AZULSIX 50 mg CHEWABLE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Azulsix 50 mg chewable tablets EFG

(Sildenafil citrate)

Read all of this leaflet carefully before you start taking this medicine.

• 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Azulsix and what is it used for
2. Before taking Azulsix
3. How to take Azulsix
4. Possible side effects
5. Storage of Azulsix
6. Further information

1. What is AZULSIX and what is it used for

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

Azulsix is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm enough erection for satisfactory sexual activity.

2. Before taking AZULSIX

Do not take Azulsix

• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Azulsix.
• 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 used 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 potentially 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 had a rare inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Take special care with Azulsix

Consult your doctor or pharmacist before starting to take Azulsix.

• If you have sickle cell anemia (a blood disorder), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden loss of vision, stop taking Azulsix and contact your doctor immediately.

Azulsix should not be used in combination with any other oral or local treatment for erectile dysfunction.

Use in children and adolescents under 18 years

The use of Azulsix is not indicated in persons under 18 years.

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.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Azulsix chewable tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform any healthcare professional that you are taking Azulsix and when you took it. Do not take Azulsix with other medicines unless your doctor advises you to do so.

Do not take Azulsix if you are taking medicines called nitrates, as the combination of these medicines can cause a potentially 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").

Do not take Azulsix if you are taking medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also cause a potentially 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 Azulsix.

Some patients who are taking an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which 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 Azulsix. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Azulsix. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Azulsix.

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

Taking Azulsix with food and drinks

Azulsix can be taken with or without food. However, you may notice that Azulsix 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 medicine, it is recommended not to consume large amounts of alcohol before taking Azulsix.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The use of Azulsix is contraindicated in women.

Driving and using machines

Azulsix can cause dizziness and affect vision. You should know how you react to Azulsix before driving or using machines.

Important information about some of the ingredients of Azulsix

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Azulsix chewable tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take AZULSIX

Follow the instructions for administration of Azulsix indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The normal starting dose is 50 mg.

The tablet should be chewed and swallowed.

Do not take more than one Azulsix tablet per day.

You should take Azulsix approximately one hour before you plan to have sex.

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

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

In the event that Azulsix 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 Azulsix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy. Do not take more tablets than recommended by your doctor.

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

4. Possible side effects

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

If you experience chest pain during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat your chest pain.
• Contact your doctor immediately.

All medicines, including Azulsix, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking sildenafil: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

There have been reports of prolonged and sometimes painful erections after taking sildenafil. If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

If you experience a sudden loss of vision, stop taking Azulsix and contact your doctor immediately.

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

Headache

Common(may affect up to 1 in 10 people): Flushing, indigestion, effects on vision (including changes in color vision, mild sensitivity, blurred vision, or decreased sharpness of vision), nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): Vomiting, skin rash, bleeding behind the eye, eye irritation, bloodshot eyes/red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, somnolence, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, and feeling tired.

Rare(may affect up to 1 in 1000 people): Hypertension, hypotension, fainting, stroke, nosebleed, and sudden loss of hearing.

Other side effects reported after marketing are: Abnormal heart rhythms, chest pain, sudden death, heart attack, or temporary reduction in blood flow to parts of the brain. Most of these men, although not all, had pre-existing heart problems before taking this medicine. It is not possible to establish whether these events were directly related to the use of Azulsix. There have also been reports of seizures or convulsions and severe skin reactions characterized by rash, blisters, skin peeling, and pain that may require immediate medical attention.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage of AZULSIX

Keep out of the reach and sight of children.

This medicine does not require any special storage temperature.

Keep in the original package to protect from light.

Do not use Azulsix after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Package contents and further information

Composition of Azulsix:

The active ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

The other ingredients are: Potassium polacrilin, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavor (composed of flavorings, maltodextrin, modified corn starch, and pulegone), magnesium stearate, potassium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH).

Appearance of the product and packaging contents

Azulsix 25 mg tablets are triangular, biconvex, and white, with "25 mg" engraved on one side.

Azulsix is available in blister packs of 1, 4, 8, or 12 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

Azulsix 50 mg, packs of 1, 2, 4, 8, or 12 tablets.

Azulsix 100 mg, packs of 1, 4, 8, or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Farmalider, S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Manufacturer

Genepharm S.A., 18km Marathon Avenue, 15351 Pallini, Greece

Or

Hameln RDS A.a.

Horna 36

Modra 900 01 Slovakia

This medicine is authorized for marketing in the EEA member states under the following names:

Azulsix 25 mg chewable tablets (Netherlands)

Azulsix 25 mg chewable tablets (Spain)

This leaflet was approved in October 2022

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