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PHORPAIN 5% W/W GEL

Active substance(s): IBUPROFEN

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Patient Information Leaflet

Phorpain® 5% 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 recommended 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 Gel and what it is used for
2. Before you use Phorpain Gel
3. How to use Phorpain Gel
4. Possible side effects
5. How to store Phorpain Gel
6. Further information
1. WHAT IS PHORPAIN GEL AND
WHAT IT IS USED FOR
Phorpain 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 Gel is used to treat a number of painful
conditions affecting the joints and muscles, such
as backache, rheumatic and muscular pain,
sprains, strains and sports injuries. It is also used
to treat pain from non-serious arthritic conditions
and nerve pain (neuralgia).
2. BEFORE YOU USE PHORPAIN GEL
DO NOT use Phorpain 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 Gel
• Protect treated areas from direct sunlight to
avoid any sensitivity reaction, e.g. a rash
• If you suffer from bronchial asthma or any
allergic disease.

• If you have had an ulcer or some other
problem affecting your stomach or
intestines in the past
• If you have asthma or wheezing attacks
(or if you have had asthma in the past)
• If you have any kidney problems
• If you develop a rash after using the gel stop
using it any further
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 Gel if you are
pregnant or breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Phorpain Gel should not affect the ability to drive
or use machines.
3. HOW TO USE PHORPAIN GEL
Phorpain Gel is designed for topical (on the
skin) application only. Never take the gel by
mouth.
Always use Phorpain Gel exactly as this leaflet
tells you. You should check with your doctor or
pharmacist if you are not sure.

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

100039/LF/049/05

Phorpain Gel 5%
100 g
Leaflet
100039
UK
Farmasierra
1
16/12/2015

AMCo.CRF.392.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

148 x 210 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours:

Cutter

Tech App. Date:
Min. Font Size:

11/01/2016
9 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 Amdipharm have license approval to
distribute this component for sale in the relevant market.
Accept Artwork ....................................................................
Reject Artwork ....................................................................
Signature ............................................................................
Name ..................................................................................
Date ....................................................................................

PAGE 1 OF 2

Check the seal is intact before first use (invert
cap to break seal).
Adults: Squeeze 4 to 10cm (i.e. 1.6 to 4 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 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 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 Gel is not recommended for
use in children under 12 years.
If the gel is accidentally swallowed:
If you accidentally swallow any Phorpain 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 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.
Side effects include:
• Itching or reddening of the skin
• A burning feeling
• Sore or weeping spots
• Abdominal Pain (pains in your stomach) or
other abnormal stomach symptoms
• 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 GEL
KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not use Phorpain 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.

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

100039/LF/049/05

Phorpain Gel 5%
100 g
Leaflet
100039
UK
Farmasierra
1
16/12/2015

AMCo.CRF.392.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

148 x 210 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours:

Cutter

Tech App. Date:
Min. Font Size:

11/01/2016
9 pt

6. FURTHER INFORMATION
What Phorpain Gel contains
The active substance is ibuprofen. Other ingredients
are hydroxyethylcellulose, sodium hydroxide, benzyl
alcohol, isopropyl alcohol, purified water.
What Phorpain Gel looks like and contents of
the pack
Phorpain Gel is supplied in aluminium tubes
containing 100g gel.
Marketing Authorisation Holder
Mercury Pharma Group Ltd,
Capital House, 85 King William Street,
London EC4N 7BL, 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
100039/LF/049/05
14313/8

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 Amdipharm have license approval to
distribute this component for sale in the relevant market.
Accept Artwork ....................................................................
Reject Artwork ....................................................................
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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