DANATROL 100 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Danatrol 100 mg Capsules

danazol

Read all of this leaflet carefully before you start taking 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Danatrol and what is it used for

Danatrol is a hormonal medicine effective in the treatment of endometriosis (growth of the mucous membrane that lines the inside of the uterus outside the uterus).

It also effectively prevents crises in patients suffering from hereditary angioedema (fluid accumulation under the skin).

2. What you need to know before you take Danatrol

Do not takeDanatrol

• if you are allergic to danazol or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or breastfeeding,
• if you have porphyria (a disorder related to red blood cells),
• if you have significant kidney (renal), liver (hepatic), or heart (cardiac) disorders,
• if you have had thrombosis (the formation of a blood clot within the circulatory system) or a thromboembolic disease,
• if you have any type of tumor whose growth is affected by hormonal agents,
• if you have abnormal vaginal bleeding that has not been diagnosed,
• you must not take Danatrol at the same time as simvastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Danatrol.

Warnings

Tell your doctor if you have had previous reactions to medicines, especially steroid medicines.

Your doctor may indicate that you have periodic blood tests to check liver function and blood cell levels.

Treatment should be discontinued if clinically significant side effects occur and particularly if there is any evidence of:

• masculinization (virilization),
• inflammation of the optic nerve (papilledema), headache, vision changes, or other signs or symptoms of increased intracranial pressure,
• yellowing of the skin or any other indication of liver disorders,
• vascular problems such as thrombosis or thromboembolism.

It should be taken into account that:

• given the relationship between danazol and steroids, liver disorders may occur due to prolonged or repeated treatment,
• the use of danazol increases the risk of ovarian cancer in patients treated for endometriosis,
• in the event of having to repeat a treatment cycle with Danatrol, the doctor must perform strict follow-up.

Precautions

Due to its side effects and interactions with other medicines, you should inform your doctor if you have any of the following diseases:

• liver or kidney disease,
• cardiovascular problems,
• high blood pressure,
• any situation that may be exacerbated by fluid retention,
• diabetes,
• lipoprotein disorders (alteration in the normal levels of lipoproteins in the blood),
• epilepsy,
• a blood disorder called polycythemia (an increase in the proportion of red blood cells per blood volume),
• a history of marked or persistent androgenic reaction to previous treatment with gonadal steroids,
• migraine.

Before starting treatment, the presence of a hormone-dependent carcinoma should be ruled out, as well as the persistence or increase of nodules in the breasts during treatment.

Treatment should be started during menstruation. Women of childbearing age must use an effective non-hormonal contraceptive treatment during treatment with Danatrol.

This medicine may increase the sensitivity of the skin to sunlight. Avoid exposure to the sun (even on cloudy days) and to ultraviolet lamps (UVA) while using this medicine.

Use in athletes

This medicine contains danazol, which may produce a positive result in doping tests.

Use of Danatrol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will decide which medication you should stop taking or if the dose should be changed.

Especially, inform your doctor if you are currently taking:

• anticonvulsants (to treat seizures),
• antidiabetics (for the treatment of diabetes),
• oral anticoagulants such as warfarin (medicines that help prevent blood clots),
• antihypertensives (medicines that lower blood pressure),
• cyclosporin or tacrolimus (used in transplants),
• steroids (medicines related to the male sex hormone),
• alfacalcidol (a medicine to treat hypocalcemia),
• statins (medicines to lower cholesterol). You must not take Danatrol at the same time as simvastatin (see section "Do not take Danatrol").

Due to possible interactions with laboratory tests for the determination of testosterone or plasma proteins, inform your doctor that you are taking Danatrol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy:

Since the use of danazol is contraindicated during pregnancy due to the risk of virilization (masculinization) of the female fetus, appropriate measures should be taken in women of childbearing age to rule out the possibility of pregnancy during treatment.

In case of pregnancy, do not take Danatrol. You should inform your doctor if you are pregnant or plan to become pregnant before starting treatment with this medicine. If you think you have become pregnant during treatment with Danatrol, you should stop treatment and consult your doctor.

Since it is essential to ensure that you are not pregnant, treatment with Danatrol should be started during menstruation and an effective non-hormonal contraceptive method should be used during treatment with this medicine.

Breastfeeding:

Danazol may theoretically produce androgenic (masculinizing) effects in breastfed infants, and therefore, treatment with danazol or breastfeeding should be discontinued. If you are breastfeeding, you should not take this medicine.

Driving and using machines

The influence of Danatrol on the ability to drive and use machines is unlikely.

Danatrol contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Danatrol

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Danatrol should be administered orally.

If you are a woman of childbearing age, you should start treatment during menstruation to rule out the possibility of starting it while pregnant. You should use a non-hormonal contraceptive method during treatment with Danatrol.

The normal dose is 200 to 800 mg of danazol per day (not exceeding 800 mg per day), divided into 2 to 4 oral doses.

The dose may be higher or lower than indicated, depending on the response obtained.

