IB-Stat

Serious side effects have been reported with hyoscyamine including the following:

• Diarrhea
• Skin rash
• Eye pain
• Fast or irregular heartbeat
• Psychosis has been reported in sensitive individuals given hyoscyamine sulfate. Tell your doctor if you notice any of these signs or symptoms:
  • confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, and/or agitation
• Hyoscyamine sulfate may decrease sweating and result fever or heat stroke. Patients with a fever or those who may be exposed to elevated environmental temperatures should use caution.

If you experience any of these symptoms, call your doctor immediately:

Hyoscyamine can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how hyoscyamine affects you.

Talk to your doctor about the risks and benefits of taking hyoscyamine if you are 65 years of age or older. Older adults should not usually take hyoscyamine because it is not as safe and may not be as effective as other medications that can be used to treat the same condition.

Do not take hyoscyamine if you:

• are allergic to hyoscyamine or to any of its ingredients
• have glaucoma
• have obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy)
• have obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis)
• have paralytic ileus
• intestinal issues
• unstable cardiovascular status in acute hemorrhage
• have severe ulcerative colitis
• have toxic megacolon complicating ulcerative colitis
• have myasthenia gravis

Take hyoscyamine exactly as prescribed.

Hyoscyamine comes as a tablet, an orally disintegrating tablet, an extended-release (long-acting) capsule, an elixir, and a solution to take by mouth.

Do not chew, divide, or break extended-release (long-acting) capsule. Swallow extended-release (long-acting) capsule whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of hyoscyamine at the same time.

• Store hyoscyamine at room temperature.
• Store medication away from excess heat and moisture (not in the bathroom).
• Throw away any medication that is outdated or no longer needed.
• Keep this and all medicines out of the reach of children.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

• diarrhea;

• confusion, hallucinations;

• unusual thoughts or behavior;

• fast, pounding, or uneven heart rate;

• rash or flushing (warmth, redness, or tingly feeling); or

• eye pain.

Less serious side effects may include:

• dizziness, drowsiness, feeling nervous;

• blurred vision, headache;

• sleep problems (insomnia);

• nausea, vomiting, bloating, heartburn, or constipation;

• changes in taste;

• problems with urination;

• decreased sweating;

• dry mouth; or

• impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to hyoscyamine: oral conventional tablets and sublingual tablets, oral extended-release capsules and tablets, oral oral solution and elixir, oral orally disintegrating tablets, parenteral injection

Side effects include:

Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.

Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; adverse effects occasionally may be obviated by a reduction in dosage but this also may eliminate potential therapeutic effects.

Adverse effects include dry mouth, urinary hesitancy and retention, blurred vision, tachycardia, palpitations, mydriasis, increased ocular tension, loss of taste, headache, nervousness, drowsiness, weakness, fatigue, dizziness, insomnia, nausea, vomiting, impotence, constipation, bloated feeling, abdominal pain, diarrhea, allergic reactions or drug idiosyncrasies, urticaria and other dermal manifestations, ataxia, speech disturbance, mental confusion and/or excitement (especially in geriatric patients), short-term memory loss, hallucinations, and decreased sweating.