IBUPROFENE ARROW 5 % Gel Tube/60g

Ibuprofen.......................................................................................................................................................5,00 g

For 100 g of gel

Excipients with known effect: benzyl alcohol 10 mg/g, propylene glycol 30 mg/g.

Short-term local symptomatic treatment, in adults and children over 15 years:

• minor trauma: sprains, contusions,

• superficial tendinitis, after medical advice.

RESERVED FOR ADULTS (OVER 15 YEARS).

Cutaneous use.

Dosage

1 application, 3 times a day.

Method of administration

Apply the gel by gentle, prolonged massage onto the painful or inflamed area. Wash hands thoroughly after each use.

Duration of treatment

The duration of treatment is limited to 5 days.

This medicine is contraindicated in the following situations:

• hypersensitivity to the active substance or to any of the excipients listed in section Composition ;

• history of allergy or asthma triggered by taking ibuprofen or substances with similar activity such as other NSAIDs, aspirin;

• pregnancy, from the beginning of month 6th month (24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding) ;

• damaged skin, whatever the lesion: weeping dermatoses, eczema, infected lesion, burn or wound.

• In the absence of specific safety studies conducted in children, this medicine is reserved for adults (over 15 years).

• Do not apply to mucous membranes, nor to the eyes.

• The appearance of a skin reaction after application of the gel requires immediate discontinuation of treatment.

• As oral ibuprofen may worsen pre-existing renal insufficiency or an active gastroduodenal ulcer, this medicine should be used on medical advice in case of a history of renal disease.

• Wash hands thoroughly after each use.

• Wearing gloves by the physiotherapist masseur, in case of intensive use, is recommended.

• Do not use under an occlusive dressing.

Severe cutaneous adverse reactions (SCAR)

Severe cutaneous adverse reactions (SCARs) such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), and acute generalised exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section Adverse effects). Most of these reactions occurred during the first month of treatment.

If signs and symptoms suggestive of these reactions appear, ibuprofen should be stopped immediately and another treatment should be considered (where appropriate).

Patients should be informed of the signs and symptoms of severe cutaneous adverse reactions and advised to consult their doctor immediately at the onset of any suggestive sign or symptom.

If the patient has developed a severe cutaneous adverse reaction such as exfoliative dermatitis, erythema multiforme, SJS, TEN, DRESS or AGEP after using ibuprofen, treatment with IBUPROFENE ARROW CONSEIL must under no circumstances be resumed.

Excipients with known effect

This medicine contains 10 mg of benzyl alcohol per gram of gel. Benzyl alcohol may cause allergic reactions and mild local irritation.

This medicine contains 30 mg of propylene glycol per gram of gel.

Due to the low systemic exposure during normal use of the gel, the drug interactions reported for ibuprofen per os are unlikely.

Pregnancy

There are no data on the use of topical forms of ibuprofen in pregnant women. Even though systemic exposure is lower compared to oral administration, it is not known whether systemic exposure to ibuprofen after topical administration may be harmful to the embryo/foetus.

During the first 5 months of pregnancy (before 24 weeks of amenorrhoea), IBUPROFENE ARROW 5 %, gel should not be used, unless absolutely necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

From the beginning of the 6th month of pregnancy (24 weeks of amenorrhoea), systemic use of prostaglandin synthesis inhibitors such as ibuprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of pregnancy, prolonged bleeding time in the mother and child may occur, and labour may be delayed. IBUPROFENE ARROW 5 %, gel is therefore contraindicated from the beginning of the 6rd month of pregnancy (24 weeks of amenorrhoea) (see section Contraindications).

Breast-feeding

NSAIDs pass into breast milk, so this medicine is not recommended for women who are breastfeeding.

In case of breastfeeding, this medicine must under no circumstances be applied to the breast.

Fertility

As with all NSAIDs, the use of this medicine may temporarily impair female fertility by affecting ovulation; it is therefore not recommended for women wishing to conceive a child. In women having difficulty conceiving or undergoing fertility testing, discontinuation of treatment should be considered.

• Adverse effects related to the route of administration:

• local cutaneous hypersensitivity reactions such as pruritus or localised erythema.

• Hypersensitivity reactions:

• dermatological;
• photosensitivity reactions (frequency not determined);
• respiratory: the occurrence of an asthma attack may in some subjects be linked to an allergy to aspirin or an NSAID (see section Contraindications) ;
• general: anaphylactic-type reactions.

• Skin and subcutaneous tissue disorders:

• severe cutaneous adverse reactions (SCAR) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) (very rare);
• drug hypersensitivity reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) (frequency not known);
• acute generalised exanthematous pustulosis (AGEP) (frequency not known).

• Other systemic effects of NSAIDs:

• they depend on the transdermal passage of the active substance and therefore on the quantity of gel applied, the surface area treated, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used (gastrointestinal and renal effects).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

In case of overdose, rinse thoroughly with water.

Application of excessively high doses may lead to exacerbation of undesirable effects.

Pharmacotherapeutic class: non-steroidal anti-inflammatory drug for topical use, ATC code: M02AA13.

Ibuprofen is a non-steroidal anti-inflammatory drug of the propionic acid group, derived from aryl-carboxylic acid.

In the form of a gel for cutaneous application, it has anti-inflammatory and analgesic activity.

The relative bioavailability of the gel containing 5 % ibuprofen compared with oral administration is 5 to 7,4 %.

3 years.

After first opening: to be stored for no more than 1 month.

This medicine does not require any particular storage precautions.

No special requirements.