Taro-Dipyridamole/ ASA: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Taro-Dipyridamole / ASA capsules are prescribed to help prevent a stroke in people who have had a prior stroke or a transient ischemic attack (TIA).

Stroke is caused by the interruption of the blood supply to the brain and often results in brain damage. A stroke can affect people in different ways. The damage caused by a stroke can affect your senses, your ability to move, your speech, your ability to understand speech, how you behave, how you think, and your memory.

Transient Ischemic Attack is a temporary interference with blood supply to the brain. The symptoms of TIA include dizziness, light-headedness, numbness, and difficulty swallowing. They may last for only a few minutes or several hours.

Taro-Dipyridamole / ASA has been prescribed to you. DO NOT give it to anyone else, even if you think they have the same condition as you.

What it does:

Taro-Dipyridamole / ASA capsules belong to a group of medicines called antiplatelet drugs. Platelets are very small structures in blood, which clump together during blood clotting.

Taro-Dipyridamole / ASA works by preventing the early formation of blood clots (a process called thrombosis).

When it should not be used:

Taro-Dipyridamole / ASA should not be used if you:

• are sensitive or allergic to any component of the

  drug, including ASA (Aspirin®) (see “What the non- medicinal ingredients are”);

• have allergy to non-steroidal anti-inflammatory drugs

  (NSAIDs);

• have active stomach or duodenal ulcers or bleeding

  disorders;

  • have asthma, rhinitis or nasal polyps;
  • have fructose and/or galactose intolerance;

  • are in the third trimester of pregnancy.

What the medicinal ingredients are:

Taro-Dipyridamole / ASA is a combination of dipyridamole and acetylsalicylic acid (ASA). Taro-Dipyridamole / ASA is not interchangeable with the individual components of ASA and dipyridamole tablets.

What the non-medicinal ingredients are (in alphabetical order):

acacia, colloidal silicon dioxide, ethyl cellulose, hypromellose, hypromellose phthalate, methacrylic acid copolymer type B, microcrystalline cellulose, starch, stearic acid, talc, tartaric acid, titanium dioxide, triacetin, and triethyl citrate.

The capsule shell contains: gelatine, imprinting ink (TEK print SW-9008 black ink), iron oxide red, iron oxide yellow, sodium lauryl sulphate, titanium dioxide, and water.

What dosage forms it comes in:

Capsules - each capsule contains yellow extended release pellets of dipyridamole (200 mg) and a round, white tablet of ASA (25 mg).

WARNINGS AND PRECAUTIONS

BEFORE you use Taro-Dipyridamole / ASA talk to your doctor or pharmacist if you

• are pregnant or intend to become pregnant. Your doctor will advise you that this medication should not be taken during the third trimester of pregnancy and will discuss with you whether it should be taken in the first and second trimester;
• are breast feeding. Both dipyridamole and ASA are excreted in human breast milk. You and your doctor will discuss this issue;
• are consuming alcoholic beverages;
• have any other health problems, including anaemia, liver disease, renal (kidney) disorders, history of stomach or duodenal ulcers, bleeding disorders (such as haemophilia), heart disease (including angina and recent heart attack), gout, and abnormal menstruation or vaginal bleeding;
• are taking any other medication, including any other medication you can buy without a prescription; medication such as acetylsalicylic acid; drugs used to reduce blood clotting such as warfarin and heparin; antiplatelet agents (e.g. clopidogrel, ticlopidine), NSAIDs used to treat painful and/or inflammatory muscle and joint conditions; or anti-diabetic medicines. (See “Interactions with this medication”);
• will be having surgery. Your doctor may ask you to stop Taro-Dipyridamole / ASA for 10 days before

your surgery;

• have a history of hemorrhagic stroke (stroke due to

  bleeding).

Long term daily use of ibuprofen can interfere with the preventative benefits of Taro-Dipyridamole / ASA. (See “Interactions with this medication”).

DO NOT take any other medication unless your doctor tells you to. Please tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements or alternative medicines.

Taro-Dipyridamole / ASA contains ASA (Aspirin®*). You should not take Taro-Dipyridamole / ASA with the following medications without the advice of your doctor:

• other medications containing ASA;
• other blood thinners (e.g. warfarin or heparin);
• antiplatelet agents (e.g. clopidogrel, ticlopidine);

• selective serotonin reuptake inhibitors (SSRIs: e.g.

  sertraline, fluoxetine);

• non-steroidal anti-inflammatory drugs (NSAIDs,

  including ibuprofen);

• methotrexate;
• drugs affecting gout;
• anagrelide (platelet-reducing agent);
• adenosine;

• cholinesterase inhibitors (e.g. some medications used

  for Myasthenia Gravis Syndrome);

• acetazolamide;

• angiotensin converting enzyme (ACE) inhibitors (e.g.

  enalapril, captopril);

• phenytoin or valproic acid;
• beta-blockers (e.g. atenolol, propanolol);
• corticosteroids (e.g. prednisone);
• diuretics (e.g. hydrochlorothiazide, furosemide);
• oral hypoglycaemics for diabetes.

