Product image of Metafen Rozkurczowy (Drotaverine Hydrochloride) supplied by GNH India

Metafen Rozkurczowy

Active Ingredient:
Drotaverine Hydrochloride
Origin:
EU

Metafen Rozkurczowy (Drotaverine Hydrochloride)

Drotaverine Hydrochloride, the active ingredient in Metafen Rozkurczowy, is a phosphodiesterase inhibitor presented as an oral formulation for oral use. It provides smooth muscle relaxation to relieve abdominal, biliary, urinary colic and menstrual cramps in adults.

GNH India supplies Metafen Rozkurczowy as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zaklady Farmaceutyczne Polpharma S.A.

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Drotaverine Hydrochloride is used to alleviate smooth‑muscle spasm in several gastrointestinal and genitourinary conditions.

  • Abdominal pain: reduces discomfort by relaxing intestinal smooth muscle.
  • Menstrual cramps: eases dysmenorrhea through uterine muscle relaxation.
  • Biliary colic: diminishes gallbladder spasm‑related pain.
  • Urinary colic: relieves renal or ureteral colic by relaxing urinary tract smooth muscle.

How It Works

  • Drotaverine Hydrochloride inhibits phosphodiesterase enzymes, primarily PDE‑4, leading to an accumulation of cyclic adenosine monophosphate (cAMP) within smooth‑muscle cells. Elevated cAMP activates protein kinase A, which phosphorylates target proteins resulting in reduced intracellular calcium concentration and subsequent smooth‑muscle relaxation. This mechanism decreases muscle tone in the gastrointestinal, biliary, urinary tracts and uterus, thereby alleviating spasm‑related pain.

Side Effects

Drotaverine Hydrochloride may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild gastrointestinal upset.
  • Dizziness: transient light‑headedness.
  • Headache: mild to moderate intensity.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, or angioedema.
  • Severe hypotension: marked blood‑pressure decrease requiring medical attention.
  • Cardiac arrhythmia: irregular heart rhythm.

Precautions & Warnings

When using Drotaverine Hydrochloride, certain precautions should be observed to ensure safety.

  • Pregnancy: safety not established; use only if clearly needed.
  • Breastfeeding: unknown; weigh benefits against potential risks.
  • Renal impairment: monitor renal function; dose adjustment may be required.
  • Hepatic impairment: use with caution; monitor liver enzymes.
  • Elderly: increased sensitivity to hypotension; start with lowest effective dose.
  • Store at room temperature: keep in original container, protect from moisture and heat.

Avoid Interactions

Drotaverine Hydrochloride can interact with other medicines; awareness of major and moderate interactions helps prevent adverse effects.

Major Interactions (Avoid)

  • Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase drug exposure.
  • Other smooth‑muscle relaxants (e.g., papaverine, nifedipine): additive hypotensive effect.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antihypertensive agents (beta‑blockers, ACE inhibitors): monitor blood pressure.
  • Anticholinergic drugs: may enhance dry‑mouth sensation.

Frequently Asked Questions

Metafen Rozkurczowy contains the antispasmodic agent drotaverine hydrochloride. It is indicated for the relief of smooth‑muscle spasm associated with abdominal pain, menstrual cramps, biliary colic and urinary colic, helping to reduce discomfort in these conditions.

Drotaverine works by inhibiting phosphodiesterase enzymes, which raises intracellular cAMP levels. The increased cAMP activates protein kinase A, leading to reduced calcium in smooth‑muscle cells and causing relaxation of the gastrointestinal, biliary, urinary tracts and uterine muscle.

The appropriate dose of Metafen Rozkurczowy is determined by the prescribing healthcare professional based on the patient’s condition, age, weight and overall health. Patients should follow the prescriber’s instructions and not alter the dose without medical advice.

Safety data for drotaverine during pregnancy and lactation are limited. It should only be used if the potential benefit justifies the possible risk to the fetus or infant, and the decision should be made by a qualified healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Metafen Rozkurczowy (drotaverine) differs from anticholinergic agents such as hyoscine butylbromide by acting as a phosphodiesterase inhibitor rather than a muscarinic antagonist. This mechanism often results in fewer anticholinergic side effects like dry mouth, while still providing effective smooth‑muscle relaxation.

Store Metafen Rozkurczowy at room temperature, preferably below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight and excessive heat to maintain its stability and potency.

Metafen Rozkurczowy is taken orally. The tablet should be swallowed whole with a glass of water, unless the prescribing clinician provides alternative instructions such as taking it with food to reduce gastrointestinal irritation.

Serious risks include allergic reactions such as rash, itching or angioedema, severe hypotension that may require medical intervention, and cardiac arrhythmias. Patients experiencing any of these symptoms should seek immediate medical attention.

Metafen Rozkurczowy should be avoided in individuals with known hypersensitivity to drotaverine or any excipients, in patients with severe uncontrolled hypotension, and in those for whom the risk of smooth‑muscle relaxation outweighs the therapeutic benefit, as determined by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Related Products

Other formulations containing Drotaverine Hydrochloride

A

A
A

A
A

A
A

A

Browse all products →

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Regulatory recognitions

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.

SGS GSDP Certification

GSDP Compliant from SGS

URS ISO 9001

URS ISO 9001 Certification

FDA Maharashtra

Licensed by FDA Maharashtra

IEC License DGFT

IEC License issued by DGFT