Doxazosin and finasteride Mylan

PACKAGE LEAFLET

Package leaflet: information for the patient

Doxazosin and Finasteride Mylan 4 mg/5 mg film-coated tablets

doxazosin/finasteride
This medicinal product is for use in men only
Please 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Doxazosina e Finasteride Mylan is and what it is used for

Doxazosina e Finasteride Mylan contains the active substances doxazosin and finasteride.
How Doxazosina e Finasteride Mylan works
Doxazosin belongs to a group of medicines known as vasodilators and may also reduce tension in the smooth muscle tissue of the prostate and urinary tract.
Finasteride belongs to a group of medicines called "5-alpha reductase inhibitors" and is able to reduce the size of the prostate in men when it is enlarged (benign prostatic hyperplasia - BPH).
Doxazosina e Finasteride Mylan is used to treat benign prostatic hyperplasia (BPH), replacing the separate administration of the two active substances.
Doxazosina e Finasteride Mylan must not be used to initiate treatment for benign prostatic hyperplasia.
BPH is a benign enlargement of the prostate gland, common in men over 50 years of age.
An enlarged prostate can press on the urethra, the tube through which urine passes out of the body, and may cause problems such as frequent urination, urgent need to urinate, difficulty in urinating, weak urine stream, and inability to completely empty the bladder. It may also lead to urinary tract infections, inability to urinate, and the need for surgical intervention.
If you have any questions, please consult your doctor.

2. What you need to know before taking Doxazosin and Finasteride Mylan

Do not take Doxazosin and Finasteride Mylan

• if you are a pregnant woman or suspect you may be pregnant (see Pregnancy, breastfeeding and fertility).
• if you are allergic to doxazosin, finasteride, or to other medicines in the same group (known as quinazolines, such as prazosin and terazosin), or to any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressure.
• if you have a history of a condition known as “orthostatic hypotension”, a form of low blood pressure that causes dizziness or mental confusion when standing up from a sitting or lying position.
• if you have an enlarged prostate associated with any of the following conditions: any type of urinary tract congestion or blockage, a long-standing urinary tract infection, or bladder stones.
• if you suffer from overflow incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without kidney problems.
• if you have severe liver disease.

The use of Doxazosin and Finasteride Mylan in women is not indicated.
Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin and Finasteride Mylan if:

• your partner is pregnant or planning a pregnancy. While taking Doxazosin and Finasteride Mylan, you must use a condom or another barrier contraceptive method. This is because your semen may contain a small amount of the finasteride medicine and could affect the normal development of the baby's sex organs.
• you need to have a blood test for PSA. This is because Doxazosin and Finasteride Mylan can affect the test results.
• you notice changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge. These signs may indicate a serious condition, such as breast cancer.
• you suffer from severe heart problems, such as severely reduced heart function, a painful tightening sensation in the chest (angina pectoris), fluid accumulation in the lungs (pulmonary edema), or heart failure. Your doctor should regularly monitor your heart function.
• you have kidney or liver problems.
• you are scheduled for cataract surgery (clouding of the lens). Before the operation, inform your ophthalmologist that you are currently taking or have previously taken Doxazosin and Finasteride Mylan. This is because doxazosin may cause complications during surgery, which can be managed if the specialist is prepared in advance.
• you are taking medicines for erectile dysfunction (phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil, tadalafil, and vardenafil). Concomitant use may cause dizziness and drowsiness due to low blood pressure, as both medicines have a vasodilating effect. To reduce the likelihood of these symptoms, it is advisable to be on a regular daily dose of Doxazosin and Finasteride Mylan before starting treatment with erectile dysfunction medicines. The medicines should be taken at sufficiently spaced intervals. Very rarely, prolonged and painful erections may occur. If this happens, contact a doctor immediately.

Before starting and regularly during treatment with Doxazosin and Finasteride Mylan, your doctor may perform tests to rule out other conditions, such as prostate cancer, which could cause the same symptoms as benign prostatic hyperplasia.
Mood changes and depression
Mood disorders such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If you experience any of these symptoms, contact your doctor as soon as possible for further evaluation.
Orthostatic hypotension
The likelihood that blood pressure drops too quickly is higher at the beginning of treatment with doxazosin or when the dose of doxazosin is increased. This may manifest as dizziness or, more rarely, fainting when changing position. To reduce the risk of this happening, your doctor will carefully monitor your blood pressure at the beginning of treatment and when the dose is increased. Therefore, at the start of treatment, you should avoid situations where dizziness or fainting could lead to injury.
Doxazosin may also affect the results of certain blood and urine tests. If you need to have a blood or urine test, make sure to inform healthcare personnel that you are taking Doxazosin and Finasteride Mylan.
Other medicines and Doxazosin and Finasteride Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Doxazosin and Finasteride Mylan. Ask your doctor or pharmacist before use if you are taking any of the following medicines, as they may alter the effect of Doxazosin and Finasteride Mylan:

• Some patients receiving alpha-blockers for the treatment of an enlarged prostate may experience dizziness or mental confusion caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms while taking medicines called PDE-5 inhibitors for erectile dysfunction (impotence) together with alpha-blockers, such as sildenafil, tadalafil, vardenafil (see section “Warnings and precautions”). To reduce the likelihood of these symptoms, you should be on a regular daily dose of the alpha-blocker before starting treatment with erectile dysfunction medicines.
• Other medicines used to treat high blood pressure, such as Doxazosin and Finasteride Mylan, may further lower blood pressure.
• Nitrates (medicines for heart problems), such as nitroglycerin and isosorbide nitrate, may exacerbate the hypotensive effect.
• Medicines that may affect liver metabolism, for example cimetidine (a medicine for stomach problems).
• Medicines that increase blood pressure, such as sympathomimetics, for example dopamine, ephedrine, adrenaline, metaraminol, methoxamine, and phenylephrine.
• Medicines for the treatment of bacterial or fungal infections, for example clarithromycin, itraconazole, ketoconazole, telithromycin, and voriconazole.
• Medicines used in the treatment of HIV, for example indinavir, nelfinavir, ritonavir, and saquinavir.
• Nefazodone, a medicine used to treat depression.

Doxazosin and Finasteride Mylan may alter certain laboratory values. Your doctor should take this into account before performing appropriate laboratory tests (e.g., for the diagnosis of pheochromocytoma).
Pregnancy, breastfeeding and fertility
Doxazosin and Finasteride Mylan is intended for use only in men.
Pregnancy
You must not take Doxazosin and Finasteride Mylan if you are pregnant or suspect you may be pregnant. Finasteride inhibits the conversion of the male sex hormone testosterone into dihydrotestosterone, the active form of the hormone produced in the prostate. If Doxazosin and Finasteride Mylan is taken by a pregnant woman, it may cause congenital malformations in male fetuses.
Do not touch crushed or broken film-coated tablets of Doxazosin and Finasteride Mylan if you are a pregnant woman or planning a pregnancy. Absorption (uptake through the skin) of finasteride may occur, making it impossible to exclude a potential risk to the male fetus. This is particularly relevant for auxiliary healthcare personnel who are at risk of exposure.
Doxazosin and Finasteride Mylan are film-coated tablets designed to prevent contact with the active ingredient during normal handling, as long as the film-coated tablets are not broken or crushed. If a pregnant woman comes into contact with crushed or broken film-coated tablets of Doxazosin and Finasteride Mylan, inform a doctor.
If your partner is pregnant or suspects she may be pregnant, you must ensure she does not come into contact with your semen, as it may contain a small amount of the medicine.
Breastfeeding
Small amounts of doxazosin may pass into breast milk. It is not known whether finasteride passes into breast milk.
Fertility
Your ability to father children may be reduced while taking finasteride.
Driving and using machines
Be cautious if you drive or operate machinery. This medicine may affect your ability to drive or use machines safely, especially at the beginning of treatment. It may cause drowsiness, weakness, or dizziness. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.
Doxazosin and Finasteride Mylan contains sodium and monohydrate lactose
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.
Lactose: If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Doxazosina e Finasteride Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one film-coated tablet per day.
This medicine is for oral use. It can be taken with or without food.
It is best to take the film-coated tablets at approximately the same time each day, with a glass of water.

If you take more Doxazosina e Finasteride Mylan than you should
The most common symptoms of overdose are a sudden drop in blood pressure accompanied by dizziness, mental confusion, or fainting.
If you have taken more than the prescribed dose, contact your doctor and/or pharmacist immediately. If you feel severely dizzy or think you might faint, lie down immediately and keep your head low.
Your doctor will decide which measures to take, depending on the severity of the overdose and the nature of the symptoms.
Take the package leaflet or the Doxazosina e Finasteride Mylan packaging with you so that the doctor knows which active substances you have taken.

If you forget to take Doxazosina e Finasteride Mylan
If you forget to take a film-coated tablet, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Doxazosina e Finasteride Mylan
Your condition may improve rapidly after starting Doxazosina e Finasteride Mylan. However, it may take at least six months before the full effect becomes evident. If you suddenly stop taking Doxazosina e Finasteride Mylan, the symptoms you experienced before starting treatment may return.
Therefore, it is advisable not to stop taking this medicine abruptly, even if you do not notice any benefit at first. If in doubt, always consult your doctor or pharmacist.

