Patient Medication Information: uses, side effects, how to take - Ticlopidine (AA Pharma)
What is TICLOPIDINE?
TICLOPIDINE is a product name for the prescription drug ticlopidine. Each film-coated tablet of TICLOPIDINE contains 250 mg of ticlopidine hydrochloride, the active ingredient. It also contains additional (non-medicinal or inactive) ingredients. These are: carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide.
Serious Warnings and Precautions
TICLOPIDINE can cause life-threatening thrombotic thrombocytopenic purpura (TTP)
(blood clots in small blood vessels) and other blood disorders.
- You will be required to have a blood test to check your white blood cells and platelets before you start taking TICLOPIDINE and then every week for the first three months you are on TICLOPIDINE. If you stop taking TICLOPIDINE for any reason within the first 3 months, you will still need to have your blood tested for an additional two weeks after you have stopped taking TICLOPIDINE.
If you have any of the following symptoms while you are taking TICLOPIDINE, or for two weeks after you have stopped taking it, STOP taking TICLOPIDINE and get immediate medical help:
- signs of infection such as fever, chills, sore throat, mouth sores
- abnormal bleeding, bruising, dark or black stools, blood in urine, vomit or stool
- bleeding from areas such as the nose or gums
- signs of liver problems (yellow eyes or skin, dark urine or light colored stool)
- excessive weakness, tiredness
- skin rash with red or purple spots
- mental changes, confusion, trouble speaking, paralysis, seizures, coma
What is TICLOPIDINE used for?
- TICLOPIDINE is used to reduce the risk of having a stroke in adults who have had a previous stroke or who experienced one or more warning episodes indicating an increased risk of stroke. Warning episodes include: transient ischemic attacks (TIA), reversible ischemic neurological deficit (RIND), transient monocular blinds (TMB) or minor strokes.
Due to the risk of serious, life-threatening blood disorders in patients taking TICLOPIDINE,
TICLOPIDINE should only be used in adults who are intolerant or allergic to acetylsalicylic acid (ASA) therapy, did not respond to ASA therapy, or are not able to use any other antiplatelet therapy.
- A stroke occurs when a clot (or thrombus) forms in a blood vessel in the brain, or forms in another part of the body and breaks off and then travels to the brain (embolus).
How does TICLOPIDINE work?
TICLOPIDINE reduces the ability of blood clotting cells (platelets) to stick to each other and to the walls of blood vessels. This makes the blood less likely to clot in unwanted places such as in narrowed blood vessels.
What are the ingredients in TICLOPIDINE?
Medicinal ingredients: Ticlopidine hydrochloride
Non-medicinal ingredients: Carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide.
TICLOPIDINE comes in the following dosage forms:
Film-coated tablet: 250 mg
Do not use TICLOPIDINE if:
you are allergic to ticlopidine hydrochloride or any of the non-medical ingredients in
TICLOPIDINE
- you have a history of blood disorders such as low white blood cell counts (neutropenia), low platelets (thrombocytopenia)
- you have a clotting disorder
- you have active bleeding problems such as stomach or intestinal ulcers, or bleeding in the brain (intracranial)
- you have severe liver disease
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TICLOPIDINE. Talk about any health conditions or problems you may have, including if you:
- have a history of bleeding such as stomach or intestinal ulcers, bleeding in the brain or are at risk of these conditions
- have liver or kidney problems
are pregnant or plan on becoming pregnant
- are breastfeeding or plan on breastfeeding. It is not known if TICLOPIDINE passes into breastmilk.
- are taking other medicines to prevent blood clots called anticoagulants.
- are going to have surgery, including dental surgery. Tell the healthcare professional that you are taking TICLOPIDINE before the procedure.
Other warnings you should know about:
Serious Side Effects: TICLOPIDINE can cause serious side effects.
- Thrombocytopenic thrombotic purpura (TTP): Blood clots in small blood vessels that can be life-threatening and cause death.
- Low levels of white blood cells: Serious infections can occur while taking TICLOPIDINE.
