RYNACROM 4% NASAL SPRAY

Active substance: SODIUM CROMOGLICATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

1. What Rynacrom Nasal Spray is and what it is used for

What Rynacrom Nasal Spray is
Rynacrom 4% Nasal Spray (called Rynacrom Nasal Spray in this
leaflet) contains a medicine called sodium cromoglicate. This
belongs to a group of medicines called anti-allergics.
How Rynacrom Nasal Spray works
It works by stopping the release of the natural substances in
your body that can lead to an allergic reaction. It also lowers
your response when you are exposed to substances to which
you are allergic. Signs of an allergic reaction include an itchy,
runny nose and sneezing.
What Rynacrom Nasal Spray is used for
Is this leaflet hard to see or read?
When used regularly, it is used to help stop nasal allergies that
Phone 01483 505515 for help
Read all of this leaflet carefully because it contains may occur
• At any time of the year (perennial allergic rhinitis) or
important information for you.
This medicine is available without prescription. However, you • During certain times of the year (seasonal allergic rhinitis or
hay fever).
still need to use Rynacrom Nasal Spray carefully to get the best
results from it.
2. Before you use Rynacrom Nasal Spray
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
Do not use this medicine and tell your doctor or
• You must contact a doctor if your symptoms worsen or do not
pharmacist if:
improve
• If any of the side effects get serious, or if you notice any side You are allergic (hypersensitive) to sodium cromoglicate, or
any of the other ingredients of Rynacrom Nasal Spray (listed
effects not listed in this leaflet, please tell your doctor or
in Section 6: Further information)
pharmacist
Signs of an allergic reaction include: a rash, swallowing or
In this leaflet:
breathing problems, swelling of your lips, face, throat or tongue
1. What Rynacrom Nasal Spray is and what it is used for
When used in the nose, signs include soreness, redness and
2. Before you use Rynacrom Nasal Spray
swelling of the nose
3. How to use Rynacrom Nasal Spray
Do not use this medicine if the above applies to you. If you
4. Possible side effects
are not sure, talk to your doctor or pharmacist before using
5. How to store Rynacrom Nasal Spray
Rynacrom Nasal Spray.
6. Further information

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are
pregnant, might become pregnant or think you may be
pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.
Important information about some of the ingredients of
Rynacrom Nasal Spray
Rynacrom Nasal Spray contains benzalkonium chloride. This
may in rare cases cause difficulty breathing, wheezing or
tightness in the chest (bronchospasm).
3. How to use Rynacrom Nasal Spray
Always use Rynacrom Nasal Spray exactly as your doctor or
pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
• Only use in your nose
• It is important you use this medicine regularly even when
you are free of the signs of allergy. This is because it works
by stopping the allergy from starting, rather than treating the
allergy that is already there
• If your symptoms worsen or do not improve, talk to your
doctor or pharmacist
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
How much Rynacrom Nasal Spray to use
• One spray into each nostril two to four times a day
How to use Rynacrom Nasal Spray:
1. Preparing the spray
• Remove the cap from bottle by
pulling upwards

2. If you are using the spray for the
first time
• Hold the bottle upright
• Pump at least 3 times until an even
spray is produced. This initial pumping
is for the purpose of filling the system
and testing the spray. It should not be
repeated after the first use in order to
avoid wasting the medicine
3. Using the spray
• Close one nostril with your finger
• Keep the bottle upright
• Bend your head slightly over the bottle
• Spray the solution into the nostril
• Breathe in gently through your nose
with your mouth closed

4. • Breathe out through your mouth

5. • Repeat for the other nostril

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 to
protect the environment.
6. Further information

What Rynacrom Nasal Spray contains
• Each spray dose contains approximately 5.2 mg of the active
substance sodium cromoglicate
• The other ingredients are disodium edetate, benzalkonium
chloride and purified water
What Rynacrom Nasal Spray looks like and contents of the
pack
If you have any further questions on the use of this Rynacrom Nasal Spray is a clear, colourless to pale yellow liquid
supplied in a 22 ml plastic bottle fitted with a metered dose
product, ask your doctor or pharmacist.
pump and plastic cover.
4. Possible side effects
Like all medicines, Rynacrom Nasal Spray can cause side effects,
Marketing Authorisation Holder and Manufacturer
although not everybody gets them.
Marketing Authorisation Holder
Stop using Rynacrom Nasal Spray and see a doctor as soon Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
as possible if:
Tel: 01483 505515
• The itching, redness or swelling gets worse or your nose Fax: 01483 535432
becomes sore. You may be allergic to these drops
email: uk-medicalinformation@sanofi.com
Talk to your doctor or pharmacist if any of the side effects Manufacturer
gets serious or lasts longer than a few days, or if you notice Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait,
any side effects not listed in this leaflet:
France
• Irritation of the nose
This leaflet does not contain all the information about your
• Wheezing or tightness in the chest
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
5. How to store Rynacrom Nasal Spray
This leaflet was last revised in August 2012
Keep this medicine in a safe place where children cannot see © Sanofi, 2001 - 2012
or reach it.
Do not use Rynacrom Nasal Spray after the expiry date which
is stated on the label and carton. The expiry date refers to the
last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order
to protect from light.
Rynacrom 519471 / 479476

