Spascupreel

Heel Inc

Spascupreel 1.1ml Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

• SPASCUPREEL DESCRIPTION
• INDICATION AND USAGE
• SPASCUPREEL DOSAGE AND ADMINISTRATION
• SPASCUPREEL CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• SPASCUPREEL ADVERSE REACTIONS
• OVERDOSAGE
• CLINICAL PHARMACOLOGY
• DOSAGE

FULL PRESCRIBING INFORMATION

SPASCUPREEL DESCRIPTION

Inactive Ingredients:

Water for injection 1,089.0 μl

Sodium Chloride 10.4 μl

INDICATION AND USAGE

Spascupreel® Injection Solution is a homeopathic drug product indicated for the relief of spasms of the smooth musculature of the gastrointestinal and the urogenital tract as well as general muscle spasms.

SPASCUPREEL DOSAGE AND ADMINISTRATION

General Considerations

• The dosage schedules listed below can be used as a general guide for the administration of Spascupreel^® Injection Solution.
• If co-administration with a local anesthetic is desired, Spascupreel^® Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician.
• Spascupreel^® Injection Solution may be administered s.c., i.d., i.m., or i.v.
• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.
• Draw up required dose into syringe.
• Discard any unused ampule contents. Do not reuse ampule.

Standard Dosage:

Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.

Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.

Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.

Acute Dosage:

Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.

Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.

Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

SPASCUPREEL CONTRAINDICATIONS

Spascupreel® Injection Solution is contraindicated in patients with known hypersensitivity to Spascupreel® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

SPASCUPREEL ADVERSE REACTIONS

Post-marketing Experience

• No adverse events have been reported with a causal relationship to Spascupreel® injection solution.

To report SUSPECTED ADVERSE REACTIONS,contact Heel Inc. 1.800.920.9203

infor@heelusa.com or FDA at 1-800-1088 or www.fda.gov/medwatch

OVERDOSAGE

 No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Spascupreel® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under Description.