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VICKS SINEX SOOTHER NASAL SPRAY

Active substance(s): OXYMETAZOLINE HYDROCHLORIDE

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Vicks Sinex Soother 0.5 mg/ml Nasal Spray, Solution Oxymetazoline hydrochloride
Package leaflet: Information for the user
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist have told
you.
This medicine is available without prescription.
However, you still need to use Vicks Sinex Soother
carefully to get the best results from it.

What is in this leaflet:
1. What Vicks Sinex Soother is and what it is
used for
2. What you need to know before you use Vicks
Sinex Soother
3. How to use Vicks Sinex Soother
4. Possible side effects
5. How to store Vicks Sinex Soother
6. Contents of the pack and other information

- 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 talk to a doctor if you do not feel better
or if you feel worse after 3 days.

1. What Vicks Sinex Soother is and what
it is used for

• Beta blockers or high blood pressure
medicines - inform your doctor before use if you
are taking any of these.
• Parkinson’s disease medicine (bromocriptine)
- inform your doctor before use if you are taking this
medicine.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this
medicine.
The spray should be used with caution during
pregnancy or if breast feeding.
Driving and using machines
Vicks Sinex Soother has no influence on the ability
to drive or use machines.
Vicks Sinex Soother contains Benzalkonium
chloride
Benzalkonium chloride (a preservative) is an
ingredient in Vicks Sinex Soother which might cause
swelling of nasal mucosa, especially during longterm use.

2.








• if you have inflamed skin or mucous membranes of
your nostrils or have scabs in your nose
Do not give this medicine to children under
Vicks Sinex Soother is a nasal spray used for
12 years of age.
localised relief of the symptoms of a blocked nose in
Warnings and precautions
association with a cold or rhinitis.
Talk to your doctor or pharmacist before using
The effect of the spray starts after several minutes
Vicks Sinex Soother if you have:
and lasts for 6 – 8 hours.
• high blood pressure
What you need to know before you use
• heart disease, including angina
Vicks Sinex Soother
• diabetes
• thyroid problems
Do not use Vicks Sinex Soother:
• enlarged prostate gland (prostatic hypertrophy)
if you are allergic (hypersensitive) to the active
substance oxymetazoline hydrochloride or any of the
Other medicines and Vicks Sinex Soother
other ingredients of this medicine (listed in section 6)
Tell your doctor or pharmacist if you are taking,
if you are taking (or have taken during the last
or have recently taken or might take any other
2 weeks) monoamine oxidase inhibitors (MAO
medicines
inhibitors are used in the treatment of Parkinson’s
• monoamine oxidase inhibitors (MAOIs) are
disease and depression)
used in the treatment of Parkinson’s disease and
if you suffer from acute heart disease or cardiac
depression). Do not use Vicks Sinex Soother if you
asthma
have taken MAOIs during the last two weeks.
if you suffer from increased eyeball-pressure
• tricyclic antidepressants – inform your doctor
(narrow-angle glaucoma)
if you are taking drugs used in the treatment of
if you have had an operation to remove your
depression such as amitriptyline and imipramine.
pituitary gland

By Richard Meggison (3 Jun 2015, 10:56 am)

Vicks Sinex Soother Nasal Spray
0.5mg/ml 15ml (P) UK v3 sub

330b
27-2-15

YA
Leaflet

210 x 148mm

REG0149827

Version 2.2

Approved

IPMS:
MPMS:
Tech Drw No: 148x210 (A5)
LINKA 1_leaflet
Region: Europe
Manf. Plant: Opava
Substrate:
Printing Process:
Printer:
Laetus:
SGS File Reference: H26913

Cutter guide
Black

Futura bold,
Univers Cond All
Body copy: 8.7pts
Min font size (codes):
7pts

Indesign CS6

3
2-6-15
NMG

initial: YA

Page 1 of 5

3. How to use Vicks Sinex Soother

1.
2.
3.
4.

REG0149827

Always use this medicine exactly as described in
this leaflet or as your doctor or your pharmacist have
told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is:
Adults and children over 12 years: 1-2 sprays
in each nostril no more than 2-3 times daily.
Children under 12 years – Do not use.
Do not exceed the recommended dose.
Do not use for longer than 5-7 days in a row.
If used over a longer period, Vicks Sinex Soother
may cause a blocked nose.
Contact your doctor if symptoms worsen or do not
improve after 3 days.
Method of administration:
Remove the cap. Keep the bottle upright with the
nasal applicator just into the nostril. Hold the other
nostril closed.
Spray and breathe in deeply through your nose at the
same time. Repeat for the other nostril.
Adults and children over 12 years may repeat steps
1 and 2 once if necessary.
Wipe the nasal applicator with a clean, wet tissue
and replace the cap immediately after application.
If you use more Vicks Sinex Soother than you
should
If you use too much Vicks Sinex Soother and you
experience any unwanted effects or symptoms, seek
medical advice immediately and take the bottle or
pack with you.
If you forget to use Vicks Sinex Soother
Do not take a double dose to make up for a forgotten
dose; instead, continue using according to the
administration instructions.

