Danazol polfarmex

Package leaflet: Information for the user

DANAZOL POLFARMEX, 200 mg, tablets
Danazolum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Danazol Polfarmex is and what it is 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 Danazol Polfarmex is and what it is used for
Danazol is a synthetic steroid, a derivative of ethinyltestosterone.
Danazol Polfarmex is indicated for:

• Endometriosis: treatment of symptoms associated with endometriosis and (or) reduction of endometriotic lesions. Danazol Polfarmex may be used in combination with surgical treatment, or as a sole treatment in patients in whom other treatments have been ineffective.
• Fibrocystic breast disease: symptomatic treatment of severe pain and tenderness.

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

2. Important information before taking Danazol Polfarmex
When not to use Danazol Polfarmex

• If you are allergic to danazol or any of the other ingredients of this medicine (listed in section 6),
• Unexplained abnormal vaginal bleeding,
• Severe impairment of liver, kidney, or heart function,
• Porphyria,
• Pregnancy and breastfeeding,
• Current or past history of thrombotic or thromboembolic disorders,
• Androgen-dependent tumors.

Warnings and precautions
Before starting Danazol Polfarmex, discuss with your doctor or pharmacist:
In case of virilization (development of male characteristics), Danazol Polfarmex should be discontinued.
Treatment with Danazol Polfarmex should be stopped if any adverse reactions occur, especially if papilledema, headache, visual disturbances, or other symptoms of increased intracranial pressure, jaundice, or other liver function abnormalities, thrombosis, or thromboembolic events occur.
Long-term use of danazol, together with 17-alpha-alkylated steroids, carries a risk of hepatic adenoma, hepatic peliosis, and liver cancer.
Danazol use may increase the baseline risk of ovarian cancer in patients treated for endometriosis.
Particular caution is required when using this medicine in patients whose condition may worsen due to fluid retention, or in patients with liver, kidney, or cardiovascular disorders.
Danazol Polfarmex should be used cautiously in patients with diabetes, polycythemia, epilepsy, or lipid metabolism disorders.
The medicine should be used with special caution in individuals who have previously experienced symptomatic or permanent virilizing reactions to sex steroid therapy.
Caution is advised in patients with migraine.
Special caution is recommended in patients with current or suspected neoplastic disease. The medicine should be used cautiously in patients whose breast nodules do not regress or increase in size during danazol treatment.
Liver function and hematological status should be monitored in patients taking Danazol Polfarmex.
In long-term treatment (>6 months) or repeated treatment, an ultrasound examination should be performed twice a year.
Danazol therapy should be initiated during menstruation. An effective non-hormonal contraceptive method should be used.
Consult your doctor, even if the above warnings refer to conditions from the past.

Children
Use of Danazol Polfarmex is not recommended in children.

Elderly patients
Use of Danazol Polfarmex is not recommended in elderly patients.

Danazol Polfarmex with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Antiepileptic therapy: Danazol Polfarmex may affect serum carbamazepine levels and may influence the patient's response to danazol and phenytoin.
Similar interactions are expected with phenobarbital.
Antidiabetic therapy: Danazol Polfarmex may cause insulin resistance.
Oral anticoagulant therapy: Danazol Polfarmex may potentiate the effect of warfarin.
Antihypertensive therapy: Due to fluid retention, Danazol Polfarmex may reduce the effectiveness of antihypertensive drugs.
Cyclosporine and tacrolimus: Danazol Polfarmex may increase serum concentrations of cyclosporine and tacrolimus, leading to increased nephrotoxic effects of these drugs.
Steroids: Interactions may occur when Danazol Polfarmex is used with other sex hormones.
Migraine treatment: Danazol Polfarmex may induce migraine attacks and may reduce the effectiveness of antimigraine drugs.
Ethyl alcohol: cases of nausea and shallow breathing have been reported.
Alfacalcidol: Danazol Polfarmex may increase serum calcium levels in primary hypoparathyroidism. Dose reduction of alfacalcidol may be necessary.
Laboratory tests: danazol may interfere with testosterone and plasma protein assays.

Pregnancy and breastfeeding
Danazol must not be used during pregnancy. Danazol use during pregnancy is associated with the risk of fetal virilization (masculinization) of female fetuses. Women of childbearing potential should use an effective non-hormonal contraceptive method. If pregnancy occurs during treatment, the drug should be discontinued immediately.
Use of Danazol Polfarmex should be discontinued during breastfeeding.

Driving and operating machinery
During danazol treatment, symptoms may occur that impair psychophysical performance and the ability to drive or operate machinery.

Danazol Polfarmex contains lactose
This medicine contains lactose; if you have been previously diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine. Each tablet contains 0.034 g of lactose (0.017 g glucose and 0.017 g galactose). This should be taken into account in diabetic patients.

