Introduction

Patient Information

Idoka 25 mg Chewable Tablets EFG

Sildenafil

Read this 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 you must 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.

1. What isIdokaand what it is used for

2. What you need to know before starting to takeIdoka

3. How to takeIdoka

4. Possible side effects

5. Storage ofIdoka

6. Contents of the pack and additional information

1. What is Idoka and how is it used

Idoka 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. Idoka will only help you achieve an erection if you are sexually stimulated.

Idoka 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.

2. What you need to know before starting to take Idoka

Do not take Idoka

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). Phosphodiesterase type 5 inhibitors, such as sildenafil, 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 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 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 sildenafil:

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. Your doctor should 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 a sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.
Do not take sildenafil if you are taking a medication called ritonavir (for HIV treatment).

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

Do not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other phosphodiesterase type 5 inhibitor.

Do not take sildenafil if you do not have erectile dysfunction. The use of Idoka is not indicated in women.

Special considerations in patients with renal or hepatic problems

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

Children and adolescents

The use of sildenafil is not indicated in individuals under 18 years old.

Other medications and Idoka

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication:

Medications containing sacubitril/valsartan, used to treat heart failure.

Sildenafil tablets may interact with some medications, 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 sildenafil and when you took it. Do not take sildenafil with other medications unless your doctor advises you to.

Do not take sildenafil if you are taking nitrates, as the combination of these medications 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 sildenafil 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 in HIV treatment, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafil.

Do not take sildenafil if you are taking the protease inhibitor ritonavir (for HIV treatment).

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 sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil.

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

Use of Idoka with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that sildenafil takes a bit longer to take effect if you take 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 sildenafil.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and operating machinery

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

Idoka contains aspartame, lactose, and sodium

This medication contains 2.15 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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

3. How to Take Idoka

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Idoka more than once a day.

Take Idoka approximately one hour before planning to have sexual intercourse. The tablet must be chewed completely before swallowing.

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

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

If Idoka 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 Idoka than you should

You may experience an increase in adverse 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

4. Possible Adverse Effects

All individuals, regardless of their medical conditions, may experience some side effects, although not all people will experience them. The side effects are not necessarily caused by the drug itself, but by the body's reaction to it. The most common side effects are mild and temporary, and they usually go away on their own. However, in some cases, side effects can be more serious and require medical attention.

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

?Severe allergic reactions – this occurs with rare frequency (may affect up to 1 in 100 people).

Los síntomas incluyen:hinchazón de la cara, labios, lengua, garganta, ojos, orejas, manos y pies, dificultad para respirar, mareos, debilidad, pérdida de conciencia, y cambios en el ritmo cardíaco.

?Dolor en el pecho – esto ocurre con poca frecuencia (puede afectar hasta 1 de cada 100 personas).

Los síntomas incluyen:dolor en el pecho, opresión en el pecho, sensación de ahogo, dificultad para respirar, sudoración excesiva, mareos, debilidad, y pérdida de conciencia.

Si apreciende cambios en su visión, dolor en los ojos, o sensibilidad a la luz, consulte a su médico inmediatamente.

Si experimenta alguno de los siguientes síntomas, consulte a su médico inmediatamente:

-Sitúese en una posición sentada inmediatamente.

-No use ni trate de parar el dolor en el pecho.

?Ereción prolongada y dolorosa – esto ocurre raramente (puede afectar hasta 1 de cada 1.000 personas).

Los síntomas incluyen:dolor en la región pélvica, dolor en la espalda, dolor en los muslos, dolor en los pies, y sensación de opresión en la región pélvica.

Si apreciende alguno de los siguientes síntomas, consulte a su médico inmediatamente:

?Disminución repentina de la visión – esto ocurre raramente.

?Reacciones graves de la piel – esto ocurre raramente.

Si experimenta alguno de los siguientes síntomas, consulte a su médico inmediatamente:

?Reacciones graves de la piel, incluyendo erupciones cutáneas, hinchazón, y dolor en la piel.