Details for: RIVA-LOPERAMIDE
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02238211 | RIVA-LOPERAMIDE | LOPERAMIDE HYDROCHLORIDE | 2 MG | TABLET | ORAL |
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
RIVA-LOPERAMIDE is used for the rapid relief of diarrhea symptoms.
What it does
RIVA-LOPERAMIDE makes the stools more solid and less frequent.
When it should not be used
You should not use RIVA-LOPERAMIDE 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 nonmedicinal 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
Caplets: Croscarmellose Sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone.
What dosage form it comes in
Caplets: 2 mg
Warnings and precautions
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF
CHILDREN.
BEFORE you use RIVA-LOPERAMIDE talk to your doctor or
pharmacist if you:
- have mucus in the stool;
- are pregnant or nursing a baby (RIVA-LOPERAMIDE is 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 RIVALOPERAMIDE;
- 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 RIVA-LOPERAMIDE stops 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 RIVA-LOPERAMIDE 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
RIVA-LOPERAMIDE should be taken by the mouth. You can
take RIVA-LOPERAMIDE 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 (4 mg) initially and 1
caplet (2 mg) every time you have a loose bowel movement, to a
maximum of 8 caplets (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
RIVA-LOPERAMIDE is usually well-tolerated and few undesired
effects are likely when it is taken as directed.
Constipation may occur. If so, stop RIVA-LOPERAMIDE and if
these effects are severe, consult your doctor.
Oversensitivity to RIVA-LOPERAMIDE 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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Abdominal pain | ✔ | ✔ | |
| Difficulty urinating | ✔ | ✔ | |
| Bloating | ✔ | ✔ | |
| Shortness of breath | ✔ | ✔ | |
| Swollen face | ✔ | ✔ | |
| Abnormal coordination | ✔ | ✔ | |
| Muscular tension | ✔ | ✔ | |
| Pupil constriction | ✔ | ✔ | |
| Abdominal pain upper | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking RIVA-LOPERAMIDE, contact your doctor or pharmacist.
How to store
RIVA-LOPERAMIDE should be stored at room temperature between 15°C and 30°C.
Reporting side effects
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/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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 Laboratoire
Riva Inc., at 1-800-363-7988.
This leaflet was prepared by:
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Last revised: December 4, 2020