Package Leaflet: Information for the User

Sildenafilo Combix50 mg Film-Coated Tablets

Read this 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, ask yourdoctororpharmacist.
• This medicine has been prescribed for you only, do 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.

Sildenafilo Combix belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowingblood to flow when sexually stimulated. Sildenafilo Combix will only help you get an erection if you are sexually stimulated. Do not take Sildenafilo Combix if you do not have erectile dysfunction. The use of Sildenafilo Combix is not indicated in women.

Sildenafilo Combix is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot get or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo

• If you are allergic (hypersensitive) to sildenafilo 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 cause a potentially 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 cause a dangerous drop in your blood pressure.
• 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 or pharmacist before starting to take Sildenafilo:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully check if your heart can handle the additional effort of having sex.
• If you have an active stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo and contact your doctor immediately.

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

Do not take Sildenafilo with treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.

Do not take Sildenafilo if you do not have erectile dysfunction.

The use of Sildenafilo is not indicated in women.

Special considerations for patients with renal or hepatic problems

You must inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo is not indicated in people under 18 years old.

Taking Sildenafilo with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Sildenafilo tablets may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafilo and when you took it. Do not take Sildenafilo with other medications unless your doctor advises you to.

Do not take Sildenafilo if you are taking nitrates, as the combination of these products may cause a dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take Sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a dangerous drop in your blood pressure.

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 Sildenafilo.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate hypertrophy, may experience dizziness or lightheadedness that may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur in the 4 hours following Sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting Sildenafilo. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo.

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

Taking Sildenafilo Combix with food, drinks, and alcohol

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

Pregnancy and breastfeeding

The use of Sildenafilo is not indicated in women.

Driving and operating machinery

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

Important information about some of the components of Sildenafilo Combix

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

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 Sildenafilo Combix more than once a day.

Do not take sildenafilo film-coated tablets with sildenafilo buccal dispersible tablets.

Take sildenafilo approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

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

If sildenafilo does not help you get an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Combix than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

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.

Do not take more tablets than recommended by your doctor.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.The side effects reported associated with the use of sildenafil are generally of mild to moderate intensity and short duration.

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

• Allergic reaction - this occurs withinfrequent frequency(may affect up to 1 in 100 people).

The symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs withinfrequent frequency.

If they occur during or after sexual intercourse:

• • Position yourself in a semi-sitting position and try to relax.
  • Do not use nitratesto treat chest pain.
• Prolonged and sometimes painful erections - this occursinfrequently(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision - this occursinfrequently.
• Severe skin reactions - this occursinfrequently.

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

• Convulsions or seizures - this occursinfrequently.

Other side effects:

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

Common(may affect up to 1 in 10 people): nausea, facial flushing, warmth (including sudden sensation of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, 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 vision, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritability, 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 is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging after CAD.The expiration date is the last day of the month indicated.

Unusedmedicaments should not be disposed of in household waste. Dispose of the packaging and unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of SildenafilCombix

• The active ingredient is sildenafil citrate. Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
• The other components are:
• • Tablet core: dihydrogen phosphate calcium dihydrate (E341ii), microcrystalline cellulose (460i), sodium croscarmellose (E468), hypromellose (E464), magnesium stearate (E470b).
  • Tablet coating:Opadry blue II 33K505028, composed of:monohydrate lactose, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), aluminum lake with indigo carmine (E132)).

Appearance of the product and content of the packaging

Coated tablets, oval, biconvex, blue or light blue in color, engraved with “50” on one face and smooth on the other face.

SildenafilCombix 50 mg is presented in OPA/AL/PVC-Aluminum or PVC/PVDC-Aluminum (with desiccant) blisters containing 2, 4, 8, and 12 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for Manufacturing

Zydus France

ZAC les Hautes Patures

Parc d’activites des Peupliers

25, Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet:April 2022

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