Patient Medication Information: uses, side effects, how to take - PDP-Benztropine (Pendopharm Division of Pharmascience, Tablet)
ABOUT THIS MEDICATION
What the medication is used for:
- Parkinson’s Disease
- Movement Disorders caused by other medications
What it does:
pdp-BENZTROPINE acts on the nervous system to correct some of the chemical changes that caused your medical condition.
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:
Corn starch, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
What dosage forms it comes in:
Tablet: 2 mg
WARNINGS AND PRECAUTIONS
BEFORE you use pdp-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
pdp-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,
you consume very large amounts of alcohol,
- you do physical work 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 pdp-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 pdp-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 beat 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 or capsules
- psychiatric medicines such as pimozide and 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
Depending on your dose, you may need to split the tablet. The pdp-BENZTROPINE tablets are crossed scored on one side (i.e. there are grooves on the tablet). Use these markings to split the tablet.
Do not change your dose or stop taking this medication without talking to your doctor first.
For the treatment of Parkinson’s Disease:
Your doctor may recommend that you or your child:
- take the dose once a day at bedtime or
- divide the dose and take /give it throughout the day (2 to 4 times a day)
Adult dose: Take your dose exactly as directed by your doctor.
Dose for children (over 3 years of age): your / your child’s doctor will decide how much you should take / give and how often it should be taken / given. Follow the doctor’s directions exactly as you are told.
For the treatment of Movement Disorders:
Your doctor may recommend you take your dose:
- once a day or
- divide the dose and take it throughout the day (2 to 3 times a day)
After 1 or 2 weeks, your doctor may stop pdp-BENZTROPINE to determine if you still need it. pdp-BENZTROPINE may need to be restarted if your movement disorder returns.
Adult dose: Take exactly as directed by your doctor.
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 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 pdp-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 side effects associated with the use of health products to Health Canada by:
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 prescribing information, prepared for health professionals can be found by contacting the sponsor, PENDOPHARM, Division of Pharmascience Inc., at:
1-888-550-6060