Ibuprofen 5% W/W Gel
PATIENT INFORMATION LEAFLET
Care Ibuprofen 5% w/w Gel
The name of your medicine is Care Ibuprofen
5% w/w Gel.
This will be referred to as Ibuprofen Gel
throughout this leaflet.
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact your doctor if your symptoms worsen at any time, or do not improve after 2 weeks.
• If you notice any side effects (see section 4) or any side effects not mentioned in this leaflet talk to your doctor or pharmacist.
In this leaflet:
1. What Ibuprofen Gel is and what it is used for
2. Before you apply Ibuprofen Gel
3. Howto use Ibuprofen Gel
4. Possible side effects
5. Howto store Ibuprofen Gel
6. Further information
1
1. WHAT IBUPROFEN GEL IS AND WHAT IT IS USED FOR
Ibuprofen Gel is applied to the skin, containing the active ingredient ibuprofen.
Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs relieve pain and reduce inflammation.
Ibuprofen Gel is used to help relieve backache, rheumatic and muscular pain, or sprains and sports injuries.
2. BEFORE YOU APPLY IBUPROFEN GEL You should not use Ibuprofen Gel if you:
• are allergic to Ibuprofen or any other ingredients of Ibuprofen Gel (see list of ingredients in section 6).
• have ever had an allergic reaction, including asthma, inflammation of the inside of the nose (rhinitis) or nettle rash (urticaria) brought on by using aspirin, ibuprofen or other NSAIDs.
• have kidney failure.
Do not use Ibuprofen Gel with plasters or other dressings.
Talk to your doctor or pharmacist if you have:
• kidney problems.
• a peptic ulcer.
• asthma.
• previously had a bad reaction to aspirin or ibuprofen.
Take special care with Ibuprofen Gel
Keep Ibuprofen Gel away from irritated or broken skin, eyes, nose and sensitive areas. Avoid exposing the treated area to excessive sunlight.
Taking other medicines
Talk to your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. In particular tell your doctor or pharmacist if you are taking any of the following:
• Aspirin.
• Other NSAIDs (similar painkillers)
as these may increase the risk of side effects.
Pregnancy and breast-feeding
You should not use Ibuprofen Gel during pregnancy or breast-feeding. It may lengthen your pregnancy and labour time.
Driving and using machines
Ibuprofen Gel is not known to affect driving or operating machinery.
24005005
2
MHRA Header Box
|
Product Title |
Care Ibuprofen 5% w/w Gel |
Colours Used |
Fonts Used | |
|
■ |
Process Black |
Helvetica | ||
|
Component |
Leaflet |
□ |
Keyline (Does not print) | |
|
Pack Size |
50g and lOOg | |||
|
IG Code |
24005005 | |||
|
Dimensions |
210 x 148mm flat (27 x 148mm folded) | |||
|
Proof No. |
1 Date 20.06.2014 | |||
3. HOW TO USE IBUPROFEN GEL
Ibuprofen Gel is applied to the skin.
Dosage
Adults, the elderly and children over 14 years:
• Squeeze 5 to 10 cm of the gel (containing 50 to 100 mg of ibuprofen) from the tube and gently rub into the affected area until absorbed.
Repeat as required every 4 hours but no more than 4 times in 24 hours. You should wash your hands after each application. Do not use more than you should.
Contact your doctor if your symptoms worsen at anytime or do not improve after 2 weeks.
Children under 14 years:
Do not use on children under 14 years of age unless your doctor tells you to.
If you use more Ibuprofen Gel than you should
Overdose with a skin gel is unlikely. Symptoms of overdose include headache, vomiting, sleepiness, and low blood pressure. If you have these symptoms or if a child has swallowed the gel, contact your doctor, pharmacist or nearest hospital immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Some people may have side effects when taking this medicine. If you experience any of the following stop using Ibuprofen Gel immediately and talk to your doctor or pharmacist:
• sudden wheeziness.
• difficulty in breathing.
• swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.
• severe peeling or blistering of the skin.
The following side effects have also been reported occasionally:
• application site irritation reactions, rashes, itching.
• tummy pain.
• indigestion.
• kidney failure (very rarely).
• asthma symptoms in patients with a history of asthma or allergies.
3
If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
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 IBUPROFEN GEL
Ibuprofen Gel should be kept out of the sight and reach of children.
Store below 25°C and replace cap tightly after use.
Do not use Ibuprofen Gel after the expiry date as indicated in the box after “EXP”. The expiry date refers to the last day of the month.
Medicine should not be disposed of in waste-water or with household waste.
Ask your pharmacist what you should do with medications you no longer need. These measures will help to protect the environment.
6. FURTHER INFORMATION What Ibuprofen Gel contains
The active substance is ibuprofen 5% w/w.
The other ingredients are: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, and purified water.
