Consumer Information for: LOMOTIL
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- LOMOTIL is used along with other medicines to treat diarrhea
What it does
- LOMOTIL reduces the movement of the muscles in your bowel. This slows down the movement of feces in your bowels.
When it should not be used
Do not use LOMOTIL if you:
- Are allergic to diphenoxylate hydrochloride or atropine sulfate.
- Are allergic to any of the other ingredients in LOMOTIL.
- Have jaundice which is a condition where your skin and the whites of your eyes are yellow.
- Have diarrhea caused by bacteria.
What the medicinal ingredient is
: diphenoxylate hydrochloride and atropine sulfate.
What the non-medicinal ingredients are
acacia, corn starch, mineral oil, magnesium stearate, sorbitol, sucrose and talc.
What dosage form it comes in
As tablets containing 2.5 mg diphenoxylate hydrochloride and 0.025 mg atropine sulfate.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LOMOTIL. Talk about any health conditions or problems you may have, including if you:
- Have a history of dependence or addiction to alcohol, medicines or drugs.
- Are pregnant or planning to become pregnant.
- Are breastfeeding or planning to breastfeed.
- Are severely dehydrated or have an electrolyte imbalance.
- Have or have had liver problems.
- Have or have had a bowel disease called ulcerative colitis.
Driving and using machines:
- LOMOTIL may cause drowsiness or dizziness. You should not drive or operate dangerous machinery when you first start to take this medicine.
- LOMOTIL is not recommended for children under the age of four. If your child’s doctor has prescribed LOMOTIL they will monitor your child closely. Doctors must be very cautious when giving LOMOTIL to a child especially if the child has Down’s syndrome. Talk to your doctor about the safe use of this product by your child. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with LOMOTIL:
- Medicines that may affect your nervous system such as:
- Barbiturates like phenobarbital,
- Benzodiazepines (medicines to help you sleep or reduce anxiety like lorazepam, alprazolam),
- Sedatives (medicines to help you sleep),
- Anxiolytics (medicines to help reduce anxiety),
- Tranquilizers (medicines to help calm you down),
- Muscle relaxants (medicines to help muscle spasms and back pain like methocarbamol, cyclobenzaprine),
- General anesthetics (medicines used during surgery),
- Antipsychotics (medicines used to treat schizophrenia or other psychiatric illness like olanzapine, clozapine, haloperidol),
- Opioids (medicines used to treat pain like oxycodone, codeine, morphine, hydromorphone, meperidine, tramadol),
- Alcohol,
- Monoamine oxidase inhibitors, like phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline, used to treat depression or Parkinson disease.
Proper use of this medication
How to take LOMOTIL:
- Always take LOMOTIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- Swallow tablet whole with a glass of water.
- You should drink plenty of water while taking LOMOTIL.
Usual Dose
- The usual first dose is 2 tablets 3 or 4 times a day.
- Your doctor will decide how much LOMOTIL you should take after that and for how long you should take it.
Usual dose in children aged 4 and older:
- Your doctor will decide how much your child will receive. The dose they receive will be based on how much they weigh.
Overdose
Side effects and what to do about them
hese are not all the possible side effects you may feel when taking LOMOTIL. If you experience any
side effects not listed here, contact your healthcare professional.
Side effects may include:
- Feeling ill
- Drowsiness
- Feeling tired
- Restlessness
- Dizziness
- Difficulty sleeping or sleepiness
- Headache
- Blurry vision
- Feeling unusually excited
- Confusion
- A feeling of pins and needles in your hands or feet or another body part
- Feeling depressed
- Loss of appetite, abdominal bloating, abdominal cramps, constipation.
- Dry skin
- Difficulty urinating
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| UNKNOWN FREQUENCY | |||
| Respiratory depression (inadequate breathing): difficult or slow breathing. | ✔ | ||
| Nervous System Effects: Depression, dizziness or drowsiness, sedation. | ✔ | ||
| Coma | ✔ | ||
| Toxic megacolon (swelling of the colon): bloating of the abdomen, bloody or heavy diarrhea, fast heart rate, fever, painful bowel movements, shock, stomach pain, tenderness of the abdomen. | ✔ | ||
| Pancreatitis (swelling of the pancreas): fast heart rate, fever, nausea, tenderness when touching the abdomen, upper abdominal pain, vomiting. | ✔ | ||
| llergic reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue, throat or face. | ✔ | ||
| Hallucinations: seeing or hearing things that aren’t there. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store between 15-25°C and protect from light.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about LOMOTIL:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hcsc.gc.ca/index-eng.php); the manufacturer’s website (http://www.pfizer.ca), or by calling 1-800-463-6001.
Last Revised: April 17, 2019
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| THYMOGLOBULIN | 02246805 | SANOFI-AVENTIS CANADA INC | ANTI-THYMOCYTE GLOBULIN (RABBIT) 25 MG / VIAL |