Package leaflet: Information for the patient

Doxafin duo, 4 mg + 5 mg, film-coated tablets
doxazosin + finasteride
This medicine is intended for men only
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

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

Table of contents

What Doxafin duo is and what it is used for
Important information before taking Doxafin duo
How to take Doxafin duo
Possible side effects
How to store Doxafin duo
Contents of the pack and other information

1. What Doxafin duo is and what it is used for

Doxafin duo contains the active substances doxazosin and finasteride.
How Doxafin duo works
Doxazosin belongs to a group of medicines known as vasodilators. It may also reduce muscle tone in the prostate gland (prostate) and urinary tract tissues.
Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. It works by reducing the size of the prostate gland in men when it is enlarged (benign prostatic hyperplasia - BPH).
Doxafin duo is used in the treatment of benign prostatic hyperplasia (BPH), instead of administering both substances separately.
Doxafin duo should not be used at the beginning of BPH treatment.
BPH is benign enlargement of the prostate gland, which commonly occurs in men over 50 years of age. An enlarged prostate may press on the urethra, the tube through which urine leaves the body, leading to symptoms such as frequent urination, urgency, difficulty in passing urine, reduced urine flow, and a feeling of incomplete bladder emptying. It may also lead to urinary tract infections, inability to pass urine, and the need for surgery.
If you have any questions regarding this, please consult your doctor.

2. Important information before using Doxafin duo

When not to use Doxafin duo

in pregnant women or women who are suspected of being pregnant (see section "Pregnancy, breastfeeding and fertility");
if the patient is allergic to doxazosin, finasteride, other medicines in the same group (known as quinazoline derivatives, such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6);
if the patient has low blood pressure;
if the patient has previously experienced orthostatic hypotension, i.e. a form of low blood pressure causing dizziness or feeling faint upon standing up from a sitting or lying position;
if the patient has an enlarged prostate and one of the following symptoms: congestion or obstruction of the urinary tract, persistent urinary tract infection, or bladder stones;
if the patient has overflow incontinence (lack of sensation to pass urine) or anuria (the body does not produce urine), regardless of whether kidney problems are present;
if the patient has severe liver function disorders.

Doxafin duo is not intended for use in women.
Warnings and precautions
Before starting treatment with Doxafin duo, discuss with your doctor or pharmacist if:

the patient's partner is pregnant or planning to become pregnant. While taking Doxafin duo, the patient should use a condom or another barrier method of contraception, as semen may contain a small amount of finasteride which could interfere with the development of male fetal genital organs.
the patient is scheduled for a blood test measuring PSA levels, because Doxafin duo may affect the results of this test.
the patient has noticed changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge. These symptoms may indicate a serious condition, e.g. breast cancer.
the patient has serious heart conditions, such as significant heart failure, chest pain or tightness (angina), fluid accumulation in the lungs (pulmonary oedema), or heart failure. The doctor should regularly monitor heart function.
the patient has kidney or liver problems.
the patient is scheduled for cataract eye surgery (clouding of the lens). Before the procedure, the ophthalmologist must be informed about current or past use of Doxafin duo. This is because doxazosin may cause complications during surgery, which can, however, be prevented if the doctor is informed in advance.
the patient is taking medications used to treat erectile dysfunction (phosphodiesterase-5 inhibitors (PDE-5 inhibitors), e.g. sildenafil, tadalafil, and vardenafil). Concurrent use of both medicines may lead to dizziness and drowsiness caused by low blood pressure, as both have vasodilating effects. To reduce the likelihood of these symptoms, the patient should be on a regular daily dose of Doxafin duo before starting treatment with PDE-5 inhibitors. The medicines should be taken with appropriate time intervals. Very rarely, prolonged painful erections (priapism) may occur. In such a case, immediate medical advice must be sought.
the patient has noticed changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge. These symptoms may indicate a serious condition, e.g. breast cancer.

Before starting and regularly during treatment with Doxafin duo, the doctor may order tests to rule out other conditions, such as prostate cancer, which may cause similar symptoms to benign prostatic hyperplasia.
Mood changes and depression
Patients taking finasteride have reported mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts. If any of these symptoms occur, immediate medical advice must be sought.
Orthostatic hypotension
The risk of a rapid drop in blood pressure is highest at the beginning of treatment or during dose escalation of doxazosin. Symptoms may include dizziness or, less commonly, fainting upon changing position. To reduce the risk of such events, the doctor will carefully monitor blood pressure at the start of treatment and during dose increases. Therefore, during the initial phase of treatment, situations in which dizziness or fainting could lead to injury should be avoided.
Doxazosin may also affect the results of certain blood and urine tests. If the patient is scheduled for blood or urine tests, they should inform the healthcare provider about taking Doxafin duo.
Doxafin duo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may interact with Doxafin duo. Before taking any of the following medicines, consult your doctor or pharmacist, as they may alter the effect of Doxafin duo.

