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FENBID 10 %W/W GEL

Active substance(s): IBUPROFEN

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Phorpain® Maximum Strength 10% w/w Gel
Ibuprofen
Read all of this leaflet carefully before you
start taking this medicine.
Keep this leaflet.You may need to read it again. If
you have any further questions, ask your doctor
or pharmacist. This medicine has been prescribed
for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours. If any of the side effects gets serious, or if
you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What is Phorpain® Maximum Strength 10% w/w
Gel and what it is used for
2. Before you use Phorpain® Maximum Strength
10% w/w Gel
3. How to use Phorpain® Maximum Strength 10%
w/w Gel
4. Possible side effects
5. How to store Phorpain® Maximum Strength
10% w/w Gel
6. Further information
1. WHAT IS PHORPAIN MAXIMUM STRENGTH
10% W/W GEL AND WHAT IT IS USED FOR
Phorpain® Maximum Strength 10% w/w Gel
contains ibuprofen and belongs to a group of
medicines called non-steroid anti-Inflammatory
drugs (NSAIDs). These medicines reduce pain and
inflammation, and bring down a high temperature.
Phorpain® Maximum Strength 10% w/w Gel is used
to treat a number of painful conditions affecting the
joints and muscles such as back pain, sprains,
strains and other sport injuries. It is also used for the
relief of pain caused by mild to moderate arthritic
conditions and nerve pain (neuralgia).
®

2. BEFORE YOU USE PHORPAIN® MAXIMUM
STRENGTH 10% W/W GEL
DO NOT use Phorpain® Maximum Strength
10% w/w Gel:
• If you are allergic to ibuprofen, aspirin or similar
medicines (e.g NSAIDs) or any of the other
ingredients in this gel (listed at the end of this leaflet)
• If you are asthmatic, or suffer from rhinitis
(allergic runny nose) or urticaria (hives)
• On broken, damaged, infected or diseased skin.

Take special care with Phorpain® Maximum
Strength 10% w/w Gel
• Protect treated areas from direct sunlight to
avoid any sensitivity reaction, e.g. a rash
• You have had an ulcer or some other problem
affecting your stomach, or intestines in the past
• You have asthma or wheezing attacks (or if you
have had asthma in the past)
• You have any kidney problems
• If you develop a rash after using the gel stop
using it any further
• If you suffer from bronchial asthma or any
allergic disease.
If any of the above apply to you, only use this
product on advice from your doctor or pharmacist.
PHORPAIN GEL IS FOR EXTERNAL USE ONLY.
Taking / Using other medicines:
Can you take Phorpain Gel with other medicines?
Please inform your doctor or pharmacist if you are
taking, or have recently taken any other medicine,
even those not prescribed by a doctor.
The effect of this medicine may affect or be
affected by taking the following medicines at the
same time:
• Medicines to lower your blood pressure
(e.g. atenolol)
• Medicines used to thin the blood (e.g. warfarin)
• Aspirin or other NSAIDs (including other forms
of Ibuprofen), used for pain and inflammation.
Please tell your doctor or pharmacist if you are
taking any of the above, or have recently taken
any other medicine - even those not prescribed.
Pregnancy and breast feeding
You should not use Phorpain® Maximum Strength
10% w/w Gel if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Phorpain® Maximum Strength 10% w/w Gel should
not affect the ability to drive or use machines.
3. HOW TO USE PHORPAIN MAXIMUM
STRENGTH 10% W/W GEL
®

Phorpain® Maximum Strength 10% w/w Gel is
designed for topical (on the skin) application
only. Never take the gel by mouth.

pharmacode read direction

Patient Information Leaflet

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:
Dimension:
Commodity No.:
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100181/LF/049/04
Phorpain Maximum
Strength 10% w/w Gel
100 g
Leaflet
100181
UK
Farmasierra
1
10/12/2015
AMCo.CRF.392.2015
148 x 210 mm
17006/5
54
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

