Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For antihistamine, decongestant, and anticholinergic combinations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reactions to antihistamines or anticholinergics, or to amphetamine, dextroamphetamine (e.g., Dexedrine), ephedrine (e.g., Ephed II), epinephrine (e.g., Adrenalin), isoproterenol (e.g., Isuprel), metaproterenol (e.g., Alupent), methamphetamine (e.g., Desoxyn), norepinephrine (e.g., Levophed), phenylephrine (e.g., Neo-Synephrine), pseudoephedrine (e.g., Sudafed), or terbutaline (e.g., Brethine). Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—For the individual ingredients of these combinations, the following apply:

• Antihistamines —Antihistamines have not been shown to cause problems in humans.
• Atropine —Studies on effects in pregnancy have not been done in humans. Atropine has not been shown to cause birth defects or other problems in animals.
• Hyoscyamine —Studies on effects in pregnancy have not been done in either humans or animals.
• Methscopolamine —Studies on effects in pregnancy have not been done in either humans or animals.
• Phenylephrine —Studies on birth defects have not been done in either humans or animals.
• Pseudoephedrine —Studies on birth defects have not been done in humans. Pseudoephedrine has not been shown to cause birth defects in animal studies. However, studies in animals have shown that pseudoephedrine causes a reduction in average weight, length, and rate of bone formation in the animal fetus.
• Scopolamine —Studies on effects in pregnancy have not been done in pregnant women. However, studies in animals at doses many times the human dose have shown that scopolamine causes a small increase in the number of fetal deaths.

Breast-feeding—Small amounts of antihistamines, decongestants, and anticholinergics may pass into the breast milk. Use is not recommended since this medicine may cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since this medicine tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some women.

Children—Very young children are usually more sensitive than adults to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur, which may lead to heat stroke. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be especially likely to cause severe side effects.

Older adults—Confusion or memory loss, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, eye pain may occur, which may be a sign of glaucoma.

Other medicines—Although certain medicines should not be used together at all, in other cases different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills), except fenfluramine (e.g., Pondimin), or
• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren]) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Digitalis medicine (heart medicine) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert)—Using any of these medicines together with a decongestant-containing combination may cause excessive stimulant side effects, such as difficulty in sleeping, heart rate problems, nervousness, and irritability

• Central nervous system (CNS) depressants—Using these combinations with CNS depressants may worsen the effects (e.g., drowsiness) of CNS depressants or antihistamines

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking an antihistamine, decongestant, and anticholinergic combination while you are taking or within 2 weeks of taking MAO inhibitors, may make the side effects of the antihistamines, decongestants, and anticholinergics more severe; these medicines should not be used together

• Other anticholinergics (medicine for abdominal or stomach spasms or cramps)—Side effects of antihistamines or anticholinergics, such as dryness of mouth, may be more likely to occur

• Potassium chloride (e.g., Kay Ciel)—Using this medicine with an anticholinergic-containing medicine may make gastrointestinal problems caused by potassium worse

• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil])—These medicines may increase or decrease the effect of the decongestant in this medicine

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Effects, such as drowsiness, may be worsened; also, taking these medicines together may make some of the anticholinergic side effects, such as dryness of mouth, more severe

Other medical problems—The presence of other medical problems may affect the use of antihistamine, decongestant, and anticholinergic combinations. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain damage in children or
• Down syndrome or
• Dryness of mouth (severe and continuing) or
• Enlarged prostate or
• Fever or
• Glaucoma or
• Intestinal blockage or other intestinal problems or
• Kidney disease or
• Liver disease or
• Lung disease or
• Mental or emotional problems or
• Myasthenia gravis or
• Toxemia of pregnancy or
• Urinary tract blockage or difficult urination—These medicines may make these conditions worse

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put diabetic patients at greater risk of having heart or blood vessel disease

• Heart or blood vessel disease or
• High blood pressure—The decongestant and anticholinergic in this medicine may cause the blood pressure to increase and may also speed up the heart rate

• Overactive thyroid—If the overactive thyroid has caused a fast heartbeat, the decongestant and anticholinergic in this medicine may cause the heart rate to speed up further