SILDECEL 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildecel 100 mg film-coated tablets EFG

sildenafil

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 symptoms 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.

Contents of the pack

1. What Sildecel is and what it is used for
2. What you need to know before you take Sildecel
3. How to take Sildecel
4. Possible side effects
5. Storage of Sildecel
6. Contents of the pack and other information

1. What Sildecel is and what it is used for

Sildecel contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). 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 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 Sildecel

Do not takeSildecel

• 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 can cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are 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 called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a dangerous drop 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). PDE5 inhibitors, such as sildenafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• 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:

• 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 penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can handle 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 this medicine 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 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 is not indicated in persons under 18 years of age.

Other medicines andSildecel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Sildenafil tablets may interfere with some medicines, 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 medicines unless your doctor advises you to.

You should not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines can also cause a dangerous drop 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 treatment with the lowest dose (25 mg) of sildenafil.

Some patients who are receiving an alpha-blocker, a medicine 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 happen within 4 hours of taking sildenafil. To minimize the chance of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting on sildenafil. Your doctor may advise you to start with the lower dose (25 mg) of sildenafil.

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

Use ofSildecelwith food, drinks, and alcohol

This medicine can be taken with or without food. However, you may notice that sildenafil takes a little longer to work if you take it with a large meal.

Drinking alcohol can temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not indicated in women.

Driving and using machines

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

Sildecelcontains lactose

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

3. How to take Sildecel

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not takeSildecelmore than once a day.

Do not take Sildecel film-coated tablets with sildenafil orodispersible tablets or other medicines that contain sildenafil.

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 sildenafil 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 it takes for sildenafil to work varies from person to person, but it normally takes between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a large meal.

In the event that sildenafil does not help you to get an erection, or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take moreSildecelthan 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 or pharmacist immediately or call the Toxicology Information Service, phone: 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 advised.

If you have any further questions on the use of this medicine, 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 Sildecel are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop takingSildeceland seek medical attention immediately:

• Allergic reaction - this occurs with rare 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 rare frequency.

• If they occur during or after 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 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 sudden feeling of heat in the upper body), indigestion, abnormal color perception, 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 (including symptoms such as runny nose, sneezing, and nasal congestion), inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), 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 of the inside of the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most of the men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to Sildecel.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildecel

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

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 ofSildecel

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• The other ingredients are:

• Core of the tablet: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, carmine indigo (E132).

Appearance of the product and contents of the pack

Sildecel film-coated tablets are blue, oblong, biconvex, 16.5 mm long and 6.5 mm wide, marked with "100" on one side.

The tablets are presented in blisters containing 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.

Pienków, ul. M. Adamkiewicza 6A

05-152 Czosnów,

Poland

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice,

Poland

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

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Date of last revision of this leaflet: July 2024

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/