Zuandol 50 mg film-coated tablets EFG: detailed information

Brand name Zuandol 50 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

SILDENAFIL CITRATE · 70,24 mg

Prescription type Prescription Only Medicine

ATC code

G04B G04BE G04BE03

Registration number 74489

Manufacturer Gp Pharm S.A.

Zuandol 50 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Zuandol is and what it is used for
2. What you need to know before taking Zuandol
3. How to take Zuandol
4. Possible adverse effects
5. Storage of Zuandol
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zuandol 50 mg film-coated tablets EFG

Sildenafil citrate

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Zuandol is and what it is used for.
What you need to know before taking Zuandol.
How to take Zuandol.
Possible side effects.
How to store Zuandol.
Contents of the pack and other information.

1. What Zuandol is and what it is used for

Zuandol contains the active substance sildenafilo, 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 into the penis 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking 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 may cause a dangerous drop in blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
If you are using any medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may cause a dangerous drop in 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 been shown to increase the hypotensive effect of riociguat. If you are taking riociguat or are unsure, consult your doctor.
If you have severe heart or liver problems.
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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Zuandol:

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
If you have a penile deformity or Peyronie’s disease.
If you have heart problems. In this case, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
If you experience sudden decrease or loss of vision, stop taking Zuandol and contact your doctor immediately.

It is not recommended to use Zuandol together with any other oral or local treatments for erectile dysfunction.

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

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

The use of Zuandol is not indicated in women.

Children and adolescents

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

Special considerations in patients with kidney or liver problems

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 taking, have recently taken, or might need to take any other medicines.

Zuandol tablets may interact with certain medicines, especially those used to treat chest pain. In 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 medicines unless your doctor advises you to do so.

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

Do not take Zuandol if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these medicines may also lead to a dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.

Some patients taking alpha-blockers, medicines used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness 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 already be on a regular daily dose of the alpha-blocker before starting Zuandol. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Inform your doctor or pharmacist if you are taking medicines containing 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 slightly longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable 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 may cause dizziness and affect vision. You should know how you react to Zuandol before driving or operating 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 instructions for use of this medicine as given by your doctor or pharmacist. If in 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 together with other medicines containing sildenafil.

You should 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 medicine 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 needed for the medicine to take effect varies from person to person, usually between half an hour and one hour. The effect of this medicine may be delayed if taken after a heavy 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 the frequency and severity of adverse effects. Doses higher than 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 may also consult your pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

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

4. Possible adverse effects

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

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

Allergic reaction – this occurs infrequently (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 infrequently

If chest pain occurs during or after sexual activity:

Sit in a semi-upright position and try to relax.
Do not use nitrates to treat your chest pain.
Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1000 people). If you have an erection lasting more than 4 hours, you must contact your doctor immediately.
Sudden decrease or loss of vision – this occurs rarely.
Severe skin reactions – this occurs rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.
Seizures or fits – this occurs rarely.

Other adverse 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 flush (including sudden feeling of warmth in the upper body), indigestion, abnormal colour vision, 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 flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of throat tightness, mouth numbness, bleeding at the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilation of the pupil, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to Zuandol.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 container to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point Black medical symbol composed of a central cross surrounded by a circular arrow rotating clockwise at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components are:

Tablet core: microcrystalline cellulose, calcium phosphate dibasic, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and contents of the pack

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

Zuandol 50 mg is available in blister packs containing 1, 2, 4 or 8 tablets per package.

Only certain package sizes may be marketed.