Baraclude 0.05 mg/ml oral solution

1. to add Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing [Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland] as an alternative site responsible for batch release
2. to change the name and amend the address of the site responsible for batch release from Bristol-Myers Squibb S.r.l. [Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy] to CATALENT ANAGNI S.R.L. [Loc. Fontana del Ceraso snc, Strada Provinciale 12 Casilina, 41 03012 Anagni (FR), Italy].

Approved Product Information (PI) changes:

• to briefly reflect data in the final clinical study reports for Study AI463-080
• to remove information on the PK of ETV in lamivudine-experienced paediatric patients currently presented in section 5.2 (as requested by CHMP)
• to remove the word “ongoing” from the descriptions of studies AI463-028 and AI463-189

4.       Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Patients treated with Baraclude have reported the following side effects:

Adults

• common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
• uncommon (at least 1 in 1,000 patients): rash, hair loss.
• rare (at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents

The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).

4.8     Undesirable effects

d. Paediatric Population

The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189). These trials provide experience in 195 HBeAg-positive nucleoside-treatment-naïve subjects treated with entecavir for a median duration of 99 weeks. The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults .(see a. Summary of the safety profile and section 5.1) with the following exception in the paediatric patients:

• very common adverse reactions: neutropenia.

The address of the Marketing Authorisation Holder has been changed.