Patient Medication Information: uses, side effects, how to take - PHL-Anagrelide
What the medication is used for:
phl-ANAGRELIDE is prescribed for the treatment of patients with thrombocythemia secondary to myeloproliferative disorders. Thrombocythemia is a condition in which there are too many platelets (the little cells which help the blood to clot) in the blood. Myeloproliferative disorders are diseases in which one or more of the types of cells that make up the blood are being overproduced.
Lowering platelet counts results in improving symptoms, including serious symptoms related to blockages in blood vessels and bleeding.
phl-ANAGRELIDE is intended for long-term usage and has not been evaluated for treatment of the short-term life threatening complications of having too many platelets in the blood.
What it does:
The way that phl-ANAGRELIDE works in the body to reduce your platelet count is not fully understood. phl-ANAGRELIDE is believed to reduce the number of platelets by affecting megakaryocytes (the cells that produce platelets). Its action slows down platelet production.
Although phl-ANAGRELIDE lowers platelet counts to more normal levels, it does not affect the body's natural process to clot blood when needed.
When it should not be used:
You should not take phl-ANAGRELIDE if you:
- Have severe liver disease
Are allergic to anagrelide or any of the other nonmedicinal
ingredients (see What the important nonmedicinal ingredients are:) in phl-ANAGRELIDE or its container.
What the medicinal ingredient is:
anagrelide hydrochloride
What the i nonmedicinal ingredients are:
Crospovidone, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide.
What dosage forms it comes in:
Capsules: 0.5 mg
WARNINGS AND PRECAUTIONS
Before you use phl-ANAGRELIDE talk to your doctor or pharmacist if:
You were born with or have family history of prolonged
QT interval (see on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes in your blood e.g., potassium, magnesium or calcium
| ||
| ||
| ||
phl-ANAGRELIDE is not recommended in women who are or may become pregnant.
Limited data are available in patients under the age of 16 years.
Caution should be used when driving vehicles or machinery.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist about any medication that you are taking, including non-prescription medications and natural health products.
Drugs that may interact with phl-ANAGRELIDE include:
- Medicines that can alter your heart rhythm
- acetylsalicylic acid
- fluvoxamine
- omeprazole
- theophylline
- milrinone
- sucralfate
- CYP1A2 substrates/inhibitors
If phl-ANAGRELIDE is taken in combination with acetylsalicylic acid (ASA), there is an increased risk of major bleeding. Before starting treatment, your doctor will consider for you the potential risks and benefits of concomitant use of anagrelide with ASA. If, for any reason, you already have an increased risk of bleeding, you should talk to your doctor.
ABOUT THIS MEDICATION
Grapefruit juice may also interact with
| phl-ANAGRELIDE |
. Food may slow down the rate at which
| phl-ANAGRELIDE |
is absorbed into your body.
PROPER USE OF THIS MEDICATION
Usual Dose:
Take as directed by your doctor.
Your doctor may check for heart disease before starting you on phl-ANAGRELIDE.
Regular blood tests will be done at the start of your treatment and then at intervals. This will help your doctor monitor the liver’s response phl-ANAGRELIDE and that phl-ANAGRELIDE is working for you. If you have kidney or liver problems, your doctor will monitor their function while you are taking phl-ANAGRELIDE.
Overdose:
Possible symptoms of an overdose of anagrelide could include low platelet count, which can potentially cause bleeding.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose at the beginning of your treatment, contact your doctor or pharmacist.
If you miss a dose during your long-term treatment, take the missed dose as soon as possible, unless it is almost time for your next dose. Skip the missed dose if it is almost time for your next regular dose. Do not take two doses at the same time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects with phl-ANAGRELIDE are:
Abdominal pain, back pain, cough, digestive problems, headache, diarrhea, fatigue, fever, gas, loss of appetite, malaise, nausea, pain, redness and itching of skin, sore throat, tingling, vomiting, whirling sensation.
You may also experience: bruises, chills, constipation, dry mouth, ear problems (ringing in the ear), flushing, flu symptoms, hair loss, infection, infection of the sinuses, insomnia (difficulty falling asleep), muscle and bone pain, neck pain, nervousness, respiratory disease, changes in weight, skin problems sweating.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| Chest pain | ✓ | |||
| Palpitations: Pounding or irregular heartbeat | ✓ | |||
| Edema: Swelling in your feet or ankles | ✓ | |||
| Trouble breathing or shortness of breath (dyspnea) | ✓ | |||
| Bleeding | ✓ | |||
| Blood in your stools or urine | ✓ | |||
| Blood Clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations. | ✓ | |||
| Confusion | ✓ | |||
| Dehydration | ✓ | |||
| Depression: inability to concentrate, low mood | ✓ | |||
| Asma: Difficulty breathing | ✓ | |||
| Difficulty swallowing | ✓ | |||
| Fast or irregular heartbeat | ✓ | |||
Respiratory Infection - (pneumonia or bronchitis): fever, cough, chest pain and shortness of breath | ✓ | |||
| High blood pressure | ✓ | |||
| Irritation or infection of the eye | ✓ | |||
| Loss of consciousness | ✓ | |||
| Loss of memory | ✓ | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom / effect Low blood pressure: lightheaded, dizzy, shortness of breath or fainting; may occur when you go from lying or sitting to standing up) Nose bleeding Heart disease or heart failure: swollen legs or ankles or difficulty breathing Trouble with vision Urinary problems | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
Only if severe | In all cases | |||
| ✓ | ||||
| ✓ | ||||
| ✓ | ||||
| ✓ | ||||
| ✓ | ||||
Ventricular tachycardia: irregular and abnormally fast heart beat. | ✓ | |||
| Allergic lung conditions: coughing, severe trouble breathing, shortness of breath, fever, chills, body aches | ✓ | |||
| Liver disorder: nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark urine and unusual tiredness | ✓ | |||
| Kidney disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | |||
| Torsades de pointes: life-threatening irregular heart rhythm, dizziness, fainting | ✓ | |||
*Frequency of event cannot be determinded from available data. This is not a complete list of side effects. For any unexpected effects while taking phl-ANAGRELIDE, contact your doctor or pharmacist.
HOW TO STORE IT
Store phl-ANAGRELIDE between 15oC and 30oC in a light-resistant container. Protect from moisture. Keep 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 0701E
Ottawa, Ontario
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.
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 obtained by contacting the sponsor, Pharmel Inc. at, 1-888-550-6060.
Pharmel Inc.
Montreal Quebec
H4P 2T4