If you have any questions about how to use 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 side effects, stop taking Doxazosin and Finasteride Mylan and
contact your doctor immediately or go to the nearest doctor or hospital:

• Allergic reactions (angioedema) with swelling of the face, tongue or throat, difficulty swallowing, hives, breathing difficulties, skin rash and itching (may affect up to 1 in 100 people).
• Palpitations with awareness of heartbeat or tachycardia with increased heart rate (may affect up to 1 in 10 people).
• Chest pain (angina pectoris), rapid or irregular heartbeat, heart attack or stroke; symptoms may include collapse, numbness or weakness of arms or legs, headache, dizziness and confusion, vision disturbances, difficulty swallowing, slurred speech and loss of speech (may affect up to 1 in 100 people).
• Hepatitis, liver disease with nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and mucous membranes, and dark urine (may affect up to 1 in 10,000 people).
• Jaundice with yellowing of the skin, mucous membranes or whites of the eyes (may affect up to 1 in 10,000 people).

The following additional side effects have been reported:
Very common side effects (may affect more than 1 in 10 people)

• Dizziness, headache, low blood pressure upon standing up from sitting or lying down (postural hypotension), weakness

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

• Respiratory tract infections (nose, throat, lungs), airway inflammation in the lungs, cough, shortness of breath, nasal congestion and/or runny nose
• Urinary tract infections (pain or burning sensation during urination or frequent need to urinate), urinary incontinence (inability to control urination), bladder inflammation (cystitis)
• Inability to achieve an erection (impotence), reduced desire for sexual intercourse (decreased libido), ejaculation problems, such as reduced amount of semen released during sexual intercourse. This reduction in semen volume does not appear to affect normal sexual function.
• Anxiety, insomnia, drowsiness, feeling of fatigue, nervousness
• Sensation of dizziness or spinning of the surroundings (vertigo), tingling or numbness of hands and feet (paresthesia), accommodation disorder
• Low blood pressure
• Stomach/abdominal pain, indigestion, dry mouth, feeling/perception of malaise, flu-like symptoms
• Itching, excessive sweating (hyperhidrosis)
• Back pain, muscle pain (myalgia)
• Swelling of feet, ankles or fingers (peripheral edema)

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

• Joint inflammation (gout), joint pain (arthralgia), general pain
• Increased appetite, anorexia (loss of appetite), thirst, weight gain
• Agitation, depression, sleep disorders, memory loss (amnesia), emotional distress
• Numbness (hypoesthesia), fainting, tremor, attention disorders
• Conjunctivitis, lacrimation disorders
• Ringing or noise in the ears
• Hot flushes, poor peripheral circulation, pallor
• Nosebleeds, pharyngitis, upper respiratory tract infection
• Reduced or altered sense of touch or sensitivity in hands and feet
• Constipation, flatulence, vomiting (feeling of malaise), inflammation of the gastrointestinal tract (gastroenteritis), altered taste (dysgeusia)
• Abnormal/increased liver function tests
• Skin rash, hair loss (alopecia), skin rash caused by subcutaneous bleeding (purpura)
• Muscle cramps, muscle weakness, muscle spasms, muscle stiffness
• Pain or discomfort during urination, increased frequency of urination, passing large volumes of urine, blood in urine
• Ejaculation disorder, erectile dysfunction, breast swelling or tenderness
• Swollen face, fever, chills
• Increased blood levels of urea and creatinine

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

• Photophobia
• Gastrointestinal obstruction
• Decreased body temperature in elderly patients

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

• Low number of white blood cells or platelets in the blood, which may cause bruising or easy bleeding
• Blurred vision
• Reduced heart rate (bradycardia)
• Difficulty breathing, wheezing or cough (bronchospasm), swelling of the larynx
• Hives
• Urination disorders, need to urinate at night, increased volume of urine passed
• Persistent painful erection (priapism)

Not known (frequency cannot be estimated from the available data)

• Testicular pain, blood in semen
• Inability to achieve an erection that may persist after stopping the medicine
• Ejaculation problems that continue after stopping the medicine, urine after orgasm (retrograde ejaculation)
• Male infertility and/or poor semen quality. Improvement in semen quality has been reported after stopping pharmacological treatment.
• Decreased sexual desire that continues after stopping the medicine
• Eye problems may occur during cataract surgery (clouding of the eye's lens). See section “Warnings and precautions”
• Male breast cancer

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 Doxazosin and Finasteride Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
"Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine 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 Doxazosina e Finasteride Mylan contains

• The active substances are doxazosin (as mesilate) and finasteride.
• The other components are: Core of the tablet: monohydrate lactose; corn starch; hypromellose; sodium lauryl sulfate; pregelatinized starch; anhydrous colloidal silica; magnesium stearate.
  Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

Description of the appearance of Doxazosina e Finasteride Mylan and package contents
Doxazosina e Finasteride Mylan is a white, round, biconvex film-coated tablet with a diameter of 7 mm.
Doxazosina e Finasteride Mylan is supplied in blister packs containing 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
Milan