GARDENAL

In adults:

· Either as monotherapy.

· Or in association with another anti-epileptic treatment:

o treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures,

o treatment of partial epilepsies: partial seizures with or without secondary generalization.

In children:

· Either as monotherapy.

· Or in association with another anti-epileptic treatment:

o treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures,

o treatment of partial epilepsies: partial seizures with or without secondary generalization.

Attention should be drawn, particularly in drivers of vehicles and users of machinery, to the risks of drowsiness and dizziness associated with the use of phenobarbital.

The classification of adverse events according to their frequency is as follows: Very frequent (≥ 10 %); Frequent (≥ 1 % - <10 %); Uncommon (≥ 0,1 % - <1 %); Rare (≥ 0,01 % - < 0,1 %); Very rare (< 0,01%); Undetermined (cannot be estimated from the available data)

Nervous system disorders

· Frequent: somnolence (difficult awakening sometimes with difficulties articulating), cognitive disorders, memory impairment.

· Uncommon: coordination and balance disorders, dizziness, headache.

· Rare: disturbance of attention.

· Undetermined frequency: dyskinesia.

Psychiatric disorders

· Frequent: behavioral abnormalities, agitation, aggression.

· Uncommon: mood disorders, sleep disorders/insomnia.

· Undetermined frequency: dependence syndrome.

Skin and subcutaneous tissue disorders

· Frequent: allergic dermatitis (in particular, morbilliform or scarlatiniform maculopapular eruptions).

· Undetermined frequency:

o fixed pigmented erythema,

o possible serious skin reactions such as extremely rare cases of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), exfoliative dermatitis (see section 4.4),

o drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) (see section 4.4).

The existence of rare cases of cross-reactions between phenobarbital, phenytoin and carbamazepine should make the replacement of phenobarbital by one or the other of the molecules cautious.

Hepatobiliary disorders

· Frequent: increase in gamma-glutamyltransferases, transaminases and/or alkaline phosphatases.

· Undetermined frequency: hepatitis.

Musculoskeletal and systemic disorders

· Frequent: palmar aponeurosis retraction (Dupuytren's disease).

· Uncommon: arthralgia (shoulder-hand syndrome or phenobarbital-induced rheumatism).

· Undetermined frequency:

o plantar aponeurosis retraction (Ledderhose disease), induration of the corpora cavernosa (Peyronie's disease).

Cases of decreased bone mineral density, osteopenia, osteoporosis and fractures have been reported in patients treated long-term with GARDENAL. The mode of action of GARDENAL on bone metabolism is unknown.

Blood and lymphatic system disorders

· Undetermined frequency: pancytopenia, aplastic anaemia, folate deficiency anaemia, agranulocytosis, neutropenia, leucopenia, thrombocytopenia.

Gastrointestinal disorders

· Frequent: nausea, vomiting.

Congenital, familial and genetic disorders

· Undetermined frequency: congenital malformations, other developmental abnormalities (see sections 4.4 and 4.6).

Serious effects affecting the hepatic and/or cutaneous systems as well as hypersensitivity reactions require discontinuation of treatment.

Reporting of suspected adverse effects

Reporting suspected adverse effects after authorization of the medicinal product is important. It allows for continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr