SILDENAFIL STADAPHARM 25 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Sildenafilo Stadapharm 25 mg film-coated tablets EFG

Sildenafilo Stadapharm 50 mg film-coated tablets EFG

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

• Keep this 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 not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Sildenafilo Stadapharm and what is it used for

Sildenafilo Stadapharm contains the active ingredient sildenafil, which belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the penis, allowing blood flow to the penis 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Stadapharm

DO NOT take Sildenafilo Stadapharm

• If you are allergic to sildenafil, peanuts, or soy, or to any of the other components of this medication (listed in section 6).
• If you are taking medications 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 medications 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 this medication:

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

Sildenafil should not be used 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 is not indicated in persons under 18 years of age.

Other medications and Sildenafilo Stadapharm

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. You should 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. You should 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 reduce 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.

Taking Sildenafilo Stadapharm with food, drinks, and alcohol

Sildenafil 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 heavy 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 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.

Sildenafilo Stadapharm contains soy lecithin

It should not be used in case of peanut or soy allergy.

Sildenafilo Stadapharm contains cochineal red A (Ponceau 4R)

This medication may cause allergic reactions.

Sildenafilo Stadapharm contains lactose and glucose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Sildenafilo Stadapharm contains sodium

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

3. How to take Sildenafilo Stadapharm

Follow the administration instructions for 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 Sildenafilo Stadapharm more than once a day.

Do not take sildenafil film-coated tablets with sildenafil orodispersible or chewable tablets.

You should take sildenafil approximately 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, inform your doctor or pharmacist.

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

If sildenafil 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 takemore Sildenafilo Stadapharm 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 nurse immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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.

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 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 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, feeling of warmth (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, impaired vision, 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, blocked or congested nasal passages, 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 urine, pain in 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 compression 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 vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, penile bleeding, presence of blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been rarely reported. It is noteworthy 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 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sildenafilo Stadapharm

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging 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. Deposit 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. Container Content and Additional Information

Composition of Sildenafilo Stadapharm

• The active ingredient is sildenafil.

Each film-coated tablet contains 25 mg of sildenafil (as citrate).

Each film-coated tablet contains 50 mg of sildenafil (as citrate).

• The other components (excipients) are:

Tablet core:

Lactose monohydrate

Microcrystalline cellulose E 460

Hydroxypropylcellulose E 464

Sodium croscarmellose

Sodium stearyl fumarate

Anhydrous colloidal silica E 551

Coating material:

Indigo carmine E 132

Medium-chain triglycerides

Hypromellose E 463

Maltodextrin

Polydextrose E 1200

Cochineal red A (Ponceau 4R) E 124

Talc E 553b

Titanium dioxide E 171

Dextrose monohydrate

Soy lecithin E 322

Maltodextrin

Aluminum and potassium silicate (E555) / Titanium dioxide

Sodium carboxymethylcellulose E 466

Appearance of the Product and Container Content

Sildenafilo Stadapharm 25 mg film-coated tablets EFG are round, biconvex, film-coated tablets with a pale blue nacreous color, with an approximate diameter of 8 mm.

Sildenafilo Stadapharm 50 mg film-coated tablets EFG are round, biconvex, film-coated tablets with a pale blue nacreous color, with an approximate diameter of 10 mm.

The tablets are supplied in PVC/PVDC-Aluminum blisters in boxes of 2, 4, and 8 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Nieuwe Donk 9

4879 AC Etten-Leur

Netherlands

or

Clonmel Healthcare Limited

3 Waterford Road

E91 D768 Clonmel

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

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

Bulgaria ?????????? ????? 25 mg/ 50 mg ????????? ????????

Estonia Sildenafil STADA

Spain Sildenafilo Stadapharm 25 mg/ 50 mg film-coated tablets EFG

Hungary Sildenafil STADA 25 mg/ 50 mg filmtabletta

Ireland Sildenafil Clonmel 25 mg/ 50 mg film-coated tablets

Italy Sildenafil EG STADA ITALIA 25 mg/ 50 mg compresse rivestite con film

Lithuania Sildanafil STADA 25 mg/ 50 mg plevele dengtos tabletes

Latvia Sildenafil STADA 25 mg/ 50 mg apvalkotas tabletes

Malta Sildenafil Clonmel 25 mg/ 50 mg film-coated tablets

Netherlands Sildenafil HTP 25 mg/ 50 mg, filmomhulde tabletten

Norway Sildenafil STADA

Romania Sildenafil STADA 25 mg/ 50 mg comprimate filmate

Date of the Last Revision of this Leaflet:November 2023.

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