SILDENAFIL COMBIX 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Combix50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Sildenafilo Combix and what is it used for
2. What you need to know before you take Sildenafilo Combix
3. How to take Sildenafilo Combix
4. Possible side effects
5. Storage of Sildenafilo Combix
6. Contents of the pack and further information

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

Sildenafilo Combix belongs to a group of medicines 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 get or maintain a firm enough erection for satisfactory sexual activity.

2. What you need to know before you take Sildenafilo Combix

Do not take Sildenafilo

• If you are allergic (hypersensitive) 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 can cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can 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 disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to a 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 blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• 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 strain of having sex.
• If you currently have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden loss of vision, stop taking Sildenafilo and contact your doctor immediately.

It is not recommended to use sildenafil at the same time as 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 withother medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Sildenafilo Combix tablets may interfere with some medicines, 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 medicines unless your doctor advises you to.

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

You should not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also cause a dangerous drop in your blood pressure.

If you are taking medicines 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 medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can 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 of taking sildenafil. To reduce the likelihood of these symptoms occurring, you should be taking 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.

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

Taking Sildenafilo Combix withfood, 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.

Drinking alcohol can temporarily make it more difficult to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking sildenafil.

Pregnancy and breastfeeding

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.

Important information about some of the ingredients of Sildenafilo Combix

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

3. How to take Sildenafilo Combix

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, 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 together with sildenafil orodispersible tablets.

You should take sildenafil about an 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, tell your doctor or pharmacist.

Sildenafil 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 can 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 medicine 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of short duration.

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

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

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

• Chest pain - this occurs with rare frequency.

If they occur during or after intercourse:

• • Sit in a semi-upright position and try to relax.
  • Do not use nitratesto treat chest pain.
• Prolonged and sometimes painful erections - this occurs very 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 loss of vision - this occurs very rarely.
• Severe skin reactions - this occurs very rarely.

The 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 very 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 flush (including symptoms such as a sudden feeling of heat in the upper body), indigestion, abnormal color perception, 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, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of tiredness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, 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 present 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, temporary reduction 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, reduction in sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling of the inside of the nose, feeling of irritability, and sudden loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been rarely reported. It should be noted that most of the 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 whether these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Combix

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Sildenafilo Combix

• The active substance is sildenafil citrate. Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
• The other ingredients are:
• • Core of the tablet: calcium 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 of indigo carmine (E132)).

Appearance of the product and contents of the pack

Film-coated tablets, oval, biconvex, blue or light blue in color, engraved with "50" on one side and smooth on the other side.

Sildenafilo Combix 50 mg is presented in OPA/AL/PVC-Aluminum or PVC/PVDC-Aluminum (with desiccant) blisters containing 2, 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 last revision of this leaflet:April 2022

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