6. After using the spray
• Before replacing the protective cap on
the spray, wipe the spray with a clean
tissue

If you take more Rynacrom than you should
Talk to your doctor or go to a hospital straight away. Remember
to take any medicine that is left with you so the doctor knows
what you have taken.
If you forget to use Rynacrom Nasal Spray
If you forget a dose, use it as soon as you remember it. However,
if it is nearly time for the next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.
If you stop using Rynacrom Nasal Spray
You should keep using this spray whilst you are still exposed to
the thing that you are allergic to. If you stop using Rynacrom
Nasal Spray, your allergy symptoms may come back.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1. What Rynacrom Nasal Spray is and what it is used for

What Rynacrom Nasal Spray is
Rynacrom 4% Nasal Spray (called Rynacrom Nasal Spray in this
leaflet) contains a medicine called sodium cromoglicate. This
belongs to a group of medicines called anti-allergics.
How Rynacrom Nasal Spray works
It works by stopping the release of the natural substances in
your body that can lead to an allergic reaction. It also lowers
your response when you are exposed to substances to which
you are allergic. Signs of an allergic reaction include an itchy,
runny nose and sneezing.
What Rynacrom Nasal Spray is used for
Is this leaflet hard to see or read?
When used regularly, it is used to help stop nasal allergies that
Phone 01483 505515 for help
Read all of this leaflet carefully because it contains may occur
• At any time of the year (perennial allergic rhinitis) or
important information for you.
This medicine is available without prescription. However, you • During certain times of the year (seasonal allergic rhinitis or
hay fever).
still need to use Rynacrom Nasal Spray carefully to get the best
results from it.
2. Before you use Rynacrom Nasal Spray
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
Do not use this medicine and tell your doctor or
• You must contact a doctor if your symptoms worsen or do not
pharmacist if:
improve
• If any of the side effects get serious, or if you notice any side You are allergic (hypersensitive) to sodium cromoglicate, or
any of the other ingredients of Rynacrom Nasal Spray (listed
effects not listed in this leaflet, please tell your doctor or
in Section 6: Further information)
pharmacist
Signs of an allergic reaction include: a rash, swallowing or
In this leaflet:
breathing problems, swelling of your lips, face, throat or tongue
1. What Rynacrom Nasal Spray is and what it is used for
When used in the nose, signs include soreness, redness and
2. Before you use Rynacrom Nasal Spray
swelling of the nose
3. How to use Rynacrom Nasal Spray
Do not use this medicine if the above applies to you. If you
4. Possible side effects
are not sure, talk to your doctor or pharmacist before using
5. How to store Rynacrom Nasal Spray
Rynacrom Nasal Spray.
6. Further information

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are
pregnant, might become pregnant or think you may be
pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.
Important information about some of the ingredients of
Rynacrom Nasal Spray
Rynacrom Nasal Spray contains benzalkonium chloride. This
may in rare cases cause difficulty breathing, wheezing or
tightness in the chest (bronchospasm).
3. How to use Rynacrom Nasal Spray
Always use Rynacrom Nasal Spray exactly as your doctor or
pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
• Only use in your nose
• It is important you use this medicine regularly even when
you are free of the signs of allergy. This is because it works
by stopping the allergy from starting, rather than treating the
allergy that is already there
• If your symptoms worsen or do not improve, talk to your
doctor or pharmacist
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
How much Rynacrom Nasal Spray to use
• One spray into each nostril two to four times a day
How to use Rynacrom Nasal Spray:
1. Preparing the spray
• Remove the cap from bottle by
pulling upwards

2. If you are using the spray for the
first time
• Hold the bottle upright
• Pump at least 3 times until an even
spray is produced. This initial pumping
is for the purpose of filling the system
and testing the spray. It should not be
repeated after the first use in order to
avoid wasting the medicine
3. Using the spray
• Close one nostril with your finger
• Keep the bottle upright
• Bend your head slightly over the bottle
• Spray the solution into the nostril
• Breathe in gently through your nose
with your mouth closed