07/01/2016
8 pt

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Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

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PAGE 1 OF 2

Always use Phorpain® Maximum Strength 10% w/w
Gel exactly as this leaflet tells you. You should check
with your doctor or pharmacist if you are not sure.
Check the seal is intact before first use (invert cap
to break seal).
Adults: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of
gel from the tube on affected area.
Massage until absorbed. This dose should not be
repeated more frequently than every four hours
and no more than four times a day in any 24 hour
period. The amount of gel squeezed would be
equivalent to 50 to 125mg of ibuprofen.
Phorpain® Maximum Strength 10% w/w Gel
should only be used on healthy, unbroken skin.
Do not use it on or near cuts or grazes or under
dressings such as plasters. Also, do not use it on
the genital area.
Do not let any gel come in contact with your eyes.
If it does, rinse your eyes with cold water and
consult your doctor. Hands should be washed
after applying Phorpain® Maximum Strength 10%
w/w Gel, unless they are the site of treatment.
If the condition does not improve after two weeks
use, or becomes worse at any time, speak to your
doctor or pharmacist.
Children: Phorpain® Maximum Strength 10% w/w
Gel is not recommended for use in children under
12 years.
If the gel is accidentally swallowed:
If you accidentally swallow any Phorpain®
Maximum Strength 10% w/w Gel, rinse out your
mouth thoroughly and contact your doctor, or
nearest hospital, as soon as possible. If
swallowed, the gel may cause an upset stomach.
If you forget to use your Phorpain® Maximum
Strength 10% w/w Gel:
If you miss a dose, just carry on with the next dose
as normal. Do not apply a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Phorpain Gel can cause side
effects, although not everybody gets them.
All medicines can cause allergic reactions
although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body)
should be reported to a doctor immediately.
Other side effects include:
• Itching or reddening of the skin
• Abdominal Pain (pains in your stomach) or other
abnormal stomach symptoms
• A burning feeling
• Sore or weeping spots
• Kidney problems (particularly in people who
have a history of kidney disease).

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 PHORPAIN® MAXIMUM
GEL STRENGTH 10% W/W
Keep this medicine out of the sight and reach of
children.
Do not use Phorpain® Maximum Strength 10%
w/w Gel after the expiry date which is stated on
the tube. The expiry date refers to the last day of
that month. It should be stored in a cool, dry
place, below 25oC. Keep the tube tightly closed.
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.
Remember:
This medicine is for you. Never give this
medicine to someone else, it could harm them,
even if their symptoms seem the same as yours.
6. FURTHER INFORMATION
What Phorpain® Maximum Strength 10% w/w
Gel contains:
The active substance is ibuprofen. Other
ingredients are hydroxyethylcellulose, sodium
hydroxide, benzyl alcohol, isopropyl alcohol,
purified water.
What Phorpain® Maximum Strength 10% w/w
Gel looks like and contents of the pack:
Phorpain® Maximum Strength 10% w/w Gel is
supplied in aluminium tubes containing 100g gel.
Marketing Authorisation Holder
Mercury Pharma Group Ltd.,
No. 1 Croydon, 12-16 Addiscombe Road,
Croydon CR0 0XT, UK.
Manufacturer:
Farmasierra Manufacturing S.L.
Carretera De Irun KM 26,200 28700,
SAN Sebastian De Los Reyes, Madrid, Spain.
This leaflet was last revised in November 2015.
Phorpain is the registered trade mark of Mercury
Pharma Group Ltd.
© Mercury Pharma Group Ltd. 2000
100181/LF/049/04
17006/5

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:
Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

100181/LF/049/04
Phorpain Maximum
Strength 10% w/w Gel
100 g
Leaflet
100181
UK
Farmasierra
1
10/12/2015
AMCo.CRF.392.2015
148 x 210 mm
17006/5
54
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

07/01/2016
8 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

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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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