Details for: TARO-DIPYRIDAMOLE/ ASA
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02471051 | TARO-DIPYRIDAMOLE/ ASA | DIPYRIDAMOLE; ACETYLSALICYLIC ACID | 200 MG; 25 MG | CAPSULE (IMMEDIATE AND EXTENDED RELEASE) | 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
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 nonmedicinal 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 ingredient is
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
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 form 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).
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.
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 TaroDipyridamole / ASA.
Children and adolescents:
Taro-Dipyridamole / ASA is not recommended for
children or adolescents below 18 years of age.
Overdose
Do not exceed the recommended dosage of TaroDipyridamole / 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 TaroDipyridamole / ASA capsules remaining. Symptoms of overdosage, especially in the elderly patients, are: ear buzzing, sensation of decreased hearing acuity, and headaches.
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.
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 TaroDipyridamole / 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: purplecolored 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:
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate help |
|---|---|---|---|
| Common | |||
| Allergic reaction (symptoms like itching, swelling of the face, lips, tongue and throat, difficulty in breathing etc.) | ✔ | ||
| Internal bleeding with symptoms such as easy bruising, bleeding nose and gums, bloody urine, dark stools, persistent abdominal pain and vomiting. | ✔ | ||
| Gastrointestinal problems such as ulcers, or gastritis (stomach inflammation) with symptoms such as abdominal pain, bloody urine or dark stools | ✔ | ||
| Anaemia (reduction in red blood cells) with symptoms such as fatigue, breathlessness, loss of stamina, fast heartbeat. | ✔ | ||
| Uncommon | |||
| Worsening of heart problems such as angina (symptoms such as weakness, pain, breathlessness) | ✔ | ||
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
- 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 TaroDipyridamole / 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 at:
www.taro.ca
or by contacting the sponsor,
Taro Pharmaceuticals Inc., at: 1-800-268-1975
This leaflet was prepared by :
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.
Last revised: December 21, 2017