Clonidine (Sivem Pharmaceuticals, 0.1 mg, 0.2 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

CLONIDINE tablets help reduce high blood pressure in patients that did not respond or who experienced unacceptable adverse events when using other medicines for high blood pressure.

What it does:

CLONIDINE tablets belong to a group of medicines called antihypertensives which are used to reduce high blood pressure.

The clonidine hydrochloride ingredient of CLONIDINE is a vasodilator which causes widening of the blood vessels and therefore an increase in blood flow. When there is less resistance to blood flow, blood pressure is lowered.

When it should not be used:

Do not take CLONIDINE if you:

• Are hypersensitive or “allergic” to the active ingredient clonidine

  hydrochloride or any other ingredient in this product or component of the container, (see ‘What the non-medicinal ingredients are:’ section)

• Have a slow heart rate due to heart problems

• Have galactosaemia (a rare genetic condition causing galactose

  intolerance)

What the medicinal ingredient is:

clonidine hydrochloride.

What the nonmedicinal ingredients are:

The CLONIDINE 0.1 mg tablets contain: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

The CLONIDINE 0.2 mg tablets contain: FD&C Yellow #6 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

What dosage forms it comes in:

Tablet; 0.1 mg (white), 0.2 mg (orange)

WARNINGS AND PRECAUTIONS

BEFORE you use CLONIDINE, tell your doctor or pharmacist about any health conditions or problems you may have, including if you:

• have Raynaud’s disease or other circulation problems

  • have any problems with circulation of blood to your brain
  • have heart or kidney problems
  • have a slow heart rate
  • are suffering from constipation
  • have symptoms of nerve disorders (such as altered sensation of the extremities or low blood pressure upon standing)
  • have been told by your doctor that you have galactose intolerance
  • are suffering from or have, in the past, suffered from depression

  • are pregnant, planning to become pregnant or if you are breast feeding

  • have pheochromocytoma (tumour of the adrenal gland)

CLONIDINE is not recommended for use in children and adolescents (under the age of 18 years).

Other warnings you should know about:

CLONIDINE tablets may cause drowsiness. If affected do not drive or operate machinery and avoid alcohol, sedatives or tranquilizers.

INTERACTIONS WITH THIS MEDICATION

Before taking CLONIDINE, tell your doctor or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines, and:

• any other medicine containing clonidine

• diuretic tablets (commonly called water tablets e.g.

  furosemide)

• other medicines to treat high blood pressure (e.g. beta blockers)
• alpha blockers (e.g. phentolamine)
• tricyclic antidepressants (e.g. imipramine)
• major tranquilizers (e.g. chlorpromazine)
• non-steroidal anti-inflammatory agents (e.g. ibuprofen)
• vasodilators (e.g. sodium nitroprusside)
• calcium antagonists (e.g. verapamil, diltiazem hydrochloride)
• ACE inhibitors (e.g. captopril, lisinopril)
• cardiac glycosides (e.g. digoxin)
• tablets which cause drowsiness
• tablets to decrease appetite
• neuroleptics (e.g. phenothiazines)

PROPER USE OF THIS MEDICATION

Follow your doctor's instructions about when and how to take your medicine and always read the label. Do not change your dose or stop taking CLONIDINE without first talking to your doctor.

Usual dose:

Initial dose: The usual starting dose is 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.

Maintenance dose: After a period of 2 to 4 weeks, a higher dose may be needed until the desired response is achieved. In those

instances where it is not possible to take the same dose of the drug in the morning and at bedtime, taking the larger dose at bedtime may help reduce the dry mouth and drowsiness side effects.

Overdose:

If you think you have taken too much CLONIDINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Always take the labelled medicine container with you whether or not there are any CLONIDINE tablets left.

Missed Dose:

If you forget to take your medicine, take your dose when you remember and then your next dose at the usual time. If you forget a dose completely, do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including CLONIDINE, may cause side effects. Most adverse events are mild and tend to diminish with continuation of therapy.

Side effects may include: dry mouth, dizziness, fatigue, headache, nausea, vomiting, constipation, malaise, sleep disorder, sedation and erectile dysfunction.

If you experience any of these effects or any other effects not mentioned above and they persist or become troublesome, consult your doctor or pharmacist.

With the exception of allergic reaction, you should not stop taking CLONIDINE without first consulting with your doctor as this may cause a severe withdrawal reaction which in rare cases can cause death.

CLONIDINE can cause abnormal blood test results. They may indicate excess sugar in blood. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking CLONIDINE, contact your doctor or pharmacist.

HOW TO STORE IT

CLONIDINE Tablets: Store between 15°C - 30°C. Protect from moisture.

Do not take this medicine after the expiry date which is printed on the packaging.

Keep this medicine out of the sight and reach of children.

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 CLONIDINE:

• Talk to 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.sivem.ca), or by calling 1-855-788-3153.

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent, Quebec

Canada H4R 2P7

Last revised: JUN 1, 2023