Bandol 12.5 mg/dose oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bandol12.5 mg/pulse, oral suspension

sildenafil

Read the entire leaflet carefully before starting to take 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, consult your doctor, pharmacist, or nurse.
• 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, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Bandol is and what it is used for

Bandol 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 into the penis during sexual stimulation. 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Bandol

Do not take Bandol

• 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 lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors such as amyl nitrate ("poppers"), as the combination may 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 Bandol have been shown to increase the hypotensive effect of this medicine. 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 hereditary eye disease (such as retinitis pigmentosa).
• If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• 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. 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 Bandol and contact your doctor immediately.

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

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

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

The use of Bandol is not indicated in women.

Special considerations in patients with renal or hepatic impairment

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

Children and adolescents

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

Taking Bandol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Do not take Bandol if you are taking medicines called nitrates, as the combination of these medicines may 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 (or "chest pain").

Do not take Bandol if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines may also cause a dangerous drop in your 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 = two sprays) of Bandol.

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 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 already be on a regular daily dose of your alpha-blocker before starting Bandol. Your doctor may advise you to start treatment with the lowest dose (1 ml equivalent to 25 mg of sildenafil, 2 sprays) of Bandol.

Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Bandol with food, drinks, and alcohol

Bandol can be taken with or without food. However, you may notice that Bandol 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 consume large amounts of alcohol before taking Bandol.

Pregnancy, breastfeeding, and fertility

The use of Bandol is not indicated in women.

Driving and using machines

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

Bandol contains sodium benzoate (E-211)

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

3. How to take Bandol

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 2 ml equivalent to 50 mg (4 pumps).

Each pump delivers 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 pumps).

Bandol must not be taken more than once a day.

Do not take Bandol together with other medications containing sildenafil.

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

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

Before the first use, perform 3 pumps and discard the content to prime the dosing pump. A lower dose may be administered without priming the dosing pump when used for the first time.

Under no circumstances should the formulation be administered by nasal route.

Method of administration

1. The bottle must be shaken vigorously for the necessary time until no drug precipitate 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: perform 3 pumps to prime the dosing pump and discard the content of the third pump (no product is dispensed during the first two pumps due to the design of the dosing pump).
4. Tilt your head slightly backward. Place the dosing pump into your mouth. Press the dosing pump the number of times required according to the dose prescribed by your doctor, and apply the suspension onto the tongue, then immediately swallow the suspension with saliva. Avoid direct contact between the tip of the dosing pump and the oral cavity or tongue. See Figure 3.

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

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

Bandol will only help you achieve an erection if you are sexually stimulated. The time needed for Bandol to take effect varies from person to person, usually between 30 minutes and one hour. The effect of Bandol may be delayed if taken with a heavy meal.

If Bandol 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 Bandol than you should

You may experience an increase in adverse effects and their severity. Doses higher than 100 mg do not increase efficacy.

You must not exceed the dose of Bandol recommended by your doctor.

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

If you have any further 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 experiences them. The adverse effects reported with the use of Bandol are generally mild to moderate in intensity and short in duration.

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

• Allergic reaction – this occurs uncommonly (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 uncommonly.

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 chest pain.

• Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 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 (symptoms include 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, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, numbness of the mouth, bleeding behind 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, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience with sildenafil, 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 sildenafil.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Bandol

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

No special storage conditions are required.

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

After first opening, the contents should be used within a maximum of 12 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bandol

• The active substance in Bandol is sildenafil. Each ml of oral suspension contains 25 mg of sildenafil (35.1 mg 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, mint flavor 501.500 TP0504 (containing corn maltodextrin, flavoring components (menthofuran 0.6%, 0.2% pulegone, estragole 0.09%) and modified corn starch E-1450 (7.9%)), taste-masking agent SC241160 (containing natural flavoring substances, sucralose E-955 (94.5%), potato maltodextrin and monoammonium glycyrrhizinate (0.4%)), purified water.

Appearance of the product and contents of the pack

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

The primary packaging material of Bandol consists of 30 ml high-density polyethylene (HDPE) bottles with a 22 mm neck opening, equipped with a polypropylene metered-dose pump delivering 0.5 ml per spray.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aspargo Labs Italia S.r.l.

Via Po, 102

00198 Rome (RM)

Italy

Manufacturer

Zinereo Pharma, S.L.U.

A Relva, s/n

36410 O Porriño - Pontevedra

Spain

Telephone: +34 986 345 200

Or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191 Valencia

Spain

Telephone: +34 962793717

Or

Farmalider, S.A.

C/ Aragoneses, 2

28108 - Alcobendas (Madrid)

Spain

Telephone: +34 91 661 23 35

Local Representative

Aspargo Labs España, S.L.U.

Calle Alcalá 75, 2nd floor

28009 - Madrid

Spain

This patient information leaflet was approved in: November 2023

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