Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL (23)A/41

UPDATED 8th DECEMBER WITH AMENDED BATCH NUMBERS (IN BOLD)

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard.

MDR Number: MDR 055-11/23

Company name: Strandhaven Ltd t/a Somex Pharma

Product description: Tramadol Hydrochloride 50mg Capsules, Hard, PL 15764/0138

SNOMED Code: N/A

Details of the affected batch:

Active Pharmaceutical Ingredient: Tramadol Hydrochloride

Brief description of problem:

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard. The PIL does not include the most up to date safety information for drug interaction of antidepressants with Tramadol, sleep-related breathing disorders, adrenal insufficiency, hiccups, and serotonin syndrome, and the need to seek medical advice if they occur. The information missing from the PILs is included below:

2. What you need to know before you take Tramadol

Warnings and precautions

• If you suffer from depression and you are taking antidepressants as some of them may interact with tramadol

Sleep-related breathing disorders

Tramadol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Talk to your doctor or pharmacist or nurse if you experience any of the following symptoms while taking Tramadol:

• Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels).

If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.

4. Possible side effects

Not known: frequency cannot be estimated from the available data

• hiccups
• Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take ’).
• dependence and addiction (see section “How do I know if I am addicted?”).

Advice to 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 Somex Pharma Website. 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.

Strandhaven Limited t/a Somex Pharma has confirmed that all future batches will contain the correct PIL. Upon request, Strandhaven Limited t/a Somex Pharma 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).

Advice to Patients:

No action is needed from patients. This issue is about missing information in the Patient information leaflets (PILs) in specific batches of Tramadol Hydrochloride 50mg film-coated tablets indicated for moderate to severe pain (pain reliever). 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

Company contacts for further information:

For more information, medical information queries, contact: regulatory@somexpharma.com, tel: 020 8590 9399, choose option 3 or 4.

For stock control queries, contact: accounts@somexpharma.com, tel: 020 8590 9399, choose option 2.

To access the full recall:

Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL(23)A/41