Adverse reactions : תופעות לוואי

4.8   Undesirable effects
LIO API MAY24 V2                                                                      Page 5 of 10 Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.

Should nausea persist following a reduction in dosage, it is recommended that Lioresal be ingested with food or a milk beverage.

In patients with a history of psychiatric illness or with cerebrovascular disorders (e.g.
stroke) as well as in elderly patients, adverse reactions may assume a more serious form.

Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

Certain patients have shown increased spasticity as a paradoxical reaction to the medication.

An undesirable degree of muscular hypotonia - making it more difficult for patients to walk or fend for themselves - may occur and can usually be relieved by re-adjusting the dosage (i.e. by reducing the doses given during the day and possibly increasing the evening dose).

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000) and Not known (cannot be estimated from the available data).

Table 1 Tabulated summary of adverse drug reactions

Immune system disorders
Not known:                    Hypersensitivity
Nervous system disorders
Very common:           Sedation, somnolence
Common:                Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare,
myalgia, headache, nystagmus, dry mouth
Rare:                  Paraesthesia, dysarthria, dysgeusia
Unknown:               Sleep Apnoea syndrome*
Eye disorders
Common:                Visual impairment, accommodation disorder
Cardiac disorders
Common:                Cardiac output decreased
Not known:             Bradycardia
Vascular disorders
Common:                Hypotension
Gastrointestinal disorders
Very common:           Nausea
Common:                Gastrointestinal disorder, constipation, diarrhoea, retching, vomiting
Rare:                  Abdominal pain
Hepatobiliary disorders
Rare:                  Hepatic function abnormal
LIO API MAY24 V2                                                                    Page 6 of 10 Skin and subcutaneous tissue disorders
Common:               Rash, hyperhidrosis
Not known             Urticaria, alopecia
Renal and urinary disorders
Common:               Pollakiuria, enuresis, dysuria
Rare:                 Urinary retention
Reproductive system and breast disorders
Rare:                 Erectile dysfunction
Not known:            Sexual dysfunction
General disorders and administration site conditions
Very rare             Hypothermia
Not known             Drug withdrawal syndrome* (see section 4.4) , swelling face and peripheral oedema

Investigations
Not known:                Blood glucose increased
*Drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral Lioresal.
* Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100 mg) in patients who are alcohol dependent.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/