BITUROL 5 MG/5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Biturol 5 mg/5 mg Film-Coated Tablets

finasteride/tadalafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Biturol and what is it used for

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

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

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

2. What you need to know before you take Biturol

Do not takeBiturol

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

• 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 pectoris ("chest pain"). It has been seen that tadalafil increases the effects of these medicines. If you are taking any type of nitrate or are not sure, tell your doctor.

effects of these medicines. If you are taking any type of nitrate or are not sure, tell your doctor.

• you have a severe heart disease or have recently had a heart attack, in the last 90 days.
• you have recently had a stroke, in the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as "eye infarction".
• 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Biturol.

Tell your doctor about your current and past medical problems and any allergy you suffer from.

Biturol is only intended for the treatment of BPH in males. Women should not use this medicine when they are or may be pregnant, nor should they be exposed to Biturol by handling crushed or broken tablets. If the active ingredient finasteride is absorbed after oral use or through the skin by a woman who is pregnant with a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with this active ingredient, she should consult her doctor. The Biturol tablets are film-coated and this will prevent contact with the 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 minimal amounts of the drug.

BPH develops over a long period of time. Sometimes the symptoms improve quickly, 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, therapy with Biturol may reduce the risk of not being able to urinate and therefore the need for surgery. You should see your doctor regularly for periodic check-ups and to assess your progress.

Since benign prostatic hyperplasia and prostate cancer can have the same 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 the 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, tell your doctor if you have:

• sickle cell anemia (a red blood cell disorder).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a serious liver problem.
• a serious kidney problem.

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

• surgery in the pelvic area.
• a surgical intervention in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

A sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a 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 should 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 take any other medicines.

Do not take Biturol if you are already using nitrates.

Some medicines may be affected by Biturol or may affect the proper functioning of Biturol. Tell 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 medicines for high blood pressure.
• riociguat, a medicine to treat pulmonary hypertension
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole (medicines to treat infections).
• other treatments for erectile dysfunction.

Taking Biturol with food, drinks, and alcohol

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, breast-feeding, and fertility

Biturol is for use in men only.

Biturol is not indicated in women.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In dogs treated with finasteride, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

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

Biturol contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Biturol contains sodium

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

3. How to take Biturol

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The Biturol tablets are for oral administration only in men. Swallow the tablet whole with a little water. Take one Biturol tablet a 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.

Recommended doseis one tablet once a 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Biturol

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

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

If you stop taking Biturol

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are generally mild to moderate.

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; hives and difficulty breathing.
• Allergic reactions including rash.
• Chest pain - do not use nitrates but seek medical help immediately.
• Priapism, a prolonged and possibly painful erection after taking tadalafil. If you suffer from this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• Sudden loss of vision, distorted, blurred, central blurred vision, or sudden decrease in vision.

You must inform your doctor immediatelyof any change in breast tissue, such as lumps, pain, enlargement, or nipple discharge, 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 the symptoms persisted, they generally disappeared after stopping the medicine.

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, high blood pressure, nasal inflammation and/or throat, nasal congestion, flu-like illness, diarrhea, decreased stomach acidity, indigestion, back pain, limb pain, facial flushing, decreased sexual desire, impotence (inability to have an erection), decreased amount of semen ejaculated during sexual intercourse. This decrease in semen amount does not seem to alter normal sexual function.

Uncommon(may affect up to 1 in 100 people)

• painful urination, skin rash, breast swelling and increased sensitivity, and problems with ejaculation, dizziness, stomach pain, nausea, vomiting, reflux, eye pain, blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, feeling of tiredness, and 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, hives (red itchy patches on the skin), exfoliative dermatitis (generalized red scaly skin), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking Biturol. Most of these men had pre-existing heart problems before taking this medicine.

Rarely, cases of decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not notified during clinical trials. These include:

• migraine, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.

Frequency not known(cannot be estimated from the available data): depression, decreased sexual desire that continued after stopping the medication, anxiety, irregular heartbeat, elevated liver enzymes, testicular pain, inability to have 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 has been reported after stopping the medication.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Medicines and Healthcare Products Agency (AEMPS) (http://www.aemps.gob.es/). By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Biturol

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

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

Appearance and packaging

Biturol is presented in the form of film-coated tablets, round, white, biconvex, and without scoring, 8 mm in size.

The tablets are available in blister packs of PVC/PCTFE and an aluminum foil in packs of 30 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet: June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).