Leaflet: information for the user

Sildenafilo Stada 25 mg film-coated tablets

Sildenafilo Stada 50 mg film-coated tablets

Read this 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 or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Sildenafilo Stada

3. How to take Sildenafilo Stada

4. Possible side effects

5. Storage of Sildenafilo Stada

6. Contents of the pack and additional information

Sildenafilo Stada contains the active ingredient sildenafilo, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the penis, allowing blood to flow in when sexually stimulated. Sildenafilo will only help you get an erection if you are sexually stimulated.

Sildenafilo is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man cannot obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo Stada

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

• If you are taking medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.

• If you are using any of the medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may lead to a dangerous drop 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 clots). Phosphodiesterase type 5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medication. 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, heart attack, or cerebral infarction, or if you have low blood pressure.

• If you have a rare inherited eye disorder (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 or pharmacist before starting to take Sildenafilo Stada.

• 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 handle the additional strain of sexual activity.

• If you have a current 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.

• Do not take sildenafil if you are taking a medication called ritonavir (for HIV treatment).

Do not use sildenafil simultaneously with any other treatment for erectile dysfunction.

Do not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other phosphodiesterase type 5 inhibitor.

Do not take sildenafil if you do not have erectile dysfunction.

Sildenafil is not indicated for use in women.

Special considerations for patients with renal or hepatic impairment

Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

Sildenafil is not indicated for use in individuals under 18 years of age.

Other medications and Sildenafilo Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Sildenafil tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, inform your doctor or pharmacist that you are taking sildenafil and when you took it. Do not take sildenafil with other medications unless your doctor advises you to.

Do not take sildenafil if you are taking medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "angina").

Do not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may lead to a dangerous drop 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 HIV treatment, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil. Do not take sildenafil if you are taking the protease inhibitor ritonavir (for HIV treatment).

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing or sitting up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur in the 4 hours following sildenafil intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of alpha-blockers before starting sildenafil. Your doctor may recommend starting 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 Stada with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that sildenafil takes a bit longer to take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability 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

Sildenafil is not indicated for use in women.

Driving and operating machinery

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

Sildenafilo Stada contains lecithin from soy

Do not use in case of allergy to peanuts or soy.

Sildenafilo Stada contains aluminum lake Ponceau 4R

May cause allergic reactions.

Sildenafilo Stada contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Sildenafilo Stada contains glucose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Sildenafilo Stada contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual starting dose is 50 mg.

Do not take sildenafilo more than once a day.

Do not take sildenafilo film-coated tablets with sildenafilo buccal dispersible tablets.

You should take sildenafilo approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the effect of sildenafilo is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you get an erection if you are sexually stimulated. The time it takes for sildenafilo to take effect varies from person to person, usually ranging from 30 minutes to one hour. The effect of sildenafilo may be delayed if you take it with a large meal.

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

If you take more Sildenafilo Stada than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Do not take more tablets than recommended by your doctor.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them. The reported side effects associated with the use of sildenafil are generally mild to moderate in intensity and of short duration.

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

• Allergic reaction -This occurs withlow frequency(may affect up to 1 in 100 people).

The symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain- This occurs withlow frequency.

If they occur during or after sexual intercourse:

• Position yourself in a semi-sitting position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections- This occursrarely(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision- This occursrarely.

• Severe skin reactions- This occursrarely.

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or attacks- This occursrarely.

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, warmth (including symptoms such as sudden heat sensation in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, 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 vision, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal swelling, 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 is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Stada

The active ingredient is sildenafil citrate.

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 are:

• Tablet core:

Lactose monohydrate

Microcrystalline cellulose E 460

Hydroxypropylcellulose E 464

Sodium croscarmellose

Sodium stearate fumarate

Anhydrous colloidal silica E 551

• Coating:

Aluminum lake carmine of indigo E 132

Medium-chain triglycerides

Hypromellose E 463

Maltodextrin

Polydextrose E 1200

Aluminum lake Ponceau 4R E 124

Talc E 553b

Titanium dioxide E 171

Monohydrate dextrose

Soy lecithin E 322

Maltodextrin

Potassium silicate/aluminum pigment potassium dioxide E 555

Sodium carboxymethylcellulose E 466

Appearance of the product and contents of the package

Sildenafilo Stada 25 mg are blue pearl-coated film-coated tablets, round biconvex, with an approximate diameter of 8 mm.

Sildenafilo Stada 50 mg are blue pearl-coated film-coated tablets, round biconvex, with an approximate diameter of 10 mm.

The tablets are presented in a blister pack containing 1, 2, 3, 4, 8, 12, 24, 36, 48, and 60 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Vienna

Austria

or

STADA Arzneimittel AG

Stadastr. 2-18,

61118 Bad Vilbel

Germany

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

Austria:Sildeanfil STADA 25 mg/50 mg Filmtabletten

Bulgaria:Sildenafil STADA 25 mg/50 mg ????????? ????????

Germany:Sildenafil AL 25 mg/50 mg Filmtabletten

Spain:Sildenafilo STADA 25 mg/50 mg comprimidos recubiertos con película EFG

Italy:Sildenafil EG 25 mg/50 mg compresse rivestite con film

Netherlands:Sildenafil STADA 25 mg/50 mg filmomhulde tabletten

Portugal:Sildenafil Ciclum

Romania:Sildenafil Hemofarm 25mg/50 mg comprimate filmate

Last review date of this leaflet:August 2022

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/