DANATROL 200 mg Hard Capsules

Зміст інструкції

1. Danatrol 50 mg hard capsules, 200 mg hard capsules
   1. What is Danatrol and what it is used for
   2. What you need to know before taking Danatrol
   3. How to take Danatrol
   4. Possible side effects
   5. How to store Danatrol
   6. Contents of the pack and other information

Danatrol 50 mg hard capsules, 200 mg hard capsules

danazol
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Danatrol is and what it is used for
• 2. What you need to know before you take Danatrol
• 3. How to take Danatrol
• 4. Possible side effects
• 5. How to store Danatrol
• 6. Contents of the pack and other information

1. What is Danatrol and what it is used for

Danatrol contains danazol, which belongs to a class of medicines called “Antigonadotropins
(inhibitor of pituitary gonadotropin releasing hormone)”.
Danatrol is indicated for:

• the treatment of disorders and/or the reduction of the extent of a disease affecting the lining of the uterus called “endometriosis”. Danatrol can be used both in association with surgery and as sole hormonal therapy, in patients who do not respond to other treatments;
• reducing the discomfort and pain of a breast disease called “fibrocystic mastopathy”. Danatrol should only be used in patients who do not respond to other treatments or for whom other therapies are not recommended;
• a disease characterized by swelling of the face, throat, limbs, with possible difficulty breathing, called “hereditary angioedema”.

2. What you need to know before taking Danatrol

Do not take Danatrol

• If you are allergic to danazol or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant (see “Pregnancy and breastfeeding”).
• If you are breastfeeding (see “Pregnancy and breastfeeding”).
• If you have abnormal vaginal bleeding (hemorrhage) without first consulting your doctor.
• If the function of your liver, kidneys or heart is severely impaired.
• If you suffer from a metabolic disease called “porphyria”.
• If you have a type of cancer that depends on certain hormones (androgen-dependent tumor).
• If you have or have had a blockage of blood vessels caused by a blood clot (thrombosis or thromboembolic events).
• If you are taking simvastatin (see “Other medicines and Danatrol”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Danatrol.
Particular care must be taken if you:

• have liver or kidney disease,
• have high blood pressure (hypertension) or other diseases of the blood vessels and heart (cardiovascular),
• suffer from fluid retention,
• have diabetes (diabetes mellitus),
• have a condition characterized by an increase in the volume of red blood cells, called “polycythemia”,
• have epilepsy,
• have changes in certain substances in the body called “lipoproteins”,
• have had disorders (evident or persistent androgenic reactions) after taking sex hormones in the past,
• suffer from migraine.

The doctor will subject you to strict checks and laboratory tests, especially if you need to continue
treatment with Danatrol for more than 6 months or if you need to have a repeated series of treatments.
Before starting therapy with Danatrol, the doctor:

• will check that you do not have a type of cancer called “hormone-dependent carcinoma”,
• will check for lumps in the breasts and subsequently their possible increase during treatment with Danatrol.

Therapy with Danatrol must be started during menstruation.
Use a safe, non-hormonal contraceptive method (see “Pregnancy and breastfeeding”) during
treatment with Danatrol.
The doctor will stop the treatment with Danatrol if you experience any unwanted effect
(see “Possible side effects”) and especially if you have:

• signs of masculinization due to an increase in male hormones (virilization). These symptoms may become irreversible if treatment with Danatrol is not stopped,
• swelling of an area between the optic nerve and the eye called “papilla” (papilledema),
• headache,
• visual disturbances or other disturbances due to increased pressure in the head (such as nausea, vomiting, headache),
• yellowing of the skin and eyes (jaundice) or another sign of liver disease,
• a blockage of a blood vessel due to a blood clot (thrombosis or thromboembolism).

If you need to repeat the treatment with Danatrol, the doctor will monitor you carefully because there is a risk of
development of benign (benign adenomas, focal nodular hyperplasia) and malignant (carcinomas) liver tumors
and a condition characterized by the presence of cavities filled with blood in the liver called “hepatic peliosis”.
The use of Danatrol may increase the risk of ovarian cancer in patients treated for endometriosis.

Children
The use of Danatrol is not recommended in children.

