Patient Medication Information: uses, side effects, how to take - PMS-Benztropine 2mg/Tab
ABOUT THIS MEDICATION
What the medication is used for:
pms-BENZTROPINE is recommended for:
- Symptoms of Parkinson’s Disease
- Movement Disorders: to reduce some movement disorders that were caused by other medications
What it does:
pms-BENZTROPINE is an Antiparkinson drug. It acts on the nervous system to correct some of the chemical imbalances that cause the symptoms of Parkinson’s disease and movement disorders.
When it should not be used:
- If you are allergic to benztropine mesylate or to any non-medicinal ingredients
In children less than 3 years of age
- If you have narrow angle glaucoma (eye disease)
What the medicinal ingredient is:
Benztropine mesylate.
What the non-medicinal ingredients are:
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
What dosage forms it comes in:
Tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use pms-BENZTROPINE talk to your doctor or pharmacist if:
- You have glaucoma (eye disease)
- You have heart rhythm problems (such as a racing heart rate)
- You have prostate problems
- You have difficulty or pain while urinating
- You have a tardive dyskinesia (uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body)
You are pregnant, plan to become pregnant or are breast-feeding
pms-BENZTROPINE may affect your ability to sweat. This can lead to dangerous increases in body temperature. Tell your doctor if you have a condition that affects your ability to sweat, and:
- you have a chronic illness or a nervous system disease,
consume excessive amounts of alcohol,
- do labour in a hot environment.
This is particularly important during hot weather.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to pms-BENZTROPINE.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Drugs that may interact with pms-BENZTROPINE include:
- other drugs used to treat movement disorders and symptoms of Parkinson’s Disease such as amantadine
- drugs used to treat bowel problems such as clidinium, dicyclomine
- drugs used to treat Alzheimer’s Disease, such as donepezil, galantamine, rivastigmine
- drugs used to treat asthma and Chronic Obstructive Pulmonary Disease (COPD) such as tiotropium
- drugs used to treat urinary and bladder difficulties such as oxybutynin
- drugs used to treat allergies such as diphenhydramine
- muscle relaxants such as cyclobenzaprine
- drugs used to treat generalized anxiety disorders such as lorazepam and diazepam.
- tricyclic antidepressants such as amitriptyline, doxepin
- drugs that help maintain a regular heart rhythm such as disopyramide, procainamide, quinidine
- MAO inhibitors such as moclobemide, phenelzine, tranylcypromine, methylene blue (used in medical procedures)
- motion sickness medication such as scopolamine, dimenhydrinate
- narcotic pain relievers such as codeine, meperidine, morphine
- potassium tablets/capsules
- psychiatric medicines such as pimozide and phenothiazine derivatives such as chlorpromazine
If you already take other drugs to treat Parkinson’s disease, the doctor may decide to adjust or gradually discontinue them. Do not suddenly stop taking them. Always follow your doctor’s instructions.
PROPER USE OF THIS MEDICATION
Dosage must be individualized according to the need of the patient. pms-BENZTROPINE is usually started at a low dose and increased gradually every 5 or 6 days until the smallest effective dose is found. pms-BENZTROPINE is taken by mouth.
Many factors can affect the dose of medication that a person needs, such as age, body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way you are taking the medication without consulting your doctor.
Usual adult dose:
Symptoms of Parkinson’s Disease:
Initial dose: 0.5 mg a day.
Maximum dose: 6 mg a day.
Usual Dose: 1 to 2 mg a day.
The dose can range from 0.5 to 6 mg a day depending on circumstances.
Your doctor may recommend you take:
- one dose at bedtime
- multiple doses spread throughout the day.
Dose for children more than 3 years old:
Dosage should be individualised based on the weight of the child. Usual dose: 0.02 – 0.05 mg/kg 1-2 times a day.
Movement Disorders:
Recommended dose: 1 to 4 mg once or twice a day.
Your doctor may recommend you take your dose as one, two or three doses in a day. After 1 or 2 weeks, your doctor may stop pms-BENZTROPINE to determine if you still need it. pms-BENZTROPINE may need to be restarted if your movement disorder returns.
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. |
Missed Dose:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- blurred vision
- nervousness, listlessness, agitation
- constipation
- numbness of the fingers
- fever
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| Common | Severe dry mouth: difficulty swallowing or speaking, loss of appetite and weight | |||
| Nausea | ||||
| Vomiting | ||||
| Frequency Unknown | Dysuria: Painful or difficult urination | |||
| Paralytic ileus: (Bowel Obstruction): abdominal pain and discomfort, constipation, nausea, vomiting, excessive burping | ||||
| Tachycardia: fast heartbeat. | ||||
| Weakness and an inability to move certain muscle groups | ||||
| Mental Confusion | ||||
| Worsening of Mental Disorders | ||||
| Hallucinations: see or hear things that are not there | ||||
| Glaucoma: increased pressure in your eyes, eye pain | ||||
| Depression: Feeling sad, unexplained weight change, sleep disturbances, lack of interest in usual activities | ||||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | |||
This is not a complete list of side effects. For any unexpected effects while taking pms-BENZTROPINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 C-30 C).
Keep 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: --------------------------------------------------------------------------
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 prescribing information, prepared for health professionals can be found by contacting the sponsor, Pharmascience Inc., at: 1-800-550-6060