This medicine is made up of belladonna alkaloids (atropine, hyoscyamine, scopolamine) and phenobarbital.

Belladonna alkaloids and phenobarbital is a combination medicine used to treat irritable bowel syndrome and ulcers in the intestine.

Belladonna alkaloids and phenobarbital may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to atropine, hyoscyamine, phenobarbital, or scopolamine. You also should not use this medicine if you have:

• a bladder obstruction, enlarged prostate, or other urination problems;
• a stomach or bowel obstruction (including paralytic ileus);
• chronic constipation or lack of bowel function (especially in older adults and those who are ill or debilitated);
• severe ulcerative colitis or toxic megacolon;
• glaucoma;
• reflux disease with a hiatal hernia;
• active bleeding with fast heartbeats, low blood pressure, shortness of breath, and cold hands or feet;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to primidone; or
• a muscle disorder called myasthenia gravis.

Tell your doctor if you have ever had:

• ulcerative colitis or a stomach ulcer;
• a colostomy or ileostomy;
• a nerve-muscle disorder;
• heart problems, high blood pressure;
• gallbladder disease;
• alcoholism or drug addiction;
• breathing problems;
• a thyroid disorder; or
• liver or kidney disease.

Belladonna alkaloids and phenobarbital may harm an unborn baby, but the benefit of treating your condition with this medicine may outweigh any risk. Tell your doctor if you are pregnant or if you become pregnant.

This medicine can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk. This medicine can slow breast milk production.

Do not give this medication to a child without the advice of a doctor.

Use Spasmolin (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and call your doctor at once if you have:

• fast or pounding heartbeats;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• diarrhea (especially if you have a colostomy or ileostomy);
• decreased sweating and hot or dry skin;
• painful or difficult urination;
• loss of coordination, slurred speech, fainting;
• confusion, agitation, depression, suicidal thoughts;
• fever, sore throat; or
• pale skin, easy bruising, unusual tiredness, cold hands and feet;

Side effects such as drowsiness, agitation, nervousness, and excitement may be likely to occur in older adults.

Common side effects may include:

• constipation;
• decreased sweating or urination;
• dizziness, drowsiness, weakness;
• blurred vision;
• feeling nervous or excited;
• dry mouth, nose, or throat;
• dry skin; or
• nausea, vomiting, bloating.

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.

This medicine may cause drowsiness or blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Drinking alcohol with this medicine can increase certain side effects.

Avoid becoming overheated or dehydrated during exercise and in hot weather. This medicine can decrease sweating and you may be more prone to heat stroke.