ARVALTI 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Arvalti 20 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 20 mg film-coated tablets are and what they are used for
2. What you need to know before you take Arvalti 20 mg film-coated tablets
3. How to take Arvalti 20 mg film-coated tablets
4. Possible side effects
5. Storage of Arvalti 20 mg film-coated tablets
6. Contents of the pack and further information

1. What Arvalti 20 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 for the treatment of 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 20 mg is used for the treatment of 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 20 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 for the treatment of 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 or liver problem.

• you have recently had a heart attack (within the last 90 days).

• you have had a stroke (including a ‘mini-stroke’ or transient ischaemic attack) within 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 ischaemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• 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 been shown to increase the hypotensive effects 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 anaemia (a disease of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukaemia (cancer of the blood cells).
• have any deformation of the penis.
• have a severe liver problem.
• have a severe kidney problem.

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

• had pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland).

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 some 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 by women.

Children and adolescents

This medicine should not be used in children and 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 taking nitrates.

Some medicines may be affected by this medicine or may affect how well tadalafil works. 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 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 food and drink

Information about the effect of alcohol is in section 3. Grapefruit juice may affect how well 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 count has been observed in some men. It is unlikely that these effects will affect 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 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 is essentially sodium-free.

3. How to take Arvalti 20 mg film-coated tablets

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

For the treatment of erectile dysfunction

The recommended doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. The tablets are for oral use.

You may take a 10 mg tablet at least 30 minutes before sexual activity.

This medicine may be effective for up to 36 hours after taking the tablet.

Do not take this medicine more than once a day. Arvalti 10 mg and 20 mg will be used before planned sexual activity and is not recommended for continuous daily use.

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

Method of administration

The 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 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, stating 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 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 taking the medicine and seek medical help immediately:

Uncommon(may affect up to 1 in 100 people)

• allergic reactions including skin 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 aches, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach ache, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in 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 that sting), bleeding from the penis, 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 problems.

Rarely, cases of sudden loss of vision in one or both eyes have been reported.

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

• migraine, swelling of 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 commonly reported side effects in men over 75 years old taking tadalafil were dizziness and diarrhoea. In men over 65 years old taking tadalafil, the most commonly reported side effect was diarrhoea.

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 and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Arvalti 20 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 that month.

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

Composition of Arvalti 20 mg

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are:

Core of the tablet: lactose monohydrate, croscarmellose sodium, hypromellose, laurilsulfate sodium, microcrystalline cellulose, magnesium stearate.

Coating of the tablet: Opadry II yellow 32K12884 contains lactose monohydrate, HPMC 2910/ hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172).

Appearance and packaging

Arvalti 20 mg is a yellow, capsule-shaped, biconvex film-coated tablet, marked with “20T” on one face and plain on the other.

Diameter: 14.10 ± 0.20 mm

Thickness: 6.10 ± 0.20 mm

Arvalti 10 mg is available in packs of 2, 4, 8, 10, or 12 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

For further information about this medicine, contact the local representative of the marketing authorisation holder:

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 Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es.