SUMMARY OF PRODUCT CHARACTERISTICS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION: 1g cream contains 10mg nadifloxacin. For excipients, see 6.1.
3. PHARMACEUTICAL FORM: Cream. White to off-white hydrophilic cream, having no distinctive odour.
4. CLINICAL PARTICULARS: 4.1 Therapeutic indications: For topical treatment of mild to moderate inflammatory forms of acne vulgaris (papulopustular acne, grade I – II). 4.2 Dosage and method of administration: Nadixa Cream should be applied to the acne lesions twice daily as a thin film, i.e. once in the morning and once in the evening before retiring, after cleaning and carefully drying the affected areas. Care should be taken to avoid the eyes and lips (see under 4.4 Special Warnings and Precautions for Use). To avoid infections, Nadixa cream should be applied with a cotton bud. Nadixa should not be used with occlusive dressing. Treatment with Nadixa Cream should be applied for up to 8 (eight) weeks. Nadixa should not be used in patients under 14 years of age. 4.3 Contraindications: Nadixa is contraindicated in known hypersensitivity to nadifloxacin or any excipient of the product. 4.4 special warnings and precautions for use: The safety and effectiveness of Nadixa cream have not been studied sufficiently in children below the age of 14 years. Therefore Nadixa should not be used in patients of this age group. Contact with the eyes or other mucous membranes should be avoided. Contact with Nadixa requires immediate flushing of eyes or mucous membranes with warm water. Hands should be washed after applying the cream in order to avoid unintentional application to other areas. Photosensitivity reactions have been known to develop under therapy with other quinolones administered systemically. While several studies in animals and man have shown neither phototoxic nor photoallergic potentials for the active ingredient nadifloxacin, the cream base may have an enhancing effect on photosensitivity. Moreover no experience is available on prolonged exposure to sunlight or artificial UV light under Nadixa. Patients using Nadixa cream should therefore avoid exposure to artificial UV irradiation (UV lamps, sun bed, solarium) as a matter of principle and exposure to sunlight whenever possible. If hypersensitivity reactions (manifesting as itching, erythema, papules, vesicles) or severe irritation occurs, use of medication should be discontinued. The product should not be applied to broken skin (cuts and abrasions). There is no data covering the safety of concomitant treatment with other acne medications (e.g. benzoyl peroxide), and Nadixa should therefore be used as a monotherapeutic only. Nadixa Cream contains: stearyl alcohol and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and benzalkonium chloride, which may be irritant and may cause skin reactions. 4.5 Interaction with other medicinal products and other forms of interaction: Absorption of nadifloxacin after application of Nadixa to the human skin is very low (see 5.2 Pharmacokinetic properties) and therefore interaction with systemic medication given concurrently is unlikely. There is no evidence to indicate that the efficacy of systemically administered drugs is influenced by the topical use of Nadixa Cream. Nadixa may cause skin irritation and therefore it is possible that the concomitant use of peeling agents, astringents or products containing irritating substances such as aromatic and alcoholic agents may result in increased skin irritation. 4.6 Pregnancy and lactation: For Nadixa cream, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal, foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women. Nadifloxacin is known to be excreted in milk and therefore Nadixa Cream should not be used during lactation. Under no circumstances must breast-feeding women apply Nadixa on their chest. 4.7 Effects on the ability to drive and use machines: Neither the pharmacodynamic profile nor clinical experience suggest any effect on the ability to drive or use machines. 4.8 Undesirable effects: Clinical trials: The most commonly reported adverse reaction in clinical trials was pruritus (> 1.8%). Adverse reactions reported as being at latest possibly drug-related and occurring more commonly with nadifloxacin cream are listed below. The frequencies correspond with: Very common: > 1/10, Common: > 1/100, d 1/10, Uncommon: > 1/1,000, d 1/100, Rare: > 1/10,000, d 1/1,000, Very rare: d 1/10,000, including isolated reports. Skin and subcutaneous tissue disorders: Common: pruritus. Uncommon: papules, dry skin, contact dermatitis, skin irritation, skin warm. Vascular disorders: Uncommon: flushing Post-Marketing Data: Isolated reports: erythema, urticaria and hypopigmentation of the skin. 4.9 Overdose: Nadixa Cream is not to be taken orally and is for cutaneous use only. Excessive repetitive applications do not accelerate or improve therapeutic outcome but rather involve the risk of marked redness or discomfort. In rats and mice oral nadifloxacin showed very low acute toxicity with minimum lethal doses exceeding 5000 mg/kg body weight. Nevertheless, an appropriate method of gastric emptying should be considered unless the amount of Nadixa accidentally ingested is small.
5. PHARMACEUTICAL PARTICULARS: 5.1 List of excipients: White soft paraffin, light liquid paraffin, stearyl alcohol, cetyl alcohol, Ceteth 5, Ceteth 20, sodium hydroxide, glycerol, diethanolamine, edetate disodium, benzalkonium chloride and purified water. 5.2 Incompatibilities: None known. 5.3 Shelf life: Tubes containing 10 g, 20 g, 25 g, 30 g and 50 g: 3 years. Tube containing 5 g (samples only): 18 month. 5.4 Special precautions for storage: No special precautions for storage. 5.5 Nature and contents of container: Collapsible aluminium tubes coated internally with epoxy-phenolic resin, fitted with a polypropylene screw cap. Nadixa is available in tubes containing 5 g (samples only), 10 g, 20 g, 25 g, 30 g and 50 g of cream. Not all pack sizes may be marketed. 5.6 Instructions for use and handling and disposal: No special requirements.
6. MARKETING AUTHORISATION HOLDER: FERRER INTERNACIONAL, S.A. Gran Vía Carlos III, 94. 08028
7. MARKETING AUTHORISATION NUMBER: Specific for each country.
8. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION: Date of first authorization: (Specific for each country). Date of last renewal: July 2005.
9. DATE OF REVISION OF THIS TEXT: August 2005. SmPC (3)
Not all dosage forms are available.
