OXYDROL 50
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What OXYDROL 50 is and what it is used for
2. What you need to know before you use OXYDROL 50
3. How to use OXYDROL 50
4. Possible side effects
5. How to store OXYDROL 50
6. Contents of the pack and other information
1. WHAT OXYDROL 50 IS AND WHAT IT IS USED FOR
Oxymetholone is an orally-effective anabolic steroid. Anabolic steroids are synthetic derivatives of testosterone. Nitrogen balance is improved with anabolic agents but only when there is sufficient intake of calories and proteins. Oxymetholone increases the production and urinary excretion of erythropoietin in patients with anemias due to bone marrow failure and often stimulates erythropoiesis in anemias due to deficient red cell production.
Anabolic steroid: Reverses catabolic processes and negative nitrogen balance by promoting protein anabolism and stimulating appetite if there is concurrently a proper intake of calories and proteins.
Antianemic: Anemias due to bone marrow failure: Increases production and urinary excretion of erythropoietin.
Anemias due to deficient red cell production: Stimulates erythropoietin production and may have a direct action on bone marrow. Anemias associated with renal disease: Increases hemoglobin and red blood cell volume.
Anqioedema (hereditary) - prophylactic: increases serum concentration of C1 esterase inhibitor and, as a result, C2 and G4 concentrations.
OXYDROL 50 is prescibed in the treatment of anemias caused by deficient red cell production. Acquired and congenital aplastic anemias, myelofibrosis and hypoplastic anemias due to the administration of myelotoxic drugs often respond to oxymetholone also used in prophylaxis and treatment of hereditary angioedema.
OXYDROL 50 tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid vitamin B12 or pyridoxine deficiency antibacterial therapy and the appropriate use of corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXYDROL 50
DO NOT USE OXYDROL 50:
• If you are allergic (hypersensitive) to any of the ingredients of this medicine
• Do not use if the above applies to you. If you are not sure do not use this medicine. Talk to your doctor, nurse or pharmacist before using OXYDROL 50.
3. HOW TO USE OXYDROL 50
OXYDROL 50 should be used for a minimum of 3 to 6 months, since a response is not always immediately observed.
Following remission of the anemia, some patients may be maintained without oxymetholone while others may be maintained on a low daily dose. Patients with congenital aplastic anemia usually require continued therapy with an appropriate maintenance dose.
Usual adult and adolescent dose: Oral 1 to 5 mg per kg of body weight per day
Note: The usual effective dose is 1 to 2 mg per kg of body weight a day, but higher doses may be required in some patients, and the dose should be individualized. Treatment of refractory anemias may require 3 to 6 months.
Children: Use of anabolic steroids in children is accompanied by the serious risk of interrupting normal growth.
IF YOU FORGET TO USE OXYDROL 50:
• If you forget to take OXYDROL 50, take it as soon as you remember.
• Do not use a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Cholestatic jaundice with, rarely, hepatic necrosis and death.
• Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy.
• Inhibition of testicular function;
• Testicular atrophy;
• Oligospermia (decrease in sperm count);
• Impotence;
• Gyanecomastia;
Bladder irritability and decrease in seminal volume, male-pattern of hair loss.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse. This include any possible side effects not listed in this leaflet.
5. HOW TO STORE OXYDROL 50
• Keep out of the reach and sight of children.
• Store in a cool dry place at controlled room temperature 15°-25°C (59°-77°F).
• Protect from moisture, freezing and excessive heat.
• Do not transfer the tablets to another container.
• Do not use this product after the expiry date that is stated in the outer package. The expiry date refers to the last day of the month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT OXYDROL 50 CONTAINS
• OXYDROL 50 consists of 50mg Oxymetholone as active ingredient in each tablet.
OXYDROL 50 package contains 50 tablets.