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 kaolin, pectin, and paregoric combination medicine, the following should be considered:

Allergies—Tell your doctor if you have ever had an unusual or allergic reaction to paregoric or any other narcotic medicine. Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been shown to cause birth defects or other problems in humans. However, too much use of opium preparations such as paregoric (contained in this combination medicine) late in pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth.

Breast-feeding—Although the paregoric in this medicine passes into breast milk, it has not been reported to cause problems in nursing babies.

Children—Children are especially sensitive to the effects of paregoric (contained in this combination medicine). This may increase the chance of side effects during treatment. Also, the fluid loss caused by the diarrhea may result in a severe condition (dehydration), which may be hidden by this medicine. For this reason, antidiarrheals must not be given to young children without first checking with their doctor. In older children with diarrhea, antidiarrheals may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Older adults—Elderly people are especially sensitive to the effects of paregoric (contained in this combination medicine). This may increase the chance of side effects during treatment. Also, the fluid loss caused by the diarrhea may result in a severe condition (dehydration), which may be hidden by this medicine. For this reason, elderly persons should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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:

• Central nervous system (CNS) depressants—Effects of CNS depressants or of paregoric, such as drowsiness, may become greater

• Naloxone (e.g., Narcan) or
• Naltrexone (e.g., ReVia)—These medicines block the effect of paregoric and make it less effective in treating diarrhea

• Other diarrhea medicine—The chance of severe constipation may be increased

Other medical problems—The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence (history of)—There is a greater chance that this medicine may become habit-forming

• Brain disease or head injury or
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones or
• Heart disease or
• Irregular heartbeat or
• Overflow incontinence or
• Seizures (convulsions) (history of)—The paregoric contained in this medicine may make these conditions worse

• Colitis or other intestinal disease—A more serious condition may develop with the use of this medicine

• Diarrhea caused by antibiotics—This medicine may make the diarrhea caused by antibiotics worse or make it last longer

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Kidney disease or
• Liver disease—In patients with kidney or liver disease, paregoric may build up in the body; smaller doses of this medicine may be needed

• Underactive thyroid—This medicine may cause central nervous system (CNS) depression and breathing problems in patients with this condition