MYONAL Tablets / Granules Ref.[11086] Active ingredients: Eperisone

Careful Administration – MYONAL should be administered with care in the following patients:

1. Patients with a history of drug hypersensitivity
2. Patients with hepatic function disorder [MYONAL may aggravate hepatic function]

Important Precautions

Weakness, light-headedness, sleepiness or other symptoms may occur. In the event of such symptoms, the dosage should be reduced or treatment discontinued. Patients should be cautioned against engaging in potentially hazardous activities requiring alertness, such as operating machinery or driving a car.

Drug Interactions

Precautions for coadministration (MYONAL should be administered with care when coadministered with the following drugs).

Adverse reactions were reported in 416 of 12,315 patients (3.38%) (At the end of the reexamination period).

Clinically significant adverse reactions (incidence unknown)

Shock and anaphylactoid reactions

Since shock and anaphylactoid reactions may occur, patients should be carefully observed. In the event of symptoms such as redness, itching, urticaria, edema of the face or other parts and dyspnea etc., treatment should be discontinued and appropriate measures taken.

Oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome)

Serious dermatopathy such as oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) may occur. Patients should be carefully observed, treatment discontinued and appropriate measures taken, in the event of symptoms such as fever, erythema, blistering, itching, ocular congestion or stomatitis, etc.

Other adverse reactions

Note 1) Since these symptoms may occur, patients should be carefully observed. In the event of such abnormalities, treatment should be discontinued and appropriate measures taken.

Note 2) In the event of such symptoms, treatment should be discontinued.

Neck-shoulder-arm syndrome, scapulohumeral periarthritis and low back pain

In open labeled clinical trials and a double blind controlled clinical trial undertaken to determine the effects of MYONAL on myotonic symptoms associated with these diseases, an efficacy rate of 52.1% (234/449) was achieved. (When fairly effective responses are included, the efficacy rate was as high as 80.4%).^2-4)

Spastic paralysis

In open labeled clinical trials and a double blind clinical trial, the usefulness of MYONAL has been established for spastic paralysis associated with diseases such as cerebrovascular disturbances, spastic spinal paralysis or cervical spondylosis. Improvement rates for rigidity and stiffness in patients with spastic paralysis were 42.3% (197/466) and 45.1% (174/386), respectively.^5-7)

MYONAL should only be used in pregnant women or women suspected of being pregnant, if the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment [The safety of MYONAL in pregnant women has not been established].

It is advisable to avoid the administration of MYONAL to nursing mothers. When MYONAL must be used, breast feeding should be discontinued during treatment [It has been reported that MYONAL is excreted in breast milk in an animal study (in rats)].

Safety in children has not been established (insufficient clinical experience).

Since the elderly often have a physiological hypofunction, it is advisable to take measures, such as reduction in dosage under careful supervision.

Precautions concerning Use

Caution in handing over drug (tablets):

For drugs that are dispensed in a press-through package (PTP), instruct the patient to remove the drug from the package prior to use [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, causing perforation and resulting in serious complications such as mediastinitis].