3. How to take Danazol Polfarmex

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral administration.

Adults:
Danazol Polfarmex should be administered continuously. The dose should be adjusted according to the severity of the condition and the patient's response to treatment. The dose may be reduced once a satisfactory response to treatment is achieved. In women of childbearing age, treatment with Danazol Polfarmex should begin on the first day of menstruation to avoid fetal exposure to the drug. If in doubt, pregnancy should be ruled out before starting treatment.
Women of childbearing age should use an effective contraceptive method during treatment with Danazol Polfarmex.

In endometriosis, the recommended dose is 200 mg to 800 mg daily for a treatment duration of 3 to 6 months. The dose should be increased if regular cyclic bleeding persists after 2 months of treatment. Dose escalation (but not exceeding 800 mg daily) may be necessary in severe cases.

In fibrocystic breast disease, treatment should start with a dose of 300 mg daily. Treatment typically lasts 3 to 6 months.

Taking more Danazol Polfarmex than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Available data suggest that even acute overdose does not carry a risk of immediate severe reaction.
In case of acute poisoning, absorption of the drug should be reduced by administering activated charcoal. The patient should be monitored for delayed reactions.

If you forget to take Danazol Polfarmex
If you miss a dose, take the usual recommended dose as soon as you remember. Take the next dose according to your doctor's instructions. Do not take a double dose to make up for a missed dose.

Stopping Danazol Polfarmex
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
If any of the symptoms listed below occur, stop taking the medicine immediately and
contact your doctor or go to the nearest hospital.
Androgenic effects include increased body weight, increased appetite, acne and seborrhoea.
Danazol may also cause hirsutism, hair loss, voice changes which may manifest as hoarseness,
sore throat, vocal instability or voice lowering. Rarely, clitoral enlargement or fluid retention may occur.

Other possible endocrine effects include menstrual disturbances: spotting, changes in cycle length, or absence of menstruation.
Cyclic bleeding and ovulation usually return within 60–90 days after discontinuation of the medicine.
Secondary amenorrhea may sometimes occur.
Facial flushing, vaginal dryness, changes in libido, irritation, and breast reduction may result from decreased estrogen levels.
In males, danazol may cause disturbances in spermatogenesis.

Metabolism and nutrition disorders: in patients with diabetes, insulin resistance may increase.
In non-diabetic patients, symptomatic hypoglycaemia has also been reported, associated with increased plasma glucagon concentration.
In addition to increased plasma insulin concentration, danazol may also cause mild impairment of glucose tolerance.
Increased activity of aminolevulinic acid synthetase (ALA) has also been observed, along with decreased concentration of T4-binding globulin and increased T3 binding, occurring without disturbances in thyroid hormone secretion. Free levothyroxine concentration remains unchanged.

Skin and subcutaneous tissue disorders: rash (maculopapular, petechial, erythematous, or urticarial, which may be accompanied by facial oedema). This may be associated with fever. Rare cases of photosensitivity have been reported. Erythematous inflammatory nodules, skin pigmentation changes, exfoliative dermatitis, and erythema multiforme have also been observed.

Musculoskeletal and connective tissue disorders: back pain, muscle cramps (which may be severe), muscle twitching, fasciculations, 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, sagittal sinus thrombosis, cerebral vessel and arterial thrombosis.

Eye disorders: blurred vision, difficulty 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, purpura. Danazol may cause reversible erythromelalgia.

Hepatobiliary disorders: sporadic increases in plasma aminotransferase activity, rarely cholestatic jaundice and hepatic adenomas. In patients treated long-term, hepatic peliosis and malignant liver tumours have been reported very rarely.

Nervous system disorders: carpal tunnel syndrome (sporadically), which may be caused by fluid retention, migraine, benign intracranial hypertension. Danazol may exacerbate symptoms of epilepsy and increase the risk of seizures in predisposed individuals.

Psychiatric disorders: emotional lability, anxiety, depression, nervousness, dizziness, nausea, headache, fatigue.

Renal and urinary disorders: haematuria (rarely) in patients with hereditary angioedema receiving long-term treatment.

Investigations: in women taking Danazol Polfarmex, transient changes in lipoprotein levels have been observed: increased LDL cholesterol, decreased HDL cholesterol, effects on all subfractions, decreased apolipoprotein A-I and A-II.

Respiratory, thoracic and mediastinal disorders: interstitial pneumonitis, chest pain.

Gastrointestinal disorders: epigastric pain, pancreatitis.

If any other adverse effects not listed in this leaflet occur, inform your doctor.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Danazol Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Danazol Polfarmex contains

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

What Danazol Polfarmex looks like and contents of the pack
Danazol Polfarmex is in the form of tablets. The package contains 100 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
Ul. Józefów 9
99-300 Kutno
Tel. (24) 357 44 44