4. • Breathe out through your mouth

5. • Repeat for the other nostril

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 to
protect the environment.
6. Further information

What Rynacrom Nasal Spray contains
• Each spray dose contains approximately 5.2 mg of the active
substance sodium cromoglicate
• The other ingredients are disodium edetate, benzalkonium
chloride and purified water
What Rynacrom Nasal Spray looks like and contents of the
pack
If you have any further questions on the use of this Rynacrom Nasal Spray is a clear, colourless to pale yellow liquid
supplied in a 22 ml plastic bottle fitted with a metered dose
product, ask your doctor or pharmacist.
pump and plastic cover.
4. Possible side effects
Like all medicines, Rynacrom Nasal Spray can cause side effects,
Marketing Authorisation Holder and Manufacturer
although not everybody gets them.
Marketing Authorisation Holder
Stop using Rynacrom Nasal Spray and see a doctor as soon Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
as possible if:
Tel: 01483 505515
• The itching, redness or swelling gets worse or your nose Fax: 01483 535432
becomes sore. You may be allergic to these drops
email: uk-medicalinformation@sanofi.com
Talk to your doctor or pharmacist if any of the side effects Manufacturer
gets serious or lasts longer than a few days, or if you notice Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait,
any side effects not listed in this leaflet:
France
• Irritation of the nose
This leaflet does not contain all the information about your
• Wheezing or tightness in the chest
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
5. How to store Rynacrom Nasal Spray
This leaflet was last revised in August 2012
Keep this medicine in a safe place where children cannot see © Sanofi, 2001 - 2012
or reach it.
Do not use Rynacrom Nasal Spray after the expiry date which
is stated on the label and carton. The expiry date refers to the
last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order
to protect from light.
Rynacrom 519471 / 479476

6. After using the spray
• Before replacing the protective cap on
the spray, wipe the spray with a clean
tissue

If you take more Rynacrom than you should
Talk to your doctor or go to a hospital straight away. Remember
to take any medicine that is left with you so the doctor knows
what you have taken.
If you forget to use Rynacrom Nasal Spray
If you forget a dose, use it as soon as you remember it. However,
if it is nearly time for the next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.
If you stop using Rynacrom Nasal Spray
You should keep using this spray whilst you are still exposed to
the thing that you are allergic to. If you stop using Rynacrom
Nasal Spray, your allergy symptoms may come back.

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Brand name Rynacrom
Article
Leaflet
Dosage
Item code 519471
40 mg/ml
Quantity
Based on 517275
22 ml
Manuf. site
GMID code 479476
Le Trait
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Date of creation
21/08/2012
By
F Nguyen
Date of modification 03/09/2012
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

1802
TRA - P040146b
TRA-P040146-1b
280x150 flat
27x150 mm folded

1. What Rynacrom Nasal Spray is and what it is used for

What Rynacrom Nasal Spray is
Rynacrom 4% Nasal Spray (called Rynacrom Nasal Spray in this
leaflet) contains a medicine called sodium cromoglicate. This
belongs to a group of medicines called anti-allergics.
How Rynacrom Nasal Spray works
It works by stopping the release of the natural substances in
your body that can lead to an allergic reaction. It also lowers
your response when you are exposed to substances to which
you are allergic. Signs of an allergic reaction include an itchy,
runny nose and sneezing.
What Rynacrom Nasal Spray is used for
Is this leaflet hard to see or read?
When used regularly, it is used to help stop nasal allergies that
Phone 01483 505515 for help
Read all of this leaflet carefully because it contains may occur
• At any time of the year (perennial allergic rhinitis) or
important information for you.
This medicine is available without prescription. However, you • During certain times of the year (seasonal allergic rhinitis or
hay fever).
still need to use Rynacrom Nasal Spray carefully to get the best
results from it.
2. Before you use Rynacrom Nasal Spray
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
Do not use this medicine and tell your doctor or
• You must contact a doctor if your symptoms worsen or do not
pharmacist if:
improve
You are allergic (hypersensitive) to sodium cromoglicate, or
• If any of the side effects get serious, or if you notice any side
any of the other ingredients of Rynacrom Nasal Spray (listed
effects not listed in this leaflet, please tell your doctor or
in Section 6: Further information)
pharmacist
Signs of an allergic reaction include: a rash, swallowing or
In this leaflet:
breathing problems, swelling of your lips, face, throat or tongue
1. What Rynacrom Nasal Spray is and what it is used for
When used in the nose, signs include soreness, redness and
2. Before you use Rynacrom Nasal Spray
swelling of the nose
3. How to use Rynacrom Nasal Spray
Do not use this medicine if the above applies to you. If you
4. Possible side effects
are not sure, talk to your doctor or pharmacist before using
5. How to store Rynacrom Nasal Spray
Rynacrom Nasal Spray.
6. Further information

