Finarand

PACKAGE LEAFLET

Package leaflet: information for the patient

Finarand 4 mg/5 mg film-coated tablets

doxazosin/finasteride
This medicinal product is intended for male patients 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Finarand is and what it is used for

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

2. What you need to know before taking Finarand

Do not take Finarand

• if you are a pregnant woman or could be pregnant (see Pregnancy, breastfeeding and fertility).
• if you are allergic to doxazosin, finasteride, or to any 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 suffer from low blood pressure.
• if you have previously had a condition known as "orthostatic hypotension", i.e. a form of low blood pressure causing dizziness or lightheadedness when standing up from a sitting or lying position.
• if you have an enlarged prostate associated with any of the following conditions: urinary tract congestion or obstruction of any kind, long-standing urinary tract infection, or bladder stones.
• if you suffer from reflex 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.

Finarand is not indicated for use in women.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finarand if:

• your partner is pregnant or planning to become pregnant. You must use a condom or another barrier contraceptive method while taking Finarand. This is because your semen may contain a small amount of the active substance finasteride, which could affect the normal development of the baby's sex organs.
• you are due to have a blood PSA test. This is because Finarand can affect the results of this test.
• 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 or a tight, painful feeling in the chest (angina pectoris), fluid accumulation in the lungs (pulmonary edema), or heart failure. Your doctor should regularly monitor your cardiac function.
• you have kidney or liver problems.
• you are undergoing eye surgery for cataract (clouding of the lens). Before the operation, inform your ophthalmologist that you are currently taking or have previously taken Finarand. This is because doxazosin may cause complications during surgery, which can be managed if your specialist is prepared in advance.
• you are taking medicines for erectile dysfunction (phosphodiesterase-5 inhibitors (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 vasodilatory effect. To reduce the likelihood of these symptoms, you should be on a regular daily dose of Finarand before starting treatment with erectile dysfunction medicines. The medicines should be taken at sufficiently spaced intervals. Prolonged and painful erections may very rarely occur. If this happens, you must contact a doctor immediately.

Before starting and regularly during treatment with Finarand, 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 changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If any of these symptoms occur, contact your doctor as soon as possible for further medical advice.
Orthostatic hypotension
The risk that blood pressure drops too quickly is higher at the beginning of treatment with doxazosin or when the doxazosin dose is increased. You may experience this 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 start of treatment and when the dose is increased. Therefore, during the initial phase 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 undergo blood or urine testing, make sure to inform the healthcare provider that you are taking Finarand.
Other medicines and Finarand
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are some medicines that may interact with Finarand. Before use, ask your doctor or pharmacist if you are taking any of these medicines, as they may alter the effect of Finarand:

• Some patients taking alpha-blockers for the treatment of enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when 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 your alpha-blocker before starting treatment with erectile dysfunction medicines.
• Other medicines used to treat high blood pressure, like Finarand, may further lower blood pressure.
• Nitrates (medicines for heart problems), such as nitroglycerin and isosorbide mononitrate, 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, e.g. dopamine, ephedrine, adrenaline, metaraminol, methoxamine, and phenylephrine.
• Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Finarand may affect certain laboratory values. Your doctor should take this into account before performing appropriate laboratory tests (e.g. diagnosis of pheochromocytoma).
Pregnancy, breastfeeding and fertility
Finarand is intended only for men.
Pregnancy
You must not take Finarand if you are pregnant or could 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 Finarand is taken by a pregnant woman, it may cause birth defects in male fetuses.
Do not touch crushed or broken Finarand film-coated tablets if you are a pregnant woman or planning to become pregnant. This is because absorption (through the skin) of finasteride, and thus a potential risk to the male fetus, cannot be ruled out. This is particularly relevant for medical personnel who may be at risk.
Finarand tablets are film-coated to prevent contact with the active substance during normal handling, provided the film-coated tablets are not broken or crushed.
If a pregnant woman comes into contact with crushed or broken Finarand film-coated tablets, speak to your doctor.
If your partner is pregnant or could be pregnant, you must prevent her from coming 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. Your medicine may affect your ability to drive or operate machinery safely, especially when you first start taking it. It may cause drowsiness and make you feel weak or dizzy. If you are affected, do not drive or operate machinery and contact your doctor immediately.
Finarand contains sodium and lactose monohydrate
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially 'sodium-free'.
Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Finarand

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one film-coated tablet daily.
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 Finarand than you should
The most common symptoms of overdose are a sudden drop in blood pressure with dizziness, lightheadedness, or fainting.
If you have taken more than the prescribed dose, you must contact your doctor and/or pharmacist immediately. If you feel extremely lightheaded or think you might faint, lie down immediately with your head lowered.
The doctor will decide which measures to take depending on the severity of the overdose and the nature of the symptoms.
Bring the package leaflet or the Finarand packaging with you so that the doctor knows which active substance you have taken.

If you forget to take Finarand
If you forget to take a film-coated tablet, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for the forgotten dose.

If you stop taking Finarand
Your condition may show early improvement after starting Finarand. However, it may take at least six months before the full effect develops. If you suddenly stop taking Finarand, the symptoms you had before starting treatment may return.
Therefore, it is advisable not to stop taking this medicine abruptly, even if you do not notice immediate benefits. Always consult your doctor or pharmacist if you are unsure.

If you have any questions 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.
If you experience any of the following side effects, stop taking Finarand immediately and contact your
doctor or go to the nearest doctor or hospital straight away:

• Allergic reactions (angioedema) with swelling of the face, tongue or throat, difficulty swallowing, hives, breathing difficulties, 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), inflammation of the airways inside the lungs, cough, shortness of breath, blocked and/or runny nose
• Urinary tract infection (pain or burning sensation when urinating or frequent need to urinate), urinary incontinence (inability to control urination), inflammation of the bladder (cystitis)
• Inability to achieve an erection (impotence), reduced desire for sex (decreased libido), ejaculation problems, such as reduced amount of semen released during sex. This reduction in semen volume does not appear to 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 disorder
• Low blood pressure
• Stomach/abdominal pain, indigestion, dry mouth, feeling of being unwell, 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 (knee), joint pain (arthralgia), generalized pain
• Increased appetite, anorexia (loss of appetite), thirst, weight gain
• Agitation, depression, sleep disorders, memory loss (amnesia), emotional discomfort
• Numbness (hypoesthesia), fainting, tremor, attention disorders
• Conjunctivitis, tear 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 unwell), gastrointestinal inflammation (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 during the night, increased volume of urine passed
• Prolonged painful erection (priapism)

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

• Testicular pain, blood in semen
• Inability to achieve an erection that may continue 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 the medicine.
• 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 (carcinoma)
• Suicidal thoughts

Reporting of side effects
If you get any side effects, including ones 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 Finarand

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 Finarand contains

• The active substances are doxazosin (as mesylate) and finasteride.
• The other components are: Tablet core: monohydrate lactose; maize starch; hypromellose; sodium lauryl sulfate; pregelatinized starch; anhydrous colloidal silica; magnesium stearate; and Coating – polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

Description of the appearance of Finarand and contents of the pack
Finarand is a white, round, biconvex film-coated tablet with a diameter of 7 mm.
Finarand is packaged in blisters containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Proge Medica S.r.l.
Largo Donegani 4/A
28100 Novara
Italy

Manufacturer
SOFARIMEX Industria Química e Farmacêutica, S.A.
Avenida das Industrias, Alto do Colaride, Agualva,
2735–213 Cacém
Portugal