Other medicines and Danatrol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The effects of Danatrol may be affected by or affect the following medicines:

• medicines used for convulsions (anticonvulsants) such as carbamazepine, phenytoin and phenobarbital: Danatrol may affect the response to these drugs;
• medicines for diabetes (antidiabetics): Danatrol may cause insulin resistance;
• medicines that serve to decrease blood coagulation used orally (oral anticoagulants): Danazol may increase the action of warfarin;
• medicines used for high blood pressure (antihypertensives): Danatrol may decrease their effectiveness;
• cyclosporine and tacrolimus (used especially after transplants): Danatrol may increase the amount of these medicines in the blood, increasing their toxicity, particularly to the kidney and liver;
• medicines based on steroid hormones: an interaction between Danatrol and therapy with steroid sex hormone medicines is likely to occur;
• alfacalcidol, used for diseases due to a lack of vitamin D: Danatrol may increase calcium concentration in the blood in patients with a hormonal alteration called “primary hypoparathyroidism”;
• medicines used for cholesterol (statins): Danatrol used together with statins metabolized by the CYP3A4 enzyme increases the risk of muscle diseases (myopathy and rhabdomyolysis). The use of Danatrol together with simvastatin (a medicine belonging to the class of statins) is contraindicated (see “Do not take Danatrol”).

Danatrol may interact with some laboratory tests, interfering with the determination of testosterone or
plasma proteins (see “Possible side effects”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Danatrol is contraindicated in pregnancy because there is a risk of masculinization (virilization) of the
female fetus.
If you are of childbearing potential, exclude a possible pregnancy before starting treatment with Danatrol.
Start therapy with Danatrol during menstruation.
Use a safe, non-hormonal contraceptive method.
If you become pregnant during treatment, the administration of Danatrol must be stopped.

Breastfeeding
Danatrol may cause masculinization in breastfed children and therefore therapy with Danatrol or breastfeeding
must be stopped.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery.

Danatrol contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine .

For athletes
The use of the medicine without therapeutic need constitutes doping and may still result in positive
doping tests.

3. How to take Danatrol

Take this medicine by mouth, always following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The treatment cycle must be continuous, without interruptions.
The doctor will adjust the dose and decide the timing of administration (dosage) depending on the severity of the
disease and your response; once a satisfactory response is obtained, the doctor may decide to reduce your
dose. The doctor will try to give you always the minimum effective dose of Danatrol.
If you are a woman of childbearing potential, start therapy during menstruation, preferably on the first day of
your cycle, in order to avoid exposure to the effects of the medicine during pregnancy.
In case of doubt, before starting therapy, perform a pregnancy test to rule out the possibility of
being pregnant.
If you are a woman of childbearing potential, use a safe non-hormonal contraceptive method during the entire
treatment cycle.
In adult female patients.
The recommended dose is:

• for the treatment of endometriosis: 200-800 mg per day, in divided doses.

If symptoms are not controlled at lower doses (200-400 mg per day) within a period of 30-60 days, the
doctor may decide to increase your dose, which should not exceed 800 mg per day.
The normal duration of treatment is from 3 to 6 months.

• For the treatment of fibrocystic mastopathy: 100-400 mg per day, in divided doses.

If symptoms are not controlled at lower doses within a period of 30-60 days, the doctor may decide to
increase your dose.
The normal duration of treatment is from 3 to 6 months.
In patients of both sexes.
The recommended dose is:

• For the treatment of hereditary angioedema: 400-600 mg per day. After a period of 2 months free from attacks, the doctor may decide to reduce your dose to 300 mg or even to 200 mg per day, in divided doses.

In all the conditions described, 2 administrations per day are recommended.

Use in the elderly
The use of Danatrol is not recommended in the elderly.

Use in children
The use of Danatrol is not recommended in children.

If you take more Danatrol than you should
Available data suggest that, in case of taking an excessive dose of Danatrol, it is unlikely to
occur serious immediate reactions.
In case of accidental ingestion/taking of an excessive dose of Danatrol, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Danatrol
Do not take a double dose to make up for a missed dose.
If you have any doubts 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.

