Spasmio-lyt^® (Tablets) Instructions for Use

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

ATC Code

G04BD09 (Tropsium)

Active Substance

Trospium chloride (Rec.INN registered by WHO)

Dosage Form

Spasmio-lyt®

Coated tablets, 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Drug reducing the tone of the smooth muscles of the urinary tract

Pharmacotherapeutic Group

M-cholinoblocker

Pharmacological Action

A drug that reduces the tone of the smooth muscles of the urinary tract. It is an M-cholinoblocker that acts on peripheral M-cholinergic receptors.

It has ganglion-blocking activity. It lowers the tone of the smooth muscles of the gastrointestinal tract.

Indications

Symptomatic treatment for spasm of the detrusor muscle of the bladder, including frequent urination urges, sensation of incomplete bladder emptying (pollakiuria), nocturia, and involuntary urination with or without urge.

ICD codes

Dosage Regimen

Administer the standard adult dose as one 20 mg tablet taken twice daily.

Take tablets on an empty stomach, at least one hour before meals.

Swallow tablets whole with a sufficient amount of liquid; do not chew or crush.

For patients with moderate renal impairment (creatinine clearance 30-60 mL/min), reduce the dose to one 20 mg tablet once daily.

This medication is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min).

Do not use in patients with severe hepatic impairment.

The use of Spasmio-lyt^® in children and adolescents under 18 years of age is contraindicated.

Regularly assess the need for continued therapy, particularly in elderly patients.

Adverse Reactions

From the digestive system frequently – dry mouth; rarely – nausea, constipation or diarrhea, vomiting.

From the cardiovascular system rarely – tachycardia, arrhythmia.

From the CNS and peripheral nervous system rarely – accommodation disorders, dizziness, mydriasis, anxiety, agitation, fatigue, headache, drowsiness or sleep disorders.

From the urinary system rarely – urinary retention, dysuria.

Other rarely – suppression of sweat gland secretion or sweating, dyspnea, skin allergic reactions; in isolated cases – metrorrhagia, mastodynia.

Contraindications

Mechanical stenosis of the gastrointestinal tract, benign prostatic hyperplasia with pronounced symptoms of residual urine, as well as other conditions accompanied by urethral stenosis, complete and partial intestinal obstruction, megacolon, glaucoma, tachyarrhythmia, myasthenia gravis, heart failure, impaired liver and kidney function, urinary tract infections, age under 18 years, hypersensitivity to trospium chloride.

Use in Pregnancy and Lactation

There are no data on the safety of trospium chloride use during human pregnancy; use is possible only for strict indications.

Experimental studies have established that trospium chloride crosses the placenta in limited amounts.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Use in Renal Impairment

Contraindicated in impaired kidney function.

Pediatric Use

Contraindicated under the age of 18 years.

Special Precautions

Use with caution in prostatic hyperplasia and bladder hypersensitivity syndrome with mild symptoms of residual urine.

Effect on the ability to drive vehicles and mechanisms

Should be used with caution in patients engaged in potentially hazardous activities requiring high speed of psychomotor reactions.

Drug Interactions

With simultaneous use, the anticholinergic effects of amantadine, tri- and tetracyclic antidepressants, neuroleptics, other M-cholinoblockers, quinidine, antihistamines, disopyramide are enhanced.

With simultaneous use, tachycardia caused by beta-adrenomimetics is enhanced.

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.