Active ingredients: Buprenorphine
Reletrans 5 microgram/hour transdermal patch.
The product is composed of a drug containing transdermal patch integrated with an oversized pale yellowish-brown cover patch without any active substance. The shape of the transdermal patch is rectangular with rounded edges. The transdermal patch contains the following imprint:
'Buprenorphinum 5 µg/h'
Each transdermal patch contains 5 mg of buprenorphine per 6.25 cm², releasing 5 micrograms of buprenorphine per hour.
For the full list of excipients, see section 6.1.
Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.
Release liner (to be removed before applying the patch):
Poly (ethylene terephthalate) foil, siliconized
Adhesive matrix (containing buprenorphine):
Poly [acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5)
Separating film (between the adhesive matrices with and without buprenorphine):
Poly (ethylene terephthalate) foil
Adhesive matrix (without buprenorphine):
Backing layer (printed):
Polyurethane backing foil
Each transdermal patch is individually packed in a child resistant sachet made of PET/Alu/PE.
Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20 transdermal patches.
Not all pack sizes may be marketed.
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Date of first authorisation: 10 February 2016
Last renewal date: 10 November 2020