Psyllium

You should not take psyllium if you have ever had an allergic reaction to it.

Ask a doctor or pharmacist if it is safe for you to take psyllium if you have other medical conditions, especially:

• stomach pain, nausea, or vomiting;

• trouble swallowing; or

• a sudden change in bowel habits lasting longer than 2 weeks.

Psyllium products may contain sugar, sodium, or artificial sweetener. These ingredients may be of concern if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Ask a doctor before using this medicine if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing.

Do not give psyllium to a child younger than 6 years old without medical advice.

Since psyllium is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

Avoid taking other oral (by mouth) medicines within 2 hours before or 2 hours after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

• Dietary Fiber Laxative [OTC] [DSC]
• Evac [OTC]
• Fiber Therapy [OTC] [DSC]
• Geri-Mucil [OTC]
• Konsyl [OTC]
• Konsyl-D [OTC]
• Metamucil MultiHealth Fiber [OTC]
• Natural Fiber Therapy [OTC]
• Natural Fiber [OTC] [DSC]
• Natural Psyllium Seed [OTC]
• Natural Vegetable Fiber [OTC]
• Reguloid [OTC]
• Sorbulax [OTC]

Relief of constipation: 12-72 hours

OTC labeling: Dietary fiber supplement; treatment of occasional constipation; reduce risk of coronary heart disease (CHD)

Hypersensitivity to psyllium or any component of the formulation; fecal impaction; GI obstruction

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions have been reported with ingestion or inhalation of psyllium in susceptible individuals.

Disease-related concerns:

• Coronary heart disease (CHD): To reduce the risk of CHD, the soluble fiber from psyllium should be used in conjunction with a diet low in saturated fat and cholesterol.

• Gastrointestinal disease: Use with caution in patients with esophageal strictures, ulcers, stenosis, or intestinal adhesions or difficulty swallowing

Special populations:

• Elderly: Use with caution in the elderly; may have insufficient fluid intake which may predispose them to fecal impaction and bowel obstruction.

Dosage form specific issues:

• Calcium: Some products may contain calcium.

• Phenylalanine: Some products may contain phenylalanine.

• Potassium: Some products may contain potassium.

• Sodium: Some products may contain sodium.

• Soy lecithin: Some products may contain soy lecithin.

Other warnings/precautions:

• Administration: Products must be taken with at least 8 ounces of fluid in order to prevent choking.

• Self-medication (OTC use): When used for self-medication (OTC), do not use in the presence of abdominal pain, nausea, or vomiting. Notify healthcare provider in case of sudden changes of bowel habits which last >2 weeks or in case of rectal bleeding. Not for self-treatment of constipation lasting >1 week.

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 any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Bloating.
• Stomach cramps.

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.