Idoka 25 mg chewable tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Idoka 25 mg chewable tablets EFG
Sildenafil
Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Idoka is and what it is used for
- What you need to know before taking Idoka
- How to take Idoka
- Possible side effects
- How to store Idoka
- Contents of the pack and other information
1. What Idoka is and what it is used for
Idoka 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 it when you are 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 achieve or maintain a firm erection adequate 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 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 prescribed to relieve angina chest pain (or “chest pain”). 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 sildenafil 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 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking sildenafil:
- 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 sildenafil and contact your doctor immediately.
- You should not take sildenafil if you are taking a medicine called ritonavir (used to treat HIV).
It is not recommended to use sildenafil together with any other oral or local treatments 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
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 of age.
Other medicines and Idoka
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:
- Medicines containing sacubitril/valsartan, used to treat heart failure.
Sildenafil tablets 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 sildenafil and when you took it. You should not take sildenafil with other medicines unless advised by your doctor.
You should not take sildenafil 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”).
You should not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination 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) of sildenafil.
You should not take sildenafil if you are taking the protease inhibitor ritonavir (used to treat HIV).
Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness, which may be caused by a drop 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 after taking sildenafil.
To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.
Taking Idoka with food, drinks, and alcohol
Sildenafil can be taken with or without food. However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.
Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to obtain the maximum benefit from the medicine, it is advisable 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 may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.
Idoka contains aspartame, lactose, and sodium
This medicine contains 2.15 mg of aspartame per tablet.
Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; thus, it is essentially “sodium-free”.
3. How to take Idoka
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
Idoka must not be taken more than once a day.
You should take Idoka approximately one hour before planning to have sexual intercourse. The tablet must 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 Idoka takes to work varies from person to person, usually between half an hour and one hour. The effect of Idoka may be delayed if taken with a heavy 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 higher than 100 mg do not increase efficacy.
You must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
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 will experience them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short-lived.
If you experience any of the following serious adverse effects, stop taking sildenafil and seek immediate medical attention:
? Allergic reaction – this occurs rarely (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 rarely.
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 longer than 4 hours, 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 of the mouth, genitals, 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 (including 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, dizziness, tinnitus (ringing in the ears), dry mouth, blocked or stuffy nose, nasal mucosa inflammation (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including 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, mouth numbness, bleeding at 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, 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, 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Idoka
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the pack following “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Idoka
? The active substance in Idoka 25 mg is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
? The other components are potassium polacrilin, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), sodium croscarmellose, mint flavour (composed of: maltodextrin (from corn), modified starch E1451 (waxy corn), and peppermint oil (Mentha arvensis)), magnesium stearate, potassium hydroxide or hydrochloric acid (for pH adjustment).
Appearance of the product and contents of the pack
Idoka 25 mg are chewable tablets, white in colour, triangular, biconvex, engraved with '25' on one side.
The 25 mg chewable tablets are available in blister packs containing 4 or 8 tablets.
Only certain 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)
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 the most recent revision of this leaflet: May 2022
Detailed and up-to-date 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/