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VICKS SINEX MICROMIST

Active substance(s): OXYMETAZOLINE HYDROCHLORIDE / OXYMETAZOLINE HYDROCHLORIDE / OXYMETAZOLINE HYDROCHLORIDE

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Vicks Sinex Micromist
Oxymetazoline hydrochloride 0.05% w/v
Patient Information Leaflet
In this leaflet:
1. What Vicks Sinex Micromist is and what
it is used for
2. Before you use Vicks Sinex Micromist
3. How to use Vicks Sinex Micromist
4. Possible side effects
5. How to store Vicks Sinex Micromist
6. Further information

Read all of this leaflet carefully because
it contains important information for you.
This medicine is available without prescription.
However, you still need to use Vicks Sinex
Micromist carefully to get the best results from it.

Do not give Vicks Sinex Micromist to children under
12 years of age

1. What Vicks Sinex Micromist is and
what it is used for
Vicks Sinex Micromist is a nasal spray used for localised
relief of the symptoms of a blocked nose in association
with a cold, hay fever or sinusitis (inflammation of the
passages leading to the nose). The effect of the spray
starts after several minutes and lasts for 6-8 hours. The
active substance is oxymetazoline hydrochloride.

2. Before you use Vicks Sinex Micromist
Do not use Vicks Sinex Micromist if you:
• are allergic (hypersensitive) to the active substance oxymetazoline
hydrochloride or any of the other ingredients of Vicks Sinex
Micromist (see section 6)
• are taking (or have taken during the last 14 days) monoamine
oxidase inhibitors (MAO inhibitors are used in the treatment of
Parkinson's disease and depression)
• have had an operation to remove your pituitary gland
• have inflamed skin or mucous membranes of your nostrils or have
scabs in your nose
• do not take with other medications containing decongestants
• have had nasal surgery
• suffer from a tumour of the adrenal glands

Driving and using machines
No effect on ability to drive or use of machinery has
been observed.
Important information about some of the ingredients of
Vicks Sinex Micromist
Benzalkonium chloride (a preservative) is an ingredient in
Vicks Sinex Micromist which might cause swelling of nasal
mucosa, especially during long-term use.

3. How to use Vicks Sinex Micromist
Always use Vicks Sinex Micromist exactly as your pharmacist or
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Vicks Sinex Micromist is for use in your nose only.
Dosage: The recommended dose is
Adults and Children over 12 years: 1 or 2 sprays per nostril
every 6 to 8 hours unless advised otherwise by your doctor.
Children under 12 years: Do not use
Do not exceed the recommended dose
Do not use for more than 7 days in a row.
If used over a longer period or more than the recommended
dose, Vicks Sinex Miromist may cause a blocked nose.
Contact your doctor if symptoms worsen or do not
improve after 7 days.
Administration:
1. Remove the cap. Keep the bottle upright with the
nasal applicator just into the nostril. Hold the other
nostril closed.
2. Spray and breathe in deeply through your nose at the
same time. Repeat for the other nostril.
3. Wipe the nasal applicator with a clean, wet tissue
and replace the cap immediately after application.

Sinex Micromist (Sinex Pump)
Nasal Spray 15ml (P) Submission
UK v3
293b
KA
13-2-15
Leaflet

IPMS/Supplier code:
MPMS:
Tech Drw No: 148x210 %28A5%29 LINKA 1
Region: Europe
Manf. Plant: Opava
Substrate: Paper
Printing process: letterpress
Printer: EUKER
Laetus:
SGS File Ref: 367709

REG0149452
210x148mm

Keyline
Black

Futura bold, Univers 57
cond/67 bold cond/57 cond
obl
Body copy: 8pts
Min font size used: 8pts













Take special care with Vicks Sinex Micromist
Before using tell your doctor if you have:
high blood pressure
heart disease including angina
diabetes
disturbance in your thyroid function
an enlarged prostate gland
hepatic or renal disorder
occlusive vascular disease
suffer from increased eyeball-pressure (narrow-angle glaucoma)
If any of the following occur, Vicks Sinex Micromist should be
stopped;
hallucinations
restlessness
sleep disturbances
Keep away from eyes

Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, even those obtained without a
prescription.
• monoamine oxidase inhibitors (MAOIs) are used in the
treatment of Parkinson's disease and depression

If you use more Vicks Sinex Micromist than you should
If you use too much Vicks Sinex Micromist you should contact
your doctor or go to a hospital immediately and take the bottle
or pack with you.
If you forget to use Vicks Sinex Micromist
Do not take a double dose if you forget to take the previous dose;
instead, continue using according to the administration instructions
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Vicks Sinex Micromist can cause
side effects, although not everybody gets them.
• Rare (occurring in less than 1 in 1,000):
Eye: Eye irritation, dryness, discomfort or redness
Respiratory: Discomfort or irritation in the nose, mouth or throat;
Sneezing
• Very rare (occurring in less than 1 in 10,000):
Cardiovascular: Tachycardia (rapid heartbeat), palpitations,
increased blood pressure
CNS: Insomnia (difficulty in sleeping), nervousness, tremor,
anxiety, restlessness, irritability, headache
Gastrointestinal: Nausea
• Prolonged and/or heavy use beyond the recommended use of 7
days, may in rare instances lead to cardiovascular and/or CNS
effects.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Vicks Sinex Micromist
Keep out of the reach and sight of children.

– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information
or advice.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
– You must contact your pharmacist if your symptoms
worsen or do not improve after 7 days.









- Do not use Vicks Sinex Micromist if you have taken MAOIs
during the last 14 days
tricyclic antidepressants - inform your doctor if
you are taking drugs used in the treatment of
depression such as amitriptyline and imipramine
high blood pressure medicines - inform your doctor
before use if you are taking bethanidine, debrisoquine
and guanethidine as their effect may be reduced
beta blockers - inform your doctor before use if you
are taking these, as their effect may be reduced
Parkinson's disease medicine (bromocriptine)
- treatment with Vicks Sinex Micromist may be affected if it is
used at the same time
appetite suppressants and amphetamine-like
psychostimulants - inform your doctor before use if you are
taking drugs for obesity
cardiac glycosides - inform your doctor before use as it can
cause irregular heart beat (dysrhythmias) if it is taken at the
same time
ergot alkaloids (ergotamine and methysergide) - inform
your doctor before use if you are taking these treatments for
migraines as they can cause increased side effects.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using
Vicks Sinex Micromist. The spray should be used with
caution during pregnancy or if breastfeeding.

Do not store above 25˚C.
Do not use Vicks Sinex Micromist after the expiry date which is
printed on the carton. The expiry date refers to the last day of
the month stated.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required.
These measures will help protect the environment.

6. Further information
What Vicks Sinex Micromist contains
The active substance is: oxymetazoline
hydrochloride 0.5 mg/ml. One spray gives 25µg of
oxymetazoline hydrochloride.
The other ingredients are: levomenthol, sorbitol,
sodium citrate dihydrate, polysorbate 80, citric acid anhydrous,
benzyl alcohol, benzalkonium chloride solution, camphor,
disodium edetate dihydrate, eucalyptol and purified water.
What Vicks Sinex Micromist looks like and
contents of the pack
Vicks Sinex Micromist is a metered dose nasal pump spray. The
pack contains an amber glass bottle with a white pump on top.
The bottle is filled with 15 ml of product.
Marketing Authorisation Holder:
Procter & Gamble (Health & Beauty Care) Limited,
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
(send all enquiries to this address).
Manufacturer: Teva Czech Industries s.r.o., Ostravská 29,
indication number 305, Opava-Komárov, Postal code 747 70,
Czech Republic
PL 00129/0133
Text Revision: 07/2016

PGT293b
00000000

4
10-8-16
CP

Y
-

Version 1.13
Print Spec

Approved

N
Illustrator CS6

Page 1 of 3

Vicks Sinex Micromist
Oxymetazoline hydrochloride 0.05% w/v
Patient Information Leaflet
In this leaflet:
1. What Vicks Sinex Micromist is and what
it is used for
2. Before you use Vicks Sinex Micromist
3. How to use Vicks Sinex Micromist
4. Possible side effects
5. How to store Vicks Sinex Micromist
6. Further information

Read all of this leaflet carefully because
it contains important information for you.
This medicine is available without prescription.
However, you still need to use Vicks Sinex
Micromist carefully to get the best results from it.

