Diarrhea Relief (Teva Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

DIARRHEA RELIEF is used for the rapid relief of diarrhea symptoms.

What it does:

DIARRHEA RELIEF makes the stools more solid and less frequent.

When it should not be used:

You should not use DIARRHEA RELIEF 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 important nonmedicinal ingredients are);
• if in doubt, ask your pharmacist or doctor for advice.

What the medicinal ingredient is:

Loperamide hydrochloride

What the important nonmedicinal ingredients are:

Non medicinal ingredients in alphabetical order include D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, magnesium stearate, lactose monohydrate, pregelatinized starch and sodium starch glycolate.

What dosage forms it comes in:

2 mg tablet

WARNINGS AND PRECAUTIONS

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

BEFORE you use DIARRHEA RELIEF talk to your doctor or pharmacist if you:

• are pregnant or nursing a baby. DIARRHEA RELIEF 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 DIARRHEA RELIEF.

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 DIARRHEA RELIEF 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.

Taking more than directed may cause serious heart problems leading to death.

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 example, some antidepressants and cold and allergy medication), because these can make the effect of DIARRHEA RELIEF 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

DIARRHEA RELIEF tablets should be taken by the mouth. You can take DIARRHEA RELIEF at any time of day. The tablets 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 tablets (4 mg) initially and 1 tablet every time you have a loose bowel movement, to a maximum of 8 tablets (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 Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

DIARRHEA RELIEF is usually well tolerated and few undesired effects are likely when it is taken as directed.

Constipation may occur. If so, stop DIARRHEA RELIEF and if these effects are severe, consult your doctor.

Over sensitivity to DIARRHEA RELIEF 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.

This is not a complete list of side effects. For any unexpected effects while taking DIARRHEA RELIEF, contact your doctor or pharmacist.

HOW TO STORE IT

Store DIARRHEA RELIEF tablets between 15°C-30°C. Boxes of unit dose strips should be stored between 15°C-25°C and protected from high humidity. Protect from light.

Keep out of reach of children.

Reporting Side Effects

MORE INFORMATION

This document plus the full Prescribing Information, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited, by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Last revised: February 28, 2017