Sandoz Loperamide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Loperamide is used for the rapid relief of diarrhea symptoms.

What it does:

Sandoz Loperamide is used for the rapid relief of diarrhea symptoms.

When it should not be used:

Sandoz Loperamide is used for the rapid relief of diarrhea symptoms.

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, 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:

The medicinal ingredient in Sandoz Loperamide is: Loperamide Hydrochloride

What the important nonmedicinal ingredients are:

The non-medicinal ingredients in Sandoz Loperamide are: magnesium stearate, lactose, starch, microcrystalline cellulose, D&C yellow #10 and FD&C blue #1.

What dosage forms it comes in:

Sandoz Loperamide is available as: 2 mg caplets.

WARNINGS AND PRECAUTIONS

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

BEFORE you use Sandoz Loperamide talk to your doctor or

pharmacist if you:

• are pregnant or nursing a baby. Sandoz 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 Sandoz Loperamide.

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

Sandoz Loperamide should be taken by the mouth. You can take Sandoz 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 IMPORTANT: PLEASE READ

Sandoz Loperamide Page 29 of 29 caplet 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 Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

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

Over sensitivity to Sandoz 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.

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

HOW TO STORE IT

Store at room temperature (15-30°C), protected from light and high humidity. Keep out of reach of children.

REPORTING SUSPECTED 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 3 ways:

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• 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, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville QC

J4B 7K8

Or by e-mail at :

medinfo@sandoz.com

Last revised: June 15, 2012.