SILDENAFIL STADAPHARM 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Stadapharm 25 mg film-coated tablets EFG

Sildenafilo Stadapharm 50 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.

Contents of the pack

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

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

Sildenafilo Stadapharm contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis 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 Sildenafilo Stadapharm

Do not take Sildenafilo Stadapharm

• If you are allergic to sildenafil, peanut, or soy, or to 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 this medicine:

• 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 withstand the extra strain of having sex.
• If you currently have stomach ulcers 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 medicines and Sildenafilo Stadapharm

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 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 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, which can 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 happen 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 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.

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 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 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 or using machines.

Sildenafilo Stadapharm contains soybean lecithin

Do not use if you are allergic to peanut or soy.

Sildenafilo Stadapharm contains cochineal red A (Ponceau 4R)

This medicine may cause allergic reactions.

Sildenafilo Stadapharm contains lactose and glucose

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

Sildenafilo Stadapharm contains sodium

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

3. How to take Sildenafilo Stadapharm

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, 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 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.

If 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 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 or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

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 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 with sildenafil are usually 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 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 symptoms such as sudden warmth 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, flashing lights, increased sensitivity to light, tearing, 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), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood 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 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, eye swelling 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, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 men who experienced these side effects, although not all, had pre-existing heart problems 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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Stadapharm

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 the month shown.

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. Package Contents 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:

Core of the tablet:

Lactose monohydrate

Microcrystalline cellulose E 460

Hydroxypropylcellulose E 464

Croscarmellose sodium

Sodium stearyl fumarate

Colloidal anhydrous 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 Package Contents

Sildenafilo Stadapharm 25 mg film-coated tablets EFG are round, biconvex, film-coated tablets with a pale blue opalescent 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 opalescent 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/