Fastum Gel contains a medicine called ketoprofen. Fastum Gel belongs to a group of medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs). These reduce inflammation and relieve pain.

Fastum Gel is used for the local treatment of rheumatic or traumatic pain in the osteo-articular and muscular systems such as:

contusions, distortions, muscle strains, stiff neck, lumbago.

In children under 12 years of age Fastum Gel is not recommended as experience in children is limited.

Do not use Fastum Gel:

·       If you have previously had any photosensitivity reactions – an abnormal reaction of the skin to sunlight which may resemble severe sunburn

·       If you are hypersensitive (allergic) to the active substance ketoprofen, UV blockers (sun creams) or perfumes

·       If you are hypersensitive (allergic) to any of the other ingredients of Fastum Gel (see Section 6, “Further information” for a list of other ingredients)

·       If you are hypersensitive (allergic) to aspirin, other NSAIDs (eg ibuprofen) or any medicines for pain relief or inflammation including tiaprofenic acid

·       If you are hypersensitive to fenofibrate (a medicine used to lower blood cholesterol)

·       If you have had wheezing (asthma), runny nose (rhinitis) or an itchy rash (hives) after taking aspirin or other NSAIDs (egibuprofen)

·       If you intend to use it on skin conditions such as eczema, acne or infected skin, an open wound or skin lesion (eg 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).

Do not expose the skin that has been treated with Fastum Gel to direct (even hazy) sunlight or sunbeds during treatment or for the following 2 weeks.

Take special care with Fastum Gel

·    If you have heart, kidney, liver, stomach or bowel problems, or a tendency to bleed easily, talk to your doctor before using Fastum Gel.

·    The duration of treatment should be kept as short as possible as the risk of skin reactions increases over time.

·    Exposure to the sun (even hazy) or to UVA 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.

·    Do not allow the gel to come into contact with mucous membranes (e.g.: nasal, oral, anal and genital) or the eyes.

·    Treatment should be discontinued immediately upon development of any skin reaction after application of Fastum Gel.

·    If you have asthma, a persistent runny nose, chronic sinusitis and/or nasal polyps, aspirin or similar medicines (such as ketoprofen) may increase the risk of allergy to aspirin, or to similar anti-inflammatory medicines such as ketoprofen which is the active constituent of Fastum Gel.

In children under 12 years of age Fastum Gel is not recommended as experience in children is limited.

Talk to your doctor if your symptoms do not improve or if your condition gets worse.

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) or methotrexate (for rheumatoid arthritis, malignant disease or psoriasis). This includes medicines you can buy without a prescription. This is because Fastum Gel can affect the way some other medicines work. Also, some other medicines can affect the way Fastum Gel works.

Pregnancy and breast-feeding

Do not use if you are pregnant or breast-feeding. It may affect your baby.

Driving and using machines

Fastum Gel should not affect your ability to drive and use machinery.

Always use the product exactly as your doctor or health care provider has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults and elderly: Apply a length of gel 5-10 cm long to the skin of the affected area one to three times daily.

Children under 12 years of age: Not recommended

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.

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 more than 25g of Fastum Gel per day. The use of large amounts of Fastum Gel may give rise to side effects such as hypersensitivity and asthma.

Protection from the sun and sunbeds

·       Do not expose the skin that has been treated with Fastum Gel to direct (even hazy) sunlight or sunbeds during treatment or for the following 2 weeks.

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.

Do not use Fastum Gel for longer than recommended due to the risk of skin reactions (contact dermatitis and photosensitivity).

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 have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Fastum Gel can cause side effects, although not everybody gets them.

Stop using Fastum Gel 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

·       Burning sensation

Rare side effects (may affect up to 1 in 1,000 people) are:

·       Increased sensitivity of your skin to sunlight.

·       Severe skin reactions (similar to severe sunburn) during exposure to sunlight

·       Blisters on the skin

·       Itchy skin rash

·       Cases of more severe forms of eczema which may spread or become generalized.

Very rare side effects (may affect less than 1 in 1,000 people) are:

·       Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing

·       Inflamed skin causing skin changes resembling eczema may develop as a delayed reaction to sunlight

·       Blisters on the lips, eyes or tongue which may swell rapidly causing swallowing or breathing problems. If this occurs, stop taking your medicine and go to a hospital straight away

Other very rare side 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:

·       Stomach ulcer, which may be bleeding, and diarrhea

·       Kidney problems (worsening of a pre-existing kidney problem)

·       Allergic reactions, which may lead to difficulty breathing and/or may be very severe (anaphylaxis). If this occurs, seek medical aid immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

Keep out of the reach and sight of children.

Store below 30°C.

Replace the cap after use.

Keep the gel away from naked flames. Do not use Fastum Gel after the expiry date which is on the carton and tube/dispenser. The expiry date refers to the last day of that month. You can use Fastum Gel 24 weeks after the first opening.

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