Powergel 2.5% Gel
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0001/13 POWERGEL™ 2.5 %W/W GEL
Ketoprofen
Read all of this leaflet carefully before you start using 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 Powergel is and what it is used for
2. Before you use Powergel
3. How to use Powergel
4. Possible side effects
5. How to store Powergel
6. Further information
1. WHAT POWERGEL IS AND WHAT IT IS USED FOR
Powergel contains a medicine called ketoprofen. Powergel belongs to a group of medicines called Non-Steroidal AntiInflammatory Drugs (NSAIDs). These reduce inflammation and relieve pain.
Powergel is used to relieve the pain of soft tissue injuries, and acute strains and sprains. Powergel should only be used by adults and children over 12 years of age.
2. BEFORE YOU USE POWERGEL
Do not use Powergel and tell your doctor if:
• you are hypersensitive (allergic) to the active substance ketoprofen, UV blockers (sun creams) or perfumes
• you are hypersensitive (allergic) to any of the other ingredients of Powergel (see Section 6, “Further information” for a list of other ingredients)
• you are hypersensitive (allergic) to aspirin, other NSAIDs (eg ibuprofen) or any medicines for pain relief or inflammation including tiaprofenic acid
• you are hypersensitive to fenofibrate (a medicine used to lower blood cholesterol)
• you have had wheezing (asthma), runny nose (rhinitis) or an itchy rash (hives) after taking aspirin or other NSAIDs (eg ibuprofen)
• you intend to use it on skin conditions such as eczema or acne, an open or infected wound, abscess, ulcer or tumour
• the area to be treated is near the eyes
• you are pregnant (see pregnancy and breast-feeding section).
Stop using Powergel immediately if you experience any skin reaction including reactions after co-application with octocrylene containing products (octocrylene is an ingredient used in several cosmetic and hygiene products such as shampoo, aftershave, shower and bath gels, skin creams, lipsticks, anti-ageing creams, make-up removers and hair sprays in order to delay product breakdown due to sunlight).
A Protect your skin from sunlight even on a bright but cloudy day. Do not use sunbeds. This applies during treatment and for two weeks after stopping.
Take special care with Powergel
• If you have heart, liver or kidney problems, talk to your doctor before using Powergel.
• The use of large amounts of Powergel may give rise to side effects such as hypersensitivity and asthma.
• Exposure to the sun (even hazy) or to UV from a sunbed or solarium of areas treated with Powergel can induce potentially serious skin reactions (photosensitisation). Therefore it is necessary to:
- protect treated areas by wearing clothing during treatment and for two weeks following its discontinuation to avoid any risk of photosensitisation.
- wash your hands thoroughly after each application of Powergel.
• Treatment should be discontinued immediately upon development of any skin reaction such as rash after application of Powergel.
• Avoid direct sunlight and solarium (sunbeds) during and for 2 weeks after treatment.
• Do not exceed the recommended length of treatment.
• Do not use near mucous membranes (eg lips, vagina).
• If you have asthma as well as a persistent runny nose, sinusitis or nasal polyps, you may have a higher risk of being allergic to aspirin or similar medicines than other people.
The safety and efficacy of Powergel in children has not been established.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, e.g. oral anticoagulants (blood thinning medicines). This includes medicines you can buy without a prescription. This is because Powergel can affect the way some other medicines work. Also, some other medicines can affect the way Powergel works.
Pregnancy and breast-feeding
Do not use if you are pregnant or breast-feeding. It may affect your baby.
Driving and using machines
Powergel should not affect your ability to drive and use machinery.
3. HOW TO USE POWERGEL
How to apply Powergel
It is important to use Powergel as directed:
• tube: unscrew the cap and pierce the aluminium seal with the point in the top of the cap.
• pump dispenser: when using the pump dispenser for the first time, press the top of the dispenser several times or push the bottom until the gel is released). Keep the dispenser in a horizontal position during use (see the pictures below).
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When and how much to use
Apply a length of gel 5-10 cm (2-4 inches) long (3-6 pushes of the pump dispenser) to the skin of the affected area two or three times daily.
How and where to use Powergel
• Powergel is for external use only
• Gently massage the gel on the area you need to treat
• Wash your hands immediately after use
• Do not apply Powergel to sore, broken or infected skin
• Do not use Powergel near the eyes, mouth, nostrils, anal and genital regions
• Stop using Powergel if you get a rash, itchy or sensitive skin after use
• Do not use with an air-tight or water-tight dressing (i.e. do not bandage, wrap, or cover the area with a plastic dressing)
• Do not use too much of this medicine.
Protection from the sun and sunbeds
• Do not expose the skin that has been treated with Powergel to direct sunlight or sunbeds during treatment or for the following 2 weeks.
How long should you use Powergel for?
Do not use Powergel for more than 10 days in a row.
If your symptoms persist after 10 days, tell your doctor.
If you use more Powergel than you should
When Powergel is externally applied (on the skin), very little reaches the blood. For this reason overdose effects are most unlikely. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Powergel can cause side effects, although not everybody gets them.
Stop using Powergel and tell your doctor if you notice any of the following side-effects:
Uncommon side effects (may affect up to 1 in 100 people) are:
• Localised allergic skin reactions such as redness, swelling, itching and blisters: in some severe cases, these might also spread beyond the area of application
• Sensation of burning skin
Rare side effects (may affect up to 1 in 1,000 people) are:
• Severe skin reactions (similar to severe sunburn) during exposure to sunlight
• Increased sensitivity of your skin to sunlight.
• Skin vesicles (skin blisters)
• Itchy skin reactions (skin rash)
• Cases of more severe forms of eczema which may spread or become generalized have occurred rarely.
Very rare side effects (may affect less than 1 in 1,000 people) are:
• Stomach ulcer, which may be bleeding, and diarrhoea
• Kidney problems (worsening of a pre-existing renal dysfunction)
Not known (cannot be estimated from the available data)
Other effects, which depend on the amount of gel applied, the extent of the area that is treated, skin thickness, length of treatment, and the use of an air-tight or water-tight dressing, are the following:
• Allergic reactions, which may lead to difficulty breathing and/or may be very severe (anaphylaxis). If this occurs, seek medical aid immediately.
• A kind of skin infection (known as impetigo)
• Higher than normal levels of eosinophils (a particular kind of blood cell)
• Hypersensitivity (a type of allergic reaction)
• Swelling of the eyelids or of the lips
• Inflammation of blood vessels (known as vasculitis)
• Loose stools
• Interruption of normal functioning of the kidneys
• Higher than normal body temperature
• Complication of wounds
Elderly people are generally more likely to suffer from side effects of Non Steroidal Anti-Inflammatory Drugs (the drug class to which Powergel belongs
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.
5. HOW TO STORE POWERGEL
Keep out of the reach and sight of children.
Store below 25°C.
Do not use Powergel after the expiry date which is on the carton and tube/dispenser. The expiry date refers to the last day of that month. 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.
6. FURTHER INFORMATION
What Powergel contains
The active substance is ketoprofen.
Powergel contains 2.5% ketoprofen.
The other ingredients are carbomer 940, ethanol, neroli essence, lavender essence, trolamine and purified water.
What Powergel looks like and contents of the pack
Powergel is a colourless, almost clear gel. Powergel is available in the following pack sizes - 50 g and 100 g tube, 50 g and 100 g pump dispenser.
This leaflet was last revised in 01/2013.
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The Marketing Authorisation is held by |
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A. Menarini Industrie Farmaceutiche Riunite S.r.l., 1-3 Via Sette Santi, Florence, Italy |
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Powergel is made by | ||
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A. Menarini Manufacturing Logistics and Services S.r.l., 3 Via Sette Santi, Florence Italy |
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