MICTONORM 15 MG (PROPIVERINE HYDROCHLORIDE) – 28 COATED TABLETS

Active Ingredient: Propiverine Hydrochloride 15 mg.

Dosage Form: Oral coated tablets.

Therapeutic Class: Urinary Antispasmodic / Antimuscarinic Agent.

ATC Code: G04BD06.

Product Overview

Mictonorm contains propiverine hydrochloride, an antimuscarinic medication used to manage symptoms associated with an overactive bladder and certain types of neurogenic bladder dysfunction.

It works by relaxing the smooth muscles of the urinary bladder, helping reduce involuntary bladder contractions and increasing bladder capacity.

Mictonorm helps improve bladder control and reduce urinary urgency, frequent urination, and episodes of urinary incontinence, thereby supporting better daily comfort and quality of life.

Each coated tablet contains 15 mg of propiverine hydrochloride (equivalent to 13.64 mg of propiverine).

Indications and Therapeutic Uses

Mictonorm is indicated for the symptomatic treatment of urinary bladder dysfunction, including:

1. Overactive Bladder (OAB): Helps manage involuntary bladder contractions associated with overactive bladder syndrome.
2. Urinary Urgency: Helps reduce sudden, compelling urges to urinate.
3. Urinary Frequency: Helps decrease frequent urination during the day.
4. Urge Urinary Incontinence: Helps reduce involuntary urine leakage associated with sudden bladder contractions.
5. Neurogenic Detrusor Overactivity: Helps manage increased bladder muscle activity resulting from neurological conditions, particularly spinal cord injuries.

Mechanism of Action

Propiverine hydrochloride works through two complementary pharmacological mechanisms:

• Antimuscarinic Action: Blocks muscarinic receptors involved in bladder muscle contraction, reducing involuntary detrusor muscle activity.
• Calcium Channel Modulation: Inhibits calcium influx into bladder smooth muscle cells, producing a direct muscle-relaxing effect.

These mechanisms contribute to:

• Reduced involuntary bladder contractions.
• Increased functional bladder capacity.
• Improved control over urination.
• Reduced urinary urgency and frequency.
• Decreased episodes of urge urinary incontinence.

Dosage and Administration

Mictonorm 15 mg is administered orally. The dosage depends on the patient's condition, treatment response, and tolerability.

Usual adult dosage:

Maximum recommended daily dose: 45 mg (3 tablets).

Method of administration:

• Take the tablets orally with water.
• Preferably administer before meals.
• Swallow the coated tablets as directed.
• Treatment duration should be determined by the treating physician.

Special populations:

• Elderly: Generally, no specific dosage adjustment is required.
• Renal impairment: In severe renal impairment (creatinine clearance below 30 mL/min), the maximum recommended daily dose is 30 mg.
• Hepatic impairment: Use cautiously in mild impairment; treatment is not recommended in moderate to severe hepatic impairment.

Important: The dosage must be individualized by a healthcare professional.

Possible Side Effects

Mictonorm may cause adverse effects, mainly related to its anticholinergic activity.

Very common side effects:

- Dry mouth.

Common side effects:

• Constipation.
• Headache.
• Abdominal pain.
• Indigestion (dyspepsia).
• Blurred vision or difficulty focusing.
• Fatigue.

Other possible side effects:

• Nausea and vomiting.
• Dizziness.
• Tremors.
• Urinary retention (difficulty emptying the bladder).
• Skin rash or itching.
• Increased heart rate (tachycardia).
• Palpitations.
• Confusion or restlessness, particularly in susceptible patients.

Patients should seek medical attention if they experience severe urinary retention, significant visual disturbances, or symptoms of an allergic reaction.

Contraindications

Mictonorm should not be used in patients with:

• Known hypersensitivity to propiverine hydrochloride or any of the product's ingredients.
• Urinary retention or significant bladder outflow obstruction.
• Gastrointestinal obstruction.
• Intestinal atony.
• Severe ulcerative colitis.
• Toxic megacolon.
• Myasthenia gravis.
• Uncontrolled angle-closure glaucoma.
• Moderate to severe hepatic impairment.
• Tachyarrhythmias (abnormally rapid heart rhythms).

Warnings and Precautions

• Urinary Retention: Use cautiously in patients with bladder outlet obstruction or difficulty emptying the bladder.
• Prostatic Enlargement: Patients with benign prostatic hyperplasia should be monitored for worsening urinary symptoms.
• Glaucoma: Use cautiously in patients at risk of angle-closure glaucoma.
• Gastrointestinal Disorders: Caution is recommended in patients with gastrointestinal motility disorders or gastroesophageal reflux.
• Cardiovascular Conditions: Patients with cardiac arrhythmias or heart failure require careful assessment.
• Renal Impairment: Dose limitations may be necessary in patients with severe renal dysfunction.
• Hepatic Impairment: Appropriate medical assessment is required before treatment.
• Visual Disturbances: Blurred vision may affect the ability to drive or operate machinery.
• Long-Term Treatment: Periodic assessment of liver enzymes may be appropriate during prolonged treatment.

Drug Interactions

Mictonorm may interact with other medications, particularly those affecting the central nervous system or having anticholinergic properties.

1. Other Anticholinergic Drugs: Concomitant use may increase anticholinergic adverse effects, including dry mouth, constipation, and urinary retention.
2. Tricyclic Antidepressants: Medications such as imipramine may increase anticholinergic effects.
3. Antipsychotics: Certain antipsychotic medications, including phenothiazines, may increase adverse effects.
4. Benzodiazepines and Sedatives: May increase drowsiness and impair alertness.
5. Metoclopramide: Propiverine may reduce the prokinetic effect of metoclopramide.
6. Cholinergic Medications: May reduce the therapeutic effect of propiverine.
7. CYP3A4 Inhibitors: Certain antifungals and macrolide antibiotics may affect propiverine metabolism, requiring additional caution in selected patients.

Patients should inform their healthcare provider about all medications they are taking before starting treatment.

Storage Conditions

• Store according to the manufacturer's instructions.
• The referenced product information specifies that no special storage conditions are required.
• Keep the tablets in their original packaging.
• Keep out of reach of children.
• Do not use after the expiry date indicated on the package.

Product Presentation

MICTONORM 15 MG

1. Medicines and Healthcare products Regulatory Agency (MHRA), UK: Official Summary of Product Characteristics for Mictonorm 15 mg Coated Tablets. Mictonorm 15 mg – Summary of Product Characteristics.
2. Indonesian National Agency of Drug and Food Control (BPOM): Mictonorm product assessment report, including composition, pharmacology, and clinical information. BPOM – Mictonorm Assessment Report.
3. Swiss Agency for Therapeutic Products (Swissmedic): Public assessment of Mictonorm and propiverine hydrochloride. Swissmedic – Mictonorm Public Assessment.
4. Lebanese Ministry of Public Health: Registered Mictonorm 15 mg, including presentation and pharmaceutical details. Lebanese Ministry of Public Health – Mictonorm.
5. Official Product Information: Mictonorm 15 mg package leaflet, including administration, precautions, and possible adverse reactions. Mictonorm – Patient Information Leaflet.

Patient Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment.

Mictonorm is a prescription medication and should only be used under the supervision of a qualified healthcare professional. Dosage and treatment duration must be determined according to the patient's medical condition and individual response.

Patients should not start, discontinue, or modify treatment without consulting their physician or pharmacist.

This product is not intended to diagnose, treat, cure, or prevent any disease without appropriate medical evaluation and supervision.