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Details for: PMS-LOPERAMIDE

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02016095PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION.2MG/MLLOPERAMIDE HYDROCHLORIDE0.2 MG / MLSOLUTIONORAL
02228351PMS-LOPERAMIDE - CAPLET 2MGLOPERAMIDE HYDROCHLORIDE2 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION are used for the rapid relief of diarrhea symptoms.

What it does

pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION makes the stools more solid and less frequent.

When it should not be used

You should not use pms-LOPERAMIDE or pms-LOPERAMIDE HYDROCHLORIDE SOLUTION if you have any of the following conditions:

  • if there is blood in the stools or you have a fever;
  • if you are constipated or your abdomen is swollen or have abdominal pain;
  • if you have a bacterial infection in your digestive system, or suspect food-poisoning due to bacterial contamination;
  • if you have an inflammation of the lower bowel;
  • if you are taking prescription drugs that may cause constipation such as anti-psychotic and anti-depressant medications;
  • if you are taking antibiotics or have ulcerative colitis;
  • if you know you are sensitive to one of the ingredients or to any other component of this formulation (see What the non-medicinal ingredients are);
  • if in doubt, ask your pharmacist or doctor for advice.
What the medicinal ingredient is

Loperamide hydrochloride.

What the non-medicinal ingredients are

Caplet: Croscarmellose Sodium, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone.

Oral Solution: Alcohol Paraben, Artificial Cherry Flavor, , Citric Acid Anhydrous (for pH adjustment), Glycerine, Methylparaben, Propylparaben, Purified Water.

What dosage form it comes in

Caplets: 2 mg

Oral Solution: 0.2 mg/mL

Warnings and precautions

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

BEFORE you use pms-LOPERAMIDE or pms-LOPERAMIDE HYDROCHLORIDE SOLUTION talk to your doctor or pharmacist if you:

  • have mucus in the stool;
  • are pregnant or nursing a baby (pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION are not recommended for nursing mothers because small amounts of loperamide can end up in your milk);
  • have meningitis or liver disease, as you may need medical supervision while taking pms-LOPERAMIDE or pms-LOPERAMIDE HYDROCHLORIDE SOLUTION;
  • have a history of abnormal heart rhythm (e.g., Brugada syndrome).

Dosage warning: Taking more than directed can cause serious heart problems or death.

STOP USE and see your doctor or pharmacist if:

  • Diarrhea gets worse, lasts longer than 48 hours or you get any unusual symptoms;
  • You are infected with HIV and you have any signs of abdominal swelling or bulging.

Although pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION stop diarrhea, it will not treat the cause of it. Whenever possible, the cause of diarrhea should also be treated.

Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal symptoms treated with loperamide. Therefore, it is advisable to use caution when driving a car or operating machinery.

Interactions with this medication

Always tell your doctor or pharmacist:

  • if you are using other drugs, including herbal medicines because some drugs should not be taken together
  • if you are taking drugs that slow down the action of the stomach and intestines (for ex., some antidepressants and cold and allergy medication), because these can make the effect of pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION too strong
  • if you are taking sedating medications

In particular, tell your doctor or pharmacist if you are taking any of the following:

  • ritonavir (used to treat HIV)
  • quinidine (used to treat abnormal heart rhythms)
  • oral desmopressin (used to treat excessive urination)
  • itraconazole or ketoconazole (used to treat fungal infections)
  • gemfibrozil (used to lower cholesterol)
Proper use of this medication

pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION should be taken by the mouth. You can take pms-LOPERAMIDE or pms-LOPERAMIDE HYDROCHLORIDE SOLUTION at any time of day. The caplets should be taken with liquid.

When you have diarrhea

  • you will lose a lot of fluids. Therefore, drink plenty of clear fluids, water, unsweetened juices or clear soups.
  • do not drink alcohol or milk and avoid fruit, green vegetables and spicy or fatty foods. These items tend to aggravate diarrhea.

Usual Dose

Adults (12 years and older): Take 2 caplets or 20 mL oral solution (4 mg) initially and 1 caplet or 10 mL oral solution (2 mg) every time you have a loose bowel movement, to a maximum of 8 caplets or 80 mL oral solution (16 mg) per day.

Stop use if you have a solid or hard stool or if you go for 24 hours without a bowel movement.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Side effects and what to do about them

pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION are usually well-tolerated and few undesired effects are likely when it is taken as directed.

Constipation may occur. If so, stop pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION and if these effects are severe, consult your doctor.

Oversensitivity to pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION is rare. It can be recognized, for instance, by skin rash or itching. If any of these signs occur, see your doctor.

The following complaints sometimes occur, but they may be due to the diarrhea itself: nausea and vomiting, tiredness, dizziness or drowsiness, dry mouth and flatulence.

Serious side effects, how often they happen and what to do about them
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 talk with your doctor or pharmacist
Uncommon
Abdominal pain   ✔ ✔
Difficulty urinating   ✔ ✔
Bloating   ✔ ✔
Shortness of breath   ✔ ✔
Swollen face   ✔ ✔
Abnormal coordination   ✔ ✔
Muscular tension   ✔ ✔
Pupil constriction   ✔ ✔
Abdominal pain. uppe   ✔ ✔

This is not a complete list of side effects. For any unexpected effects while taking pms-LOPERAMIDE or pms-LOPERAMIDE HYDROCHLORIDE SOLUTION, contact your doctor or pharmacist.

How to store

pms-LOPERAMIDE and pms-LOPERAMIDE HYDROCHLORIDE SOLUTION should be stored at room temperature between 15°C and 30°C.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc., at 1-888-550-6060.

This leaflet was prepared by:
Pharmascience Inc.
Montréal, QC, Canada
H4P 2T4

www.pharmascience.com

Last revised: July 2, 2019

Date modified: