MHRA Class 4 Medicines Defect Information: Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution (Dawa Limited)

Class 4 Medicines Defect Information: Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution (Dawa Limited)

Drug alert number: EL (24)A/37

Date issued: 14 August 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution (Dawa Limited)

Company name: Dawa Limited

Product name: Trazodone Hydrochloride 50mg Capsules, PL 30684/0250

SNOMED Code: 35807611000001105

Product name: Trazodone Hydrochloride 100mg Capsules, PL 30684/0251

SNOMED Code: 35807111000001102

Product name: Trazodone Hydrochloride 50mg/5ml Oral Solution, PL 30684/0268

Active Pharmaceutical Ingredient:  trazodone hydrochloride

Brief description of the problem

Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.

The PIL does not contain the latest safety information relating to serotonergic products (trazodone) and the interaction with buprenorphine.

The missing information on the Trazodone Hydrochloride 50mg Capsules & Trazodone Hydrochloride 100mg Capsules PIL is as follows:

Check with your doctor or pharmacist before taking this medicine if you:
–           are taking buprenorphine (a strong pain killer). The use of buprenorphine with Trazodone hydrochloride capsules can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Trazadone hydrochloride capsules”).

Tell your doctor if you are taking any of the following medicines:
–           Buprenorphine/opioids. These medicines may interact with Trazodone hydrochloride capsules and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

The missing information on the Trazodone Hydrochloride 50mg/5ml Oral Solution is as follows:

Talk to your doctor or pharmacist or nurse before  taking Trazodone Oral Solution:-
–           if you are taking buprenorphine (a strong pain killer). The use of buprenorphine with Trazodone Oral Solution can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Trazodone Oral Solution”).

Tell your doctor if you are taking any of the following medicines:
–           buprenorphine/opioids. These medicines may interact with Trazodone Oral Solution and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the following links:

• Trazodone Hydrochloride 50mg Capsules
• Trazodone Hydrochloride 100mg Capsules
• Trazodone 50mg/5ml Oral Solution

If it is not possible to provide an updated PIL, please advise patients of the missing information, discuss if this medicine is still suitable for them, and the need to seek medical advice if these signs or symptoms occur.

The distributor, Drugsrus Limited, has confirmed that all future batches will contain the correct PIL. Upon request, Drugsrus Limited will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information (see contact details below).

View full alert here.

Advice for patients

No action is needed from patients. This issue is about missing information in the Patient Information Leaflets in specific batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution indicated for anxiety and depression. The medication itself is not affected.

These products will have been prescribed and dispensed by qualified healthcare professional(s) responsible for your care. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.