Version 2.2

If you have any further questions on the use of
thismedicine, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• Uncommon (may affect up to 1 in 100 people):
Sneezing, dryness or irritation in the nose, mouth
or throat.
• Rare (may affect up to 1 in 1000 people):
Anxiety, fatigue, irritability, disturbed sleep in
children, rapid heartbeat, palpitations, raised blood
pressure, blocked nose, swelling of the nasal
lining, headache, nausea, flushing, rash and visual
disturbances.
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 Soother

Keep this medicine out of the sight and reach
of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which
is stated on the carton and label of the bottle after
EXP. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

Approved

6. Contents of the pack and other information

What Vicks Sinex Soother contains
The active substance is: oxymetazoline
hydrochloride 0.5 mg/ml. One spray (equivalent to
0.05 ml) contains approximately 25 micrograms
oxymetazoline hydrochloride.
The other ingredients are: sorbitol, sodium citrate,
polysorbate 80, benzyl alcohol, citric acid anhydrous,
benzalkonium chloride solution, acesulfame
potassium, levomenthol, cineole, disodium edetate,
aloes dry extract, levocarvone, water, purified.
(See section 2 Vicks Sinex Soother contains
Benzalkonium chloride).
What Vicks Sinex Soother looks like and
contents of the pack
Vicks Sinex Soother nasal spray solution 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Procter & Gamble(Health & Beauty Care) Limited,
Weybridge, Surrey KT13 0XP United Kingdom
Manufacturer:
Teva Czech Industries s.r.o.
Ostravská 29, indication number 305,
Opava-Komárov, Postal code 747 70,
Czech Republic
PL 00129/0356
This leaflet was last revised in 06/2015.
PGT330b
00000000

Page 2 of 5

Vicks Sinex Soother 0.5 mg/ml Nasal Spray, Solution Oxymetazoline hydrochloride
Package leaflet: Information for the user
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist have told
you.
This medicine is available without prescription.
However, you still need to use Vicks Sinex Soother
carefully to get the best results from it.

What is in this leaflet:
1. What Vicks Sinex Soother is and what it is
used for
2. What you need to know before you use Vicks
Sinex Soother
3. How to use Vicks Sinex Soother
4. Possible side effects
5. How to store Vicks Sinex Soother
6. Contents of the pack and other information

- 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 talk to a doctor if you do not feel better
or if you feel worse after 3 days.

1. What Vicks Sinex Soother is and what
it is used for

• Beta blockers or high blood pressure
medicines - inform your doctor before use if you
are taking any of these.
• Parkinson’s disease medicine (bromocriptine)
- inform your doctor before use if you are taking this
medicine.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this
medicine.
The spray should be used with caution during
pregnancy or if breast feeding.
Driving and using machines
Vicks Sinex Soother has no influence on the ability
to drive or use machines.
Vicks Sinex Soother contains Benzalkonium
chloride
Benzalkonium chloride (a preservative) is an
ingredient in Vicks Sinex Soother which might cause
swelling of nasal mucosa, especially during longterm use.

2.








• if you have inflamed skin or mucous membranes of
your nostrils or have scabs in your nose
Do not give this medicine to children under
Vicks Sinex Soother is a nasal spray used for
12 years of age.
localised relief of the symptoms of a blocked nose in
Warnings and precautions
association with a cold or rhinitis.
Talk to your doctor or pharmacist before using
The effect of the spray starts after several minutes
Vicks Sinex Soother if you have:
and lasts for 6 – 8 hours.
• high blood pressure
What you need to know before you use
• heart disease, including angina
Vicks Sinex Soother
• diabetes
• thyroid problems
Do not use Vicks Sinex Soother:
• enlarged prostate gland (prostatic hypertrophy)
if you are allergic (hypersensitive) to the active
substance oxymetazoline hydrochloride or any of the
Other medicines and Vicks Sinex Soother
other ingredients of this medicine (listed in section 6)
Tell your doctor or pharmacist if you are taking,
if you are taking (or have taken during the last
or have recently taken or might take any other
2 weeks) monoamine oxidase inhibitors (MAO
medicines
inhibitors are used in the treatment of Parkinson’s
• monoamine oxidase inhibitors (MAOIs) are
disease and depression)
used in the treatment of Parkinson’s disease and
if you suffer from acute heart disease or cardiac
depression). Do not use Vicks Sinex Soother if you
asthma
have taken MAOIs during the last two weeks.
if you suffer from increased eyeball-pressure
• tricyclic antidepressants – inform your doctor
(narrow-angle glaucoma)
if you are taking drugs used in the treatment of
if you have had an operation to remove your
depression such as amitriptyline and imipramine.
pituitary gland

