Patient Medication Information: uses, side effects, how to take - Mint-Clonidine (Mint Pharmaceuticals, 0.025 mg)
ABOUT THIS MEDICATION
What the medication is used for:
MINT-CLONIDINE tablets are used to provide relief from hot flushes that may occur in women at menopause (change of life).
What it does:
MINT-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 MINT-CLONIDINE or have a rare hereditary problem of galactose intolerance or the Lapp lactose deficiency. MINT-CLONIDINE contains lactose.
You have a severe slow heart rate; MINT- CLONIDINE can lower the heart and pulse rate.
What the medicinal ingredient is:
clonidine hydrochloride.
What the nonmedicinal ingredients are:
The MINT-CLONIDINE (clonidine hydrochloride) tablet core contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and pregelatinized maize starch.
The MINT-CLONIDINE tablet coating contains: FD&C Blue #2, hypromellose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
What dosage forms it comes in:
MINT-CLONIDINE is available in tablets. Each tablet contains 0.025 mg of clonidine hydrochloride.
WARNINGS AND PRECAUTIONS
BEFORE you use MINT-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.
MINT-CLONIDINE is not to be used in patients under 18 years of age.
MINT-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
- alpha receptor blockers such as phentolamine
- methylphenidate
- indomethacin and other non-steroidal anti- inflammatory 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 MINT-CLONIDINE without talking to your doctor since
stopping MINT-CLONIDINE suddenly may cause a severe withdrawal reaction, which in rare cases can cause death.
Overdose:
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.
MINT-CLONIDINE can cause abnormal blood test results. MINT-CLONIDINE may also increase blood sugar, you may need to test your blood sugar more often.
This is not a complete list of side effects. For any unexpected effects while taking MINT-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.
MINT-CLONIDINE tablets should be stored between 15°C - 30°C. Protect from moisture.
Keep this medicine out of the sight and reach of children.
If you think you, or a person you are caring for, have taken too much MINT-CLONIDINE, contact a healthcare professional, hospital emergency department, or a regional poison control centre immediately, even if there are no symptoms
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
| √ |
| 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 | 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) | √ | ||
Reporting Side Effects
You can report any suspected side effects 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/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling 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
If you want more information about MINT-CLONIDINE:
- Talk with your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.mintpharmaceuticals.com), or by calling 1-877-398-9696.
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3