Ratio-Pentoxifylline: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Pratio-PENTOXIFYLLINE has been prescribed to you by your health provider to treat your chronic vascular (blood flow) disorders in your extremities (legs and arms).

What it does:

Pratio-PENTOXIFYLLINE belongs to a group of medicines known as vasoactive drugs which improve peripheral blood flow and thus enhances peripheral tissue oxygenation.

When it should not be used:

Do not use Pratio-PENTOXIFYLLINE if:

• You are allergic to it or other xanthine such as

  caffeine, theophylline and theobromine and to any of the components of its formulation.

• You have any heart disease
• You have uncontrolled bleeding or are at risk of such
• You have peptic (stomach) ulcers

What the medicinal ingredient is:

Pentoxifylline

What the important nonmedicinal ingredients are:

Benzyl alcohol, FD&C red no.3 (colouring agent), hydoxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 8000, povidone, talc, titanium dioxide.

What dosage forms it comes in:

Sustained released tablets of 400 mg

WARNINGS AND PRECAUTIONS

BEFORE you use Pratio-PENTOXIFYLLINE talk to your health provider if:

• You have liver disease or disorder
• You have kidney disease or disorder
• You have coagulation disorder

• You are pregnant

  • You are a nursing mother
  • You have low or labile blood pressure

Almost all patients can drive or operate machinery while taking Pratio-PENTOXIFYLLINE, but you should not perform these tasks, which may require attention, until you know how you tolerate your medicine.

INTERACTIONS WITH THIS MEDICATION

Sometimes drugs can interact with other drugs, so tell your doctor or pharmacist if you are taking any other medications, including prescription, non-prescription and natural health products. In particular, tell your doctor if you are taking any of the following:

• Drugs to reduce blood pressure (eg. ACE inhibitors, angiotensin II receptor antagonist)
• Sympathomimetics (eg amphetamines)
• Medication for asthma (eg. theophylline)
• Medication for diabetes
• Anticoagulants (eg. heparin, warfarin)
• Erythromycin (an antibiotic)
• Medication to treat ulcers (eg. cimetidine)

PROPER USE OF THIS MEDICATION

This drug is specifically prescribed for you. Do not give it to others, even if they have the same symptoms, and you yourself must not use it for any condition other than the one for which it was prescribed.

It is important that you take Pratio-PENTOXIFYLLINE as prescribed by your doctor.

Usual dose:

Usually your doctor will prescribe Pratio-PENTOXIFYLLINE tablets at a dose of 400 mg twice or three times daily, which will be individualized based on your condition.

A maximum of 400 mg three times daily should not be exceeded.

Swallow the tablets whole with a glass of water after meals. You should always respect the prescribed interval between the doses. Never change the dose of Pratio-PENTOXIFYLLINE you are taking unless your doctor tells you to.

Overdose:

If you have accidentally taken too much Pratio-PENTOXIFYLLINE contact your doctor or nearest hospital emergency department immediately, even if you do

Page 20 of 20 not feel sick. If you go to the doctor or the hospital, take the

Pratio-PENTOXIFYLLINE container with you.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its beneficial effects, Pratio-PENTOXIFYLLINE like all other drugs, may sometimes cause undesirable effects. The most frequent ones are:

• nausea, vomiting,
• headache, dizziness (light-headedness),
• abdominal discomfort,
• bloating,
• diarrhoea,
• dyspepsia (heart burns) and
• flushing, and
• malaise

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

HOW TO STORE IT

Store your tablets at room temperature (15° – 30°C). Protect from light. Protect from moisture and excessive heat.

There is an expiration date on the label. Do not use the medicine after this date.

Return any leftover tablets to the pharmacist, unless the doctor tells you to keep them at home.

As with all medicines, keep Pratio-PENTOXIFYLLINE

out of reach of children.

REPORTING SUSPECTED 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 0701C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect .

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,

ratiopharm inc.

17 800 Lapointe, Mirabel

Quebec, Canada, J7J 1P3

1-800-337-2584

Last revised: September 18, 2009