GARDENAL

In adults:

· Either as monotherapy.

· Either in combination with another antiepileptic 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.

· Either in combination with another antiepileptic 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%); Unspecified (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.

· Unspecified frequency: dyskinesia.

Psychiatric disorders

· Frequent: behavioral abnormalities, agitation, aggression.

· Uncommon: mood disorders, sleep disorders/insomnia.

· Unspecified frequency: dependence syndrome.

Skin and subcutaneous tissue disorders

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

· Unspecified 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.

· Unspecified frequency: hepatitis.

Musculoskeletal and systemic disorders

· Frequent: palmar fascia contraction (Dupuytren's disease).

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

· Unspecified frequency:

o plantar fascia contraction (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

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

Gastrointestinal disorders

· Frequent: nausea, vomiting.

Congenital, familial and genetic disorders

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

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

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization 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.