Details for: MYLAN-HYDROXYUREA
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02242920 | MYLAN-HYDROXYUREA | HYDROXYUREA | 500 MG | CAPSULE | 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
Mylan-Hydroxyurea (hydroxyurea) is used to treat cancer of the head and neck (excluding the lips) in combination with radiation, as well as cancer of the skin and a type of blood cancer (resistant chronic myelocytic leukemia)
What it does
Mylan-Hydroxyurea seems to interfere with the growth of cancer cells by preventing them from dividing.
When it should not be used
Mylan-Hydroxyurea should not be used if:
- you have problems with your bone marrow (low blood count e.g. severe anemia)
- you are sensitive/allergic to hydroxyurea or any other component of this medication (See “What the important nonmedicinal ingredients are” in this leaflet). Tell your doctor if you think you have had an allergic reaction to any of these ingredients.
What the medicinal ingredient is
Hydroxyurea.
What the non-medicinal ingredients are
Colloidal silicon dioxide, magnesium stearate, D & C Red #28, FD & C Blue #1, FD & C Red #40, D & C Yellow # 10, titanium dioxide, gelatin, black SW-9008/SW-9009.
What dosage form it comes in
Mylan-Hydroxyurea is available in capsules containing 500 mg hydroxyurea.
Warnings and precautions
BEFORE you use Mylan-Hydroxyurea talk to your doctor or pharmacist if:
- you have problems with your kidney because the dose of Mylan-Hydroxyurea may need to be adjusted
- you are breast feeding. Mylan-Hydroxyurea can pass into your breast milk and harm your baby. Do not breast-feed if you are taking Mylan-Hydroxyurea.
- you have problems with low blood count or anemia
- you have received radiation therapy as this may increase your chances of developing redness of the skin if Mylan-Hydroxyurea is used with radiation treatment.
- you are pregnant or planning on becoming pregnant. Mylan-Hydroxyurea can harm the fetus when given to a pregnant woman. Women should avoid becoming pregnant while undergoing treatment with Mylan-Hydroxyurea.
- you are a male contemplating conception. Mylan-Hydroxyurea may cause an absence or low amount of sperm in the semen (sometimes these events are reversible) and damage DNA in your sperm. Therefore you should seek advice on sperm conservation prior to treatment with Mylan-Hydroxyurea and use safe contraceptive measures during and at least 1 year after therapy ends.
- you have HIV/AIDS and are receiving treatment as this can increase your chances of developing pancreatitis (inflammation of the pancreas) and liver problems.
- you recently received a vaccination or are scheduled for any vaccination. Patients taking Mylan-Hydroxyurea should not receive live vaccines.
- you are receiving treatment with interferon. Inflammation of the blood vessels of the skin, sometimes leading to formation of ulcers or death of the blood vessels has been reported mostly in patients who have received or are currently receiving interferon treatment.
Interactions with this medication
Make sure you talk to your doctor about any other conditions you may have and all other medications you are taking, including prescription, non-prescription and herbal and/or natural products.
Concurrent use of hydroxyurea and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression or other adverse events.
Proper use of this medication
While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.
Usual dose
The dose of Mylan-Hydroxyurea will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, your weight, and whether or not other medicines are also being taken. Follow your doctor’s orders.
Depending on your condition, the usual dose could be 80 mg/kg, or 20-30 mg/kg given orally. The dose and frequency will vary with your disease. Please follow your doctor’s orders.
Overdose
Missed Dose
It you miss a dose of this medicine check with your doctor.
Side effects and what to do about them
Along with their needed effects, medicines like hydroxyurea can sometimes cause unwanted effects such as blood problems and other side effects.
The following information describes the most important side effects of which you should be aware. It is not a comprehensive list of all side effects. You should report any unusual symptoms to your doctor.
Check with your doctor if any of the following side effects occur:
- Inflammation in or around the mouth
- Loss of appetite.
- High fevers (≥40 degrees Celsius)
- Nausea and vomiting.
- Diarrhea and constipation.
- Inflammation of the blood vessels of the skin, sometimes leading to formation of ulcers or death of the blood vessels has been reported mostly in patients who have received or are currently receiving interferon treatment.
- Rash, redness and ulceration in the face, skin or extremities. Any skin or nail changes.
Discontinue medication and check with your doctor if any of the following side effects occur:
- Lack of urination, severe muscle weakness, abnormal heart beat, and seizures (symptoms of tumour lysis syndrome)
- Yellowing of skin and eyes, feeling tired, stomach ache, nausea, diarrhea, no appetite, fever, headaches (symptoms of Hepatitis)
- Clay-colored or white stools, dark urine, inability to digest certain foods, itching, nausea or vomiting, pain in the right upper part of the abdomen, yellow skin or eyes (symptoms of cholestasis)
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Common | |||
| Mouth sores (inflammation in or around the mouth) | ✔ | ||
| Nausea and vomiting | ✔ | ||
| Diarrhea and constipation | ✔ | ||
| Dark urine, Clay colored or white stools, itchiness, inability to digest certain foods, pain in right upper part of the abdomen | ✔ | ||
| Yellowing of the skin and eyes, feeling tired, stomach ache, fever | ✔ | ||
| Uncommon | |||
| Loss of appetite | ✔ | ||
| Drowsiness, headache and dizziness | ✔ | ||
| Disorientation, hallucinations, and convulsions | ✔ | ||
| Rare | |||
| Lack of urination, and seizures | ✔ | ||
| Skin redness, sores, and/or ulcers if you have been or, are currently being, treated with interferon. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Mylan-Hydroxyurea, contact your doctor or pharmacist.
How to store
Mylan-Hydroxyurea should be stored at room temperature (15°C – 30˚C). Protect from excessive heat and moisture.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and
sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
More information
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
This leaflet was prepared by Mylan Pharmaceuticals ULC Etobicoke, Ontario M8Z 2S6
Revised on: November 28, 2017
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca