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Indicated for the symptomatic relief of muscle and joint pain: contractures, back pain, back pain ...
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1. NAME OF THE MEDICINE
Hansaterm Adhesive Dressing
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dressing contains 112-167 mg soft extract of cayenne pepper (4-7: 1), corresponding to 4.8 mg of capsaicinoids, calculated as capsaicin. The solvent extract is 80% ethanol (v / v).
3. PHARMACEUTICAL FORM
Medicated dressing. Adhesive bandage, perforated rectangular (18x12 cm), provided with a support of viscose.
4.1 Therapeutic indications
In external use for muscle pain relief, such as low back pain.
4.2 Dosage and method of administration
Adolescents, adults and elderly: Dressing for external use. One dressing per day will be used most. It is applied directly on the painful region, by adhering to dry skin and uninjured. It covers the dressing is clear and placed with the adhesive side toward skin in the painful area where it should stay for at least 4 hours and up to 8 hours.
To remove the dressing, lift one corner and carefully pull it. After handling the dressing, you need to wash your hands with soap and water. Any residue that may remain on the skin after removal of the dressing can be removed with vegetable oil, with a moisturizer or cold water, being careful not to rub on the area of application.
It must allow a minimum interval of 12 hours before using a new dressing in the same area of application.
If necessary, if the pain continues, you can apply new dressings, up to three weeks of treatment. It should advise the patient to consult a doctor if symptoms persist.
The dressing is contraindicated in:
- In individuals with known hypersensitivity to the active substance, other sources of capsaicinoids or any of the other ingredients of the dressing.
- In damaged skin and wounds.
4.4 Special warnings and precautions for use
· The dressing should not be applied close to the eyes or mucous membranes areas. · It is recommended not to scratch in the application area to prevent skin lesions. · Avoid applying other heat sources during treatment. Treatment should be discontinued if you feel excessive heat. · The product contains wool fat (lanolin) which in turn may contain traces of butylated hydroxytoluene (E321), which may cause local skin reactions or irritations of the eyes or mucous membranes. · Pregnancy and lactation: See also section 4.6. · There are no clinical data on the use of adhesive dressing Hansaterm Medicamentous in children, so their use in children under 12 years old is not recommended. · Recommendations for the patient contained in the prospectus: Consult your doctor before using the dressing if the pain is accompanied by redness of the skin, swelling or warmth in the joints, permanent discomfort of joints, severe back pain that radiates legs, associated or not with neurological syndromes such as eg numbness and tingling.
4.5 Interaction with other medicinal products and other forms of interaction
The dressing is not intended to be used together with other products (eg other rubefacients or gels for pain relief) in the same application. Interactions with other products applied in the same treatment area may even occur several hours after dressing removal.
4.6 Pregnancy and lactation
There is no data to support the safety of Adhesive Dressing Drug Hansaterm during pregnancy. Some animal studies have shown that subcutaneous administration of high doses of capsaicin may cause reproductive toxicity (see section 5.3).
Although prenatal and neonatal effects of capsaicin took place much higher than the recommended maximum clinical Adhesive Dressing for Hansaterm Drug doses, these dressings should be used during pregnancy and lactation only after consultation with your doctor.
Recommendations for the patient contained in the prospectus: Do not use this dressing if you are pregnant, planning a pregnancy or breastfeeding without first consulting your doctor.
4.7 Effects on ability to drive and use machines
No conducted studies of the effects on the ability to drive and use machines.
4.8 Adverse reactions
The active ingredient of the dressing, capsaicinoids (expressed as capsaicin) usually causes hyperemia with erythema pronounced. This reaction is part of normal pharmacological action of the preparation and, in general, usually subsides after a short time after removing the dressing. If during the first days of treatment these feelings sharp (and / or itching or tingling) seem excessive, treatment should be discontinued. Although less frequent (<1 / 10,000,> 1 / 1,000) the occurrence of allergic skin reactions (such as hives or blistering) can occur in these cases, treatment should be discontinued.
Overdosing with this dressing is very unlikely.
5. PHARMACEUTICAL DATA
5.1 List of excipients
Liquid glucose 2,2'-methylene purified water-bis- (6-tert-butyl-4-methylphenol) 2,2 '- (propane-1,2-diildiiminodimetil) diphenol mixture iris root powder / rice flour rubber poly (butadiene-block-styrene) (76.5: 23.5) cis-1,4-polyisoprene talc (E553b) beta-pinene homopolymer copolymer of 2-methyl-2-butene and piperylene hydrogenated rosin ester with glycerol liquid paraffin light wool grease (lanolin) (it contains butylhydroxytoluene (E321)) viscose fabric (support of the dressing) silicone paper on one side (cover dressing)
5.3 Shelf life
3 years in its original packaging.
After first opening the sealed envelope must be used within 3 months.
5.4 Special precautions for storage
The product is stable under storage conditions of 25 ° C ± 2 ° C / 60% RH (long-term) and at 40 ± 2 ° C / 75% RH (accelerated). Therefore, the product is not require any special storage conditions within the territory of the European Union (Climate Zone 2).
5.5 Nature and contents of container
On paper / polyethylene / aluminum / brushed laminate, sealed with one or two medicated dressings. Any format can not be marketed.
Beiersdorf AG Hamburg Germany Unnastrasse 48 20245