Package Insert: Information for the Patient

Biturol 5 mg/5 mg Film-Coated Tablets

finasteride/tadalafil

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

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

Do not takeBiturol

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

- are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.

- have a serious heart disease or have had a heart attack recently, within the last 90 days.

- have had a recent stroke, within the last 6 months.

- have low or uncontrolled high blood pressure.

- have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.

- are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). Phosphodiesterase type 5 inhibitors, including tadalafil, have been shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Biturol.

Inform your doctor of your current and past medical problems and any allergies you may have.

Biturol is only intended for the treatment of BPH in men. Women should not use this medication when they are or may be pregnant, nor should they be exposed to Biturol when handling crushed or broken tablets. If the active ingredient finasteride is absorbed after oral use or through the skin by a pregnant woman, her male fetus may be born with abnormalities in his sex organs. If the pregnant woman has come into contact with this active ingredient, she should consult her doctor. Biturol tablets are coated, which will prevent contact with their active ingredients during normal handling, as long as the tablets are not crushed or broken. If you have any doubts, ask your doctor.

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

BPH develops over a prolonged period of time. Sometimes symptoms improve immediately, but you may need to take Biturol for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, Biturol therapy may reduce the risk of being unable to urinate and therefore the need for surgery. You should visit your doctor regularly for periodic check-ups and to evaluate your progress.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer check before starting treatment with Biturol for benign prostatic hyperplasia. Biturol does not treat prostate cancer.

Biturol may lower levels of prostate-specific antigen (PSA), a substance in the body that increases when the prostate grows and can 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 (a blood disorder).

- multiple myeloma (bone marrow cancer).

- leukemia (blood cancer).

- any deformity of the penis.

- a serious liver problem.

- a serious kidney problem.

We do not know if Biturol is effective in patients who have undergone:

- pelvic surgery.

- a surgical procedure in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

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 should not be used in children or adolescents under 18 years old.

Other medications and Biturol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Biturol if you are already using nitrates.

Some medications may be affected by Biturol or may affect the proper functioning of Biturol. Inform your doctor or pharmacist if you are using:

- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).

- other medications to treat high blood pressure.

- riociguat, a medication to treat pulmonary hypertension.

- medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.

- phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).

- rifampicin, erythromycin, clarithromycin, or itraconazole (medications to treat infections).

- other treatments for erectile dysfunction.

Biturol with food, drinks, and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of Biturol and should be taken with caution. Consult your doctor for more information.

Pregnancy, lactation, and fertility

Biturol is for exclusive use in men.

Biturol is not indicated in women.

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

In dogs treated, a decrease in sperm production by the testicles was observed. Some men have experienced a reduction in sperm count. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Some men who took tadalafil (one of the components of this medication) during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.

Biturol contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medication.

Biturol contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Biturol tablets are for oral administration only in men. Swallow the tablet whole with a little water. Take one Biturol tablet per day, with or without food.

Consuming alcohol 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 when standing up.

Therecommended doseis one tablet per day, approximately at the same time. Do not take Biturol more than once a day.

If you take more Biturol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Biturol

If you realize you have forgotten to take your dose, wait for the next daily dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withBiturol

If you stop taking this medication, initial symptoms may reappear or worsen. Consult your doctor at all times if you are considering interrupting treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.These side effects are generally of mild to moderate intensity.

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

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

You must inform your doctor immediatelyof any change in breast tissue, such as lumps, pain, increase, or discharge from the nipple, as these may be signs of a serious disease, such as breast cancer. In some cases, these side effects disappeared despite the patient continuing to take the medicine. When symptoms persisted, they generally disappeared after stopping this medicine.

Other side 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, decreased stomach acidity, indigestion, back pain, limb pain, facial flushing, reduced sexual desire, impotence (inability to achieve an erection), decreased semen volume expelled during sexual intercourse. This decrease in semen volume does not appear to affect normal sexual function.

Rare(may affect up to 1 in 100 people)

• painful urination, skin rash, swelling and increased sensitivity in the chest, and ejaculation problems, dizziness, stomach pain, nausea, vomiting, reflux, eye pain, blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of the hands, feet, or ankles, feeling of fatigue, and Peyronie's disease (causing curved and painful erections).

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

• loss of consciousness, convulsions, and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), exfoliative dermatitis (generalized red peeling), bleeding in the penis, blood in the semen, and increased sweating.

Infarction and stroke have also been reported in rare cases in men takingBiturol. Most of these men had some heart problem before taking this medicine.

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

Some rare additional side effects have been reported in men takingtadalafilthat were not reported during clinical trials. These include:

- migraine, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.

Unknown frequency(cannot be estimated from available data): depression, decreased sexual desire that continued after stopping medication, anxiety, irregular heart rate, elevated liver enzymes, testicular pain, inability to achieve an erection that continued after stopping medication; ejaculation problems that continued after stopping medication, male infertility, or poor semen quality. Improved semen quality has been reported after stopping medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Biturol

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

Appearance of the product and contents of the packaging

Biturolis presented in the form of coated tablets, round, white, biconvex, and unnotched, 8 mm in size.

The tablets are available in packaging with PVC/PCTFE blisters and an aluminum foil in packaging of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: June 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).