SILDENAFIL ALMUS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil ALMUS 50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Sildenafil Almus is and what it is used for
2. What you need to know before taking Sildenafil Almus
3. How to take Sildenafil Almus
4. Possible side effects
5. Storage of Sildenafil Almus
6. Package contents and additional information

1. What Sildenafil Almus is and what it is used for

Sildenafil Almus contains the active substance sildenafil, 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 flow when you are sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated.

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for sexual activity.

2. What you need to know before taking Sildenafil Almus

Do not take Sildenafil Almus

• If you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If you are taking medicines called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can lead to a dangerous decrease in your blood pressure.
• If you are taking riociguat. This medication 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 Sildenafil, have shown that they 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 disease (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).

If you have a penis deformity or Peyronie's disease.

• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Almus and contact your doctor immediately.

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

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

You should not take Sildenafil if you do not have erectile dysfunction.

The use of Sildenafil is not indicated in women.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafil Almus is not indicated in persons under 18 years of age.

Use of Sildenafil Almus with other medications

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

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

You should not take Sildenafil if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease 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 angina pectoris (or "chest pain").

You should not take Sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications can also lead to a dangerous decrease 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 in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafil.

Some patients who are receiving 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 decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafil. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafil. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafil.

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

Use of Sildenafil Almus with food, drinks, and alcohol

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

Consuming alcohol can temporarily make it more difficult 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 Sildenafil.

Pregnancy, breastfeeding, and fertility

The use of Sildenafil Almus is not indicated in women.

Driving and using machines

Sildenafil can cause dizziness and affect vision. You should know how you react to the medication before driving vehicles or using machinery.

Sildenafil Almus contains sodium

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

3. How to take Sildenafil Almus

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafil Almus more than once a day.

Do not take Sildenafil film-coated tablets with Sildenafil orodispersible tablets.

You should take Sildenafil approximately 1 hour before you plan to have sex. 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.

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time it takes for this medication to work varies from person to person, usually between half an hour and 1 hour. The effect of Sildenafil can be delayed if you take it with a large meal.

In the event that this medication does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafil Almus than you should:

You may experience an increase in side 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 further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The side effects reported in association with the use of Sildenafil are generally mild to moderate and short-lived.

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

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

If they occur during or after having sex:

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

- Do not use nitratesto treat chest pain.

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

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

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

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

• Seizures or fits - this occurs rarely.

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, hot flushes (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, 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, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal stuffiness or congestion, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of tightness in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in the color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling of the inside of the nose, 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 noteworthy that most of the 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 whether these side effects were directly related to sildenafil.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sildenafil Almus

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

Do not use this medication after the expiration date stated on the carton and blister, after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sildenafil Almus

• The active substance is sildenafil.

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

• The other ingredients are:

Core of the tablet: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.

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

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

Appearance of the product and package contents

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

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710 – 228

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

France: Sildenafil Almus 50 mg, film-coated tablet

Italy: Sildenafil Almus

Spain: Sildenafil Almus 50 mg film-coated tablets EFG

Date of the last revision of this package leaflet: March 2023

Other sources of information

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