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Hyoscine Butylbromide Tablets

Intended composition: Hyoscine Butylbromide 10 mg (verify: supplied ingredient text incorrectly lists Hydralazine HCl BP 10 mg).

Usage: Relief of abdominal cramps and gastrointestinal smooth-muscle spasms.

Category: Antispasmodic Drugs

Therapeutic category: Antispasmodic / Antimuscarinic

SKU: Hyoscine Butylbromide Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Hyoscine Butylbromide Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Hyoscine Butylbromide Tablets 10 mg

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. presents Hyoscine Butylbromide Tablets 10 mg, an antimuscarinic antispasmodic medicine used for relief of gastrointestinal smooth-muscle spasm and abdominal cramps, including symptoms associated with irritable bowel syndrome where approved.

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified; verify current certification)
Exported by: Healthy Inc (Star Export House; verify current status)

Composition verification required: The supplied heading names Hyoscine Butylbromide 10 mg, but the supplied ingredient line states Hydralazine HCl BP 10 mg. These are different drugs. Do not print or approve labels until the correct active ingredient is confirmed.

2. Product Specifications

ParameterSpecification
Product nameHyoscine Butylbromide Tablets
Intended active ingredientHyoscine Butylbromide — requires verification against original composition
Intended strength10 mg per tablet (unverified ingredient identity)
Therapeutic classAntispasmodic / antimuscarinic
Dosage formOral tablet; coating type to be confirmed
CAS number149-64-4 (hyoscine butylbromide)
Other strength20 mg appears in descriptive copy but no corresponding product composition was supplied
Packaging, shelf life, standardsConfirm against product-specific approved documents

3. Manufacturing Hyoscine Butylbromide Tablets

Tablet manufacturing may include validated blending, compression, optional film or sugar coating, and moisture-protective packaging as appropriate to the approved formulation. Specific coating technology, equipment, site controls and batch capacity require verification from manufacturing records; these are not confirmed by the submitted composition.

4. Quality Assurance

Quality assessment typically includes identity, assay, content uniformity, dissolution or disintegration, related substances, microbiological quality where applicable, and stability under the approved specification. Pharmacopoeial claims, analytical limits and shelf life should be published only when supported by the product dossier and certificate of analysis.

5. Pharmacology and Clinical Use

Hyoscine butylbromide is a peripheral antimuscarinic agent that reduces smooth-muscle spasm in the gastrointestinal tract. It may relieve cramping associated with certain gastrointestinal conditions. It is not an antihypertensive or a diuretic and does not treat high blood pressure. Severe or unexplained abdominal pain requires medical assessment rather than repeated self-treatment.

6. Export and Regulatory Support

For contract manufacturing and export enquiries, request the product-specific certificate of analysis, approved artwork, stability information, regulatory certificates, and CTD/ACTD documentation where available. Import approval and classification vary by destination market.

7. Frequently Asked Questions

Q: Is this product the same active ingredient as Buscopan?
A: Some Buscopan products contain hyoscine butylbromide. Product-specific equivalence or registration should not be assumed.

Q: Does it treat high blood pressure?
A: No. Hyoscine butylbromide is an antispasmodic; the high-blood-pressure wording appears to have been copied from a Hydralazine listing.

Q: Does it enter the brain?
A: As a quaternary ammonium compound, it has limited penetration of the blood-brain barrier, although adverse effects and individual responses can vary.

Q: Is 20 mg available?
A: The supplied product composition confirms neither a 20 mg formulation nor its packaging.

8. Dosage and Administration

Use only as directed by the prescriber or the locally approved product label. Recommended schedules and maximum daily doses depend on patient age, indication and market-specific labeling. Swallow oral tablets with water as directed. Do not use a product with conflicting ingredient information until the label is corrected and verified.

9. Side Effects and Precautions

  • Possible effects include dry mouth, constipation, blurred vision, palpitations and urinary retention.
  • Avoid or seek specialist advice in conditions such as myasthenia gravis, certain types of glaucoma, megacolon, intestinal obstruction and urinary retention, as specified by local labeling.
  • Seek urgent care for severe or worsening abdominal pain, fever, vomiting, fainting or blood in stool.
  • Pregnancy, breastfeeding, older age and concurrent anticholinergic medicines require individualized advice.

10. Storage Instructions

Store according to the approved pack label in the original packaging, protected from excess heat and moisture. Keep out of reach of children. The proposed below-30°C limit must be verified against stability and approved labeling.