Biturol 5 mg/5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Biturol 5 mg/5 mg film-coated tablets

finasteride/tadalafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Biturol is and what it is used for

Biturol is a combination of two different active substances, called finasteride and tadalafil. Finasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tadalafil belongs to a group of medicines known as phosphodiesterase type 5 inhibitors.

This medicine is used in men to treat symptoms caused by an enlarged prostate (benign prostatic hyperplasia), such as difficulty starting to urinate, weak urine stream, the sensation of not completely emptying the bladder, and frequent need to urinate (including at night). This medicine is used in patients whose symptoms are already controlled with finasteride and tadalafil taken together.

Finasteride helps reduce the size of an enlarged prostate and relieve symptoms. Tadalafil works by improving blood flow and relaxing the muscles of the prostate and bladder, which helps reduce symptoms.

2. What you need to know before taking Biturol

Do not take Biturol

• if you are allergic to finasteride or tadalafil, or to any of the other ingredients of this medicine (listed in section 6).

• if you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.

• if you have severe heart disease or have recently had a heart attack (within the last 90 days).

• if you have recently had a stroke (within the last 6 months).

• if you have low blood pressure or uncontrolled high blood pressure.

• if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as "eye stroke".

• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Biturol.

Inform your doctor about any current or past medical conditions and any allergies you may have.

Biturol is intended only for the treatment of BPH in men. Women must not use this medicine if they are or could be pregnant, nor should they be exposed to Biturol by handling crushed or split tablets. If the active ingredient finasteride is absorbed orally or through the skin by a pregnant woman carrying a male fetus, the baby may be born with abnormalities of the genital organs. If a pregnant woman has been exposed to this active ingredient, she should consult a doctor. Biturol tablets are coated, which prevents contact with the active ingredients during normal handling, provided the tablets are not crushed or broken. If you have any doubts, ask your doctor.

If your sexual partner is or could be pregnant, you should avoid exposing her to your semen, as it may contain trace amounts of the medicine.

BPH develops over a long period of time. Sometimes symptoms improve quickly, but you may need to take Biturol for at least six months to determine whether your symptoms improve. Even if you do not feel any improvement or change in symptoms, treatment with Biturol may reduce the risk of being unable to pass urine and therefore the need for surgery. You should visit your doctor regularly for periodic check-ups and evaluation of your progress.

Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform a prostate cancer screening before starting treatment with Biturol for benign prostatic hyperplasia. Biturol does not treat prostate cancer.

Biturol may decrease levels of prostate-specific antigen (PSA; a substance in the body that increases when the prostate enlarges and may cause obstruction). If you have had a PSA test, tell your doctor that you are taking Biturol.

Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

It is not known whether Biturol is effective in patients who have undergone:

• pelvic surgery.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking finasteride/tadalafil, stop taking Biturol immediately and contact your doctor.

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Biturol and contact your doctor immediately.

Biturol is not intended for use in women.

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 you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Biturol must not be used in children or adolescents under 18 years of age.

Other medicines and Biturol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Biturol if you are already using nitrates.

Some medicines may be affected by Biturol or may affect how well Biturol works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines for treating high blood pressure.
• riociguat, a medicine used to treat pulmonary hypertension.
• medicines such as ketoconazole tablets (for treating fungal infections) or protease inhibitors for treating AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole (medicines used to treat infections).
• other treatments for erectile dysfunction.

Taking Biturol with food, drinks, and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well Biturol works and should be taken with caution. Consult your doctor for further information.

Pregnancy, breastfeeding, and fertility

Biturol is for use in men only.

Biturol is not indicated for use in women.

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

In treated dogs, a decrease in sperm production by the testes was observed. A reduction in sperm count has also been observed in some men. These effects are unlikely to result in infertility.

Driving and using machines

Some men who took tadalafil (one of the components of this medicine) in clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Biturol contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Biturol contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Biturol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Biturol tablets are for oral use only in men. Swallow the tablet whole with a small amount of water. Take one tablet of Biturol daily, with or without food.

Alcohol consumption may temporarily lower your blood pressure. If you have taken or are planning to take Biturol, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness upon standing.

The recommended dose is one tablet once daily, taken at approximately the same time each day. Do not take Biturol more than once a day.

If you take more Biturol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

Consult your doctor. You may experience adverse effects described in section 4.

If you forget to take Biturol

If you realize you have missed a dose, wait until your next scheduled daily dose.

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

If you stop taking Biturol

If you stop taking this medicine, your initial symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:

• If you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; hives; and breathing difficulties.
• Allergic reactions including rashes.
• Chest pain – do not use nitrates, but seek immediate medical help.
• Priapism, a prolonged and possibly painful erection after taking tadalafil. If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision, distorted or blurred central vision, or sudden decrease in vision.

You must immediately inform your doctor of any changes in breast tissue, such as lumps, pain, enlargement, or nipple discharge, as these may be signs of a serious condition, such as breast cancer. In some cases, these side effects disappeared even while the patient continued taking the medicine. When symptoms persisted, they usually resolved after stopping this medicine.

Other adverse effects that have been reported:

Frequent (may affect up to 1 in 10 people)

• Headache, high blood pressure, nasal and/or throat inflammation, nasal congestion, flu-like illness, diarrhea, reduced stomach acidity, indigestion, back pain, limb pain, facial flushing, reduced sexual desire, impotence (inability to achieve an erection), decreased volume of semen ejaculated during sexual activity. This reduction in semen volume does not appear to affect normal sexual function.

Uncommon (may affect up to 1 in 100 people)

• Pain when urinating, skin rash, swelling and increased sensitivity in the chest, problems with ejaculation, dizziness, stomach pain, nausea, vomiting, reflux, eye pain, presence of blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears (tinnitus), swelling of the hands, feet, or ankles, feeling tired and ill, Peyronie's disease (causes curved and painful erections).

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

• Fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin welts), exfoliative dermatitis (generalized red peeling skin), penile bleeding, presence of blood in the semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking Biturol. Most of these men had pre-existing heart problems before taking this medicine.

Rare cases of partial, transient, or permanent vision decrease or loss in one or both eyes have been reported.

Some additional rare adverse effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

• Migraine, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.

Frequency not known (cannot be estimated from available data): depression, suicidal thoughts, decreased sexual desire that continued after stopping the medication, anxiety, irregular heart rate, elevated liver enzymes, testicular pain, inability to achieve an erection that continued after stopping the medication, ejaculation problems that continued after stopping the medication, male infertility or poor semen quality. Improvement in semen quality after discontinuation of the medication has been reported.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Biturol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Biturol

• The active substances are finasteride and tadalafil. Each tablet contains 5 mg of finasteride and 5 mg of tadalafil.
• The other components are: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, pregelatinized starch, sodium croscarmellose, sodium carboxymethyl starch type A (from potato), sodium lauryl sulfate, polysorbate 80.

Coating: magnesium stearate, hypromellose, titanium dioxide (E-171), triacetin.

Appearance of the product and contents of the container

Biturol is presented as film-coated tablets, round, white, biconvex, and unmarked, 8 mm in diameter.

The tablets are available in PVC/PCTFE blisters sealed with an aluminum foil, in packages containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).