Do not give Vicks Sinex Micromist to children under
12 years of age

1. What Vicks Sinex Micromist is and
what it is used for
Vicks Sinex Micromist is a nasal spray used for localised
relief of the symptoms of a blocked nose in association
with a cold, hay fever or sinusitis (inflammation of the
passages leading to the nose). The effect of the spray
starts after several minutes and lasts for 6-8 hours. The
active substance is oxymetazoline hydrochloride.

2. Before you use Vicks Sinex Micromist
Do not use Vicks Sinex Micromist if you:
• are allergic (hypersensitive) to the active substance oxymetazoline
hydrochloride or any of the other ingredients of Vicks Sinex
Micromist (see section 6)
• are taking (or have taken during the last 14 days) monoamine
oxidase inhibitors (MAO inhibitors are used in the treatment of
Parkinson's disease and depression)
• have had an operation to remove your pituitary gland
• have inflamed skin or mucous membranes of your nostrils or have
scabs in your nose
• do not take with other medications containing decongestants
• have had nasal surgery
• suffer from a tumour of the adrenal glands

Driving and using machines
No effect on ability to drive or use of machinery has
been observed.
Important information about some of the ingredients of
Vicks Sinex Micromist
Benzalkonium chloride (a preservative) is an ingredient in
Vicks Sinex Micromist which might cause swelling of nasal
mucosa, especially during long-term use.

3. How to use Vicks Sinex Micromist
Always use Vicks Sinex Micromist exactly as your pharmacist or
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Vicks Sinex Micromist is for use in your nose only.
Dosage: The recommended dose is
Adults and Children over 12 years: 1 or 2 sprays per nostril
every 6 to 8 hours unless advised otherwise by your doctor.
Children under 12 years: Do not use
Do not exceed the recommended dose
Do not use for more than 7 days in a row.
If used over a longer period or more than the recommended
dose, Vicks Sinex Miromist may cause a blocked nose.
Contact your doctor if symptoms worsen or do not
improve after 7 days.
Administration:
1. Remove the cap. Keep the bottle upright with the
nasal applicator just into the nostril. Hold the other
nostril closed.
2. Spray and breathe in deeply through your nose at the
same time. Repeat for the other nostril.
3. Wipe the nasal applicator with a clean, wet tissue
and replace the cap immediately after application.

Sinex Micromist (Sinex Pump)
Nasal Spray 15ml (P) Submission
UK v3
293b
KA
13-2-15
Leaflet

IPMS/Supplier code:
MPMS:
Tech Drw No: 148x210 %28A5%29 LINKA 1
Region: Europe
Manf. Plant: Opava
Substrate: Paper
Printing process: letterpress
Printer: EUKER
Laetus:
SGS File Ref: 367709

REG0149452
210x148mm

Keyline
Black

Futura bold, Univers 57
cond/67 bold cond/57 cond
obl
Body copy: 8pts
Min font size used: 8pts













Take special care with Vicks Sinex Micromist
Before using tell your doctor if you have:
high blood pressure
heart disease including angina
diabetes
disturbance in your thyroid function
an enlarged prostate gland
hepatic or renal disorder
occlusive vascular disease
suffer from increased eyeball-pressure (narrow-angle glaucoma)
If any of the following occur, Vicks Sinex Micromist should be
stopped;
hallucinations
restlessness
sleep disturbances
Keep away from eyes

Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, even those obtained without a
prescription.
• monoamine oxidase inhibitors (MAOIs) are used in the
treatment of Parkinson's disease and depression

