Leaflet: information for the patient

Sildenafilo Stadafarma 100 mg film-coated tablets EFG

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, consult 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 Stadafarma is and what it is used for

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

3. How to take Sildenafilo Stadafarma

4. Possible side effects

5. Storage of Sildenafilo Stadafarma

6. Contents of the pack and additional information

Sildenafilo Stadafarma 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 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 Stadafarma

• 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 certain 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 "chest pain"). 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). PDE5 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 or heart attack, 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, pharmacist, or nurse before starting to take sildenafil:

• If you have sickle cell anemia (a blood disorder), leukemia (blood 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 check if your heart can handle the additional strain of sexual activity.
• If you 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.
• Do not take sildenafil if you are taking a medication called ritonavir (for HIV treatment).

Sildenafil is not recommended to be used simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

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

Sildenafil use is not indicated in women.

Special considerations in patients with renal or hepatic problems

You should inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

Sildenafil use is not indicated in individuals under 18 years old.

Use of Sildenafilo Stadafarma with other medications

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, you should inform your doctor, pharmacist, or nurse 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 of these medications may lead to a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these medications may also 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 that you start 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 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.

Use of Sildenafilo Stadafarma 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 use is not indicated 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 Stadafarma contains lecithin from soy, aluminum lake Ponceau 4R, lactose, glucose, and sodium

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

This medication may cause allergic reactions because it contains aluminum lake Ponceau 4R.

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

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

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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg. The tablet can be divided into equal doses.

How to divide the tablet

Place the tablet on a hard and flat surface,with the smallest notch facing down. Next, divide the tablet by applying simultaneous strong pressure with both thumbs on the right and left sides of the notch.

Do not take sildenafilo more than once a day.

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

You should take sildenafilo 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 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 half an hour to one hour. The effect of sildenafilo may be delayed if taken 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 Stadafarma than you should

You may experience an increase in adverse 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

Like all medicines, this medicine can cause 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 severe side effects, stop taking sildenafil and seek medical attention immediately:

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

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

• Chest pain – this occurs withinfrequent 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 occursinfrequently(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 occursinfrequently.

• Severe skin reactions - this occursinfrequently.

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

• Convulsions or seizures - this occursinfrequently.

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 in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(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, ringing in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as coughing, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as stomach burning), 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 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 Pharmacovigilance 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.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Any divided part of the remaining tablet must be discarded after 4 weeks.

Composition of Sildenafilo Stadafarma

The active ingredient is sildenafil.

Each tablet contains 100 mg of sildenafil (as citrate).

The other components are:

Tablet core:

Lactose monohydrate, microcrystalline cellulose E-460, hydroxypropyl cellulose E-463, sodium croscarmellose E-468, sodium stearate fumarate, anhydrous colloidal silica E-551

Coating:

Indigo carmin lake of aluminium E-132, medium-chain triglycerides, hypromellose E-464, maltodextrin, polydextrose E-1200, lake of aluminium Ponceau 4R E-124, talc E-553b, titanium dioxide E-171, dextrose monohydrate, soy lecithin E-322, pigment E-555 (aluminium silicate potassium and titanium dioxide), sodium carboxymethylcellulose E-466.

Appearance of the product and content of the container

Sildenafilo Stadafarma 100 mg are blue pearl-coated tablets, round, biconvex, with an approximate diameter of 12 mm and a cross-score on both faces.The tablet can be divided into equal doses..

Sildenafilo Stadafarma is available in containers containing 4, 8 or 12 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Last review date of this leaflet:July 2022

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