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Dificlir granules

Dificlir 40 mg/ml granules for oral suspension

Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections in adults and paediatric patients from birth to <18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents.¹

Adults

200 mg (5 ml) BD (twice a day (every 12 hours) for 10 days¹

Paediatrics

The recommended dose by body weight BD (twice a day) for 10 days is presented in the table below

Dificlir 40 mg/ml granules for oral suspension paediatrics dosing by weight

Weight band of patient

mg per dose ( Every 12 hours)

Volume of Dificlir oral suspension (every 12 hours)

<4.0kg

40mg

1ml

4.0 - <7.0kg

80mg

2ml

7.0 - <9.0kg

120mg

3ml

9.0 - <12.5kg

160mg

4ml

>12.5kg

200mg

5ml

Preparation of Dificlir 40 mg/ml granules for oral suspension

Each bottle contains: 1 x 7.7g white to yellowish white Dificlir granules for oral suspension

Sugar-free
Mixed berry flavour

Dificlir granules for oral suspension should be prepared by a pharmacist or other HCP, and not by patients or caregivers at home.¹

The reconstituted suspension must be stored at refrigerated temperature (2°C – 8°C) before and after use¹

Instructions for reconstitution¹

Shake the glass bottle to ensure the granules move around freely and no caking of the granules has occurred

Reconstitute with 105 ml purified water and shake vigorously for at least 1 minute (If any caked granules or lumps remain, shake vigorously again for 1 minute). Let bottle stand for 1 minute and then verify that the suspension is homogenous

Write the date of expiration of the reconstituted suspension on the bottle label (the shelf-life of the reconstituted suspension is 27 days)

Dispense liquid medicine using an oral syringe and adaptor (not included in the pack)

After preparation

Each bottle contains: 1 x 110 ml oral suspension
Each ml of oral suspension contains: 40 mg Dificlir

Report a side effect

Adverse events should be reported. Reporting forms and information can be found at:

https://www.hpra.ie/report-an-issue/medicines-for-human-use/side-effects

Adverse events should also be reported to Tillotts Pharma UK Ltd on:

Tel: +353 1 2942015

Email: Pvireland@tillotts.com

References
1. DIFICLIR™ 40 mg/ml granules for oral suspension SmPC.

PM-DIF200-IE-00016 | October 2025