Some patients taking alpha-blockers for enlarged prostate may experience dizziness or lightheadedness due to low blood pressure when standing up quickly. Some patients experienced these symptoms when taking PDE-5 inhibitors for erectile dysfunction (impotence) together with alpha-blockers, e.g. sildenafil, tadalafil, vardenafil (see section "Warnings and precautions"). To reduce the likelihood of these symptoms, patients should be on a regular daily dose of alpha-blockers before starting PDE-5 inhibitor therapy.
Other antihypertensive medicines, as Doxafin duo may further lower blood pressure.
Nitrates (medicines used for heart conditions), such as nitroglycerin and isosorbide nitrate, which may enhance the blood pressure-lowering effect.
Medicines that may also affect hepatic metabolism, e.g. cimetidine (a medicine used for stomach disorders).
Medicines that increase blood pressure, such as sympathomimetics, e.g. dopamine, ephedrine, adrenaline, metaraminol, methoxamine, and phenylephrine.
Medicines used to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
Medicines used to treat HIV, e.g. indinavir, nelfinavir, ritonavir, saquinavir.
Nefazodone, a medicine used to treat depression.

Doxafin duo may affect certain laboratory test results. The doctor should take this into account before ordering appropriate laboratory tests (e.g. diagnosis of pheochromocytoma).
Pregnancy, breastfeeding and fertility
Doxafin duo is intended for use in men only.
Pregnancy
Women who are pregnant or suspect they may be pregnant must not take Doxafin duo. Finasteride inhibits the conversion of the male sex hormone testosterone into dihydrotestosterone, the active form of the hormone produced in the prostate gland. Taking Doxafin duo during pregnancy may cause congenital malformations in male fetuses.
Pregnant women and women planning pregnancy should not handle crushed or broken coated tablets of Doxafin duo. Absorption of finasteride through the skin cannot be ruled out, which may pose a potential risk of disturbances in a male unborn child. This is particularly relevant for medical support staff who may be exposed.
Doxafin duo is formulated as coated tablets, which prevents contact with the active substance during normal handling, provided the tablets are not broken or crushed. If a pregnant woman comes into contact with crushed or broken coated tablets of Doxafin duo, medical advice should be sought immediately.
The patient's partner who is pregnant or suspects she may be pregnant should avoid contact with the patient's semen, as it may contain a small amount of the medicine.
Breastfeeding
Small amounts of doxazosin may pass into human milk. It is not known whether finasteride passes into human milk.
Fertility
Fertility may be reduced during treatment with finasteride.
Driving and operating machinery
Exercise caution when driving or operating machinery. The medicine may impair the ability to drive safely or operate machinery, especially when first starting treatment. It may cause drowsiness, weakness, or dizziness. If such symptoms occur, the patient should not drive or operate machinery and should contact their doctor immediately.
Doxafin duo contains sodium and lactose monohydrate
Sodium: The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. the medicine is considered "sodium-free".
Lactose: If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Doxafin duo

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose is one coated tablet per day.
This medicine is intended for oral administration. Tablets may be taken with food or on an
empty stomach.
Coated tablets should preferably be taken at the same time each day, swallowed with water.
Taking more Doxafin duo than recommended
The most common symptoms of overdose include a sudden drop in blood pressure accompanied by dizziness,
a feeling of faintness, or fainting.
If you have taken more than the recommended dose, contact your doctor or pharmacist immediately. In case of severe dizziness or if the patient feels faint, they should immediately lie down with the head kept low.
The doctor will decide on the necessary actions depending on the degree of overdose or symptoms.
Please bring the package leaflet or the Doxafin duo packaging so that the doctor can identify which active substance has been taken.
Missing a dose of Doxafin duo
If you forget to take a dose, skip that dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Doxafin duo treatment
After taking Doxafin duo, the patient's condition may improve rapidly. However, to achieve a beneficial response to treatment, it may be necessary to continue taking the medicine for at least six months. Premature discontinuation of Doxafin duo may lead to recurrence of symptoms.
Early discontinuation of the medicine is not recommended, even if the patient initially does not feel any improvement in health. If in doubt, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine and immediately contact your doctor or go to the
emergency department of the nearest hospital if any of the following adverse reactions occur:

Allergic reactions (angioedema) including swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties, skin rash and itching (may occur in up to 1 in 100 people).
Palpitations (awareness of irregular heartbeat) or tachycardia (rapid heart rate) (may occur in up to 1 in 10 people).
Chest pain (angina), rapid or irregular heartbeat, myocardial infarction (heart attack) or stroke, symptoms of which may include sudden collapse, numbness or weakness of arms or legs, headache, dizziness and disorientation, visual disturbances, difficulty swallowing, slurred speech or loss of speech (may occur in up to 1 in 100 people).
Hepatitis (liver inflammation), liver disease with nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and mucous membranes, and dark urine (may occur in up to 1 in 10,000 people).
Jaundice with yellowing of the skin, mucous membranes or whites of the eyes (may occur in up to 1 in 10,000 people).

