PATIENT INFORMATION LEAFLET

Zuandol 50 mg Film-Coated Tablets

Sildenafil Citrate

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. Do 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.

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

Zuandol is indicated for the treatment of male erectile dysfunction, sometimes referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Zuandol

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking certain medications called nitrates, as the combination may cause 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 nitrite ("poppers"), as the combination may cause 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 Zuandol, 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 experienced 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 Zuandol:

• 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. In this case, your doctor must 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 sudden vision loss, stop taking Zuandol and contact your doctor immediately.

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

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

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

Zuandol is not indicated for use in women.

Children and adolescents

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

Special considerations in patients with renal or hepatic problems

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

Other medications and Zuandol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Do not take Zuandol if you are taking nitrates, as the combination of these medications may cause 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 Zuandol if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications may also cause 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 to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafil.

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

Zuandol can be taken with or without food. However, you may notice that Zuandol takes a little longer to take effect if you ingest it 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 Zuandol.

Pregnancy, breastfeeding, and fertility

Zuandol is not indicated for use in women.

Driving and operating machinery

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

Zuandol 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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not take Zuandol more than once a day..

Do not take Zuandol with other medications that contain sildenafil.

Take Zuandol 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 this medication is too strong or too weak, inform your doctor or pharmacist.

Zuandol will only help you achieve an erection if you are sexually stimulated. The time it takes to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of this medication may be delayed if taken with a large meal.

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

If you take more Zuandol 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. You can also consult immediately with your pharmacist or call theToxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

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

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

• Allergic reaction - this occurs withlow frequency(may affect up to 1 in 100 people). 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 your chest pain.

• Prolonged and sometimes painful erections – this occursrarely(may affect up to 1 in 1000 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. 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 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 eruptions,eye irritation, eye discharge/ red eyes, eye pain,lightning-like vision, visual clarity, light sensitivity, watery eyes,palpitations, rapid heart rate,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 heartburn), blood in urine,arm or leg pain,nosebleed,sensation of heat and feeling of fatigue.

Rare(may affect up to 1 in 1000 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 interior swelling, sensation 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 medication. It is not possible to determine if these side effects were directly related to Zuandol.

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 prospectus. You can also report them directly through the Spanish System for 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 medication.

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

Store in the original packaging to protect it from moisture.

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.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zuandol 50 mg

The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

The other components are:

Core tablet:microcrystalline cellulose, dibasic calcium phosphate, sodium croscarmellose and magnesium stearate.

Coating:polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc and aluminium lake of indigo carmine.

Appearance of the product and contents of the packaging

Zuandol 50 mg tablets have a coating, are elliptical in shape and are blue in color.

Zuandol 50 mg is presented in blisters of 1, 2, 4 or 8 tablets per package.

Only some package sizes may be marketed.

Other presentations:

Zuandol 100 mg, packages with 4 or 8 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Tel: 93 6388000

Fax: 93 6389393

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira, 2710-089 Sintra (Portugal).

Last review date of this leaflet:March2025

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