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HAPPINOSE 0.3% OINTMENT

Active substance(s): LEVOMENTHOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Happinose



BAL M

0.3% w/w levomenthol ointment

Please read all of this leaflet carefully before you start using this product.
This medicine is available without prescription. However, you still need to use it carefully
to get the best results from it. Keep this leaflet. You may need to read it again. Ask your
doctor or pharmacist if you need more information or advice. You must contact a doctor
or pharmacist if your symptoms do not improve after 10 to 14 days. If any of the side
effects gets serious, or if you notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1. What Happinose is and what it is used for
2. Before you use Happinose
3. How to use Happinose
4. Possible side effects
5. How to store Happinose
6. Further information

1. WHAT HAPPINOSE IS AND WHAT IT IS USED FOR
• Happinose is a soothing balm for application in and around the nose
to relieve congestion (blocked nose) associated with the common cold,
catarrh, head colds and hay fever.
• If you wish to, you may also massage it onto the lips, throat, chest and
between the shoulders.
• Happinose is suitable for use by adults, the elderly and children over
5 years old.
• The active ingredient in this product is levomenthol.
• When inhaled, the levomenthol produces a cooling sensation in the nasal
passages, helping to relieve the symptoms of congestion. The lubricating
ointment base also helps to soothe irritated skin around the nose.

2. BEFORE YOU USE HAPPINOSE
Do not use Happinose if you are allergic (hypersensitive) to levomenthol
or any of the other ingredients of Happinose listed in Section 6.
Do not use it on children under the age of 5 years.
Take special care with this product:
• Keep the product away from the eyes.
• Wash hands after use.
Using other medicines
This product is not known to affect, or to be affected by, any other medicines.
Pregnancy and breast-feeding
This product can be used during pregnancy and while breast-feeding. The ingredients
have been in widespread use in this and similar preparations for many years,
without reports of problems. However, safety trials have not been conducted.
Driving and using machinery
Using this product is not known to affect your ability to drive or use machinery.
Use it only in and around the nose, on the lips, throat, chest and between the shoulders.
Before you use this tube for the first time, open it as follows:
Unscrew the cap, turn it upside down and use the sharp point in the top of the
cap to pierce the tube membrane.
For adults:
• Blow the nose.
• Using the little finger, carefully apply up to 1 cm of Happinose in and around
each nostril, and then inhale through the nose.
Continued overleaf

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3. HOW TO USE HAPPINOSE

• You may also gently massage the ointment onto the lips, throat,
chest and between the shoulders.
• Re-apply every 4 hours or as required.
• Wash hands after use.
• If your symptoms last for longer than 10 to 14 days, tell your doctor
or pharmacist.
For children, 10 years and over:
Follow the above instructions for adults, but using up to ½ cm of ointment
in and around each nostril.
Children, between 5 to 9 years:
Follow the above instructions for adults, but using up to ¼ cm of ointment
in and around each nostril.
If the ointment accidentally gets into the eyes, it may cause irritation.
If this happens, rinse the eyes with plenty of water. If rinsing one eye, take care
to avoid washing product into the other eye. If irritation persists, tell your
doctor or pharmacist.
If you forget to use Happinose
Do not worry if you occasionally forget to use this product, just carry on using
it when you remember.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Happinose can cause side effects although not everybody
gets them.
In some rare cases, irritant or allergic skin reactions (involving itching,
swelling and redness) may occur on extremely sensitive skin.
• Stop using this product if it feels uncomfortable.
• Stop using this product and tell your doctor or pharmacist if any side effect
gets serious, or if you notice any other side effect not mentioned in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 HAPPINOSE









Keep out of the reach and sight of children.
Do not use Happinose after the expiry date shown on the fold of the tube
and on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Always replace the cap after use.
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.

What Happinose contains:
The active ingredient is levomenthol (0.3% w/w).
The other ingredients are cineole (eucalyptol), geranium oil, white soft paraffin,
and light liquid paraffin.
What Happinose looks like and contents of the pack
The product is a translucent ointment.
The product is available in aluminium tubes containing 14 g and fitted with screw caps.
The Marketing Authorisation holder is Diomed Developments Ltd,
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is Aeropak, Viking Road, Great Yarmouth, Norfolk,
NR31 0NU, UK.
The Distributor is DDD Limited, 94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This Patient Information Leaflet was last revised in January 2015.
To listen to or request a copy of this leaflet in Braille, large print or audio,
please call free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Happinose Ointment, 00173/0177.
This is a service provided by the Royal National Institute of Blind People.

HD4/15/1 201343

6. FURTHER INFORMATION ABOUT HAPPINOSE

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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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