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Spasmex® (Tablets) Instructions for Use

ATC Code

G04BD09 (Tropsium)

Active Substance

Trospium chloride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Drugs used in urology; other drugs for the treatment of frequent urination and urinary incontinence

Pharmacological Action

An agent that reduces the tone of the smooth muscles of the urinary tract. It is an M-cholinergic blocker 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 urge to urinate, feeling of incomplete bladder emptying (pollakiuria), nocturia, and involuntary urination with or without urge.

ICD codes

ICD-10 code Indication
N32.8 Other specified disorders of bladder (including hyperactive bladder)
N39.3 Stress incontinence
R32 Urinary incontinence
R35 Polyuria (including frequent micturition, nocturia)
ICD-11 code Indication
GC01.Z Unspecified lesions of the urinary bladder
GC50.0 Overactive bladder
GC50.1Z Absent or impaired bladder sensation, unspecified
MF50.0 Frequent micturition
MF50.1 Pollakiuria
MF50.20 Stress urinary incontinence
MF50.2Z Unspecified urinary incontinence
MF55 Polyuria

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take one 20 mg tablet orally twice daily for the treatment of overactive bladder symptoms.

Administer the doses approximately 12 hours apart to maintain consistent therapeutic levels.

Swallow the tablet whole with a sufficient amount of water; do not chew or crush.

Take the tablets on an empty stomach, at least 1 hour before a meal, to ensure optimal absorption.

Adhere strictly to the prescribed twice-daily schedule; do not increase the dose or frequency without medical consultation.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose; in that case, skip the missed dose and continue the regular schedule. Do not take a double dose.

The maximum recommended daily dose is 40 mg. Treatment duration is determined by the physician based on clinical response and tolerability.

Regularly assess the need for continued therapy. Discontinue treatment if no significant clinical benefit is observed.

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 disturbances, 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 penetrates 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 18 years of age.

Special Precautions

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

Influence 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-cholinergic blockers, quinidine, antihistamines, and disopyramide are enhanced.

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

Storage Conditions

Store at 15°C (59°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

PRO.MED.CS Praha, a.s. (Czech Republic)

Manufactured By

Dr. Pfleger Arzneimittel GmbH (Germany)

Dosage Form

Bottle Rx Icon Spasmex® Tablets 5 mg: 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, almost white.

1 tab.
Trospium chloride 5 mg

Excipients : lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), stearic acid, povidone K25, colloidal anhydrous silicon dioxide.

10 pcs. – blisters (3) – cardboard packs with first opening control.
10 pcs. – blisters (5) – cardboard packs with first opening control.

Marketing Authorization Holder

PRO.MED.CS Praha, a.s. (Czech Republic)

Manufactured By

Dr. Pfleger Arzneimittel GmbH (Germany)

Dosage Form

Bottle Rx Icon Spasmex® Film-coated tablets, 15 mg: 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on the break – a core and a film coating of white or almost white color; tablet weight – 259.6 mg.

1 tab.
Trospium chloride 15 mg

Excipients : lactose monohydrate – 100 mg, microcrystalline cellulose – 75 mg, corn starch – 44 mg, sodium carboxymethyl starch – 10 mg, stearic acid – 2 mg, povidone-25 thousand – 1 mg, colloidal silicon dioxide – 3 mg.

Shell composition hypromellose – 6.24 mg, titanium dioxide – 1.44 mg, microcrystalline cellulose – 0.96 mg, stearic acid – 0.96 mg.

10 pcs. – blisters (3) – cardboard packs with first opening control.
10 pcs. – blisters (5) – cardboard packs with first opening control.

Marketing Authorization Holder

PRO.MED.CS Praha, a.s. (Czech Republic)

Manufactured By

Dr. Pfleger Arzneimittel GmbH (Germany)

Dosage Form

Bottle Rx Icon Spasmex® Film-coated tablets, 30 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on the break – a core and a film coating of white or almost white color; tablet weight – 259.6 mg.

1 tab.
Trospium chloride 30 mg

Excipients : lactose monohydrate – 100 mg, microcrystalline cellulose – 60 mg, corn starch – 41 mg, sodium carboxymethyl starch – 10 mg, stearic acid – 5 mg, povidone-25 thousand – 1 mg, colloidal silicon dioxide – 3 mg.

Shell composition hypromellose – 6.24 mg, titanium dioxide – 1.44 mg, microcrystalline cellulose – 0.96 mg, stearic acid – 0.96 mg.

10 pcs. – blisters (3) – cardboard packs with first opening control.

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