Procysbi 25mg / 75mg gastro-resistant hard capsules

4.2      Posology and method of administration

Missed doses

If a dose is missed, it should be taken as soon as possible. If it is within four hours of the next dose, the missed dose should be skipped going back to the regular dosing schedule. The dose should not be doubled.

4.6    Fertility, pregnancy and lactation

Women of childbearing potential

 Women of childbearing potential should be informed about the risk of teratogenicity and advised to use an adequate method of contraception during the course of treatment. A negative pregnancy test should be confirmed before starting treatment.

• Harmonisation of the PIL in line with the SmPC to include administration via feeding tube in section 3:
  • Method of administration

You should take this medicine only by mouth.

In order for this medicine to work correctly, you must do the following:

-        Swallow the whole capsule with an acidic drink (such as orange juice or any acidic juice) or water. Do not crush or chew capsules or capsule contents. Do not give gastro-resistant hard capsules to children under 6 years of age because they may not be able to swallow them and they may choke. For patients who cannot swallow the whole capsule, the gastro-resistant hard capsule may be opened and the contents may be sprinkled on food (such as apple sauce or berry jelly) and eaten or administered through feeding tubes or mixed in with an acidic drink (such as orange juice or any acidic juice) or water. Consult your child’s doctor for complete directions.

• Update to include Chiesi Farmaceutici SpA as a local representative for UK(NI)

Following the below approval to change the local representative in IT, we have now been advised to update the PIL revision date in line with Italy (10/2020) – please note all other content remains the same.

The new PIL code is CP0062-6 superseding CP0062-5.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 10 - Date of revision of the text

Date of revision of text on the SmPC:01-09-2019

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Shelf life now changed from 18 months to 24 months:

6.3 Shelf life

24 months

 In-use shelf life: 30 days

Date of revision of text changed to  

09/2018

Admin error on last entry identified

The national reporting adverse event reporting information was missing from bottom of section 4.8.

This was changed from

Reporting of suspected adverse reactions

 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This was changed to

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard  

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

No other changes have been made