OXYLAN 20 mg Oxycodone Hidrochloride 10 prolonged tablets in One Blister

1. Name of the medicinal product
Oxylan 20 mg prolonged-release tablets

2. Qualitative and quantitative composition
Oxylan 20 mg prolonged-release tablets

1 film-coated tablet contains 20 mg oxycodone hydrochloride corresponding to 17.93 mg oxycodone.

Excipient with known effect:

Soya lecithin 0.105 mg per tablet

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Prolonged-release tablet

Oxylan 20 mg prolonged-release tablets

Pale pink, round and biconvex film-coated tablets.

Diameter: 5.1 mm

Thickness: 3.8 mm

4. Clinical particulars
4.1 Therapeutic indications
Severe pain, which requires opioid analgesics to be adequately managed.

4.2 Posology and method of administration
DOSAGE

The dosage depends on the pain intensity and the patient’s individual susceptibility to the treatment.

For doses not realisable/practicable with this strength, other strengths of this medicinal product are available.

The following general dosage recommendations apply:

Paediatric population

Oxylan is not recommended for children under 12 years of age.

Adults and adolescents 12 years and older

Dose titration and adjustment

In general, the initial dose for opioid-naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimize the incidence of adverse reactions.

Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies.

According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation.

Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Oxycodone hydrochloride prolonged-release tablets after conversion from other opioids, with 50-75% of the calculated oxycodone dose.

Some patients who take Oxycodone hydrochloride prolonged-release tablets following a fixed schedule need rapid-release analgesics as rescue medication in order to control breakthrough pain. Oxycodone hydrochloride prolonged-release tablets are not indicated for the treatment of acute pain and/or breakthrough pain. The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Oxycodone hydrochloride prolonged-release tablets. Use of the rescue medication more than twice daily indicates that the dose of Oxycodone hydrochloride prolonged-release tablets needs to be increased. The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved.

Following a dose increase from 10 mg to 20 mg, taken every 12 hours, dose adjustments should be made in steps of approximately one third of the daily dose. The aim is a patient-specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed.
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Marketing authorisation holder
G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria