Ibugel

Gel Non-greasy, fragrance-free, clear aqueous-alcoholic gel

4.1 Therapeutic indications For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.4.2 Posology and method of administration Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively. Hands should be washed immediately after use (unless treating them). Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor. The same dosage and dosage schedule applies to all age groups, although Ibugel is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.4.3 Contraindications Not to be used in cases of sensitivity to any of the ingredients, particularly if asthmatic or suffer from allergic disease, and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers Not to be used on broken skin. Do not use during pregnancy or lactation.4.4 Special warnings and precautions for use Seek medical advice if symptoms worsen or persist. Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occur within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using Ibugel. Propylene glycol may cause skin irritation. Keep away from the eyes and mucous membranes. For external use only. The label will include statements to the following effect: If symptoms persist, consult your doctor or pharmacist. Do not use if sensitive to any of the ingredients, particularly if asthmatic, suffer from rhinitis or urticaria and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers. Consult your doctor before use if you are taking aspirin or other painkillers. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.4.6 Fertility, pregnancy and lactation Do not use during pregnancy or lactation. Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast fed infants adversely.4.7 Effects on ability to drive and use machines None known4.8 Undesirable effects Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). | | | | | --- | --- | --- | | **System Organ Class** | **Frequency** | **Adverse reaction** | | Skin and subcutaneous tissue disorders | Very rare | Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) | | Not known | Photosensitivity reactions Skin rash Pruritus Skin irritation Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) | | Immune System Disorders | Not known | Hypersensitivity 1 | | Renal and urinary disorders | Not known | Renal impairment 2 | | Gastrointestinal disorders | Not known | Abdominal pain Dyspepsia | *1 Hypersensitivity*: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme). *2 Renal*: renal impairment can occur in patients with a history of kidney problems. **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 reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use. ATC code: M02A A13 Ibugel is a topical preparation which has anti-inflammatory and analgesic properties. It contains the active ingredient, ibuprofen, which exerts its effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis. Because it is formulated in an aqueous/alcoholic gel, Ibugel also exerts a soothing and cooling effect when applied to the affected area.5.2 Pharmacokinetic properties Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively, achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side effects, other than in rare individuals who are hypersensitive to ibuprofen. Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion of ibuprofen.5.3 Preclinical safety data Published information on subchronic toxicity studies confirms that topically applied ibuprofen is well tolerated both locally and by the gastro-intestinal tract. Any local erythema is only mild and no signs of mucosal lesions or ulcerogenic effects have been determined in the gastro-intestinal tract. In the course of assessing mucosal tolerance, topical ibuprofen has been found to cause acute, but reversible, irritant reactions in the eyes and mucous membranes.

6.1 List of excipients IMS Carbomer Propylene Glycol (E 1520) Diethylamine Purified Water6.2 Incompatibilities None known.6.3 Shelf life 30 g, 50 g and 100 g containers: 36 months from the date of manufacture. 4 g containers: 18 months from the date of manufacture.6.4 Special precautions for storage Do not store above 25°C.6.5 Nature and contents of container

1. Membrane sealed, epoxy resin coated, collapsible aluminium tube, fitted with a screw cap (containing 4 g, 30 g, 50 g or 100 g of product)
2. Membrane-sealed laminate tube, made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with a screw cap (containing 30 g, 50 g or 100 g of product)
3. Laminate tube made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with an air-return-free 'Precitube' pump head and cap (containing 30 g, 50 g or 100 g of product). Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Not applicable