Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
IBUPROFEN
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany
M02AA13
IBUPROFEN 5 % (W/W)
GEL
IBUPROFEN 5 % (W/W)
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Withdrawn
2006-11-24
PACKAGE INSERT IBUTOP® GEL Active ingredient: Ibuprofen COMPOSITION: 100 g of Ibutop Gel contain: _Active ingredient_: ibuprofen 5 g _Excipients_: 2-propanol, 2,2-dimethyl-4-hydroxymethyl-1,3-dioxolane, poloxamer, medium- chain triglycerides, water, lavender oil, neroli oil PHARMACOTHERAPEUTIC GROUP: Pain-relieving and anti-inflammatory substance for topical application. INDICATIONS Topical or supporting treatment in cases of muscular rheumatism, painful degenerative articular affections (arthrosis), inflammatory rheumatic affections of the joints and of the vertebral column, swelling or inflammation of the soft tissues adjacent to the joints (e. g. bursae, tendines, tendon sheaths, ligaments and articular capsules), shoulder stiffness, myalgia, lumbago, sports and accident-related injuries such as contusions, sprains, strains. CONTRAINDICATIONS Hypersensitivity to ibuprofen or other drugs having the same mode of action. Allergic diathesis. Ibutop Gel must not be applied to open wounds or mucosae. The present data are not sufficient in order to assess the security of the use in humans during pregnancy. During the last third of pregnancy Ibutop Gel should not be applied for a prolonged time and to large skin areas. Due to the mode of action tocolysis, obstruction of Botallo´s duct before term, increased hemorrhagic diathesis in mother and child and increased proneness to edemas in the mother might occur. Though so far no teratogenic effects (malformations) have been observed, Ibutop Gel should not be applied to large skin areas for a prolonged period during the first six months of pregnancy. Small amounts of ibuprofen penetrate into the breast milk. An application to large skin areas or for a prolonged period during lactation should be avoided. In order to avoid the infant´s contact with Ibutop Gel, this preparation should n Baca dokumen lengkapnya
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibutop® Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 g of gel contain 5 g of ibuprofen For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel 100 g of gel contain 5 g of ibuprofen 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For topical, supporting treatment in cases of - acute strains, sprains or contusions of the limbs caused by blunt trauma, e. g. sports injuries - muscular rheumatism - painful degenerative articular affections (arthrosis), inflammatory rheumatic affections of the joints and of the vertebral column, swelling or inflammation of the soft tissues adjacent to the joints (e. g. bursae, tendines, tendon sheaths, ligaments and articular capsules), shoulder stiffness, low back pain, lumbago. A physician should be contacted if the discomforts persist for more than 3 days 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ibutop® Gel is applied 3 – 4 times daily. According to the size of the affected aching area a 4 - 10 cm long strip of gel, corresponding to 2 – 5 g of gel (corresponding to 100 – 250 mg of ibuprofen) is necessary. The maximum daily dosage amounts to 12 g of gel (corresponding to 600 mg of ibuprofen). Apply only externally! Not for oral use! Ibutop® Gel is applied thinly to the affected part of the body and rubbed in lightly. Ibutop® Gel should dry on the skin for some minutes before a dressing is put on. Ibutop® Gel should not be applied under an occlusive dressing. Page 2 of 6 The penetration of the active ingredient through the skin can be intensified by iontophoresis (a special form of electrotherapy). Ibutop® Gel is to be applied under the cathode (negative pole). The current intensity should be 0.1 – 0.5 mA per 5 cm² of electrode surface, the duration of treatment up to approx.15 minutes. The duration of treatment is determined by the physician. In most cases an application over 1 – 2 weeks is sufficient. There are no data available concerning a therapeutic app Baca dokumen lengkapnya