Danazol Polfarmex

Package Leaflet: Information for the User

DANAZOL POLFARMEX, 200 mg, tablets

Danazolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Danazol Polfarmex and what is it used for
• 2. Important information before taking Danazol Polfarmex
• 3. How to take Danazol Polfarmex
• 4. Possible side effects
• 5. How to store Danazol Polfarmex
• 6. Contents of the pack and other information

1. What is Danazol Polfarmex and what is it used for

Danazol is a synthetic steroid, a derivative of ethinyltestosterone.
Danazol Polfarmex is indicated for use in:

• endometriosis: treatment of symptoms associated with endometriosis and/or reduction of endometriosis foci. Danazol Polfarmex may be used in combination with surgical treatment, as well as a single drug, in patients for whom other treatments are ineffective.
• fibrocystic breast disease: symptomatic treatment of severe pain and compressive tenderness.

Danazol Polfarmex should only be used in patients for whom other treatments have been ineffective or are contraindicated.

2. Important information before taking Danazol Polfarmex

When not to take Danazol Polfarmex

• if you are allergic to danazol or any of the other ingredients of this medicine (listed in section 6),
• abnormal vaginal bleeding of unknown cause,
• severe liver, kidney, or heart dysfunction,
• porphyria,
• pregnancy and breastfeeding,
• thrombotic or thromboembolic disorders, currently or in history
• hormone-dependent tumors.

Warnings and precautions

Before starting treatment with Danazol Polfarmex, discuss it with your doctor or pharmacist:
In case of virilization (appearance of male characteristics), Danazol Polfarmex should be discontinued.
Treatment with Danazol Polfarmex should be stopped if any adverse reactions occur, especially if papilledema, headache, vision disturbances, or other symptoms of increased intracranial pressure, jaundice, or other liver function disorders, thrombosis, or thromboembolic disorders occur.
Long-term use of danazol with 17-alkylated steroids carries a risk of liver peliosis, liver hemangioma, and liver cancer.
Danazol may increase the basic risk of ovarian cancer in patients treated for endometriosis.
Particular caution should be exercised when using the drug in patients whose condition may worsen due to fluid retention, with liver, kidney, and cardiovascular disorders.
Danazol Polfarmex should be used with caution in patients with diabetes, erythremia, epilepsy, and lipid metabolism disorders.
The drug should be used with particular caution in patients who have had symptomatic or persistent virilizing reactions in response to previous treatment with sex steroids.
Caution should be exercised in patients with migraine.
Particular caution is recommended in patients with current or suspected cancer. The drug should be used with caution in patients with breast nodules that do not regress or increase during danazol treatment.
In patients taking Danazol Polfarmex, liver function and hematological status should be monitored.
In long-term studies (> 6 months) or repeated treatment, it is recommended to perform ultrasound examination twice a year.
Danazol therapy should be started during menstruation. Effective non-hormonal contraception should be used.
You should consult a doctor, even if the above warnings relate to situations that have occurred in the past.

Children

Danazol Polfarmex is not recommended for use in children.

Elderly

Danazol Polfarmex is not recommended for use in elderly patients.

Danazol Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Anticonvulsant therapy: Danazol Polfarmex may affect carbamazepine serum levels and affect the patient's reaction to danazol and phenytoin.
Similar interactions are expected with phenobarbital.
Antidiabetic therapy: Danazol Polfarmex may cause insulin resistance.
Oral anticoagulant therapy: Danazol Polfarmex may enhance the effect of warfarin.
Antihypertensive therapy: Probably due to fluid retention, Danazol Polfarmex may weaken the effect of antihypertensive drugs.
Cyclosporine and tacrolimus: Danazol Polfarmex may increase cyclosporine and tacrolimus serum levels, causing an increase in the toxic effect of these drugs on the kidneys.
Steroids: Interaction may occur when using Danazol Polfarmex with other sex hormones.
Migraine treatment: Danazol Polfarmex may cause migraine and may weaken the effect of antimigraine drugs.
Ethyl alcohol: cases of nausea and shallow breathing have been reported.
Alfacalcidol - Danazol Polfarmex may cause an increase in serum calcium levels in primary hypoparathyroidism. It is then necessary to reduce the dose of the drug.
Laboratory tests: danazol may falsify the results of testosterone and serum protein tests.

Pregnancy and breastfeeding

Danazol should not be used during pregnancy. The use of danazol during pregnancy is associated with the risk of virilization (masculinization) of female fetuses. Women of childbearing age should use effective non-hormonal contraception. If a patient becomes pregnant during treatment, the drug should be discontinued immediately.
The use of Danazol Polfarmex should be stopped during breastfeeding.

Driving and using machines

During danazol treatment, symptoms may occur that limit psychophysical fitness and the ability to drive vehicles.

Danazol Polfarmex contains lactose

The drug contains lactose; if the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the drug. The drug contains 0.034 g of lactose (0.017 g of glucose and 0.017 g of galactose) per tablet. This should be taken into account in patients with diabetes.

