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FASTUM GEL

Active substance(s): KETOPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FASTUM 2.5% GEL
Ketoprofen
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
 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 only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
 If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet:
1. What Fastum Gel is and what it is used for
2. What you need to know before you use Fastum Gel
3. How to use Fastum Gel
4. Possible side effects
5. How to store Fastum Gel
6. Contents of the pack and other information
1. What Fastum gel is and what it is used for
Fastum Gel contains a medicine called ketoprofen. Fastum Gel belongs to a group of medicines called NonSteroidal Anti- Inflammatory Drugs (NSAIDs). These reduce inflammation and relieve pain.
Fastum Gel is used to relieve the pain of soft tissue injuries, and acute strains and sprains. Fastum Gel should
only be used by adults and children over 12 years of age.
2. What you need to know bbefore you use Fastum gel
Do not use Fastum Gel:
 If you are allergic to ketoprofen or to any of the other ingredients of this medicine (listed in Section 6)
 If you are allergic to UV blockers (sun creams) or perfumes
 If you are allergic to aspirin, other NSAIDs (eg ibuprofen) or any medicines for pain relief or inflammation
including tiaprofenic acid. Signs of an allergic reaction include wheezing (asthma), runny nose (rhinitis) or
an itchy rash (hives)
 If you are allergic to fenofibrate (a medicine used to lower blood cholesterol)
 If you intend to use it on skin conditions such as eczema or acne, an open or infected wound, abscess, ulcer
or tumour
 If the area to be treated is near the eyes
 If you are pregnant (see pregnancy and breast-feeding section).
Stop using Fastum Gel 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, after-shave, 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).

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.
Warnings and precautions
Talk to your doctor before using Fastum Gel:
 If you have heart, liver or kidney problems.
 The use of large amounts of Fastum Gel 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 Fastum Gel can
induce potentially serious skin reactions (photosensitisation). Therefore it is necessary to:
o Protect treated areas by wearing clothing during treatment and for two weeks following its
discontinuation to avoid any risk of photosensitisation.
o Wash your hands thoroughly after each application of Fastum Gel.
 Treatment should be discontinued immediately upon development of any skin reaction such as rash after
application of Fastum Gel.
 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.
Children and adolescents
The safety and efficacy of Fastum Gel in children has not been established.
Other medicines and Fastum Gel
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, e.g. oral
anticoagulants (blood thinning medicines).
Fastum Gel with food, drink and alcohol
No known effects
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Fastum Gel should not affect your ability to drive and use machinery.
3. How to use Fastum gel
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

How to apply Fastum Gel
It is important to use Fastum Gel as directed:
 tube: unscrew the cap and pierce the aluminium seal with the point in the top of the cap.

Apply a length of gel 5-10 cm (2-4 inches) long to the skin of the affected area two or three times daily.



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).

Apply 3-6 pushes of the pump dispenser to the skin of the affected area two or three times daily.
How and where to use Fastum Gel
 Fastum Gel 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 Fastum Gel to sore, broken or infected skin
 Do not use Fastum Gel near the eyes, mouth, nostrils, anal and genital regions
 Stop using Fastum Gel 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 Fastum Gel to direct sunlight or sunbeds during treatment
or for the following 2 weeks.
Use in children and adolescents
Do not use in children under 12 years of age.
How long should you use Fastum Gel for?
Do not use Fastum Gel for more than 10 days in a row.
If your symptoms persist after 10 days, tell your doctor.
If you use more Fastum Gel than you should
When Fastum Gel is externally applied (on the skin), very little reaches the blood. For this reason overdose
effects are most unlikely.
If you forget to use Fastum Gel
If you forget a dose, use it as soon as you remember. However, if it is nearly time for the next dose, skip the
missed dose. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Fastum Gel can cause side effects, although not everybody gets them.
Stop using Fastum Gel and see your doctor or go to a hospital straight away if you notice any of the
following side-effects:
 Localised allergic skin reactions such as redness, swelling, itching and blisters: in some severe cases,
these might also spread beyond the area of application (uncommon side effects, may affect up to 1 in
100 people)

 Severe skin reactions (similar to severe sunburn) during exposure to sunlight (rare side effects, may
affect up to 1 in 1,000 people)
 Allergic reactions, which may lead to difficulty breathing and/or may be very severe (anaphylaxis). If
this occurs, seek medical aid immediately. (not known: frequency cannot be estimated from the available
data)
 Cases of more severe forms of eczema which may spread or become generalized have occurred rarely.
(rare side effects, may affect up to 1 in 1,000 people)
Tell your doctor or pharmacist if you have any of the following side effects:
Uncommon side effects (may affect up to 1 in 100 people) are:
 Sensation of burning skin
Rare side effects (may affect up to 1 in 1,000 people) are:
 Increased sensitivity of your skin to sunlight.
 Skin vesicles (skin blisters)
 Itchy skin reactions (skin rash)
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:










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 Fastum Gel belongs).
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
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 Fastum gel
Keep out of the sight and reach of children.
Store below 25°C.

Do not use Fastum Gel after the expiry date which is stated on the carton and tube/dispenser. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fastum Gel contains
The active substance is ketoprofen.
The other ingredients are carbomer 940, ethanol, neroli essence, lavender essence, triethanolamine and purified
water.
What Fastum Gel looks like and contents of the pack
Fastum Gel is a colourless, almost clear gel. Fastum Gel is available in the following pack sizes - 50 g and 100 g
tube, 50 g pump dispenser.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
A Menarini Industrie Farmaceutiche Riunite S.r.l.
Via Sette Santi, 3
50131 Florence
Italy
Manufacturer
A.Menarini Manufacturing, Logistics and Service, S.R.L.
via Sette Santi 3
50131 Florence
Italy
This leaflet was last revised in 10/2015.

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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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