone): The laterally actuated metered-dose spray ensures that the solution is well distributed over the surface of the nasal mucosa by spraying a fine mist.
Before using for the first time, prime the pump by actuating 5 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 actuations.
Vertically actuated pump (Freepod): Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.
The recommended dose should not be exceeded, especially in children and the elderly.4.3 Contraindications
Known hypersensitivity to xylometazoline.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Narrow-angle glaucoma.
Rhinitis sicca or atrophic rhinitis.
Otrivine 0.1% is contraindicated in children aged less than 12 years.
Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.4.4 Special warnings and precautions for use
Patients are advised not to take decongestants for more than seven consecutive days, prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus.
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Keep medicines out of the sight and reach of children.
\*\*Information concerning excipients\*\*
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.4.5 Interaction with other medicinal products and other forms of interaction
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (\*see Contraindications\*).4.6 Fertility, pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.4.7 Effects on ability to drive and use machines
Otrivine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
| | | |
| --- | --- | --- |
| \*\*MeDRA SOC\*\* | \*\*Adverse reaction\*\* | \*\*Frequency\*\* |
| Immune System Disorders | Hypersensitivity reaction (angioedema, rash, pruritus) | Very rare |
| Nervous System Disorders | Headache | Common |
| Eye Disorders | Transient visual impairment | Very rare |
| Cardiac Disorders | Heart rate irregular Heart rate increased | Very rare Very rare |
| Respiratory, thoracic and mediastinal disorders | Nasal Dryness Nasal Discomfort Epistaxis | Common Common Uncommon |
| Gastrointestinal disorders | Nausea | Common |
| General disorders and administration site | Application site burning | Common |
Other side effects include:
• A burning sensation in the nose and throat
\*\*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 and Signs\*\*
Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
\*\*Treatment\*\*
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Otrivine Adult Measured Dose Sinusitis Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Adult Measured Dose Sinusitis Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Measured Dose Sinusitis Spray is generally well tolerated and does not impair the function of ciliated epithelium.
In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.5.2 Pharmacokinetic properties
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.5.3 Preclinical safety data
Not applicable.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Benzalkonium chloride
Disodium phosphate dodecahydrate (Sodium phosphate)
Disodium edetate
Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)
Sodium chloride
Sorbitol
Hypromellose
Purified water6.2 Incompatibilities
None6.3 Shelf life
36 months
After first opening, the nasal spray can be used until the end of the shelf-life.6.4 Special precautions for storage
Freepod: No special precautions.
Khone: Do not store above 30°C.6.5 Nature and contents of container
High density polyethylene bottle with a vertically actuated polypropylene/polyethylene metered dose pump (materials in contact with the solution: low density polyethylene, high density polyethylene, polyethylene/butyl, stainless steel) and a polypropylene nozzle with a protective cap in a cardboard carton.
Or
High density polyethylene bottle with a laterally actuated metered dose pump (materials in contact with product: low density polyethylene/polyethylene compound, lubricant, stainless steel, polydimethyl-siloxane, PTFE/PET layer) with a polypropylene nozzle with protective cap.
Pack size 10 ml.6.6 Special precautions for disposal and other handling
Medicines should be kept out of the reach of children.
- Instruction Content
- ## Composition
Active ingredient: 0.1% \*wlv\* Xylometazoline Hydrochloride
For excipients see 6.1
## Pharmaceutical Form
Nasal spray, solution (Nasal Spray)
A clear, colourless solution
## Clinical Particulars
4.1 Therapeutic indications
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.4.2 Posology and method of administration
Adults and elderly: One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.
Not suitable for children under 12 years.
Route of administration: Application to the nasal passages.
Laterally actuated pump (Khone): The laterally actuated metered-dose spray ensures that the solution is well distributed over the surface of the nasal mucosa by spraying a fine mist.
Before using for the first time, prime the pump by actuating 5 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 actuations.
Vertically actuated pump (Freepod): Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.
The recommended dose should not be exceeded, especially in children and the elderly.4.3 Contraindications
Known hypersensitivity to xylometazoline.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Narrow-angle glaucoma.
Rhinitis sicca or atrophic rhinitis.
Otrivine 0.1% is contraindicated in children aged less than 12 years.
Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.4.4 Special warnings and precautions for use
Patients are advised not to take decongestants for more than seven consecutive days, prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus.
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Keep medicines out of the sight and reach of children.
\*\*Information concerning excipients\*\*
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.4.5 Interaction with other medicinal products and other forms of interaction
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (\*see Contraindications\*).4.6 Fertility, pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.4.7 Effects on ability to drive and use machines
Otrivine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
| | | |
| --- | --- | --- |
| \*\*MeDRA SOC\*\* | \*\*Adverse reaction\*\* | \*\*Frequency\*\* |
| Immune System Disorders | Hypersensitivity reaction (angioedema, rash, pruritus) | Very rare |
| Nervous System Disorders | Headache | Common |
| Eye Disorders | Transient visual impairment | Very rare |
| Cardiac Disorders | Heart rate irregular Heart rate increased | Very rare Very rare |
| Respiratory, thoracic and mediastinal disorders | Nasal Dryness Nasal Discomfort Epistaxis | Common Common Uncommon |
| Gastrointestinal disorders | Nausea | Common |
| General disorders and administration site | Application site burning | Common |
Other side effects include:
• A burning sensation in the nose and throat
\*\*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 and Signs\*\*
Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
\*\*Treatment\*\*
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Otrivine Adult Measured Dose Sinusitis Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Adult Measured Dose Sinusitis Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Measured Dose Sinusitis Spray is generally well tolerated and does not impair the function of ciliated epithelium.
In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.5.2 Pharmacokinetic properties
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.5.3 Preclinical safety data
Not applicable.
## Pharmaceutical Particulars
6.1 List of excipients
Benzalkonium chloride
Disodium phosphate dodecahydrate (Sodium phosphate)
Disodium edetate
Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)
Sodium chloride
Sorbitol
Hypromellose
Purified water6.2 Incompatibilities
None6.3 Shelf life
36 months
After first opening, the nasal spray can be used until the end of the shelf-life.6.4 Special precautions for storage
Freepod: No special precautions.
Khone: Do not store above 30°C.6.5 Nature and contents of container
High density polyethylene bottle with a vertically actuated polypropylene/polyethylene metered dose pump (materials in contact with the solution: low density polyethylene, high density polyethylene, polyethylene/butyl, stainless steel) and a polypropylene nozzle with a protective cap in a cardboard carton.
Or
High density polyethylene bottle with a laterally actuated metered dose pump (materials in contact with product: low density polyethylene/polyethylene compound, lubricant, stainless steel, polydimethyl-siloxane, PTFE/PET layer) with a polypropylene nozzle with protective cap.
Pack size 10 ml.6.6 Special precautions for disposal and other handling
Medicines should be kept out of the reach of children.
