Patient Medication Information: uses, side effects, how to take - NTP-Clonidine (Teva Canada, 0.025 mg)
ABOUT THIS MEDICATION
What the medication is used for:
NTP-CLONIDINE Tablets are used to provide relief from hot flushes that may occur in women at menopause (change of life).
What it does:
NTP-CLONIDINE Tablets belong to a group of medicines called vasodilators which cause widening of the blood vessels and therefore an increase in blood flow. This results in a reduction in the frequency, severity and duration of hot flushes attacks associated with menopause. NTP-CLONIDINE will not correct or relieve other menopausal changes that are due to hormonal deficiencies. The response to NTP-CLONIDINE is gradual and once you stop taking it, there is a gradual return of the symptoms.
When it should not be used:
Tell your doctor or pharmacist if you say yes to any of the following as you should not take this medicine:
You are hypersensitive or “allergic” to the active
ingredient clonidine hydrochloride or any other ingredient in this product
- You have a slow heart rate due to heart problems
What the medicinal ingredient is:
NTP-CLONIDINE tablets contain the active ingredient called clonidine hydrochloride.
What the important nonmedicinal ingredients are:
The NTP-CLONIDINE (clonidine hydrochloride) tablet core contains clonidine HCI and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate (spray dried), magnesium stearate and pregelatinized starch.
The NTP-CLONIDINE tablet coating contains: FD&C Blue #2, hypromellose, polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, talc and titanium dioxide.
What dosage forms it comes in:
NTP-CLONIDINE is available in tablets. Each tablet contains 0.025 mg of clonidine hydrochloride.
WARNINGS AND PRECAUTIONS
BEFORE you use NTP-CLONIDINE talk to your doctor or pharmacist if you say yes to any of the following:
You are pregnant, planning to become pregnant or if you are breast feeding
- You suffer from heart or kidney problems
- You suffer from Raynaud’s disease or other circulation problems
- You have any problems with circulation of blood to your brain
- You are suffering from constipation
- You are suffering from or have, in the past, suffered from depression
- You have been told by your doctor that you have an intolerance to some sugars as NTP-CLONIDINE Tablets contain lactose.
You drink alcohol
If in doubt, ask your doctor or pharmacist.
NTP-CLONIDINE is not to be used in children under 18 years of age.
NTP-CLONIDINE may cause drowsiness which can be made worse by taking alcohol, sedatives or tranquilizers. If affected, do not drive or operate machinery and avoid taking alcohol, sedatives or tranquilizers.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist all the medicines you are taking including all prescription, non-prescription and natural health products, particularly if you are taking the following medicines:
- any other medicine containing clonidine
- antihypertensives (medicines that lower blood pressure)
- vasodilators (e.g. sodium nitroprusside)
diuretics (commonly called water tablets e.g.
furosemide) beta-blockers (e.g. atenolol)
- alpha-blockers (e.g. phenolamine and tolazoline)
- cardiac glycosides (e.g. digoxin)
- tricyclic antidepressants (e.g. imipramine)
- other antidepressants (e.g. mirtazipine)
- neuroleptics (e.g. phenothiazines)
- tranquillisers (e.g. chlorpromazine)
- hypnotics (medicines to help you sleep or for anxiety)
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor’s instructions about when and how to take your medicine and always read the label.
The usual recommended dose is 0.05 mg (two 0.025 mg tablets) twice a day. The tablets should be swallowed whole with water.
Do not change your dose or stop taking NTP-CLONIDINE without first talking to your doctor.
Overdose:
In case of accidental overdose, consult a physician immediately or contact your regional Poison Control Centre. Always take the labelled medicine container with you whether or not there are any NTP-CLONIDINE Tablets left.
Missed Dose:
If you forget to take a dose take one as soon as you remember, then carry on as before.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, NTP-CLONIDINE can have side-effects. Most side effects are mild and decrease with continued treatment. If you experience any of these side effects and they persist or become troublesome contact your doctor.
The most frequently occurring side effects are:
- dryness of mouth
- sedation
- lowering of blood pressure
Less frequently occurring side effects are:
- constipation
- nausea (feeling sick)
- vomiting,
- headache
- malaise (a vague feeling of discomfort and fatigue)
- impotence
- decreased libido (sex drive)
- gynaecomastia (enlargement of male breast tissue)
orthostatic symptoms (fall in blood pressure on
standing)
paresthesia of the extremities (altered sensation at
the finger tips, toes, etc)
Raynauds’s phenomenon (a problem with
circulation to the fingers and toes
- pain in the parotid gland (gland below the ear)
- dryness of the lining of the nose
reduction in the production of tears in the eyes (this
may be a problem for people who wear contact lens)
- skin reactions such as rash, urticaria (nettle rash), itching
- hair loss
Rarely occurring side effects are:
- sleep disturbances
- nightmares
- depression
- perceptual disorders
- hallucinations
- confusion
- disturbances of accommodation
- transient rise of blood sugar
Very rarely occurring side effects are:
Pseudo-obstruction of the large bowel in predisposed patients (symptoms include: colicky pain, constipation and vomiting)
NTP-CLONIDINE may increase the possibility of irregular or slow beating of the heart.
Adverse events reported during treatment with NTP-CLONIDINE include fatigue, muscle or joint pain and cramps, drowsiness and dizziness. In addition, there have been rare cases of increased dental cavities due to continual dry mouth, in patients receiving higher doses of clonidine hydrochloride.
If you experience any other side-effects not mentioned above, consult your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking NTP-CLONIDINE, contact your doctor or pharmacist.
HOW TO STORE IT
The tablets should not be taken after the expiry date which is printed on the label.
NTP-CLONIDINE Tablets should be stored at room temperature (15- 30oC). Protect from moisture.
Keep this medicine out of the sight and reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on
serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345 By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate Health Products and Food Branch
Health Canada
Tunney's Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Canada Vigilance, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full Prescribing Information, prepared for health professionals can be found at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9