ZUANDOL 50 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zuandol 50 mg film-coated tablets EFG

Sildenafil citrate

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Zuandol is and what it is used for.
2. What you need to know before you take Zuandol.
3. How to take Zuandol.
4. Possible side effects.
5. Storage of Zuandol.
6. Contents of the pack and other information.

1. What Zuandol is and what it is used for

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

Zuandol is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot get or maintain a firm erection, adequate for satisfactory sexual activity.

2. What you need to know before you take Zuandol

Do not take Zuandol

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination can cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine 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 Zuandol, have shown that they increase the hypotensive effect of this medicine. 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 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 (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. In this case, your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Zuandol and contact your doctor immediately.

It is not recommended to use Zuandol at the same time as any other oral or local treatment for erectile dysfunction.

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

You must not take Zuandol if you do not have erectile dysfunction.

The use of Zuandol is not indicated in women.

Children and adolescents

The use of Zuandol is not indicated in persons under 18 years of age.

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.

Other medicines and Zuandol

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Zuandol tablets may interfere with some medicines, 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 Zuandol and when you took it. Do not take Zuandol with other medicines unless your doctor advises you to.

You must not take Zuandol if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

You must not take Zuandol if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines can also cause a dangerous drop in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines 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 who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a decrease 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 of taking Zuandol. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Zuandol. Your doctor may advise you to start treatment with the lower dose (25 mg) of sildenafil.

Tell your doctor or pharmacist if you are taking medicines that contain sacubitril/valsartan, used to treat heart failure.

Using 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 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 medicine, it is recommended not to drink large amounts of alcohol before taking Zuandol.

Pregnancy, breastfeeding, and fertility

The use of Zuandol is not indicated in women.

Driving and using machines

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

Zuandol contains sodium

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

3. How to take Zuandol

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

You must not take Zuandol more than once a day.

Do not take Zuandol with other medicines that contain sildenafil.

You should take Zuandol about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you notice that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Zuandol will only help you achieve an erection if you are sexually stimulated. The time it takes to work varies from person to person, usually between half an hour and one hour. The effect of this medicine can be delayed if you take it with a large meal.

In the event that Zuandol 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 Zuandol than you should

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

You must not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised. You can also consult your pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of Zuandol are usually mild to moderate and of short duration.

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

• 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 they occur during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat your chest pain.

• Prolonged and sometimes painful erections – this occurs very rarely(may affect up to 1 in 1000 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, feeling hot (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, seeing flashes of light, increased sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, 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 present in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired.

Rare(may affect up to 1 in 1000 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, decreased sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling of the inside of the nose, feeling irritable, 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 of the men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to Zuandol.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zuandol

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

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zuandol 50 mg

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

The other ingredients are:

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

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

Appearance of the product and contents of the pack

Zuandol 50 mg tablets are film-coated, elliptical, and blue in color.

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

Not all pack sizes may be marketed.

Other presentations:

Zuandol 100 mg, packs with 4 or 8 tablets.

Marketing authorization holder and manufacturer

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

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira, 2710-228 Sintra (Portugal).

Date of the last revision of this leaflet:March 2025

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