Formulation R rectal

Name: Formulation R rectal

What is the most important information I should know about Formulation R (phenylephrine rectal)?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have heart disease, high blood pressure, an enlarged prostate, urination problems, diabetes, a thyroid disorder, or if you take an antidepressant or blood pressure medication.

Always ask a doctor before using phenylephrine rectal on a child. Do not give this medicine to a child younger than 2 years old.

Do not use phenylephrine rectal for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve, or if they get worse after treatment.

Ask a doctor or pharmacist before taking any cough, cold, or allergy medicine. Phenylephrine is contained in many combination medicines. Taking certain products together can cause you to get too much phenylephrine. Check the label to see if a medicine contains phenylephrine, or a decongestant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to it; or to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: diabetes, heart problems (e.g., chest pain, heart attack), high blood pressure, overactive thyroid (hyperthyroidism), difficult urination due to blockage (e.g., enlarged prostate).

Do not use this product in children 12 years or younger without talking with the doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this product, tell your doctor or pharmacist if you use any of the following prescription or nonprescription/herbal products: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), drugs to treat high blood pressure (e.g., guanethidine, beta blockers such as metoprolol).

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Bleeding from rectum or rectal pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Formulation R may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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