Package Insert: Information for the Patient

Bandol12.5 mg/beat, Oral Suspension

sildenafil

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Bandol 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 in the penis, allowing blood to flow when sexually stimulated. Bandol will only help you achieve an erection if you are sexually stimulated.

Bandol is indicated for the treatment of erectile dysfunction in adult men, 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 takeBandol

• 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 lead to 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 lead to 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 Bandol, 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 had 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 Bandol:

• 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. Your doctor must carefully check if your heart can handle the additional strain of sexual activity.
• If you have a current stomach ulcer or bleeding problems (such as hemophilia).
• If you experience sudden vision loss, stop taking Bandol and contact your doctor immediately.

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

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

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

Bandol is not indicated for use in women.

Special considerations for patients with renal or hepatic problems

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

Children and adolescents

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

Use ofBandolwith other medications

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

Bandol 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 Bandol and when you took it. Do not take Bandol with other medications unless your doctor advises you to.

Do not take Bandol if you are taking medications called nitrates, as the combination may lead to 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 Bandol if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to 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 = 2 sprays) of Bandol.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing or sitting up quickly. Some patients have experienced these symptoms when taking Bandol with alpha-blockers. This is more likely to occur within 4 hours after taking Bandol.

To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Bandol. Your doctor may recommend that you start treatment with the lower dose (1 ml equivalent to 25 mg of sildenafil, 2 sprays) of Bandol.

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

Use ofBandol with food, drinks, and alcohol

Bandol can be taken with or without food. However, you may notice that Bandol takes a bit 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 Bandol.

Pregnancy, breastfeeding, and fertility

Bandol is not indicated for use in women.

Driving and operating machinery

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

Bandol contains sodium benzoate (E-211)

This medication contains 1 mg of sodium benzoate (E-211) in each milliliter of suspension.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 2 ml equivalent to 50 mg (4 pulses).

Each pulse releases 0.5 ml of suspension containing 12.5 mg of sildenafil.

The maximum daily dose is 4 ml equivalent to 100 mg of sildenafil (8 pulses).

Do not takeBandolmore than once a day.

Do not take Bandol with other medications that contain sildenafil.

You should take Bandol approximately one hour before you plan to have sexual intercourse.

Shake vigorously before taking.The medication will be administered orally.

Before the first administration, it is necessary to perform 3 pulses discarding its content to prime the dosing pump. A lower dose may be administered without priming the dosing pump when used for the first time.

The formulation will not be administered via nasal route in any case.

Administration Method

1. The bottle must be shaken vigorously for the necessary time until no precipitate of the drug is observed in the bottle before each use. See Figure 1.

2. Turn the dosing pump to the open position. See Figure 2.

3. Only for the first administration: give 3 pulses to prime the dosing pump and discard the product of the third pulse (in the first two pulses, there is no product due to the design of the dosing pump).
4. Lean your head slightly back.Place the dosing pumpin your mouth.Press the dosing pump the required number of times, according to the dose prescribed by your doctor and apply the suspension to the tongue and immediately afterwards swallow the suspension with saliva. Avoid direct contact between the tip of the dosing pump and the oral cavity and the tongue. See Figure 3.

5. Turn the dosing pump to the closed position. See Figure 4.

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

Bandol will only help you get an erection if you are sexually stimulated. The time it takes for Bandol to take effect varies from person to person, usually ranging from half an hour to one hour. The effect of Bandol may be delayed if you take it with a large meal.

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

If you take moreBandolthan you should

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

You must not exceed the dose ofBandol recommended by your doctor.

Contact your doctor if you have taken more Bandol than advised.

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

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

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

The symptoms include sudden hissing when 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 chest pain.

If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden loss or decrease in vision - this occursrarely.

• Severe skin reactions - this occursrarely.

The 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 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 rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, 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, feeling of heat, and feeling tired.

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 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, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience of sildenafil, 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 pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the 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 medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Once opened, the contents should be used within a maximum period of 12 months.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition ofBandol

• The active ingredient of Bandol is sildenafil. Each ml of suspension contains 25 mg of sildenafil (35.1 as citrate).
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sucralose (E-955), potassium acesulfame (E-950), hypromellose (15 cP), xanthan gum, peppermint flavor 501.500 TP0504 (which contains corn maltodextrin, flavoring agents (mentofurano 0.6%, 0.2% pulegona, estragol 0.09%) and modified corn starch E-1450 (7.9%)), masking flavor SC241160 (which contains natural flavoring agents, sucralose E-955 (94.5%), potato maltodextrin and monoammonium glycirricinate (0.4%)), purified water.

Appearance of the product and content of the container

Bandol is white in color, with a mint aroma and taste.

The primary container material of Bandol consists of high-density polyethylene (HDPE) 30 ml bottles with a 22 mm mouth width, equipped with a polypropylene dosing pump of 0.5 ml per spray.

Holder of the marketing authorization and responsible for manufacturing

Holder

Aspargo Labs Italia S.r.l.

Via Po, 102

00198 Rome (RM)

Italy

Responsible for manufacturing

Zinereo Pharma, S.L.U.

A Relva, s/n

36410 O Porriño - Pontevedra

Spain

Phone: +34 986 345 200

Or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191 Valencia

Spain

Phone: +34 962793717

Or

Farmalider, S.A.

c/ Aragoneses, 2

28108 - Alcobendas (Madrid)

Spain

Phone: +34 91 661 23 35

This leaflet has been approved in:November2023

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