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IBUTOP RALGEX IBUPROFEN GEL

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Ibutop
Ralgex
Ibuprofen gel
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before starting to use the gel.
What the gel contains
The transparent gel contains ibuprofen 5% w/w. This substance is one of a group of a
medicines called non-steroidal anti-inflammatory agents. Ibuprofen has analgesic
(painkilling), anti-inflammatory (reduces swelling), and anti-pyretic (tempature
reducing) properties.
The gel also contains isopropyl alcohol, solketal, poloxamer 407, miglyol 812, water,
lavender oil and neroli oil
What is the gel used for?
For the relief of rheumatic pain, muscular aches, pains and swelling such as strains,
sprains and sports injuries
Who supplies this gel?
The Product Licence Holder is Seton Healthcare Group plc, Tubiton house, Oldham
0L1 3HA. It is manufactured by Seton Prebbles Ltd, st Johns Rd, Bootle, Merseyside
L20 8NJ.
The distributor is Seton Healthcare Group plc, Tubiton House, Oldham OL1 3HS
Before you use this medicine
• Are you sensitive to ibuprofen or to any of the other ingredients listed above?
• Are you pregnant or breast feeding an infant?
• Do you suffer from asthma, rhinitis or urticaria?
• Are you allergic to aspirin or other non-steroidal anti-inflammatory drugs?
• Are you taking aspirin or any other pain relieving medicines?
If you answer YES to any of the above, do not use the gel. Talk to your doctor or
pharmacist.
What precautions should you take?
• Apply the gel with gentle massage
• Do not use Ralgex Ibuprofen Gel on children under 12 years of age
• Do not apply to inflamed or broken skin, lips or near the eyes
• Stop use if a rash develops
• Do not put a plaster or dressing on the same area after applying the gel
• Wash hands straight away after applying the gel
How should you use this medicine?
The gel is only for use on the skin

Adults, the Elderly and children over 12 years:
• The recommended dose of Ibuprofen is 50-125mg 3-4 times daily. 2.56.25cm (1-2.5 inches) strip of gel is equivalent to about 50 – 125mg of
ibuprofen.
• Check the seal is unbroken before first use.
• Apply the gel to the affected area 3 -4 times daily. Squeeze approximately 2.5
to 6.25cm (1 – 2.5 inches) of the gel and rub gently into the skin.
• Do not apply the gel more frequently than every 4 hourse and no more than 4
times in any 24 hour period.
• Do not exceed the stated dose.
• Replace the cap after use
• If your symptoms do not improve, or get worse, consult your doctor or
pharmacist
Are there any side effect to this medicine?
The following side effects have been reported following use of this product:
• Asthma which may occur in patients with asthma or allergic disease
• Digestive upsets and abdominal pain
• Unexplained wheezing, shortness of breath, skin rash, itching, bruising or
facial swelling
If you experience these or any other form of reaction then discontinue use and report
this to your doctor or pharmacist who will advise you on the necessary action to take.
What happens if you swallow some of the gel?
• Rinse out your mouth thoroughly with water
• If swallowed, the gel may cause an upset stomach. It might cause breathing
difficulties in patients who have had asthma or allergic disease in the past.
• If you require further advice, consult you pharmacist or doctor, remembering
to take the tube with you.
Storing your gel
• Store below 25oC (i.e at room temperature)
• Do not keep it in the refrigerator
• Keep Ralgex Ibuprofen Gel and all medicines out of the reach of children
• Do not use the gel after the expiry date printed on the tube
Remember
Keep this medicine for your own use. Do not offer it to any one else. It may not suit
them, even if they seem to have the same symptoms as you. If you have any further
questions Ralgex Ibuprofen Gel, consult your pharmacist or doctor,
PL Holder: SSL International plc. Venus, 1 Old Park Lane, Trafford Quays,Urmston
Manchester. M41 7HA.
Date of Revision: January 2013
PL 17905/0020

Manufactured for and distributed by the PL Holder.
SSL International plc. Venus, 1 Old Park Lane, Trafford Quays,Urmston
Manchester. M41 7HA.

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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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