Patient Medication Information: uses, side effects, how to take - PMS-Anagrelide
Serious Warnings and Precautions
The following serious problems have been reported in people taking pms-ANAGRELIDE:
If you have any of the symptoms listed above while you are taking pms-ANAGRELIDE tell your healthcare professional immediately.
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What is pms-ANAGRELIDE used for?
- pms-ANAGRELIDE is used in patients 16 years of age and older with thrombocythemia caused by myeloproliferative neoplasms. Thrombocythemia is a condition in which there are too many platelets (the little cells which help the blood to clot) in the blood. Myeloproliferative neoplasms are diseases in which one or more of the types of cells that make up the blood are being overproduced.
- Lowering platelet counts improves symptoms, including serious symptoms related to blockages in blood vessels and bleeding.
How does pms-ANAGRELIDE work?
The way that pms-ANAGRELIDE works in the body to reduce your platelet count is not fully understood. pms-ANAGRELIDE is believed to reduce the number of platelets by affecting megakaryocytes (the cells that produce platelets). Its action slows down platelet production.
Although pms-ANAGRELIDE lowers platelet counts to more normal levels, it does not affect the body's natural process to clot blood when needed.
What are the ingredients in pms-ANAGRELIDE?
Medicinal ingredients: anagrelide hydrochloride monohydrate
Non-medicinal ingredients: Crospovidone, Lactose, Magnesium Stearate, Microcrystalline Cellulose and Povidone. Capsule shells contain Gelatin, Silicon Dioxide, Sodium Lauryl Sulfate, and Titanium Dioxide
pms-ANAGRELIDE comes in the following dosage forms:
Capsule; 0.5 mg
Do not use pms-ANAGRELIDE if you:
- have severe liver disease
- are allergic to anagrelide or any of the other non-medicinal ingredients (see What are the ingredients in pms-ANAGRELIDE?) in pms-ANAGRELIDE or its container.
have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
because lactose is a non-medicinal ingredient in pms-ANAGRELIDE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-ANAGRELIDE. Talk about any health conditions or problems you may have, including if you:
- were born with or have family history of prolonged QT interval (seen 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)
- have heart, lung, liver or kidney disease
- are pregnant or planning a pregnancy
- are breastfeeding
Other warnings you should know about:
pms-ANAGRELIDE and ASA: Use of anagrelide hydrochloride with acetylsalicylic acid (ASA) has been associated with a risk of major bleeding events. Tell your healthcare professional if you are taking ASA. Also tell your healthcare professional if you have an increased risk of bleeding. Before starting treatment, your healthcare professional will consider the potential risks and benefits of using pms-ANAGRELIDE with ASA.
Risk of Stroke: Stopping or reducing your dose of pms-ANAGRELIDE suddenly can cause serious problems including stroke. If you have stopped taking pms-ANAGRELIDE or reduced your dose and have any of the following symptoms, get immediate medical help: sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty in walking or loss of balance or coordination; suddenly feeling dizzy or sudden severe headache with no known cause.
Pregnancy and Breastfeeding:
- pms-ANAGRELIDE is not recommended in women who are or may become pregnant.
- pms-ANAGRELIDE can harm your unborn baby. You should not get pregnant while you are taking pms-ANAGRELIDE. Your healthcare professional will do a test to make sure you are not pregnant before you start taking pms-ANAGRELIDE.
- You must use an effective form of birth control while you are taking pms-ANAGRELIDE. If you think you might be pregnant tell your healthcare professional immediately.
- Talk to your healthcare professional if you are breastfeeding or planning to breastfeed. You should not breastfeed while you are taking pms-ANAGRELIDE as it can cause serious side effects in your baby.
Blood Tests: pms-ANAGRELIDE can cause abnormal blood tests results. Your healthcare professional will do blood tests before you start treatment and while you are taking pms-ANAGRELIDE to closely monitor your platelet levels and to see how well your liver and kidneys are working.
Driving and Using Machines: Caution should be used when driving vehicles or machinery.