If you use more Vicks Sinex Micromist than you should
If you use too much Vicks Sinex Micromist you should contact
your doctor or go to a hospital immediately and take the bottle
or pack with you.
If you forget to use Vicks Sinex Micromist
Do not take a double dose if you forget to take the previous dose;
instead, continue using according to the administration instructions
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Vicks Sinex Micromist can cause
side effects, although not everybody gets them.
• Rare (occurring in less than 1 in 1,000):
Eye: Eye irritation, dryness, discomfort or redness
Respiratory: Discomfort or irritation in the nose, mouth or throat;
Sneezing
• Very rare (occurring in less than 1 in 10,000):
Cardiovascular: Tachycardia (rapid heartbeat), palpitations,
increased blood pressure
CNS: Insomnia (difficulty in sleeping), nervousness, tremor,
anxiety, restlessness, irritability, headache
Gastrointestinal: Nausea
• Prolonged and/or heavy use beyond the recommended use of 7
days, may in rare instances lead to cardiovascular and/or CNS
effects.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Vicks Sinex Micromist
Keep out of the reach and sight of children.

– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information
or advice.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
– You must contact your pharmacist if your symptoms
worsen or do not improve after 7 days.









- Do not use Vicks Sinex Micromist if you have taken MAOIs
during the last 14 days
tricyclic antidepressants - inform your doctor if
you are taking drugs used in the treatment of
depression such as amitriptyline and imipramine
high blood pressure medicines - inform your doctor
before use if you are taking bethanidine, debrisoquine
and guanethidine as their effect may be reduced
beta blockers - inform your doctor before use if you
are taking these, as their effect may be reduced
Parkinson's disease medicine (bromocriptine)
- treatment with Vicks Sinex Micromist may be affected if it is
used at the same time
appetite suppressants and amphetamine-like
psychostimulants - inform your doctor before use if you are
taking drugs for obesity
cardiac glycosides - inform your doctor before use as it can
cause irregular heart beat (dysrhythmias) if it is taken at the
same time
ergot alkaloids (ergotamine and methysergide) - inform
your doctor before use if you are taking these treatments for
migraines as they can cause increased side effects.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using
Vicks Sinex Micromist. The spray should be used with
caution during pregnancy or if breastfeeding.

Do not store above 25˚C.
Do not use Vicks Sinex Micromist after the expiry date which is
printed on the carton. The expiry date refers to the last day of
the month stated.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required.
These measures will help protect the environment.

6. Further information
What Vicks Sinex Micromist contains
The active substance is: oxymetazoline
hydrochloride 0.5 mg/ml. One spray gives 25µg of
oxymetazoline hydrochloride.
The other ingredients are: levomenthol, sorbitol,
sodium citrate dihydrate, polysorbate 80, citric acid anhydrous,
benzyl alcohol, benzalkonium chloride solution, camphor,
disodium edetate dihydrate, eucalyptol and purified water.
What Vicks Sinex Micromist looks like and
contents of the pack
Vicks Sinex Micromist is a metered dose nasal pump spray. The
pack contains an amber glass bottle with a white pump on top.
The bottle is filled with 15 ml of product.
Marketing Authorisation Holder:
Procter & Gamble (Health & Beauty Care) Limited,
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
(send all enquiries to this address).
Manufacturer: Teva Czech Industries s.r.o., Ostravská 29,
indication number 305, Opava-Komárov, Postal code 747 70,
Czech Republic
PL 00129/0133
Text Revision: 07/2016

PGT293b
00000000

4
10-8-16
CP

Y
-

Version 1.13
Print Spec

Approved

N
Illustrator CS6

Page 2 of 3

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 MOCKUP PIL PL00129-0133

APPROVALS
Signed by
Martina Tredget

REG0149452

Meaning of Signature
Regulatory Affairs Approval

Version 1.13

Approved

Server Date
10-Aug-2016 02:01:13 PM

Page 3 of 3

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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