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warnings and cautions
WARNINGS AND PRECAUTIONS: Do not exceed recommended dosage. This drug may make you dizzy or drowsy or cause blurred vision; use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Limit alcohol consumption. Cross sensitivity and/or related problems – patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. There have been no studies to establish the safety of prolonged use of this product in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential. Pregnancy: Teratogenic Effects. Pregnancy Category C: Hyoscyamine Sulfate and Methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether Methylphen tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methylphen tablets should be given to a pregnant woman only if clearly needed. Nursing Mothers: Problems in humans have not been documented; however, Methenamine and traces of Hyoscyamine Sulfate are excreted in breast milk. Accordingly, Methylphen tablets should be given to a lactating woman only if clearly needed. Discuss the risks and benefits with your doctor. Pediatric Use: Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids (Hyoscyamine Sulfate). This product contains salicylate, which is related to aspirin. Children and teenagers should not take aspirin, aspirin-containing or aspirin-related medications if they have chickenpox, influenza, or any undiagnosed illness without first consulting a doctor. A rare but serious illness known as Reye’s syndrome may occur. This medication is not recommended for use in children up to 12 years of age. Geriatric Use: Kidney function becomes impaired with age. This medication is removed by the kidneys. Therefore, use with caution in elderly patients as they may respond to usual doses of Hyoscyamine Sulfate with excitement, agitation, drowsiness or confusion.
ADVERSE REACTIONS: Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficulty urinating, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.