SILDENAFIL ALMUS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil ALMUS 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Contents of the pack

1. What Sildenafil Almus is and what it is used for
2. What you need to know before you take Sildenafil Almus
3. How to take Sildenafil Almus
4. Possible side effects
5. Storage of Sildenafil Almus
6. Contents of the pack and other 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 in the penis, allowing blood flow when you are sexually stimulated. Sildenafil will only help you to get an erection if you are sexually stimulated.

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes also called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafil Almus

Do not take Sildenafil Almus

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may lead to a dangerous decrease in your blood pressure.
• If 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).

if you have a severe 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 a loss of vision 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 disorder of the red blood cells), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).

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

• If you have heart problems. Your doctor should carefully check if your heart can tolerate the extra strain of having sex.
• If you have currently stomach ulcers 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 at the same time as any other oral or local treatment for erectile dysfunction.

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

You must 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 tell 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.

Using Sildenafil Almus with other medicines

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

Sildenafil tablets may interact with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist, or nurse that you are taking Sildenafil and when you last took it. Do not take Sildenafil Almus with other medicines unless your doctor tells you to.

You must not take Sildenafil if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, often given to relieve angina pectoris (or "chest pain").

You must not take Sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start with a 25 mg dose of Sildenafil.

Some patients who are taking alpha-blockers, medicines used to treat high blood pressure or prostate enlargement, may experience dizziness or fainting, which can be caused by low blood pressure when getting up quickly from a sitting or lying position. Some patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is more likely to happen within 4 hours after taking Sildenafil. To minimize the chance of these symptoms, you should be on a regular daily dose of your alpha-blocker before starting Sildenafil Almus. Your doctor may advise you to start with a 25 mg dose of Sildenafil.

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

Using Sildenafil Almus with food, drinks, and alcohol

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

Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink 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 this medicine before driving or using machines.

Sildenafil Almus contains sodium

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

3. How to take Sildenafil Almus

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. 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 at the same time as Sildenafil orodispersible tablets.

You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

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

Sildenafil will only help you to get an erection if you are sexually stimulated. The time this medicine takes to work varies from person to person, but it normally takes between 30 minutes and 1 hour. The effect of Sildenafil may be delayed if you take it with a large meal.

If this medicine does not help you to get an erection, or if the erection does not last long enough for you to complete sexual intercourse, you should 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Do not take more tablets than your doctor recommends.

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

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of Sildenafil are usually mild to moderate and of short duration.

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

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

If they occur during or after intercourse:

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

- Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occurs very 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 very rarely.
• Severe skin reactions - this occurs very rarely.

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

• Seizures or fits - this occurs very 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 flush (including a feeling of warmth), indigestion, abnormal color vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashes of light, increased sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and stuffy nose), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood present in urine, pain in arms or legs, nosebleeds, feeling hot, and feeling tired.

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 in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, there have been rare reports of unstable angina (heart disease) and sudden death. It should be noted that most men who experienced these side effects had pre-existing heart disease before taking this medicine. It is not possible to determine whether these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Almus

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 other information

Composition of Sildenafil Almus

• The active substance is sildenafil.

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.

• The other ingredients are:

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

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 and packaging

Sildenafil Almus 100 mg film-coated tablets are blue, elliptical, and engraved with a "+" on one side, 15.9 mm long and 7.9 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 Farmacéutica, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

France: Sildenafil Almus 100 mg, film-coated tablet

Italy: Sildenafil Almus

Spain: Sildenafil Almus 100 mg film-coated tablets EFG

Date of last revision of this leaflet: March 2023

Other sources of information

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