This combination product contains loperamide and simethicone. Loperamide belongs to the class of medications called antidiarrheals. Simethicone belongs to the class of medications called antiflatulant (anti-gas) agents. Together, they are used to control the occasional symptoms of diarrhea and gas. These two medications do not get rid of the cause of the diarrhea, they only help control the symptoms.

Loperamide works by slowing the speed that material passes through the digestive system, allowing water to be reabsorbed into the body. Simethicone works by breaking down gas bubbles that cause bloating and cramping that sometimes occur with diarrhea.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

For adults and children over 12 years of age, the recommended starting dose of loperamide-simethicone is 2 caplets after the first loose bowel movement. After this first dose, 1 caplet should be taken after each loose bowel movement. No more than 4 caplets should be taken each day.

For children 6 to 11 years of age, this medication should only be used on the advice of a physician. The recommended starting dose of loperamide-simethicone is 1 caplet after the first loose bowel movement. After this dose, ½ caplet should be taken after each loose bowel movement. Children aged 9 to 11 years may take a maximum of 3 caplets each day. Children aged 6 to 8 years may take a maximum of 2 caplets each day.

If you still require loperamide-simethicone after 2 days, contact your doctor for further advice.

This medication should not be used for more than 2 days.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor.

Loperamide-simethicone should be taken on an empty stomach; 1 hour before or 2 hours after meals. Swallow the caplet with a full glass of water.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Caplet

Each white caplet with a vanilla odour, debossed with "IMO" on one side and scored and debossed with "2" and "125" on the other side contains 2 mg of loperamide hydrochloride and 125 mg of simethicone. Nonmedicinal ingredients: acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, maltodextrin, microcrystalline cellulose, propylene glycol, and stearic acid.

Do not take loperamide-simethicone if you:

• are allergic to loperamide, simethicone or any ingredients of the medication
• have blood in the stools
• have a fever
• have diarrhea caused by bacterial infection
• have diarrhea caused by antibiotics
• have active ulcerative colitis
• have a medical condition where constipation must be avoided
• have difficulty swallowing

Do not give this medication to children under 2 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• dizziness
• drowsiness
• flatulence (gas)
• nausea
• tiredness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• bloating
• constricted or "pin-point" pupils
• decreased coordination
• difficulty urinating
• itching
• muscle tension
• shortness of breath
• skin rash
• swollen face

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abdominal swelling or bulging (if infected with HIV)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Dehydration: Diarrhea may cause dehydration due to the amount of fluid lost from the body in watery bowel movements. Make sure to drink plenty of clear fluids while you are taking loperamide-simethicone to replace the water your body is losing in the diarrhea. If you experience symptoms of dehydration such as thirst; a dry, sticky mouth; tiredness; headache; or reduced urine output, increase the amount of fluid you are drinking. If you experience symptoms of severe dehydration, such as irritability, confusion, lack of sweating, or very little urine production, seek medical attention, as this is considered a medical emergency.

Drowsiness/reduced alertness: Loperamide-simethicone may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Liver function: Loperamide is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are taking loperamide-simethicone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Although dosing recommendations are available for children, loperamide-simethicone should not be used by children under 12 years of age without the advice of a doctor. Do not give this medication to children less than 2 years old.

There may be an interaction between loperamide-simethicone and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.