The following other adverse reactions have been reported:
Very common adverse reactions (may occur in more than 1 in 10 people):

Dizziness, headache, low blood pressure upon changing from sitting or lying position (orthostatic hypotension), fatigue.

Common adverse reactions (may occur in up to 1 in 10 people):

Respiratory tract infections (nose, throat, lungs), bronchitis, cough, shortness of breath, nasal congestion and/or nasal discharge.
Urinary tract infection (pain or burning during urination or frequent urination), urinary incontinence (loss of bladder control), cystitis.
Difficulty achieving erection (impotence), reduced sexual desire (decreased libido), ejaculation problems, reduced volume of semen during intercourse. Reduced semen volume probably does not affect normal sexual function.
Anxiety, insomnia, drowsiness, feeling of tiredness, nervousness.
Sensation of spinning or dizziness, tingling or numbness of hands and feet (paresthesia), accommodation disorders.
Low arterial blood pressure.
Stomach/abdominal pain, indigestion, dry mouth, nausea/malaise, flu-like symptoms.
Itching (pruritus), increased sweating.
Back pain, muscle pain.
Swelling of feet, ankles or fingers (peripheral edema).

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Joint inflammation (gout), joint pain (arthralgia), generalized pain.
Increased appetite, loss of appetite, thirst, weight gain.
Restlessness, depression, sleep disturbances, memory loss (amnesia), emotional lability.
Hypoesthesia, fainting, tremor, attention/concentration disturbances.
Conjunctivitis, excessive tearing.
Ringing or buzzing in the ears.
Hot flushes, peripheral ischemia, pallor.
Nosebleeds, sore throat, upper respiratory tract infection.
Reduced or altered sense of touch in hands and feet.
Constipation, bloating, vomiting (nausea), gastritis and enteritis, taste disturbances.
Abnormal/increased liver function test results.
Rash, excessive hair loss (alopecia), rash caused by bleeding under the skin (purpura).
Muscle cramps, muscle weakness, muscle twitching, muscle stiffness.
Pain or difficulty urinating, increased need to urinate, increased urine volume, blood in urine.
Ejaculation disorders, erectile dysfunction, breast enlargement or tenderness.
Facial swelling, fever, chills.
Increased blood urea and creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

Photophobia.
Gastrointestinal obstruction.
Decreased body temperature in elderly people.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

Decreased white blood cell or platelet count, which may result in bruising or easy bleeding.
Blurred vision.
Decreased heart rate (bradycardia).
Breathing difficulties, wheezing or cough (bronchospasm), laryngeal edema.
Urticaria.
Urination disorders, need to urinate at night, increased urine volume.
Persistent, painful erections (priapism).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

Testicular pain, blood in semen.
Inability to achieve erection persisting after discontinuation of the medicine.
Persistent ejaculation disorders after discontinuation of the medicine, cloudy urine after orgasm (retrograde ejaculation).
Male infertility and/or poor semen quality. Improvement in semen quality has been reported after discontinuation of the medicine.
Persistent reduction in sexual desire after discontinuation of the medicine.
During cataract removal surgery (clouding of the eye lens), eye complications may occur. See section "Warnings and precautions".
Breast cancer in men.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Doxafin duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after "EXP". The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
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. Contents of the packaging and other information

What Doxafin duo contains

The active substances in this medicinal product are doxazosin (in the form of mesylate) and finasteride.
Other components are:
Tablet core: monohydrate lactose; maize starch; hypromellose 2910; sodium lauryl sulfate; pregelatinized starch; colloidal anhydrous silica; magnesium stearate.
Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

What Doxafin duo looks like and contents of the pack
Doxafin duo is a white, round, film-coated tablet, convex on both sides, with a diameter of 7 mm.
Doxafin duo is packed in blisters of 10, 30 and 90 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel
Germany
e-mail: [email protected]

Manufacturer:
MIP Pharma GmbH
Mühlstr. 50
66386 St. Ingbert
Germany

This medicinal product is authorised in the following European Economic Area countries:
Bulgaria: Доксазозин/Финастерид-MIP 4 mg/5 mg филмирани таблетки
Germany: Doxa-Fin 4 mg/5 mg Filmtabletten
Croatia: Doksazosin/finasterid MIP 4 mg/5 mg filmom obložene tablete
Austria: Doxazosin/Finasterid MIP 4 mg/5 mg Filmtabletten
Poland: Doxafin duo
Romania: Doxazosin/Finasteridă MIP 4 mg/5 mg comprimate filmate