SILDENAFIL STADAFARMA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo Stadafarma 100 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sildenafilo Stadafarma and what is it used for
2. What you need to know before taking Sildenafilo Stadafarma
3. How to take Sildenafilo Stadafarma
4. Possible side effects
5. Storage of Sildenafilo Stadafarma
6. Package Contents and Additional Information

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

Sildenafilo Stadafarma 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 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 get or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Stadafarma

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 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 nitrate ("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 a loss of vision due to a 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 red blood cell abnormality), 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 check if your heart can withstand the extra effort 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.
• You should not take sildenafil if you are taking a medication called ritonavir (for the treatment of HIV).

It is not recommended to use sildenafil 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.

Use of Sildenafilo Stadafarma with Other Medications

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. 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 nitrate ("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.

You should not take sildenafil if you are taking the protease inhibitor ritonavir(for the treatment of HIV).

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.

In order to reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of the alpha-blocker regularly before starting sildenafil. Your doctor may indicate 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 little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to get 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 Stadafarma Contains Soy Lecithin, Aluminum Lake Ponceau 4R, Lactose, Glucose, and Sodium

Do not use this medication if you are allergic 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 an intolerance to certain sugars, consult with them before taking this medication.

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, 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".

3. How to Take Sildenafilo Stadafarma

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. The tablet can be divided into equal doses.

How to Divide the Tablet

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

Do not take sildenafil more than once a day.

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

You should take sildenafil about 1 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 1 hour. The effect of sildenafil may be delayed if you take it with a large meal.

In the event that 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 Take More Sildenafilo Stadafarma 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

If you have any further 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 gets 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 rare frequency(may affect up to 1 in 100 people).

The 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 having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to 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.

The 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 flushes (including symptoms such as a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, 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, nasal stuffiness or congestion, 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 the urine, pain in the 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 tightness in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decrease in visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in the color of the white of the eye, penile bleeding, presence of blood in the 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 of the 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 if these side effects were directly related to sildenafil.

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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 Stadafarma

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

Do not use this medication after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

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

6. Package Contents and Additional Information

Composition of Sildenafilo Stadafarma

The active ingredient is sildenafil.

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

The other ingredients are:

Core of the tablet:

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

Coating:

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

Appearance of the Product and Package Contents

Sildenafilo Stadafarma 100 mg are blue, pearl-colored, round, biconvex film-coated tablets with a diameter of approximately 12 mm and a cross-shaped notch on both sides. The tablet can be divided into equal doses.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of the Last Revision of this Package Leaflet:July 2022

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