SILDENAFIL COMBIX 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the UserSildenafilo Combix 100 mg film-coated tablets EFG.

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

• Keep this package leaflet, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Sildenafilo Combix and what is it used for
2. What you need to know before taking Sildenafilo Combix
3. How to take Sildenafilo Combix
4. Possible side effects

5 Conservation of Sildenafilo Combix

1. Contents of the pack and further information

1. What is Sildenafilo Combix and what is it used for

Sildenafilo Combix belongs to a group of medications called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafilo Combix will only help you achieve an erection if you are sexually stimulated. You should 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 obtain or maintain a firm erection sufficient for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Combix

Do not take Sildenafilo

• If you are allergic (hypersensitive) 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 cause a potentially dangerous decrease in blood pressure. Consult your doctor if you are taking any of these medications, which are often administered 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 cause a dangerous decrease in blood pressure.
• If you have a serious heart or liver problem.
• If you have recently suffered 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 or pharmacist before starting to take Sildenafilo:

• 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 penis 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 stomach ulcers or bleeding problems (such as hemophilia).
• If you experience sudden or decreased vision loss, stop taking Sildenafilo and contact your doctor immediately.

It is not recommended to use sildenafil 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 sildenafil is not indicated in women.

Special considerations in patients with kidney or liver 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 persons under 18 years of age.

Taking Sildenafilo Combix with other medications

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

Sildenafilo Combix 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 products can cause a dangerous decrease in blood pressure. You should always inform your doctor or pharmacist 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 products can also cause a dangerous decrease in 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 sildenafil.

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. To minimize the likelihood of these symptoms, you should be taking 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.

Medications that contain 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 sildenafil takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult 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 and breastfeeding

The use of sildenafil is not indicated in women.

Driving and using machines

Sildenafilo can cause dizziness and affect vision. You should know how you react to sildenafil before driving vehicles or using machinery.

Important information about some of the components of Sildenafilo Combix

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.

3. How to take Sildenafilo Combix

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

You should not take Sildenafilo Combix more than once a day.

Do not take sildenafil film-coated tablets with sildenafil orodispersible tablets.

You should take sildenafil approximately one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you think the effect of sildenafil is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you achieve an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a large meal.

In the event that sildenafil does not help you achieve an erection or if the erection is not maintained 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

You should not take more tablets than recommended by your doctor.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The side 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 side effects, stop taking sildenafil and seek medical attention immediately:

• Allergic reaction - this occurs infrequently (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 infrequently.

If it occurs during or after sex:

• 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 that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden or decreased vision loss - this occurs rarely.
• Severe skin reactions - this occurs rarely.

Symptoms can 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 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, hot flushes (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, nasal congestion, and dizziness.

Uncommon(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 sense of touch, vertigo, ringing in the ears, dry mouth, nasal stuffiness or congestion, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

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, 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 or decreased hearing loss.

During post-marketing experience, unstable angina (heart disease) and sudden death have been rarely reported. It should be noted that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects

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

5. Conservation of Sildenafilo Combix

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. 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 collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sildenafilo Combix

• The active ingredient is sildenafil citrate. Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
• The other components are:
  • Core of the tablet: dicalcium phosphate dihydrate (E341ii), microcrystalline cellulose (460i), sodium croscarmellose (E468), hypromellose (E464), magnesium stearate (E470b).
  • Coating of the tablet: Opadry blue II 33K505028, composed of: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), aluminum lake with carmine indigo (E132).

Appearance of the product and contents of the pack

Film-coated tablets, oval, bisected, blue or light blue in color, engraved with "100" on one side and smooth on the other side.

Sildenafilo Combix 100 mg is presented in OPA/AL/PVC-Aluminum or PVC/PVDC-Aluminum (with desiccant) blisters containing 4, 8, and 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

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

Date of the last revision of this package leaflet: April 2022

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