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|Histex I/E Extended-Release Capsules

Histex I/E Extended-Release Capsules

Histex I/E Extended-Release Capsules is used for:

Treating allergy symptoms such as runny nose, watery/itchy eyes, rash, or hives. It may also be used for other conditions as determined by your doctor.

Histex I/E Extended-Release Capsules is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Histex I/E Extended-Release Capsules if:

• you are allergic to any ingredient in Histex I/E Extended-Release Capsules
• you are taking sodium oxybate (GHB) or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Histex I/E Extended-Release Capsules:

Some medical conditions may interact with Histex I/E Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma, glaucoma, difficulty urinating, a stomach or bladder blockage, prostate problems, increased pressure in the eye, an underactive thyroid, heart disease, or high blood pressure

Some MEDICINES MAY INTERACT with Histex I/E Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Histex I/E Extended-Release Capsules may be increased
• Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Histex I/E Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Histex I/E Extended-Release Capsules:

Use Histex I/E Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Histex I/E Extended-Release Capsules may be taken with or without food.
• Swallow Histex I/E Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Histex I/E Extended-Release Capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Histex I/E Extended-Release Capsules.

Important safety information:

• Histex I/E Extended-Release Capsules may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Histex I/E Extended-Release Capsules. Using Histex I/E Extended-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Use Histex I/E Extended-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Histex I/E Extended-Release Capsules with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Histex I/E Extended-Release Capsules can cause harm to the fetus. If you become pregnant while taking Histex I/E Extended-Release Capsules, discuss with your doctor the benefits and risks of using Histex I/E Extended-Release Capsules during pregnancy. It is unknown if Histex I/E Extended-Release Capsules is excreted in breast milk. If you are or will be breast-feeding while you are using Histex I/E Extended-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Histex I/E Extended-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; blurred vision; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; headache; heartburn; nausea; nervousness; thickening of mucus in the nose or throat; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include double vision; excitement; frequent urination; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness. In children, symptoms may include abnormal eye movement; abnormal tongue movement; agitation; bizarre behavior; confusion; difficulty urinating; excitation; flushed face; irritability; loss of consciousness; loss of coordination; restlessness; seizures; slurred speech; tiredness; trembling; twitching.

Store Histex I/E Extended-Release Capsules between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Histex I/E Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Histex I/E Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Histex I/E Extended-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Histex I/E Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.