STAXAR 50 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Staxar 50 mg Oral Disintegrating Films

Read the entire package leaflet carefully before starting to take the 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, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Staxar and what is it used for

This medication contains the active ingredient sildenafil, which belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. This medication will only help you achieve an erection if you are sexually stimulated.

This medication is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Staxar

Do not take Staxar

• If you are allergic to sildenafil or 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 administered 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 experienced a stroke or heart attack, or if you have low blood pressure.

• If you suffer from 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 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 a stomach ulcer or bleeding problems (such as hemophilia).

• If you experience a sudden decrease or loss of vision, stop taking this medication and contact your doctor immediately.

It is not recommended to use sildenafil simultaneously with any other oral or local treatment for erectile dysfunction.

You should not take this medication 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 this medication 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 this medication is not indicated in persons under 18 years of age.

Other medications and Staxar

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

This medication 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 Staxar and when you took it. Do 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 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 should reconsider treatment with sildenafil and recommend starting treatment with a lower dose (25 mg) for which other presentations are available.

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 possibility of these symptoms, you should receive a regular daily dose of your alpha-blocker before starting sildenafil. Your doctor may reconsider your treatment with this medication.

Using Staxar with food, drinks, and alcohol

Staxar can be taken with or without food. However, you may notice that Staxar takes a little longer to work if you take it with a heavy 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 this medication.

Pregnancy, breastfeeding, and fertility

The use of this medication is not indicated in women.

Driving and using machines

This medication can cause dizziness and affect vision. You should know how you react to sildenafil before driving vehicles or using machinery.

3. How to take Staxar

Follow the administration instructions for this medication exactly as indicated 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 Staxar more than once a day.

Do not take Staxar 50 mg oral disintegrating films with other presentations that contain sildenafil.

You should take this medication approximately one hour before you plan to have sex. The time it takes for sildenafil to work varies from person to person, usually between half an hour and one hour.

Place the oral disintegrating film in your mouth, on your tongue, where it will dissolve in seconds, and then swallow it with your own saliva or water.

The oral disintegrating films should be taken on an empty stomach, as you will notice that it takes longer to start working if you take it with a heavy meal.

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

This medication will only help you achieve an erection if you are sexually stimulated.

In case sildenafil does not help you achieve an erection or if the erection is not maintained long enough to complete sexual activity, consult your doctor.

If you take more Staxar 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 doses of Staxar 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.

How to administer the Staxar oral disintegrating film

• Sildenafil is available as a 50 mg oral disintegrating film that dissolves in the mouth.
• Open the Staxar oral disintegrating film packet with dry hands.
• The oral disintegrating film should be placed on the tongue, where it dissolves and can be swallowed with saliva.
• The oral disintegrating film can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany ingestion of films with liquids.

Instructions for use

Important: Do not handle the oral disintegrating film with wet hands!

Instructions for use:

Step 1.Hold the packet with the back towards you. Locate the arrow on the side, which is in the top left corner of the packet, and hold it with the side facing up. The packet is partially sealed on this side with two exposed flaps.

Step 2.Hold the two exposed flaps of the packet on the arrow mark. With a gentle separating motion, start to remove both flaps from the packet in opposite directions and separate the two layers of the packet.

Step 3.Continue with the separating motion until the two layers of the packet are almost separated. The oral disintegrating film is now visible inside the packet. It is not necessary to completely separate both layers of the packet to access the oral disintegrating film.

Steps 4, 5, and 6.Carefully remove the oral disintegrating film from the packet and place the oral disintegrating film on the top of your tongue. It will dissolve in seconds.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 Staxar and seek immediate medical attention:

• 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 it occurs during or after having 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 flushes (including 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, 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 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, transient decrease in blood flow to some parts of the brain, feeling of tightness in the throat, numbness of 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 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, unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting 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 if these side effects were directly related to this medication.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Staxar

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the packet after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not remove the oral disintegrating film from the outer aluminum packet until you are ready to take the medication inside. Do not use the medication if you notice that the aluminum packet is damaged.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Staxar

The active ingredient is sildenafil. Each oral disintegrating film contains 50 mg of sildenafil (as citrate).

• The other ingredients are:

Hypromellose 50 cps

Propylene glycol (E 1520)

Povidone

Sodium carbonate anhydrous

Polysorbate 80

Polyvinyl alcohol

Sucralose

Hypromellose 15 cps

Sodium lauryl sulfate

Neotame

Bitterness masker (B.T.M.) NG-410-146-4

Raspberry flavor

Peppermint oil

FD & C Blue 1 (E 133)

Appearance of the product and package contents

Staxar 50 mg is an oral disintegrating film, opaque, rectangular, non-sticky, blue in color.

The Staxar 50 mg oral disintegrating film is available in packets that contain a single oral disintegrating film.

Package of 2, 4, or 8 oral disintegrating films in a box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmitalia s.r.l

Via Pinciana 25

00198 Rome,

Italy

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Estate

Paola PLA 3000, Malta

Date of the last revision of this package leaflet: March 2024

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/