其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Oxylan prolonged-release tablets, all strengths (oxycodone hydrochloride) (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that G.L. Pharma GmbH T/A Healthcare Pharma Ltd has informed MHRA that the Patient Information Leaflet (PIL) within the packs for the specified batches of Oxylan prolonged-release tablets is missing important safety relevant text changes. The affected products are:
- Oxylan 10 mg prolonged-release tablets (batch number: 9F115A, 9F116A)
- Oxylan 20 mg prolonged-release tablets (batch number: 9J114A)
- Oxylan 40 mg prolonged-release tablets (batch number: 9F119A)
- Oxylan 80 mg prolonged-release tablets (batch number: 9F120A)
The changes to the PIL include the addition of the following information:
- Warnings and precautions: If you have poor adrenal gland function (your adrenal gland is not working properly) for example Addinson’s disease.
- Other medicines and Oxylan: The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
- Possible side effects, Frequency unknown: Long term use of Oxylan during pregnancy may cause life-threatening withdrawal symptoms in the new-born. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.
It is important that any patients are provided with information on warnings, precautions and using other medicines whilst taking Oxylan. Additionally, patients who notice the symptoms/side effects should seek immediate medical advice.
Healthcare professionals are advised that, when dispensing this product, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information.
The current PILs includes the special warning and precautions and should be issued when this product is dispensed. The PILs is available from the electronic medicines compendium (emc).
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-oxylan-prolonged-release-tablets-all-strengths-oxycodone-hydrochloride-el-20-a12
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Feb 28, 2020
Issued at HKT 16:00
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