Tephine 400microgram sublingual tablets

Summary of Product characteristics

                                OBJECT 1
TEPHINE 400 MICROGRAM SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 27-Jan-2017 | Sandoz
Limited
1. Name of the medicinal product
Tephine 400 microgram Sublingual Tablets
2. Qualitative and quantitative composition
Each tablet contains 400 microgramm of buprenorphine (as buprenorphine
hydrochloride).
Excipient: 44.8 mg lactose (as lactose monohydrate).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet.
White to off white, round, biplane tablet with facet and one-sided
ornamental notch (diameter:
approximately 5.00 mm).
The score line is not intended for breaking the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Tephine is used as astrong analgesic for the relief of severe pain,
e.g. following surgery or injuries,
myocardial infarction and in cancer.
Use of Tephine is NOT indicated in the treatment of headache,
toothache, migraine or other conditions
involving pain which can be treated using peripherally active
analgesics and/or spasmolytics.
4.2 Posology and method of administration
_Dosage _
The dosage of Tephine should generally be adjusted to the intensity of
the pain and the individual
sensitivity of the patient.
The recommended single dose in patients with a bodyweight greater than
45 kg is 1 sublingual tablet
Tephine 400 microgram.
The onset of effects generally occurs within 30 minutes after
sublingual administration.
The average duration of effects is 6 – 8 hours.
If necessary, 1 sublingual tablet Tephine 400 microgram may be
administered every 6 – 8 hours.
In severe chronic pain, the dose of Tephine should be adjusted to the
intensity of the pain and
administered regularly in accordance with a fixed schedule
corresponding to the duration of effects.
Patients with a bodyweight of 35 – 45 kg should be given a single
dose of 1 sublingual tablet Tephine 200
microgram, if necessary, every 6 – 8 hours. This is equivalent to an
average single dose of 5
micrograms/kg bodyweight.
Patients with a bodyweight of 16 – 35 kg should
                                
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