Vicks Sinex Soother Nasal Spray
0.5mg/ml 15ml (P) UK v3 sub

330b
27-2-15

YA
Leaflet

210 x 148mm

REG0149827

Version 2.2

Approved

IPMS:
MPMS:
Tech Drw No: 148x210 (A5)
LINKA 1_leaflet
Region: Europe
Manf. Plant: Opava
Substrate:
Printing Process:
Printer:
Laetus:
SGS File Reference: H26913

Cutter guide
Black

Futura bold,
Univers Cond All
Body copy: 8.7pts
Min font size (codes):
7pts

Indesign CS6

3
2-6-15
NMG

initial: YA

Page 3 of 5

3. How to use Vicks Sinex Soother

1.
2.
3.
4.

REG0149827

Always use this medicine exactly as described in
this leaflet or as your doctor or your pharmacist have
told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is:
Adults and children over 12 years: 1-2 sprays
in each nostril no more than 2-3 times daily.
Children under 12 years – Do not use.
Do not exceed the recommended dose.
Do not use for longer than 5-7 days in a row.
If used over a longer period, Vicks Sinex Soother
may cause a blocked nose.
Contact your doctor if symptoms worsen or do not
improve after 3 days.
Method of administration:
Remove the cap. Keep the bottle upright with the
nasal applicator just into the nostril. Hold the other
nostril closed.
Spray and breathe in deeply through your nose at the
same time. Repeat for the other nostril.
Adults and children over 12 years may repeat steps
1 and 2 once if necessary.
Wipe the nasal applicator with a clean, wet tissue
and replace the cap immediately after application.
If you use more Vicks Sinex Soother than you
should
If you use too much Vicks Sinex Soother and you
experience any unwanted effects or symptoms, seek
medical advice immediately and take the bottle or
pack with you.
If you forget to use Vicks Sinex Soother
Do not take a double dose to make up for a forgotten
dose; instead, continue using according to the
administration instructions.

Version 2.2

If you have any further questions on the use of
thismedicine, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• Uncommon (may affect up to 1 in 100 people):
Sneezing, dryness or irritation in the nose, mouth
or throat.
• Rare (may affect up to 1 in 1000 people):
Anxiety, fatigue, irritability, disturbed sleep in
children, rapid heartbeat, palpitations, raised blood
pressure, blocked nose, swelling of the nasal
lining, headache, nausea, flushing, rash and visual
disturbances.
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 Soother

Keep this medicine out of the sight and reach
of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which
is stated on the carton and label of the bottle after
EXP. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

Approved

6. Contents of the pack and other information

What Vicks Sinex Soother contains
The active substance is: oxymetazoline
hydrochloride 0.5 mg/ml. One spray (equivalent to
0.05 ml) contains approximately 25 micrograms
oxymetazoline hydrochloride.
The other ingredients are: sorbitol, sodium citrate,
polysorbate 80, benzyl alcohol, citric acid anhydrous,
benzalkonium chloride solution, acesulfame
potassium, levomenthol, cineole, disodium edetate,
aloes dry extract, levocarvone, water, purified.
(See section 2 Vicks Sinex Soother contains
Benzalkonium chloride).
What Vicks Sinex Soother looks like and
contents of the pack
Vicks Sinex Soother nasal spray solution 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Procter & Gamble(Health & Beauty Care) Limited,
Weybridge, Surrey KT13 0XP United Kingdom
Manufacturer:
Teva Czech Industries s.r.o.
Ostravská 29, indication number 305,
Opava-Komárov, Postal code 747 70,
Czech Republic
PL 00129/0356
This leaflet was last revised in 06/2015.
PGT330b
00000000

Page 4 of 5

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-PL00129-0356

APPROVALS
Signed by
Martina Tredget

REG0149827

Meaning of Signature
Regulatory Affairs Approval

Version 2.2

Approved

Server Date
16-Sep-2015 03:10:49 PM

Page 5 of 5

Expand view ⇕

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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