If you experience symptoms such as dizziness or confusion you should avoid potentially hazardous tasks such as driving or operating machinery.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults (including the elderly);

The recommended dosage is one capsule twice daily, once in the morning and once in the evening, with or without food. The capsules should be swallowed whole without chewing.

Alternative regimen in case of intolerable headaches: In the event of intolerable headaches soon after starting treatment with Taro-Dipyridamole / ASA, talk to your doctor about an alternative dosing regimen. This regimen is comprised of one capsule of Taro-Dipyridamole / ASA at bedtime and a low dose of ASA in the morning. Headaches should become less of a problem as treatment continues, usually within one week. After a week or so without headache, your doctor will generally recommend that you return to the usual twice-daily dosing regimen of Taro-Dipyridamole / ASA.

Children and adolescents:

Taro-Dipyridamole / ASA is not recommended for children or adolescents below 18 years of age.

Missed dose:

If you forget to take a dose, take it as soon as you remember, but if it is almost time for the next dose, wait and take your next dose. Do not take a double dose.

Overdose:

If you think you have taken too much of TARO-DIPYRIDAMOLE/ASA, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Do not exceed the recommended dosage of Taro-Dipyridamole / ASA. If you accidentally take too many capsules, you should get medical help immediately, either by calling your doctor or by going to the nearest hospital. Always take the labelled medicine container with you whether or not there are any Taro-Dipyridamole / ASA capsules remaining. Symptoms of overdosage, especially in the elderly patients, are: ear buzzing, sensation of decreased hearing acuity, and headaches.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

You should be aware that Taro-Dipyridamole / ASA as a prescription medicine may cause side effects. In most cases these side effects are mild and may disappear with continued treatment. Discuss with your doctor the risks of taking Taro-Dipyridamole / ASA against the expected benefits. If you do experience any unusual or unwanted effects while you are using Taro-Dipyridamole / ASA, you should contact your doctor.

Some patients starting on Taro-Dipyridamole / ASA may develop a severe headache due to the dilation of the vessels in the brain related to the dipyridamole component of the drug. This headache tends to decrease and go away as the body gets used to the medicine. If you develop a severe headache call

your doctor.

Taro-Dipyridamole / ASA is a blood thinner and you may experience bleeding from the nose, bleeding around the gums when eating or brushing teeth, blood in the urine or in the stools, or bruising more easily. If you notice abnormal or excessive bleeding tell your doctor.

Very common side effects include: headache, dizziness, dyspepsia, diarrhoea, nausea, abdominal pain.

Common side effects include: anaemia, hypersensitivity reaction (such as rash, urticaria, bronchospasm, edema), migraine like headache, vomiting, fainting, muscle pain, bleeding inside the brain.

Uncommon side effects include: low blood pressure, stomach ulcer, rapid heartbeat, bleeding inside the eye, hot flashes.

Rare side effects include: iron deficiency anemia, reduction in platelet count and erosions in the stomach lining.

The following side effects have also been reported: purple- colored spots and patches on the skin, prolonged bleeding time, bleeding after surgery or other procedures.

If you experience any of the above symptoms that become bothersome, consult your doctor.

Consult your doctor immediately if you experience any of the following:

Do not be alarmed by this list of possible side effects. You may not experience any of them.

This is not a complete list of side effects. For any unexpected effects while taking Taro-Dipyridamole / ASA, contact your doctor or pharmacist.

HOW TO STORE IT

• Taro-Dipyridamole / ASA capsules must be kept out of the reach of children.
• Taro-Dipyridamole / ASA should be stored at room temperature (15 °C - 30 °C). Keep Taro-Dipyridamole / ASA in the sealed container provided by your doctor or pharmacist, and protect from excessive moisture.
• The expiry date of this medicine is printed on the label. Do not use the medicine after this date has passed.

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.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

This document plus the full product monograph, prepared for health professionals can be found at: www.taro.ca

or by contacting the sponsor,

Taro Pharmaceuticals Inc., at: 1-800-268-1975

Taro Pharmaceuticals Inc. 130 East Drive

Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: December 21, 2017