Pilocarpine Hydrochloride Tablets, USP: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Pilocarpine Hydrochloride Tablets, USP are used to treat dry mouth and/or your dry eyes caused by radiotherapy in people with head and neck cancer or by Sjögren’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:

Pilocarpine Hydrochloride Tablets, USP cause your salivary glands and your tear glands to make more of your natural saliva and tears.

When it should not be used:

Pilocarpine Hydrochloride Tablets, USP 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:

Microcrystalline cellulose, stearic acid, and coating (titanium dioxide, Polydextrose, hypromellose, macrogol and Triacetin).

What dosage forms it comes in:

Tablets, 5 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use Pilocarpine Hydrochloride Tablets, USP 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 if you should be taking Pilocarpine Hydrochloride Tablets, USP
  • 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 Pilocarpine Hydrochloride Tablets, USP 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 Pilocarpine Hydrochloride Tablets, USP.

Drugs that may interact with Pilocarpine Hydrochloride Tablets, USP 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 Pilocarpine Hydrochloride Tablets, USP three to 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 (30 mg) per day.

Take Pilocarpine Hydrochloride Tablets, USP 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.

Missed Dose:

If you miss a dose of Pilocarpine Hydrochloride Tablets, USP, take the next dose when you normally would. Do not take more than two tablets at a time.

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

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
• flushing (redness in face)

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

This is not a complete list of side effects. For any unexpected effects while taking Pilocarpine Hydrochloride Tablets, USP, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15-25°C). Protect from light. Do not store in the bathroom where heat and moisture may damage this medicine.

Keep Pilocarpine Hydrochloride Tablets, USP out of the reach and sight of children.

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.sterimaxinc.com

or by contacting the sponsor, SteriMax Inc.,

at: 1-800-881-3550.

Last revised: June 23, 2015