IDOKA 25 mg CHEWABLE TABLETS

Introduction

Prospect: patient information

Idoka 25 mg chewable tablets EFG

Sildenafil

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

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

Contents of the prospectus

1. What is Idoka and what is it used for
2. What you need to know before taking Idoka
3. How to take Idoka
4. Possible adverse effects
5. Storage of Idoka
6. Package contents and additional information

1. What is Idoka and what is it used for

Idoka contains the active ingredient sildenafil, which belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood 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 called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking 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 medications called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can lead to a dangerous decrease 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 blood clots). PDE5 inhibitors, such as sildenafil, have shown that they 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 experienced a stroke or heart attack, or if you have low blood pressure.
• If you suffer from 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

Consult your doctor, pharmacist, or nurse before starting to take sildenafil:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer)
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently 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.
• You should not take sildenafil if you are taking a medication called ritonavir (for the treatment of HIV).

Sildenafil should not be used simultaneously with any other oral or local treatment for erectile dysfunction.

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

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

Special considerations in patients with kidney or liver problems

You must 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 persons under 18 years of age.

Other medications and Idoka

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

• Medications that contain sacubitril/valsartan, used to treat heart failure.

Sildenafil tablets may interfere 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. You should not take sildenafil with other medications unless your doctor advises you to do so.

You should not take sildenafil if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease in your blood pressure. You should always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these medications can also lead to a dangerous decrease 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 the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafil.

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

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours of taking sildenafil.

In order 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 indicate 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 little longer to take effect 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 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 using machines

Sildenafil can cause dizziness and affect vision. You should know how you react to sildenafil before driving vehicles or using 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 can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

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

3. How to take Idoka

Follow the administration instructions of this medication exactly 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.

You should take Idoka approximately one hour before you plan to have sex. The tablet should be chewed completely before swallowing.

If you notice that the effect of Idoka is too strong or too 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, usually between half an hour and one hour. The effect of Idoka may be delayed if you take it with a large meal.

In the event that Idoka does not help you achieve an erection or if the erection is not maintained long enough to complete the sexual act, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. The adverse effects reported in association with the use of sildenafil are generally mild to moderate and short-lived.

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

? Allergic reaction - this occurs with low frequency(may affect up to 1 in 100 people).

The symptoms include sudden whistling when breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

? Chest pain – this occurs with low frequency.

If they occur during or after having sex:

• Sit in a semi-sitting 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 that lasts more than 4 hours, you should contact your doctor immediately.

? Sudden decrease or loss of vision -this occurs rarely.

? Severe skin reactions - this occurs rarely.

The symptoms may include severe scaling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

? Seizures or attacks - this occurs rarely.

Other adverse effects:

Very frequent(may affect more than 1 in 10 people): headache.

Frequent(may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, nasal congestion, and dizziness.

Infrequent(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced touch sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or stuffiness, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in 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 color of the white of the eye, penile bleeding, presence of blood in semen, dry nose, nasal swelling, feeling of irritability, 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 men who experienced these adverse effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these adverse effects were directly related to sildenafil.

Reporting adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Idoka

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

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Idoka

? The active ingredient of Idoka 25 mg is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

? The other components are potassium polacrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), sodium croscarmellose, peppermint flavor (composed of: maltodextrin (from corn), modified corn starch E1451, and peppermint oil (Mentha arvensis)), magnesium stearate, potassium hydroxide or hydrochloric acid (for pH adjustment).

Appearance of the product and package contents

Idoka 25 mg are chewable tablets, white, triangular, biconvex, engraved with '25' on one face.

The 25 mg chewable tablets are available in blister packs of 4 or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Genéricos, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

Genepharm S.A.

18 km Marathon Avenue,

Pallini Attikis 15351

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola

PLA 3000

Malta

Date of last revision of this prospectus:May 2022

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