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 pms-ANAGRELIDE:
- medicines that can alter your heart rhythm
- acetylsalicylic acid (ASA), used for pain and fever
- fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used to treat depression
- ciprofloxacin, an antibiotic used to treat bacterial infections
- omeprazole, used to treat stomach problems such as ulcers and acid reflux
- theophylline, used to treat breathing problems such as COPD and asthma
- milrinone, used to treat heart failure
- sucralfate, used to treat ulcers
Grapefruit juice may also interact with pms-ANAGRELIDE.
How to take pms-ANAGRELIDE:
- Take as directed by your healthcare professional.
- To avoid experiencing serious side effects, do not stop taking pms-ANAGRELIDE or change the dose without talking to your healthcare professional first.
Usual dose (16 years of age and older):
Starting dose: 2 mg daily, taken as either 0.5 mg 4 times a day or 1 mg twice a day. Your healthcare professional will slowly increase your dose until the right dose is found.
Overdose:
| If you think you, or a person you are caring for, have taken too much pms-ANAGRELIDE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Possible symptoms of an overdose of pms-ANAGRELIDE could include low levels of platelets in your blood, which can cause bleeding and low blood pressure.
Missed Dose:
If you miss a dose at the beginning of your treatment, tell your healthcare professional.
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.
What are possible side effects from using pms-ANAGRELIDE?
These are not all the possible side effects you may have when taking pms-ANAGRELIDE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
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, dizziness.
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 (trouble sleeping), muscle and bone pain, neck pain, nervousness, breathing problems, changes in weight, skin problems, sweating.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| VERY COMMON | ||||||
| Chest pain | ✓ | |||||
Palpitations: pounding or irregular heartbeat | ✓ | |||||
| Edema: swelling in your feet or ankles | ✓ | |||||
| Trouble breathing or shortness of breath | ✓ | |||||
| COMMON | ||||||
| Bleeding | ✓ | |||||
| Blood in your stools or urine | ✓ | |||||
| Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch, sudden chest pain, difficulty breathing, heart palpitations | ✓ | ||
|---|---|---|---|
| Confusion | ✓ | ||
| Dehydration | ✓ | ||
| Depression: inability to concentrate, low mood | ✓ | ||
| Asthma: difficulty breathing | ✓ | ||
| Difficulty swallowing | ✓ | ||
| Fast or irregular heartbeat | ✓ | ||
| Respiratory infection (pneumonia or bronchitis): fever, cough, chest pain, shortness of breath | ✓ | ||
| High blood pressure | ✓ | ||
Hypoesthesia: decreased or loss of feeling or sensation such as numbness | ✓ | ||
| Irritation or infection of the eye | ✓ | ||
| Loss of consciousness | ✓ | ||
| Loss of memory | ✓ | ||
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 | ✓ | ||
| RARE | |||
| Supraventricular tachycardia, Ventricular tachycardia : irregular and abnormally fast heartbeat | ✓ | ||
| Pulmonary hypertension: shortness of breath, swelling in legs or ankles or lips, skin can turn bluish colour | ✓ | ||
| FREQUENCY NOT KNOWN | |||
Allergic lung conditions: coughing, severe trouble | ✓ | ||
| breathing, shortness of breath, fever, chills, body aches | |||
| Liver problems: nausea, vomiting, loss | ✓ |
| of appetite, yellowing of the skin or eyes, dark urine, unusual tiredness | |||
|---|---|---|---|
| Kidney problems: decreased urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | ||
Torsades de pointes (life- threatening irregular heart rhythm): dizziness, fainting, heart palpitations, chest pain, rapid heartbeat, shortness of breath, cold sweats, nausea | ✓ | ||
| Prinzmetal angina: painful spasm of the blood vessels on the heart (while resting, usually at night or early morning) | ✓ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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.
Storage:
Store pms-ANAGRELIDE between 15oC and 30oC in a light-resistant container. Protect from moisture.
Keep out of reach and sight of children.
If you want more information about pms-ANAGRELIDE:
- 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), or by contacting the sponsor Pharmascience Inc. at: 1-888-550-6060.