AGIDECOTYL®

Composition: Each film-coated tablet contains:
Mephenesin . . . . . . . . . . . . . . . . . . . . . . 250 mg
Presentation:
Cardboard box with 10 blisters of 10 film-coated tablet.
HD plastic bottle containing 100, 200 hard capsules.
Indications:
Supportive treatment for painful muscle spasm associated with musculoskeletal conditions in degenerative vertebral disease and postural and cervical vertebrae disorders, torticollis, lumbago, and low back pain.

Additional information

Dosage and administration

Dosage:
Adults and children over 15 years of age: 2 tablet x 3 times a day.
Administration: Oral administration with a glass of water.

Contraindications

Hypersensitivity to mephenesin or any of excipients.
Patients with porphyria.
Pregnant women and breast-feeding mothers.

Warnings and precautions for use

Patients with a history of allergies, bronchial asthma, allergy to the drug, especially hypersensitivity to aspirin.
Patients with respiratory illness, muscle weakness, a history of drug addiction, impaired liver or kidney function.
Drug-related adverse events usually worsen with concomitant use of alcohol and CNS inhibitors.
As medication may cause drowsiness and reduce the ability to coordinate muscle activity during voluntary movements, patients taking mephenesin should not drive and operate machines.
This medicine contains lactose. Patients with rare genetic abnormalities of galactose tolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine.

Recommendation for pregnancy and breastfeeding

Pregnancy:
There are no reliable data on teratogenicity of mephenesin in animal experiments.
Up to now, data relevant to or with sufficient quantities to assess the effect of mephenesin on causing fetal teratogenicity or toxicity are not available when it is taken during pregnancy.
Thus, to be safe, mephenesin should not be taken during pregnancy.
Breast-feeding:
There are insufficient data to show whether mephenesin passes into breast milk. Therefore, it is safe to avoid taking mephenesin while breastfeeding.

Effects on ability to drive and use machines

Mephenesin may cause drowsiness. Therefore, caution should be exercised when driving or operating machines.

Interactions, incompatibilities of medicine

The effects of mephenesin on the central nervous system may be enhanced if alcohol or other nervous system inhibitors are taken concomitantly during the treatment with this medicine.
To avoid interactions between drugs, inform your physician or pharmacist about the drugs you are taking.

Undesirable effects (ADRs)

Mephenesin can cause undesirable effects such as convulsions, tremors, abdominal cramps, nausea, sweating. These symptoms usually occur in patients who take the drug for a long time.
Common, ADR > 1/100
Fatigue, somnolence, sluggish, dyspnea, muscle weakness, ataxia.
Uncommon, 1/1000 < ADR < 1/100
Joint pain, malaise, nausea, exasperation, diarrhea, constipation, rash. In some special cases loss of appetite, vomiting, agitation, hallucinations may be seen, and anaphylactic shock may occur.
Rarely, ADR < 1/1000
Allergic reactions. Very rarely, anaphylactic shock may occur.
Drowsiness, hives.
How to handle ADR: Unwanted effects of mephenesin usually occur rapidly and are less severe, thus, ADRs management is primarily to reduce the doses or discontinue the therapy, symptomatic and intensively supportive treatment to restore health are required. First aid measures for anaphylaxis should be always ready although it rarely occurs.
Inform your doctor if any of side effects occurs when using this medicine.

Overdose and management

Symptoms:
Mephenesin overdose may cause following clinical signs: Decreased muscle tone, hypotension, visual disturbances, drowsiness, loss of coordination, hallucination, respiratory paralysis and comatose.
Overdose causes seizures in children and can cause strong emotions and confusion in the elderly.
Treatment: In all cases of overdose, patients should be carefully monitored for respiration, pulse and blood pressure.
If the patient is conscious, he or she should immediately be treated by inducing vomiting, gastric lavage and symptomatic treatment or be transferred to healthcare facilities.
Carry out gastric lavage along with general supportive treatment, ensure ventilation, and intravenous infusion administration of fluids.
It is also possible to treat CNS inhibition by selecting appropriate medicines.
In case of unconsciousness, artificial respiration is performed and transfer patients to specialized healthcare facilities.

Pharmacodynamic properties

Mephenesin is a centrally acting skeletal muscle relaxant.
It causes mild tranquilization and muscle relaxation due to neuromuscular blocking mechanism with systemic effect. It also has effect at contact site for topical use.

Pharmacokinetic properties

Mephenesin is rapidly absorbed from the gastrointestinal tract and distributed in most tissues in the body, peak plasma concentrations are reached in less than one hour.
Mephenesin is mainly metabolized in the liver.
Elimination half-life is about 45 minutes.
Mephenesin is excreted in the urine mainly as metabolites and partly as unchanged form.

Storage conditions, shelf-life, quality specification of the medicine

Storage conditions: Protect from humidity and light, below 30 degrees C.
Shelf – life: 24 months from the manufacture date.
Quality specification: In house specification.