What Ibuprofen Gel looks like and contents of the pack
Ibuprofen Gel is available in an aluminium tube containing 50g or 10Og.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK.
T (j| R
This leaflet was last revised in June 2014
24005005
4
Data Matrix: 24005005 VERIFIED
PATIENT INFORMATION LEAFLET
Radian B
ANTI-INFLAMMATORY IBUPROFEN 5% W/W GEL
Ibuprofen
The name of your medicine is Radian B Anti-inflammatory ibuprofen 5% w/w gel.
This will be referred to as Radian B throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact your doctor if your symptoms worsen at any time, or do not improve after 2 weeks.
• If you notice any side effects (see section 4) or any side effects not mentioned in this leaflet talk to your doctor or pharmacist.
In this leaflet:
1. What Radian B is and what it is used for
2. Before you apply Radian B
3. How to use Radian B
4. Possible side effects
5. How to store Radian B
6. Further information
1. WHAT RADIAN B IS AND WHAT IT IS USED FOR
Radian B is a gel, which is applied to the skin, containing the active ingredient ibuprofen. Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain and reduce inflammation.
Radian B is used to help relieve backache, rheumatic and muscular pain, or sprains and sports injuries.
2. BEFORE YOU APPLY RADIAN B You should not use Radian B if you:
• are allergic to ibuprofen or any other Kjj ingredients of Radian B (see list of ingredients in Section 6).
• have ever had an allergic reaction, including asthma, inflammation of the inside of the nose (rhinitis) or nettle rash (urticaria) brought on by using aspirin, ibuprofen or other NSAIDs.
• have kidney failure.
Do not use Radian B with plasters or other dressings.
Talk to your doctor or pharmacist if you have:
• kidney problems.
• a peptic ulcer.
• asthma.
• previously had a bad reaction to aspirin or ibuprofen.
Take special care with Radian B
Keep Radian B away from irritated or broken skin, eyes, nose and sensitive areas.
Avoid exposing the treated area to excessive sunlight.
Taking other medicines
Talk to your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the following:
• Aspirin
• Other NSAIDs (similar painkillers)
as these may increase the risk of side effects.
Pregnancy and breast-feeding
You should not use Radian B during pregnancy or breast-feeding. It may lengthen your pregnancy and labour time.
Driving and using machines
Radian B is not known to affect driving or operating machinery.
23928106
2
MHRA Header Box
|
Product Title |
Radian B Anti-inflammatory Ibuprofen 5% w/w Gel |
Colours Used |
Fonts Used | |
|
■ |
PANTONE 281 C |
Cachet | ||
|
Component |
Leaflet |
□ |
Keyline (Does not print) | |
|
Pack Size |
30g | |||
|
IG Code |
23928106 | |||
|
Dimensions |
21 Ox 148mm flat (27x 148mm folded) | |||
|
Proof No. |
1 Date 23.06.2014 | |||
3. HOWTO USE RADIAN B
Radian B is applied to the skin.
Dosage
Adults, the elderly and children over 14 years:
• Squeeze 5 to 10 cm of the gel (containing
50 to 100 mg of ibuprofenj from the tube and gently rub into the affected area until absorbed.
Repeat as required every 4 hours but no more than 4 times in 24 hours. You should wash your hands after each application. Do not use more than you should.
Contact your doctor if your symptoms worsen at any time or do not improve after 2 weeks.
Children under 14 years:
Do not use on children under 14 years of age unless your doctor tells you to.
If you use more Radian B than you should
Overdose with a skin gel is unlikely. Symptoms of overdose include headache, vomiting, sleepiness, and low blood pressure. If you have these symptoms or if a child has swallowed the gel, contact your doctor, pharmacist or nearest hospital immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Some people may have side effects when taking this medicine. If you experience any of the following stop using Radian B immediately and talk to your doctor or pharmacist:
• sudden wheeziness
• difficulty in breathing
• swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body
• severe peeling or blistering of the skin.
The following side effects have also been reported occasionally:
• application site skin reactions, rashes, itching
• tummy pain
• indigestion
23928106
3
• kidney failure (very rarely)
• asthma symptoms In patients with a history of asthma or allergies
If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional.
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 RADIAN B
Radian B should be kept out of the sight and reach of children.
Store below 25°C and replace cap tightly after use.
Do not use Radian B after the expiry date as indicated on the box after "EXP". The expiry date refers to the last day of the month.
Medicine should not be disposed of in waste-water or with household waste.
Ask your pharmacist what you should do with medications you no longer need. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Radian B contains
The active substance is ibuprofen 5% w/w.
The other ingredients are: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, and purified water.
What Radian B looks like and contents of the pack
Radian B is available in an aluminium tube containing 30g, 50g or lOOg of ibuprofen gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK.
t(J|r
This leaflet was last revised in June 2014
4
Data Matrix: 23928106 VERIFIED