ARVALTI 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Arvalti 2.5 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 Arvalti 2.5 mg film-coated tablets are and what they are used for
2. What you need to know before you take Arvalti 2.5 mg film-coated tablets
3. How to take Arvalti 2.5 mg film-coated tablets
4. Possible side effects
5. Storage of Arvalti 2.5 mg film-coated tablets
6. Contents of the pack and other information

1. What Arvalti 2.5 mg film-coated tablets are and what they are 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 you 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 2.5 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 a hard erect penis suitable for sexual activity.

2. What you need to know before you take Arvalti 2.5 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 to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase 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 condition 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). Phosphodiesterase 5 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, tell your doctor.

Before taking the tablets, tell 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 taking 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 be affected by this medicine or may affect the way tadalafil works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).
• 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 (anti-epileptic 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 cause a lack of fertility.

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Arvalti contains lactose

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

3. How to take Arvalti 2.5 mg film-coated tablets

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. 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 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 alcohol may temporarily lower 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 it may increase the risk of dizziness when standing up.

Consuming alcohol may affect your ability to get an erection.

Method of administration

The 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

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.

If you have any further questions on the use of this medicine, 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 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, you should 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 pain, pain in arms and legs, facial 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 transient loss of memory, 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 conditions.

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

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

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rash, certain disorders that affect blood flow to the eyes, irregular heartbeat, 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 commonly reported side effects in men over 75 years old taking tadalafil were dizziness and diarrhea. In men over 65 years old taking tadalafil, the most commonly 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Arvalti 2.5 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 packaging and blister after EXP. The expiry date is 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. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Arvalti 2.5 mg

• The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredients are:

Core of the tablet: lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, lauryl sulfate sodium, microcrystalline cellulose, magnesium stearate.

Coating of the tablet:

Opadry yellow 03K520010 which contains:

HPMC 2910/hypromellose

titanium dioxide (E171)

triacetin

talc

iron oxide yellow (E172)

Appearance of the product and contents of the pack

Arvalti 2.5 mg is a film-coated tablet of pale yellow-pink color, round, biconvex, marked with “2.5T” on one face and smooth on the other.

Diameter: 6.10±0.20 mm

Arvalti 2.5 mg is available in packs with blisters of 28 film-coated tablets.

Marketing authorization 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 request more information about this medicine by contacting the local representative of the marketing authorization holder:

Cipla Europe NV, branch in Spain,

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