Pharmacode
Brandmark/name
Country example
Font size

176
A1 - 06.10.2006
CRGB - V1 - 05/2012
10 pt
Plan

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are
pregnant, might become pregnant or think you may be
pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.
Important information about some of the ingredients of
Rynacrom Nasal Spray
Rynacrom Nasal Spray contains benzalkonium chloride. This
may in rare cases cause difficulty breathing, wheezing or
tightness in the chest (bronchospasm).
3. How to use Rynacrom Nasal Spray
Always use Rynacrom Nasal Spray exactly as your doctor or
pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
• Only use in your nose
• It is important you use this medicine regularly even when
you are free of the signs of allergy. This is because it works
by stopping the allergy from starting, rather than treating the
allergy that is already there
• If your symptoms worsen or do not improve, talk to your
doctor or pharmacist
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
How much Rynacrom Nasal Spray to use
• One spray into each nostril two to four times a day
How to use Rynacrom Nasal Spray:
1. Preparing the spray
• Remove the cap from bottle by
pulling upwards

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Brand name Rynacrom
Article
Leaflet
Dosage
Item code 519471
40 mg/ml
Quantity
Based on 517275
22 ml
Manuf. site
GMID code 479476
Le Trait
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

2. If you are using the spray for the
first time
• Hold the bottle upright
• Pump at least 3 times until an even
spray is produced. This initial pumping
is for the purpose of filling the system
and testing the spray. It should not be
repeated after the first use in order to
avoid wasting the medicine
3. Using the spray
• Close one nostril with your finger
• Keep the bottle upright
• Bend your head slightly over the bottle
• Spray the solution into the nostril
• Breathe in gently through your nose
with your mouth closed

4. • Breathe out through your mouth

5. • Repeat for the other nostril

PAD
Tech. specif.
Tech. area
Size (mm)

1802
TRA - P040146b
TRA-P040146-1b
280x150 flat
27x150 mm folded

If you take more Rynacrom than you should
Talk to your doctor or go to a hospital straight away. Remember
to take any medicine that is left with you so the doctor knows
what you have taken.
If you forget to use Rynacrom Nasal Spray
If you forget a dose, use it as soon as you remember it. However,
if it is nearly time for the next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.
If you stop using Rynacrom Nasal Spray
You should keep using this spray whilst you are still exposed to
the thing that you are allergic to. If you stop using Rynacrom
Nasal Spray, your allergy symptoms may come back.

Pharmacode
Brandmark/name
Country example
Font size

176
A1 - 06.10.2006
CRGB - V1 - 05/2012
10 pt
Plan

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 to
protect the environment.
6. Further information

What Rynacrom Nasal Spray contains
• Each spray dose contains approximately 5.2 mg of the active
substance sodium cromoglicate
• The other ingredients are disodium edetate, benzalkonium
chloride and purified water
What Rynacrom Nasal Spray looks like and contents of the
pack
If you have any further questions on the use of this Rynacrom Nasal Spray is a clear, colourless to pale yellow liquid
supplied in a 22 ml plastic bottle fitted with a metered dose
product, ask your doctor or pharmacist.
pump and plastic cover.
4. Possible side effects
Like all medicines, Rynacrom Nasal Spray can cause side effects,
Marketing Authorisation Holder and Manufacturer
although not everybody gets them.
Marketing Authorisation Holder
Stop using Rynacrom Nasal Spray and see a doctor as soon Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
as possible if:
Tel: 01483 505515
• The itching, redness or swelling gets worse or your nose Fax: 01483 535432
becomes sore. You may be allergic to these drops
email: uk-medicalinformation@sanofi.com
Talk to your doctor or pharmacist if any of the side effects Manufacturer
gets serious or lasts longer than a few days, or if you notice Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait,
any side effects not listed in this leaflet:
France
• Irritation of the nose
This leaflet does not contain all the information about your
• Wheezing or tightness in the chest
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
5. How to store Rynacrom Nasal Spray
This leaflet was last revised in August 2012
Keep this medicine in a safe place where children cannot see © Sanofi, 2001 - 2012
or reach it.
Do not use Rynacrom Nasal Spray after the expiry date which
is stated on the label and carton. The expiry date refers to the
last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order
to protect from light.
Rynacrom 519471 / 479476

6. After using the spray
• Before replacing the protective cap on
the spray, wipe the spray with a clean
tissue

Date of creation
21/08/2012
By
F Nguyen
Date of modification 03/09/2012
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

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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