Details for: SALAGEN
Company: AMDIPHARM LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02216345 | SALAGEN | PILOCARPINE HYDROCHLORIDE | 5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal 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 (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
- 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).
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 (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 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.
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.
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
- flushing (redness in face)
Tell your doctor right away if you find the above listed side effects continue, bother you, or are severe.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate emergency medical help |
|---|---|---|---|
| Uncommon | |||
| Weakness | ✔ | ||
| Confusion, agitation, or very depressed | ✔ | ||
| Vision abnormalities | ✔ | ||
| Chest pain, a rapid heart beat, or your pulse races | ✔ | ||
| unknown | |||
| Difficulty breathing | ✔ | ||
| Severe pain in your stomach or abdomen | ✔ | ||
| Fainting | ✔ | ||
| 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 (Pilocarpine Hydrochloride tablets), contact your doctor or pharmacist.
How to store
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 side effects
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffectcanada/adverse-reactionreporting.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.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.methapharm.com or by contacting the distributor Methapharm Inc., at: 1-800-287-7686 x7804.
This leaflet was prepared by Amdipharm Limited,
3 Burlington Road, Dublin 4, Ireland.
Last revised: February 28, 2020