Common side effects(may affect up to 1 in 10 people)

• headache,
• nausea,
• vomiting,
• skin redness with spots (maculopapular, petechial or purpuric rash) which may be accompanied by fever, facial swelling (edema), sensitivity to light, acne, increased sebum (seborrhea), increased hair growth (hirsutism), hair loss,
• back pain,
• muscle cramps, sometimes with increased levels of creatine phosphokinase,
• muscle tremors,
• muscle contractions (fasciculation),
• limb pain,
• joint pain and swelling,
• hot flushes,
• sweating,
• change in voice tone,
• weight gain,
• increased appetite,
• absence of menstruation (amenorrhea),
• menstrual cycle disturbances,
• appearance of blood spots between periods (intermenstrual spotting),
• vaginal dryness,
• vaginal burning and itching,
• changes in sexual desire,
• emotional instability,
• anxiety,
• depressed mood,
• nervousness.

Uncommon side effects(may affect up to 1 in 100 people)

• urticaria,
• reduction in breast volume,
• increases in the values of some blood tests (transaminases).

Rare side effects(may affect up to 1 in 1,000 people)

• increased blood pressure (hypertension),
• heart rhythm disturbances and increased heart rate (palpitations, tachycardia),
• changes in the number of blood cells (polycythemia, leukopenia, thrombocytopenia, increased red blood cell and platelet count),
• increased pressure inside the skull (benign intracranial hypertension),
• dizziness,
• vertigo,
• increased skin sensitivity (hyperesthesia),
• eye disease called “cataract”, which leads to decreased transparency of the lens,
• visual disturbances (blurred vision, difficulty focusing, difficulty using contact lenses and the need to use glasses),
• inflammatory disease of the pancreas called “pancreatitis”,
• constipation,
• bleeding gums,
• blockage of blood vessels due to blood clots (thrombotic events, such as sagittal sinus thrombosis, cerebrovascular thrombosis, arterial thrombosis),
• fluid retention,
• fatigue,
• yellowing of the skin and eyes (cholestatic jaundice),
• benign liver tumors (benign hepatic adenomas),
• increase in the volume (hypertrophy) of the clitoris.

Very rare side effects(may affect up to 1 in 10,000 people)

• a condition characterized by the presence of blood-filled cavities in the spleen (splenic peliosis),
• alteration of some blood cells (eosinophilia),
• a disease of the nervous system called “Guillain-Barré syndrome”,
• worsening of epilepsy,
• pain and numbness in the hand (carpal tunnel syndrome),
• migraine,
• stomach pain (epigastric),
• pneumonia (interstitial pneumonia),
• chest pain (pleuritic),
• blood in the urine (hematuria) following prolonged use in patients treated for “hereditary angioedema”,
• skin changes (exfoliative dermatitis, erythema multiforme, erythematous inflammatory nodules, altered skin pigmentation),
• malignant liver tumor and presence of blood-filled cavities in the liver (hepatic peliosis) following prolonged treatment,
• reduced sperm formation.

Frequency not known(the frequency cannot be estimated from the available data):

• increased insulin resistance,
• increased blood levels of a substance in the body called “glucagon”,
• abnormalities in glucose tolerance tests,
• alteration of some substances in the blood: increased low-density lipoproteins (LDL), decreased high-density lipoproteins (HDL), decreased apolipoproteins AI and AII,
• metabolic effects (induction of aminolevulinic acid synthase (ALA) and reduction of thyroid hormone-binding globulin and T4 with increased T3 uptake, without interference with thyroid-stimulating hormone or free thyroxine index),
• liver disorders (hepatocellular lesions, liver failure, hepatocellular jaundice, focal nodular hyperplasia of the liver),
• heart attack.

Additional rare side effects in children

• In children, an alteration in bone formation (premature closure of bone epiphyses) may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Danatrol

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.” The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Danatrol contains
Danatrol 50 mg hard capsules

• The active ingredient is danazol. 1 capsule contains 50 mg of danazol.
• The other ingredients are: corn starch, lactose, talc, magnesium stearate, titanium dioxide, gelatin, red iron oxide.

Danatrol 200 mg hard capsules

• The active ingredient is danazol. 1 hard capsule contains 200 mg of danazol.
• The other ingredients are: corn starch, lactose, talc, magnesium stearate, titanium dioxide, gelatin, red iron oxide, yellow iron oxide.

Description of the appearance of Danatrol and contents of the pack
Danatrol is presented in the form of

• Hard capsules in packs of 30 capsules.

Marketing Authorisation Holder
Fidia farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
Zentiva k.s. – U Kabelovny 130, 102 37 – Prague 10 – Czech Republic