ARVALTI 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Arvalti 5 mg Film-Coated Tablets EFG

Tadalafil

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

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Arvalti 5 mg film-coated tablets and what is it used for
2. What you need to know before you take Arvalti 5 mg film-coated tablets
3. How to take Arvalti 5 mg film-coated tablets
4. Possible side effects
5. Storage of Arvalti 5 mg film-coated tablets
6. Contents of the pack and further information

1. What is Arvalti 5 mg film-coated tablets and what is it used for

Arvalti contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Arvalti is used to treat erectile dysfunction. After sexual stimulation, Arvalti acts by helping to relax the blood vessels in your penis, allowing the flow of blood into the penis. The result is an improvement in erectile function. Arvalti will not help if you do not have erectile dysfunction.

It is important to note that Arvalti is not effective if there is no sexual stimulation.Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Arvalti 5 mg is used to treat erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Arvalti has been shown to significantly improve the ability to get an erection that lasts long enough for satisfactory sexual activity.

Arvalti 5 mg film-coated tablets are used to treat the symptoms of benign prostatic hyperplasia (a condition in which the prostate gland is enlarged). This can cause problems with the flow of urine. The symptoms include difficulty in starting to pass urine, a feeling of not being able to pass urine completely, needing to pass urine more often, even at night. Tadalafil improves blood flow and relaxes the muscles in the prostate and the bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in a short period of time, such as 1-2 weeks after starting treatment.

2. What you need to know before you take Arvalti 5 mg film-coated tablets

Do not takeArvalti if:

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

• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor (see section "Using Arvalti with other medicines").

• you have a severe heart disease or have had a heart attack in the last 90 days.

• you have had a stroke in the last 6 months.

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

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

• 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, such as tadalafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check this before starting treatment with Arvalti 5mg film-coated tablets for benign prostatic hyperplasia. Arvalti 5mg film-coated tablets do not treat prostate cancer.

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

• sickle cell anemia (a condition that affects red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if tadalafil is effective in patients who have been surgically treated:

• in the pelvic area.
• with a surgical procedure in which the prostate has been partially or totally removed and the nerves of the prostate have been 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 tadalafil, stop taking this medicine and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in patients who have taken tadalafil. Although it is not known if these cases are directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

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

Using Arvalti with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take tadalafil if you are already using nitrates.

Some medicines may affect the way this medicine works or this medicine may affect the way other medicines work. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• 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.
• other treatments for erectile dysfunction.

Taking Arvalti with drinks and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production 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 during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Arvalti contains lactose and sodium

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

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

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3. How to take Arvalti 5 mg film-coated tablets

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

For the treatment of erectile dysfunction

If you anticipate frequent use of tadalafil (at least twice a week), a low daily dose may be suitable for you, according to your doctor's judgment.

The recommended dose is one 5 mg tablet taken once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take Arvalti more than once a day.

Arvalti taken daily may be useful in men who anticipate having sexual activity at least twice a week.

Arvalti taken daily allows you to get an erection at any time during the 24 hours of the day, provided that you are sexually stimulated.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol may temporarily reduce your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Consuming large amounts of alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet taken once a day, approximately at the same time. If you have benign prostatic hyperplasia and erectile dysfunction, the dose is one 5 mg tablet taken once a day.

Do not take Arvalti 5 mg more than once a day.

Method of administration

Arvalti tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

If you take more Arvalti than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Arvalti

Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten doses. Do not take Arvalti more than once a day.

4. Possible side effects

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

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

Uncommon(may affect up to 1 in 100 people)

• allergic reactions including rash.
• chest pain - do not use nitrates but seek medical help immediately.

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

• Priapism, a prolonged and possibly painful erection after taking tadalafil. If you experience this type of erection, which can last for more than 4 hours, contact a doctor immediately.
• sudden loss of vision.

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

• Distorted, blurred, central blurred vision, or sudden loss of vision

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs, flushing, nasal congestion, indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, presence of blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, and ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, and hives (red itchy patches on the skin), bleeding from the penis, presence of blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease.

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

Some additional rare side effects have been reported in men taking tadalafil that were not observed in clinical trials, including:

• migraine, swelling in the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, 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)

• Distorted, blurred, central blurred vision, or sudden loss of vision

The most frequently reported side effects in men over 75 years old taking tadalafil were dizziness and diarrhea. In men over 65 years old treated with tadalafil, the most frequently reported side effect was diarrhea.

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 package leaflet. You can also report side effects directly via the 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. Storage of Arvalti 5 mg film-coated tablets

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 further information

1. Contents of the pack and further information

Composition of Arvalti 5 mg

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:

Core of the tablet: Lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, laurilsulfate sodium, microcrystalline cellulose, magnesium stearate.

Coating of the tablet: Opadry yellow 03K520010 contains HPMC 2910/Hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Arvalti 5 mg is a yellow-pink, round, biconvex film-coated tablet, marked with "5T" on one face and smooth on the other.

Diameter: 8.10 ± 0.20 mm

Arvalti 5 mg is available in packs with blisters containing 14, 28, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Cipla Europe NV

De Keyserlei 58-60, Box-19, 2018

Antwerp,

Belgium

Manufacturer

Cipla Europe NV

De Keyserlei 58-60

Box-19, 2018 Antwerp, Belgium

You can obtain further information on this medicine from the representative of the marketing authorisation holder in your country:

Cipla Europe NV, Spanish branch,

C/Guzmán el Bueno, 133, Edif. Britannia, 28003 Madrid

Date of last revision of this package leaflet:November 2023

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