Salagen: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

or if you:

• are pregnant, become pregnant, or are breast feeding your baby. Your doctor will tell you should be taking SALAGEN (Pilocarpine Hydrochloride 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 (Pilocarpine Hydrochloride 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).

What the medication is used for:

SALAGEN (Pilocarpine Hydrochloride 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 (Pilocarpine Hydrochloride 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 (Pilocarpine Hydrochloride Tablets) 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:

Pilocarpine Hydrochloride.

What the nonmedicinal ingredients are:

Stearic acid, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80 and carnauba wax.

What dosage forms it comes in:

Tablets, 5 mg.

BEFORE you use SALAGEN (Pilocarpine Hydrochloride tablets), 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

  Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies while on SALAGEN (Pilocarpine Hydrochloride tablets).

  Drugs that may interact with SALAGEN (Pilocarpine Hydrochloride tablets) 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
• Ulcers
• Urinary problems

PROPER USE OF THIS MEDICATION

Usual adult dose:

Take SALAGEN (Pilocarpine Hydrochloride 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 (Pilocarpine hydrochloride tablets) with or without food. Do not chew or bite on the tablet.

Overdose:

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.

inflammation of the eye (iritis),

• frequent heartburn or indigestion, ulcers
• difficulty urinating, kidney failure or kidney stones
• gall stones,
• confusion, tremors, psychiatric illness

WARNINGS AND PRECAUTIONS

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. INTERACTIONS WITH THIS MEDICATION

Missed Dose:

If you miss a dose of SALAGEN (Pilocarpine Hydrochloride tablets), 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
• chills
• nausea (feeling sick) and vomiting
• diarrhea
• passing urine more often
• problems with digestion
• dizziness
• runny eyes
• runny nose

• headache

  This is not a complete list of side effects.

  For any unexpected

• flushing (redness in face)

Tell your doctor right away if you find the above listed side effects continue, bother you, or are severe.

effects while taking SALAGEN (Pilocarpine Hydrochloride tablets), contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15 - 30ºC). Do not store in the bathroom where heat and moisture may damage this medicine.

Keep SALAGEN (Pilocarpine Hydrochloride 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 Health Canada by:

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• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or Call toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

http://www.methapharm.com

MORE

INFORMATION

This document plus the full product monograph, prepared for

health professionals can be found at:

or by contacting

the distributor

Methapharm Inc., at:

1-800-287-7686

x7804.

Amdipharm Limited,

3 Burlington Road, Dublin 4, Ireland.

Last revised: February 28, 2020