Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19)

News By 22nd October 2019

Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19)

Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.

Product information
PL number
PL 16853 / 0147

MDR Number
MDR 025-10/19

Company name
Alliance Pharmaceuticals Limited

Product description
Xonvea 10 mg/10 mg gastro-resistant tablets (doxylamine succinate and pyridoxine hydrochloride)

Batch number/expiry
Batch Number Expiry Date Pack Size First Distributed
1510 30 November 2021 1 x 20 25 September 2018
1525 31 December 2021 1 x 20 05 December 2018
1527 31 January 2022 1 x 20 17 December 2018
Brief description of the problem
Alliance Pharmaceuticals Ltd has informed us that the Patient Information Leaflet (PIL) is missing the possible side effects from post-marketing experience and the associated class effects that are documented in the Summary of Product Characteristics (SmPC). The change concerns:

Possible side effects (not present on the PIL):

hypersensitivity (allergic reactions)
feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disorientated
headaches or migraines
tingling, pricking or numbness of skin
restlessness and a need to move constantly
problems with eyesight or blurred vision
sensation of spinning dizziness
difficulty breathing, awareness of heartbeat or increased heart rate
full or bloated feeling, stomach pains, constipation or diarrhoea
excessive sweating, skin reactions such as itchiness or rash
difficulties or pain with passing urine *discomfort in the chest
general discomfort, feeling irritable
Class effects (not present on the PIL):

Anticholinergic effects (blockage of the activity of organs that receive nerve impulses through a substance called acetylcholine) include: dry nose and throat; double vision (diplopia); ringing or humming in the ears (tinnitus); inflammation of the inner ear which develops within a short time (acute labyrinthitis); shaking (tremors) and nervousness; involuntary repetitive movements of the face (facial dyskinesia). In addition, feeling of tightness in the chest, thick mucus in the chest (bronchial secretions); high-pitched whistling sound often associated with difficulty in breathing (wheezing); stuffy nose, feeling chills; early menses; altered state of mind such as hallucinations, delusions, confusion and disturbed thoughts (toxic psychosis); or feeling faint have been reported.

Rarely, in patients using some antihistamines, low levels of white blood cells (agranulocytosis), reduced blood in the body due to increased destruction of blood cells (haemolytic anaemia), decreased clotting blood cells (thrombocytopenia), decreased red, white and clotting cells in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been reported.

It is important that any patients who notice the symptoms seek immediate medical advice.

Alliance Pharmaceuticals Ltd is in process of updating the PIL and this will be effective on release of all new batches to the market.

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 SmPC includes the missing side effects and class effects:

https://www.medicines.org.uk/emc/product/9344

Further Information
For more information or medical information queries, please contact: medinfo@alliancepharma.co.uk

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.