FINASTERIDE/TADALAFIL ALTER 5 mg/5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Finasteride/Tadalafil Alter 5 mg/5 mg film-coated tablets

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 Finasteride/Tadalafil Alter and what is it used for
2. What you need to know before you take Finasteride/Tadalafil Alter
3. How to take Finasteride/Tadalafil Alter
4. Possible side effects
5. Storing Finasteride/Tadalafil Alter
6. Contents of the pack and other information

1. What is Finasteride/Tadalafil Alter and what is it used for

Finasteride/Tadalafil Alter 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 taken at the same time.

Finasteride helps to 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 to reduce symptoms.

2. What you need to know before you take Finasteride/Tadalafil Alter

Do not take Finasteride/Tadalafil Alter

• 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 form 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 form of nitrate or are not sure, tell your doctor.

effects of these medicines. If you are taking any form 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 condition 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 Finasteride/Tadalafil Alter.

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

Finasteride/Tadalafil Alter is only intended for the treatment of BPH in men. Women should not use this medicine when they are or may be pregnant, nor should they be exposed to Finasteride/Tadalafil Alter 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 of the genital organs. If a pregnant woman comes into contact with this active ingredient, she should consult a doctor. The tablets of Finasteride/Tadalafil Alter are film-coated and this will prevent contact with the active ingredients during normal handling, provided that 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 Finasteride/Tadalafil Alter 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 Finasteride/Tadalafil Alter 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 BPH and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer check before starting treatment with Finasteride/Tadalafil Alter for BPH. Finasteride/Tadalafil Alter does not treat prostate cancer.

Finasteride/Tadalafil Alter 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 Finasteride/Tadalafil Alter.

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

• sickle-cell anaemia (a disorder of the red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (cancer of the blood cells).
• any deformation of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known if Finasteride/Tadalafil Alter is effective in patients who have undergone:

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

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

A sudden 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 loss of hearing, stop taking Finasteride/Tadalafil Alter and contact your doctor immediately.

Finasteride/Tadalafil Alter 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

Finasteride/Tadalafil Alter should not be used in children or adolescents under 18 years of age.

Other medicines and Finasteride/Tadalafil Alter

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

Do not take Finasteride/Tadalafil Alter if you are already using nitrates.

Some medicines may be affected by Finasteride/Tadalafil Alter or may affect the way Finasteride/Tadalafil Alter works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with BPH).
• other medicines to treat 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 HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole (medicines to treat infections).
• other treatments for erectile dysfunction.

Taking Finasteride/Tadalafil Alter with food, drinks, and alcohol

Information about the effect of alcohol is found in section 3. Grapefruit juice may affect the way Finasteride/Tadalafil Alter works and should be taken with caution. Consult your doctor for more information.

Pregnancy, breast-feeding, and fertility

Finasteride/Tadalafil Alter is for use in men only.

Finasteride/Tadalafil Alter 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 you take the tablets before driving or using machines.

Finasteride/Tadalafil Alter 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.

Finasteride/Tadalafil Alter contains sodium

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

3. How to take Finasteride/Tadalafil Alter

Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The tablets of Finasteride/Tadalafil Alter are for oral administration only in men. Swallow the tablet whole with a little water. Take one Finasteride/Tadalafil Alter tablet per day, with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Finasteride/Tadalafil Alter, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

The recommended doseis one tablet once a day, approximately at the same time. Do not take Finasteride/Tadalafil Alter more than once a day.

If you take more Finasteride/Tadalafil Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 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 Finasteride/Tadalafil Alter

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 Finasteride/Tadalafil Alter

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 experience 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, or diminished vision, central blurred vision, or sudden loss of 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 even though the patient continued to take the medicine. When the symptoms persisted, they generally disappeared after stopping this 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, diarrhoea, decreased stomach acidity, indigestion, back pain, limb pain, facial flushing, reduced sexual desire, impotence (inability to have an erection), decreased amount of semen ejaculated during intercourse. This decrease in semen does not seem to alter normal sexual function.

Uncommon(may affect up to 1 in 100 people)

• difficulty urinating, skin rash, breast swelling and increased sensitivity, 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 tired, 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 or transient loss of hearing, hives (red itchy patches on the skin that sting), 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 Finasteride/Tadalafil Alter. Most of these men had pre-existing heart disease before taking this medicine.

Sudden or transient loss of vision, partial, transient, or permanent in one or both eyes has been reported rarely.

Some additional rare side effectshave been reported in men taking tadalafil that were not reported 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; problems with ejaculation that continued after stopping the medication, male infertility or poor semen quality. An 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 via the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Finasteride/Tadalafil Alter

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 is the last day of the month stated.

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. Packaging Content and Additional Information

Composition of Finasteride/Tadalafil Alter

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

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

Product Appearance and Packaging Content

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

The tablets are available in packs with PVC/PCTFE blisters 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 the Last Revision of this Leaflet: July 2024

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