3. How to take Danazol Polfarmex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Oral administration.

Adults:

Danazol Polfarmex should be administered continuously. The dose should be adjusted according to the severity of the case and the patient's response to treatment. Dose reduction is possible when a satisfactory response to treatment is achieved. In women of childbearing age, administration of Danazol Polfarmex should start on the first day of menstruation to avoid exposing the fetus to the drug. If there are doubts, it should be checked whether the woman is pregnant before starting treatment. Women of childbearing age should use effective non-hormonal contraception during treatment with Danazol Polfarmex.
In endometriosis, the recommended dose is 200 mg to 800 mg per day for a treatment period of 3 to 6 months. The dose should be increased if normal cyclical bleeding persists after 2 months of treatment. Dose increase (but not more than 800 mg per day) may be necessary in severe cases.
In fibrocystic breast disease, treatment should be started with a dose of 300 mg per day. Treatment usually lasts from 3 to 6 months.

Taking a higher dose of Danazol Polfarmex than recommended

If you have taken more than the recommended dose of the drug, contact your doctor or pharmacist immediately.
Available studies suggest that even acute overdose does not carry the risk of an immediate severe reaction.
In case of acute poisoning, the absorption of the drug should be reduced by administering activated carbon. The patient should be under observation in case of delayed reactions.

Missing a dose of Danazol Polfarmex

If you miss a dose, take the normal recommended dose as soon as you remember. The next dose is taken as directed by your doctor. Do not take a double dose to make up for the missed dose.

Stopping treatment with Danazol Polfarmex

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking the medicine immediately and inform your doctor or go to the nearest hospital.

Androgenic effects include weight gain, increased appetite, acne, and seborrhea. Danazol may also cause hirsutism, hair loss, voice changes, which may manifest as hoarseness, sore throat, instability, or lowering of the voice. Rarely, it may lead to clitoral hypertrophy or fluid retention.
Other possible endocrine interactions include menstrual disorders: spotting, change in cycle length, amenorrhea. Cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of the drug. Sometimes, secondary amenorrhea occurs.
Flushing, vaginal dryness, changes in libido, irritation, and breast reduction may be caused by decreased estrogen levels. In men, danazol may cause disturbances in spermatogenesis.
Metabolism and nutrition disorders:in patients with diabetes, insulin resistance may increase.
In non-diabetic patients, symptomatic hypoglycemia has also been reported, which manifested as an increase in glucagon serum levels. In addition to increased insulin levels in the serum, danazol may also cause mild impairment of glucose tolerance.
It has also been observed that there is an increase in the activity of aminolevulinic acid synthetase (ALA), a decrease in T4-binding globulin levels with a simultaneous increase in T3 binding, which occurs without disorders in thyroid hormone secretion. The level of free thyroxine remains unchanged.
Skin and subcutaneous tissue disorders: rash (papular, maculopapular, purpuric, erythematous, or urticaria-like, which may occur with facial edema). It may be accompanied by fever. Rare cases of sun sensitivity have been reported. There have also been reports of erythematous nodules, changes in skin pigmentation, exfoliative dermatitis, and erythema multiforme.
Musculoskeletal and connective tissue disorders:back pain, muscle spasms (which can be severe), muscle tremors, muscle twitching, limb pain, and joint pain and swelling. Danazol may also lead to increased creatine kinase activity.
Cardiac disorders: palpitations, tachycardia, myocardial infarction.
Vascular disorders:hypertension, thrombosis of the sagittal sinus, cerebral vessels, arteries.
Eye disorders:blurred vision, problems with focusing, intolerance to contact lenses, refractive errors requiring correction.
Blood and lymphatic system disorders: increased red blood cell count and platelet count, eosinophilia, leukopenia, thrombocytopenia, petechiae. Danazol may cause reversible erythrocytosis.
Liver and bile duct disorders:occasional increase in serum aminotransferase activity, rarely - cholestatic jaundice, liver hemangioma. In patients taking the drug long-term, very rare cases of liver peliosis and liver cancer have been reported.
Nervous system disorders:carpal tunnel syndrome (rarely), which may be caused by fluid retention, migraine, mild intracranial hypertension. Danazol may exacerbate epilepsy symptoms and increase the risk of epilepsy in predisposed individuals.
Psychiatric disorders: emotional instability, anxiety, depression, nervousness, dizziness, nausea, headaches, fatigue.
Renal and urinary disorders:hematuria (rarely) in patients with hereditary angioedema who have been taking the drug for a long time.
Diagnostic tests:in women taking Danazol Polfarmex, transient changes in lipoprotein levels have been observed: increased LDL cholesterol levels, decreased HDL cholesterol levels, effect on all subfractions, decrease in apolipoproteins Al and AII.
Respiratory, thoracic, and mediastinal disorders:interstitial lung disease, chest pain.
Gastrointestinal disorders: abdominal pain, pancreatitis.
If you experience any other side effects not mentioned in this leaflet, please inform your doctor.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Danazol Polfarmex

Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the packaging.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Danazol Polfarmex contains

• The active substance of the drug is danazol. One tablet contains 200 mg of danazol.
• Excipients: potato starch, lactose monohydrate, polysorbate 80, povidone, colloidal silica, talc, magnesium stearate.

What Danazol Polfarmex looks like and contents of the pack

Danazol Polfarmex is in the form of tablets. The pack contains 100 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Phone: (24) 357 44 44

Date of last revision of the leaflet: