Sildecel 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sildecel 50 mg film-coated tablets EFG

sildenafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Sildecel is and what it is used for
2. What you need to know before taking Sildecel
3. How to take Sildecel
4. Possible side effects
5. How to store 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 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into it 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 referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildecel

Do not take Sildecel

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

Talk to your doctor, pharmacist, or nurse before taking sildenafil:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully assess whether your heart can tolerate the additional physical stress of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.

It is not recommended to use sildenafil together with any other oral or local treatments 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

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 individuals under 18 years of age.

Other medicines and Sildecel

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

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking sildenafil and when you took it. You should not take sildenafil with other medicines unless advised by your doctor.

Do not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines may 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 (or "chest pain").

Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also cause a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in HIV treatment, your doctor may recommend starting sildenafil at the lowest dose (25 mg).

Some patients taking alpha-blockers, medicines used to treat high blood pressure or prostate enlargement, may experience dizziness or feeling faint, which may be caused by a drop 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 after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of your alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildecel with food, drinks, and alcohol

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

Drinking alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medicine, it is advisable 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 may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.

Sildecel contains lactose

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

3. How to take Sildecel

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Sildecel film-coated tablets must not be taken more than once a day.

Do not take Sildecel film-coated tablets together with sildenafil orodispersible tablets or other medicines containing sildenafil.

You should take sildenafil 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 sildenafil 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 required for sildenafil to take effect varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.

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

If you take more Sildecel than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

You must 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with the use of Sildecel are generally mild to moderate in intensity and short in duration.

If you experience any of the following serious adverse effects, stop taking Sildecel and seek immediate medical attention:

• Allergic reaction – occurs rarely (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 – occurs rarely.

• If chest pain occurs during or after sexual activity:

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

  • Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections – occurs rarely (may affect up to 1 in 1,000 people). If you have an erection lasting longer than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – occurs rarely.

• Severe skin reactions – occurs rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – occurs rarely.

Other adverse 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 sudden sensation of heat in the upper body), indigestion, abnormal colour 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, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, dry mouth, nasal blockage or congestion, nasal mucosal swelling (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to parts of the brain, throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to Sildecel.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildecel

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

• The other components are:

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

• Film coating: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, indigo carmine (E132).

Appearance of the product and contents of the pack

Sildecel coated tablets are blue, round, biconvex tablets, marked with "50" on one side.

The tablets are supplied in blisters containing 4, 8 or 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Date of the most recent review of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/