Salagen - Consumer Medicine Information
|Ingredients:||pilocarpine HCl, stearic acid, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80, carnauba wax|
About This Medication
What the Medication Is Used For
SALAGEN tablets are used to treat dry mouth and/or your dry eyes caused by radiotherapy in people with head and neck cancer or by Sjogren′s syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth).
What It Does
SALAGEN tablets cause your salivary glands and your tear glands to make more of your natural saliva and tears.
When It Should not be Used
SALAGEN should not be taken if you have:
- uncontrolled asthma
- acute inflammation of the iris or narrow-angle (angle closure) glaucoma
- a known sensitivity to pilocarpine, or to any of the tablet′s ingredients
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Stearic acid, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80 and carnauba wax.
What Dosage Form It Comes In
Tablets, 5 mg.
Warnings and Precautions
BEFORE you use SALAGEN, talk to your doctor or pharmacist if you have:
- an abnormal heart beat or have had heart failure
- either high blood pressure or low blood pressure,
- asthma or difficulty breathing, bronchitis or emphysema
- liver disease such as hepatitis, cirrhosis or other
- blurred vision, difficulty seeing at night, glaucoma or inflammation of the eye (iritis),
- frequent heartburn or indigestion, ulcers
- difficulty urinating, kidney failure or kidney stones
- gall stones,
- confusion, tremors, psychiatric illness
or if you:
- are pregnant, become pregnant, or are breast feeding your baby. Your doctor will tell you should be taking SALAGEN tablets.
- are taking, or begin taking, any other medicines, even medicines you buy without a prescription. Some medicines may interfere with each other in your body.
Some people find SALAGEN tablets affect their vision. Make sure you know how this medicine affects you before you do dangerous activities at night or in low light (example: drive a car or use machines).
Interactions With This Medication
Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies while on SALAGEN.
Drugs that may interact with SALAGEN include:
- vitamins, nutritional supplements, and herbal products
and medications used to treat:
- Myasthenia Gravis (e.g. ambenonium)
- Common cold or motion sickness (e.g. some antihistamines)
- Hypertension (e.g. beta blockers like propranolol and metoprolol)
- irritable bowel disease,
- Parkinson′s disease
- Urinary problems
Proper Use of This Medication
Usual Adult Dose
Take SALAGEN tablets three or four times a day as directed by your doctor. Your doctor may recommend a reduced dosage if you suffer from liver or kidney problems. Do not take more than six tablets (30mg) per day.
Take SALAGEN tablets with or without food.
Do not chew or bite on the tablet.
Overdose symptoms include salivation, sweating, vomiting, difficulty breathing, changes in blood pressure, diarrhea, nausea and shock. Mental confusion and an irregular heartbeat can also occur.
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.
If you miss a dose of SALAGEN, take the next dose when you normally would. Do not take more than two tablets at a time.
Side Effects and What to Do About Them
Most side effects that could occur have been generally mild or of moderate intensity. The possible side effects are:
- mild to moderate sweating
- nausea (feeling sick) and vomiting
- passing urine more often
- problems with digestion
- runny eyes
- runny nose
- flushing (redness in face)
Tell your doctor right away if you find the above listed side effects continue, bother you, or are severe.
Serious Side Effects, how Оften They Happen and What to Do About Them
|Symptom / effect||Talk with your|
|Confusion, agitation, or very depressed||✓|
|Chest pain, a rapid heart beat, or your pulse races||✓|
|Severe pain in your stomach or abdomen||✓|
|unknown||Allergic reaction: skin rash, hives, itching or swelling of the eyes, face, lips, tongue or throat, difficulty swallowing or breathing||✓|
This is not a complete list of side effects. For any unexpected effects while taking SALAGEN, contact your doctor or pharmacist.
How to Store It
Store at room temperature (15 - 30°C). Do not store in the bathroom where heat and moisture may damage this medicine.
Keep SALAGEN tablets out of the reach and sight 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:
- 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
Postal Locator 0701E
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.
This document plus the full product monograph, prepared for health professionals can be found at:
or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001