Patient Information

Idoka 50 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

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.

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 also 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 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 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 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 should not be used 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 PDE5 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 renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

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

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 to treat HIV, 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 in the 4 hours following sildenafil intake.

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 taken 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 4.3 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 because the body is unable 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".

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 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 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.

All individuals, regardless of their medical history, may experience some side effects, although not all of them. The following side effects are not common, but they can occur. They are usually mild and temporary.

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

• Angina (chest pain) – this occurs with a low frequency (it may affect up to 1 in 100 people).

Other side effects that may occur include:

• Sexual dysfunction – this occurs rarely (it may affect up to 1 in 1,000 people).

• Disminución repentina de la visión – this occurs rarely.

• Reacción grave – this occurs rarely.

• Convulsiones o ataques epilépticos – this occurs rarely.

• Angina inestable (heart disease) and sudden death – these have been reported rarely during post-marketing experience. Most men who experienced these side effects, although not all of them, had heart problems before taking this medication. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Idoka

• The active ingredient of Idoka 50 mg is sildenafil. Each tabletcontains 50 mg of sildenafil (as citrate).
• The other components are potassium acrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), croscarmellose sodium, peppermint flavor (compound of: cornstarch (corn), modified cornstarch E1451 (carnauba wax) and peppermint oil (Mentha arvensis)), magnesium stearate,potassium hydroxide or hydrochloric acid (for pH adjustment).

Appearance of the product and content of the packaging

Idoka 50 mg are chewable tablets, white, triangular, biconvex, engraved with ‘50’on one face.

The chewable tablets of 50 mg are available in blister packs of 4 or 8 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Generics, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

Genepharm S.A.

18 km Marathon Avenue,

Pallini Attikis 15351

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial, Park, Paola

PLA 3000

Malta

Last review date of this leaflet:May 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/