Patient Medication Information: uses, side effects, how to take - Tapazole (Paladin Pharma)
What is Tapazole used for?
Tapazole is used in adults:
- to treat hyperthyroidism (overactive thyroid gland).
- to treat and prepare for thyroidectomy (removal of the thyroid gland) or for radioactive iodine treatment.
- when the overactive thyroid gland cannot be removed.
How does Tapazole work?
Tapazole is a type of medication called antithyroid agents. It works by stopping the thyroid gland from making thyroid hormones.
What are the ingredients in Tapazole?
Medicinal ingredient: Methimazole
Non-medicinal ingredients: Corn starch, lactose monohydrate, magnesium stearate, and talc.
Tapazole comes in the following dosage forms:
Tablets: 5 mg, 10 mg, and 20 mg
Do not use Tapazole if:
- you are allergic to methimazole or any of the ingredients in Tapazole.
- you are breastfeeding. Tapazole can be transferred into your breast milk.
- you have or have had problems with your pancreas after taking methimazole.
Serious Warnings and Precautions
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects. |
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To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tapazole. Talk about any health conditions or problems you may have, including if you:
- have a low white blood cell count.
- have joint pain.
- have liver problems.
- have skin problems.
- are intolerant to some sugars (e.g., lactose, a milk sugar which is a component of Tapazole).
- have a large goitre (swelling in the front neck), the goitre may grow during treatment making it difficult to breath.
- are taking medications that are known to cause agranulocytosis (decrease in white blood cell count).
Other warnings you should know about:
Tapazole can cause the following:
- Arthralgia (joint pain): The development of arthralgia may indicate severe transient migratory polyarthritis also known as antithyroid arthritis syndrome (pain that spreads from one joint to another). Your healthcare professional will stop your treatment if this occurs.
- Acute pancreatitis (inflammation of the pancreas): Methimazole therapy has been reported to cause acute pancreatitis. If you notice any signs and symptoms of acute pancreatitis, your healthcare professional will immediately stop your treatment with Tapazole.
- Exfoliative dermatitis (severe inflammation of the entire skin surface): Tell your healthcare professional right away if you notice signs of exfoliative dermatitis such as redness or peeling of the skin over large areas of your body. Your treatment with Tapazole should be stopped.
- Vasculitis (inflammation and narrowing of blood vessels): This can cause long-term organ damage or even be life-threatening. Tell your healthcare professional if you notice or develop any symptoms of vasculitis. They will stop your treatment and may initiate an appropriate intervention.
Other blood problems: Methimazole therapy can cause:
- leukopenia (low white blood cells),
- thrombocytopenia (low blood platelets), and
- aplastic anemia (when cells meant to develop into mature blood cells are damaged).
Your healthcare professional may monitor your health (including your bone marrow function) and may stop your treatment if this occurs.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Pregnancy:
- If you are able to get pregnant or think you are pregnant, there are specific risks you must discuss with your healthcare professional.
- Treatment with Tapazole may harm your unborn baby, especially in the first trimester of pregnancy. Your healthcare professional will decide if taking Tapazole is right for you and your baby.
- You should use effective methods of birth control during your treatment.
- If you become pregnant or think you are pregnant while taking Tapazole, tell your healthcare professional right away.
Check-ups and testing: Your healthcare professional will monitor your health before and during your treatment. This may including having regular blood tests. This will tell your healthcare professional how Tapazole is affecting you.
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 Tapazole:
- medicines known as anticoagulants (blood thinners) such as warfarin.
How to take Tapazole:
- Take Tapazole exactly as prescribed by your doctor.
- Tapazole is usually taken orally three times a day (every 8 hours).
Usual Dose:
The initial dose is 15 mg to 60 mg per day depending on your condition. The maintenance dose is 5 mg to 15 mg per day.
Overdose:
If you take too many Tapazole tablets, you may experience:
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| If you think you, or a person you are caring for, have taken too much Tapazole, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
Talk to your healthcare professional if you miss one of your scheduled doses of Tapazole. You should not take a double dose to make up for a forgotten dose. Take your next scheduled dose as usual.
What are possible side effects from using Tapazole?
These are not all the possible side effects you may have when taking Tapazole. If you experience any side effects not listed here, tell your healthcare professional.
Some common side effects include:
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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 | ||
| UNCOMMON | |||
| Agranulocytosis (decrease in white blood cell count): frequent infection with fever, chills, sore throat. | ✓ | ||
| Liver problems (including hepatitis): abdominal pain, yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea, vomiting, unusual dark urine, unusual tiredness. | ✓ | ||
| RARE | |||
| Aplastic anemia (when cells meant to develop into mature blood cells are damaged): fatigue, weakness, pale skin, fevers, frequent infection, tendency to bruise and bleed easily. | ✓ | ||
| Drug fever: fever greater than 40.5°C (105˚F). | ✓ | ||
| Nephritis (inflammation of the kidney): decreased appetite, difficulty breathing, fatigue, frequent urination, itchiness, nausea, vomiting. | ✓ | ||
| VERY RARE | |||
| Vasculitis (inflammation of blood vessels): fever, headache, fatigue, weight loss, night sweats, rash, blood in urine, coughing up blood, shortness of breath. | ✓ | ||
| UNKNOWN | |||
| Insulin autoimmune syndrome (an immune response against your body’s own cells that causes low blood sugar): numbness in the extremities, low levels of blood sugar. | ✓ | ||
| Lupus-like syndrome (when your body’s immune system attacks your own tissues and organs, including your joints, skin, kidneys, blood cells, heart and lungs): fatigue, fever, joint pain, stiffness and swelling, rash on the face that covers the cheeks and the bridge of the nose or rashes elsewhere on the body, skin lesions, shortness of breath, chest pain, dry eyes, headaches, confusion, memory loss. | ✓ | ||
| Acute pancreatitis (inflammation of the pancreas): upper abdominal pain, severe stomach pain that last and gets worse when | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
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| Only if severe | In all cases | ||
|---|---|---|---|
| you lie down, rapid heart beat, fever, nausea, vomiting. | |||
| Hypoprothrombinemia (abnormally low levels of prothrombin, used for blood-clotting): bleeding problems, easy bruising. | ✓ | ||
| Periarteritis (inflammation of the tissue surrounding an artery): pain in the muscles and joints. | ✓ | ||
| Arthralgia (joint pain). | ✓ | ||
| Exfoliative dermatitis (severe inflammation of the entire skin surface): redness or peeling of the skin over large areas of your body. | ✓ | ||
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:
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. Keep the bottle tightly closed.
Keep out of reach and sight of children.
If you want more information about Tapazole:
- 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 www.paladinlabs.com, or by calling 1-888-867-7426.