FASTUM GEL MAX 2.5% [SIN15511P]

Product Info

FASTUM GEL MAX 2.5%

[SIN15511P]

Indication

1. What Fastum® Gel Max is and what it is used for

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

Dosing

3. How to use Fastum® Gel Max
Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist has told you. Check with your doctor or, pharmacist if you are not sure.

The recommended dose is:
Apply a thin layer of gel on the area of affected skin, once or twice a day, gently massaging to help absorption.

Opening of the soft tube: unscrew the cap and pierce the aluminium seal with the point in the top of the cap.

Pre-filling of the 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).

Use in Children under 12 years of age:
The safety and efficacy of ketoprofen gel in children have not been established.

How and where to use Fastum® Gel Max

• Fastum® Gel Max is for external use only

• Gently massage the gel on the area you need to treat

• Wash your hands immediately after use

• Do not use too much of this medicine.

How long should you use Fastum® Gel Max for?
Use Fastum® Gel Max only for brief treatment periods.
Consult the doctor if the disorder recurs repeatedly or if you have noted any recent changes in its characteristics.

Do not use Fastum® Gel Max for more than 2 weeks unless directed by a doctor or pharmacist.
Do not use Fastum® Gel Max for longer than recommended due to the risk of skin reactions (contact dermatitis and photosensitivity).

If you use more Fastum® Gel Max than you should
When Fastum® Gel Max is externally applied (on the skin) very little reaches the blood. For this reason overdose effects are most unlikely. In case of accidental ingestion of an excessive dose of FASTUM, immediately call your doctor or go to the closest hospital.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Contraindications

2. What you need to know before you use Fastum® Gel Max

Do not use Fastum® Gel Max:

• If you have a history of skin allergy to UV blockers or perfumes

• If you have a history of any photosensitivity reaction

• If you are hypersensitive (allergic) to the active substance ketoprofen or any of the other ingredients of Fastum® Gel Max (see section 6, "Further information" for a list of other ingredients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• If you are hypersensitive (allergic) to tiaprofenic acid, acetylsalicylic acid, other NSAIDs (e.g. ibuprofen) or any medicines for pain relief or inflammation (allergic symptoms are wheezing (asthma), runny nose (rhinitis) or an itchy rash (hives)).

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

• If you have pathological skin changes such as eczema or acne; or infectious skin or open wounds.

• If you are in the last three months of pregnancy (see section “Pregnancy and breastfeeding” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Do not expose treated areas to sunlight or UV light from solarium during the treatment and for 2 weeks after discontinuation.