Mendilex^® (Tablets) Instructions for Use

Marketing Authorization Holder

Alkaloid AD Skopje (Republic of North Macedonia)

ATC Code

N04AA02 (Biperiden)

Active Substance

Biperiden (Rec.INN registered by WHO)

Dosage Form

Mendilex®

Tablets 2 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, biconvex, with a score on one side.

Excipients: magnesium stearate, lactose monohydrate, microcrystalline cellulose.

10 pcs. – blisters (5) – cartons.

Clinical-Pharmacological Group

Antiparkinsonian drug – inhibitor of cholinergic transmission in the CNS

Pharmacotherapeutic Group

Central anticholinergic agent

Pharmacological Action

Antiparkinsonian agent. It has a central m-cholinolytic action, inhibiting the enhanced inhibitory function of cholinergic neurons of the striatum (a structural component of the extrapyramidal system).

It also has a moderately pronounced peripheral m-cholinolytic action, myotropic antispasmodic and ganglioblocking action. Causes psychomotor agitation.

Pharmacokinetics

When taken orally, C_max is 1.01-6.53 ng/ml and is reached within 0.5-2 hours. C_ss when taking 2 mg twice a day is reached after 15.7-40.7 hours.

Plasma protein binding is 91-94%. Oral bioavailability is 33%. Plasma clearance is 11.6 ml/min/kg. It is completely metabolized.

The main metabolites are bicycloheptane and piperidine. Elimination occurs in two phases with T_1/2 of 1.5 hours in the first phase and 24 hours in the second phase.

It is excreted by the kidneys and through the intestines. It is excreted in breast milk.

Indications

Parkinson’s disease, parkinsonism syndrome (as part of combination therapy), extrapyramidal disorders caused by antipsychotic agents (neuroleptics).

ICD codes

Dosage Regimen

For adults when taken orally at the beginning of treatment – 1 mg twice a day, then the frequency of administration can be gradually increased and 2 mg 2-4 times a day can be used.

The dose can be increased to 6-16 mg/day. When administered intramuscularly or intravenously, a single dose is 2.5-5 mg. Repeated administration at the same dose is possible every 30 minutes, but no more than 4 times a day.

Maximum doses when taken orally – 16 mg/day; with parenteral administration – 20 mg/day.

Adverse Reactions

From the central nervous system weakness, asthenia, dizziness, numbness, anxiety, memory impairment, confusion, hallucinations.

From the organ of vision mydriasis, accommodation disturbance.

From the cardiovascular system tachycardia; rarely – bradycardia; with parenteral administration – decreased blood pressure.

From the digestive system dry mouth, dyspepsia, constipation.

From metabolism decreased sweating.

From the urinary system in patients with prostatic hyperplasia – difficulty urinating.

Allergic reactions skin rash, itching.

Contraindications

Angle-closure glaucoma, prostatic hyperplasia, obstructive conditions of the gastrointestinal tract (including pyloric stenosis, paralytic ileus), megacolon; hypersensitivity to biperiden.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

It is recommended to discontinue breastfeeding during treatment.

Use in Renal Impairment

It should be used with caution in patients with impaired renal function.

Pediatric Use

Oral administration in children under 3 years of age is contraindicated. It can be used in children according to indications in doses and dosage forms recommended for the respective age.

Geriatric Use

It is used with caution in elderly patients to avoid worsening of concomitant diseases.

Special Precautions

Use with caution in patients with epilepsy, arrhythmia, and in elderly patients.

Development of drug dependence is possible.

Treatment should be discontinued gradually due to the risk of withdrawal syndrome.

The safety of biperiden use in children has not been established, so its use is not recommended.

Avoid alcohol consumption during treatment.

Effect on the ability to drive vehicles and operate machinery

Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with anticholinergic drugs, an increase in central and peripheral anticholinergic effects is possible.

With simultaneous use with antipsychotic agents (neuroleptics), the risk of developing tardive dyskinesia increases.

With simultaneous use with biperiden, the effect of histamine H₁-receptor blockers and anticonvulsants is enhanced.

With simultaneous use with levodopa, an increase in m-cholinolytic action and dyskinesia is possible.

With simultaneous use, Biperiden reduces the effectiveness of metoclopramide.

With simultaneous use with quinidine, the risk of developing dyskinesia increases. It potentiates the effect of ethanol.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.