Details for: TEVA-CLONIDINE 0.1MG, 2MG
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02304163 | TEVA-CLONIDINE | CLONIDINE HYDROCHLORIDE | 0.025 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
TEVA-CLONIDINE Tablets are used to provide relief from hot flushes that may occur in women at menopause (change of life).
What it does
TEVA-CLONIDINE Tablets helps reduce the frequency, severity and duration of menopausal flushing (due to decreased estrogen levels).
When it should not be used
Do not take this medicine if:
- You are allergic to clonidine hydrochloride or any other ingredients in TEVA-CLONIDINE or have a rare hereditary problem of galactose intolerance or the Lapp lactose deficiency. TEVA-CLONIDINE contains lactose.
- You have a severe slow heart rate; TEVACLONIDINE can lower the heart and pulse rate.
What the medicinal ingredient is
clonidine hydrochloride.
What the non-medicinal ingredients are
The TEVA-CLONIDINE (clonidine hydrochloride) tablet core contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate (spray dried), magnesium stearate and pregelatinized starch.
The TEVA-CLONIDINE tablet coating contains: FD&C Blue #2, hypromellose, polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, talc and titanium dioxide.
What dosage form it comes in
TEVA-CLONIDINE is available in tablets. Each tablet contains 0.025 mg of clonidine hydrochloride.
Warnings and precautions
BEFORE you use TEVA-CLONIDINE talk to your doctor or pharmacist about any health conditions or problems you may have, including if you:
- have low blood pressure;
- have a slow heart rate, or heart failure, or irregular heart rate, or a recent heart attack;
- have or have had a stroke;
- have poor blood circulation to hands and feet such as Raynaud’s syndrome;
- are suffering from constipation;
- have kidney disease;
- have eye problems such as dry eye or wear contact lenses;
- have or have had depression;
- are pregnant or planning to become pregnant;
- are breast-feeding.
TEVA-CLONIDINE is not to be used in patients under 18 years of age.
TEVA-CLONIDINE may cause sleepiness, dizziness and fainting. Do not drive or operate machinery until you know how the drug affects you.
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:
- drugs that contain clonidine
- drugs that lower blood pressure such as water pills, betablockers, vasodilators, calcium antagonists, ACE-inhibitors
- drugs that slow the heart rate
- drugs for depression and MAO inhibitors
- alpha2 receptor blockers such as phentolamine
- methylphenidate
- indomethacin and other non-steroidal antiinflammatory agents
- barbiturates or other sedatives, including alcohol
Proper use of this medication
Follow your doctor’s instructions about when and how to take your medicine and always read the label.
Usual Dose
0.05 mg (two 0.025 mg tablets) twice a day. The tablets should be swallowed whole with water.
Do not stop taking TEVA-CLONIDINE without talking to your doctor since stopping TEVA-CLONIDINE suddenly may cause a severe withdrawal reaction, which in rare cases can cause death.
Overdose
If you take more TEVA-CLONIDINE tablets than you should or in case of drug overdose, contact your doctor or a poison control centre or go to the emergency room of the hospital near you.
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
Side effects may include: dry mouth, dizziness, tiredness, headache, nausea, vomiting, constipation, feeling weak (malaise), sleepiness, drowsiness and erectile dysfunction (trouble getting or keeping an erection), itchiness, rash, hive, hair loss.
If you experience any of these effects or any other effects not mentioned above and they continue or become troublesome, talk to your doctor or pharmacist.
TEVA-CLONIDINE can cause abnormal blood test results. TEVA-CLONIDINE may also increase blood sugar, you may need to test your blood sugar more often.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Blood pressure effects: Fall in blood pressure on standing | ✔ | ||
| Urinary effects: Urinary difficulty or retention | ✔ | ||
| Uncommon | |||
| Allergic reaction: Hives, swelling of lips, face or throat with difficulty breathing or speaking (signs of angioedema) | ✔ | ||
| Hypersensitivity reactions: Skin rash, skin eruption or other effect on the skin or eyes | ✔ | ||
| Muscle or joint effects: Muscle or joint pain and cramps of the lower limbs | ✔ | ||
| Hallucination: Problem with circulation to the fingers and toes (Raynaud’s pheonomenon) | ✔ | ||
| Rare | |||
| Heart effects: Racing or irregular heart rate, slow heart rate | ✔ | ||
| Blockage of the large bowel: Colicky pain, constipation, vomiting, liver problems | ✔ | ||
| Liver disorder: Symptoms such as nausea, vomiting, dark/brown urine | ✔ | ||
| Not Known | |||
| Confusion state | ✔ | ||
| Disability of the eye to change its focus from near to distant objects | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-CLONIDINE, contact your doctor or pharmacist.
How to store
The tablets should not be taken after the expiry date which is printed on the label.
TEVA-CLONIDINE Tablets should be stored at room temperature (15°C - 30°C). Protect from moisture.
Keep this medicine out of the sight and reach of children.
Reporting 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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 product monograph, prepared for
health professionals can be found by contacting
Teva Canada Limited
at: 1-800-268-4127 ext. 1255005 (English)
or 1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: February 6, 2014