The effective lowest dose should always be administered.

This medicine should not be taken by children or elderly patients.

If you take more Danatrol than you should

As with other medicines, an overdose can be dangerous.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and leaflet of the medicine to the healthcare professional.

You should remain under observation in case late reactions appear.

If you forget to take Danatrol

It is recommended to take the forgotten dose as soon as possible. Do not take the next dose until at least 4 hours have passed, then continue with the schedule indicated by your doctor.

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Adverse reactions are presented grouped by organ system and frequency:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the available data.

Blood and lymphatic system disorders

• Rare: increase in the proportion of red blood cells per blood volume (polycythemia), decrease in the number of white blood cells (leukopenia), and decrease in the number of platelets (thrombocytopenia).
• Very rare: elevation of the number of eosinophils in the blood (eosinophilia), spleen disease (peliosis splenica).

Metabolism and nutrition disorders

• Increased resistance to insulin, abnormal glucose tolerance.
• Common: increased appetite.
• Rare: fluid retention.

Psychiatric disorders

• Common: alteration of affectivity, anxiety, depressive state, nervousness, changes in sexual desire.

Nervous system disorders

• Common: headache, muscle tremors, muscle contractions.
• Rare: dizziness, benign intracranial hypertension.
• Very rare: worsening of epilepsy, onset of migraine, pain in the wrists and fingers (carpal tunnel syndrome).

Eye disorders

• Rare: visual disturbances such as blurred vision, difficulty focusing objects, discomfort wearing contact lenses, and alterations in refraction that require correction.

Ear and labyrinth disorders

• Rare: vertigo.

Cardiac disorders

• Rare: palpitations and tachycardia. Cases of myocardial infarction have also been reported.

Vascular disorders

• Common: hot flashes.
• Rare: hypertension. Effects caused by the presence of a blood clot in a blood vessel (including sagittal sinus thrombosis, cerebrovascular thrombosis, as well as arterial thrombosis) have also been observed.

Respiratory, thoracic, and mediastinal disorders

• Common: change in voice.
• Very rare: thickening and scarring of the lungs (interstitial pneumonitis), chest pain.

Gastrointestinal disorders

• Common: nausea.
• Rare: pancreatitis (inflammation of the pancreas).
• Very rare: pain in the upper part of the stomach.

Hepatobiliary disorders

• Rare: yellowing of the skin (cholestatic jaundice), benign liver tumor (benign liver adenoma).
• Very rare: in cases of prolonged use, liver disorders (malignant liver tumor and peliosis hepatica) have been observed.
• Frequency not known: liver cell damage, liver function impairment, yellowing of the skin and/or mucous membranes due to liver cell injury (hepatocellular jaundice), benign liver tumor (focal nodular hyperplasia).

Skin and subcutaneous tissue disorders

• Common: skin rashes that may be accompanied by fever. Facial edema and increased sensitivity of the skin to sunlight (photosensitivity) have also been reported. Acne, oily skin (seborrhea), significant increase in facial or body hair (hirsutism), hair loss.
• Uncommon: red, raised patches on the skin surface (urticaria).
• Very rare: inflammatory skin disease (erythematous inflammatory nodule), skin pigmentation disorders, exfoliative dermatitis, and allergic reaction affecting the skin (erythema multiforme).

Musculoskeletal and connective tissue disorders

• Common: back pain, muscle cramps, sometimes accompanied by an increase in creatine phosphokinase levels, pain in the limbs, joint pain and inflammation.

Renal and urinary disorders

• Very rare: presence of blood in the urine with prolonged use in cases of hereditary angioedema.

Reproductive system and breast disorders

• Common: menstrual cycle disorders, intermenstrual bleeding, absence of menstruation, vaginal dryness, vaginal irritation.
• Uncommon: decrease in breast size.
• Rare: increase in clitoris size.
• Very rare: decrease in sperm production.

General disorders

• Rare: fatigue.

Investigations

• Increased plasma glucagon level, increased LDL cholesterol, decreased HDL cholesterol, and decreased apolipoproteins AI and AII.

Other metabolic changes include the induction of ALA synthetase (aminolevulinic acid synthetase) and the decrease in thyroxine-binding globulin and T4, with an increase in T3 absorption, but without alteration of thyroid-stimulating hormone or free thyroxine index.

• Common: weight gain.
• Uncommon: isolated increases in liver enzyme levels (transaminases) in the blood.
• Rare: increase in the number of red blood cells and platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Danatrol

Keep out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Danatrol

• The active ingredient is danazol. Each capsule contains 100 mg of danazol.
• The other ingredients are lactose, cornstarch, talc, and magnesium stearate.

Appearance of the product and package contents

Capsules with a white opaque body and a gray opaque cap, with the inscription D100.

Each package contains 60 capsules in a PVC/Aluminum blister pack.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona

Avenida de Europa, 24 - Edificio A - 1 B

28108 Alcobendas - Madrid - Spain

Manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Date of the last revision of this leaflet: June 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/