Prospect: Information for the Patient

Sildenafilo ALMUS 50 mg Film-Coated Tablets

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

• Consult your doctor, pharmacist, or nurse if you experience any adverse effects, even if they are not listed in this prospect. See section 4.

Sildenafilo Almus contains the active ingredient sildenafilo, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. Sildenafilo will only help you get an erection if you are sexually stimulated.

Sildenafilo is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man cannot obtain or maintain a firm, adequate erection for sexual activity.

Do not take Sildenafilo Almus

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking certain medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.
• If you are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots) and the PDE5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

• If you have a serious heart or liver problem.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.

• If you have a rare inherited eye disorder (such as retinitis pigmentosa).
• If you have experienced previous vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sildenafilo Almus:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).

Cancer of the blood cells or bone marrow.

• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully check if your heart can handle the additional strain of sexual activity.
• If you have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Almus and contact your doctor immediately.

It is not recommended to use Sildenafilo simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take Sildenafilo with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do not take Sildenafilo if you do not have erectile dysfunction.

The use of Sildenafilo is not indicated in women.

Special considerations in patients with renal or hepatic problems

You must inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Almus is not indicated in individuals under 18 years old.

Use of Sildenafilo Almus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Sildenafilo tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafilo and when you took it. Do not take Sildenafilo with other medications unless your doctor advises you to.

Do not take Sildenafilo if you are taking nitrates, as the combination may lead to a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take Sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur in the 4 hours following Sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting Sildenafilo. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo.

Inform your doctor or pharmacist if you are taking medications that contain sacubitril/valsartan, used to treat heart failure.

Use of Sildenafilo Almus with foods, beverages, and alcohol

Sildenafilo Almus can be taken with or without food. However, you may notice that this medication takes a little longer to take effect if you ingest it with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Almus is not indicated in women.

Driving and operating machinery

Sildenafilo may cause dizziness and affect your vision. You must know how you react to the medication before driving vehicles or operating machinery.

Sildenafilo Almus contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Almus more than once a day.

Do not take Sildenafilo film-coated tablets with Sildenafilo buccal dispersible tablets.

Take Sildenafilo approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you get an erection if you are sexually stimulated. The time it takes for this medication to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of Sildenafilo may be delayed if taken with a large meal.

If this medication does not help you get an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Almus than you should:

You may experience an increase in adverse effects and their severity. Doses above 100 mg do not increase efficacy.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of Sildenafilo are generally mild to moderate in intensity and of short duration.

If you experience any of the following serious side effects, stop taking Sildenafilo Almus and seek medical attention immediately:

• Allergic reaction - this occurs withlow frequency(may affect up to 1 in 100 people). Symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - this occurs withlow frequency.

If they occur during or after sexual intercourse:

- Sit in a semi-upright position and try to relax

-Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occursinfrequently(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision - this occursinfrequently.
• Severe skin reactions - this occursinfrequently.

Symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures - this occursinfrequently.

Other side effects:

Very common(may affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, facial flushing, warmth (including symptoms such as sudden heat sensation in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights vision, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as sneezing, runny nose, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these side effects were directly related to sildenafilo.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sildenafilo Almus

• The active ingredient is sildenafilo.

Each film-coated tablet contains sildenafilo citrate equivalent to 50 mg of sildenafilo.

• The other components are:

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.

Film coating(Opadry II, 85F20464 Blue): polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, indigo carmine (E132).

(Sildenafilo Almus contains sodium, see also section 2).

Appearance of the product and content of the container

Sildenafilo Almus 50 mg tablets are blue film-coated, elliptical tablets, 12.6 mm in length and 6.3 mm in width. Available in blisters containing 4, 8, 12, or 24 film-coated tablets.

Possible commercialization only of some container sizes.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

France: Sildenafil Almus 50 mg, film-coated tablet

Italy: Sildenafil Almus

Spain:Sildenafilo Almus 50 mg film-coated tablets EFG

Last review date of this leaflet: March 2023

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)