- Low levels of platelets in the blood: Serious bleeding problems.
- Liver problems
- Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
- Stomach and gut problems
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Blood Tests and Monitoring: Since TICLOPIDINE can cause serious blood disorders your healthcare professional will do blood tests before you start taking TICLOPIDINE and regularly during treatment. They will also check the health of your liver and your cholesterol and blood fat levels. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TICLOPIDINE:
- Other medications used to prevent blood clots such as: heparins, oral anticoagulants and other antiplatelet drugs
- Non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid (ASA), used to treat pain and inflammation. ASA can also be used as an antiplatelet drug.
- Theophylline, used to treat breathing problems like asthma and COPD
- Digoxin, used to treat heart problems
- Cimetidine and other antacid medicines, used to treat heartburn and digestion problems
- Phenytoin, used to treat seizures
- Cyclosporine, used to suppress the immune system
How to take TICLOPIDINE:
- Take TICLOPIDINE exactly as prescribed by your healthcare professional.
TICLOPIDINE should be taken with food to reduce stomach upset.
Usual dose:
The usual dosage is 250 mg twice daily with meals.
Overdose:
If you think you, or a person you are caring for, have taken too much TICLOPIDINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take TICLOPIDINE, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time to make up for a missed dose.
What are possible side effects from using TICLOPIDINE?
These are not all the possible side effects you may have when taking TICLOPIDINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea, nausea, vomiting
- bloating, gas, indigestion
- stomach pain, loss of appetite
- rash, itching
- dizziness
- headache
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare | Stop taking drug and get immediate medical help | ||||||
| professional | ||||||||
| Only if | In all cases | |||||||
| severe | ||||||||
| COMMON | ||||||||
| Low levels of white blood cells: signs of infection such as fever, chills, sore throat, mouth sores | ✓ | |||||||
| UNCOMMON | ||||||||
| Low levels of platelets: abnormal bleeding, bruising, dark stool, rash with red or purple spots, bleeding under the skin | ✓ | |||||||
| RARE | ||||||||
| Bleeding in the brain: weakness, tingling or numbness and pain in the hands and feet, paralysis, headache, nausea, vomiting | ✓ | |||||||
| Immune system problems (including systemic lupus erythematosus): pain and swelling in the joints, skin rash, fatigue, fever | ✓ | |||||||
| Kidney problems: decreased urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | |||||||
| Stomach and gut problems: severe diarrhea, stomach pain, vomiting blood, blood in the stool or black stool | ✓ | |||||||
| Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome): painful swelling under the skin, severe skin rash with flushing, severe skin rash with fever, blisters or ulcers | ✓ | |||||||
| Thrombocytopenic thrombotic purpura (TTP): blood in the urine, vomit or stool, abnormal bleeding, red or purple skin rash, fatigue, fever, mental changes, confusion, trouble speaking, paralysis, seizures, coma | ✓ | |||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare | Stop taking drug and get immediate medical help | ||||||
| professional | ||||||||
| Only if | In all cases | |||||||
| severe | ||||||||
| VERY RARE | ||||||||
| Liver problems: yellowing of the skin and white part of the eye, dark urine, pale stool, nausea, abdominal pain | ✓ | |||||||
| NOT KNOWN | ||||||||
| Bleeding Problems: bruising, nose bleeds, blood in urine, bleeding in the eye, vomiting blood, blood in stool | ✓ | |||||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
| You can report any suspected side effects associated with the use of health products to | |
| Health Canada by: | |
| |
| (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 | |
| |
| 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. |
Storage:
Store at room temperature 15°C to 30°C. Protect from light.
Do not use this medicine after the expiry date on the package.
Keep out of the reach of children.
If you want more information about TICLOPIDINE:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes
this Patient Medication 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 http:// https://www.aapharma.ca/en/, or by calling 1-877-998-9097.
AA PHARMA INC.
1165 Creditstone Road Unit #1
Vaughan, Ontario
L4K 4N7
