Class 4 Medicines Defect Information: Oxylan Prolonged-release tablets, all strengths (oxycodone hydrochloride), (EL (20)/A12)
G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
MDR Number
MDR 188-01/20
Company Name
G.L. Pharma GmbH T/A Healthcare Pharma Ltd
Product description
Oxylan 10 mg prolonged-release tablets PL 21597/0062
- Batch number: 9F115A
- Expiry date: 05/2024
- Pack size: 56
- First distributed: 16/01/20
- Batch number: 9F116A
- Expiry date: 05/2024
- Pack size: 56
- First distributed: 16/01/20
Oxylan 20 mg prolonged-release tablets PL 21597/0063
- Batch number: 9J114A
- Expiry date: 08/2024
- Pack size: 56
- First distributed: 16/01/20
Oxylan 40 mg prolonged-release tablets PL 21597/0064
- Batch number: 9F119A
- Expiry date: 05/2024
- Pack size: 56
- First distributed: 16/01/20
Oxylan 80 mg prolonged-release tablets PL 21597/0065
- Batch number: 9F120A
- Expiry date: 05/2024
- Pack size: 56
- First distributed: 16/01/20
Active Pharmaceutical Ingredient: oxycodone hydrochloride
Brief description of the problem
G.L. Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the above batches is missing important safety relevant text changes. The changes to the PIL include the addition of the following information:
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Warnings and precautions: If you have poor adrenal gland function (your adrenal gland is not working properly) for example Addinson’s disease.
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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.
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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.
Advice for healthcare professionals
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. Click here or Oxylan PR Tablet PILs available from the electronic medicines compendium (emc).
Further Information
For more information or medical information queries, please contact: GL Pharma GmbH on +43 3136 82577 or office@gl-pharma.at.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. .
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