Azurvig

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Azurvig, 12.5 mg/dose, oral suspension

Sildenafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Azurvig and what is it used for
• 2. Important information before taking Azurvig
• 3. How to take Azurvig
• 4. Possible side effects
• 5. How to store Azurvig
• 6. Contents of the pack and other information

1. What is Azurvig and what is it used for

Azurvig contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Azurvig helps achieve an erection only if there is prior sexual stimulation.

Azurvig is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Azurvig

When not to take Azurvig

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous use may also lead to a dangerous decrease in blood pressure.
• Severe heart or liver disease.
• Recently suffered a stroke or heart attack, and in cases of low blood pressure.
• Hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If the patient has ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
• If the patient is taking riociguat. This medicine is used to treat pulmonary 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). It has been shown that PDE5 inhibitors, such as Azurvig, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting to take Azurvig, the patient should discuss it with their doctor, pharmacist, or nurse in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Ulcer disease or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Azurvig and contact their doctor immediately.

Azurvig should not be used with other oral or topical treatments for erectile dysfunction.

Azurvig should not be used with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other PDE5 inhibitors.

Azurvig should not be taken if the patient does not have erectile dysfunction. Azurvig is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Azurvig.

Children and adolescents

Azurvig oral suspension should not be used in people under 18 years of age.

Azurvig and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

If the patient is already taking riociguat, they should inform their doctor or pharmacist.

Azurvig may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition that requires immediate medical attention, the patient should inform their doctor, pharmacist, or nurse about taking Azurvig and the time it was taken. Azurvig should not be taken with other medicines without the doctor's recommendation.

Azurvig should not be used if the patient is taking nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris ("chest pain").

Azurvig should not be used if the patient is taking medicines that release nitric oxide (such as amyl nitrite), as their simultaneous use may also cause a dangerous decrease in blood pressure.

In the case of taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (2 doses equivalent to 25 mg of sildenafil) of Azurvig.

In some patients who take alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking Azurvig and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking Azurvig. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Azurvig. The doctor may decide to use a lower initial dose (2 doses equivalent to 25 mg of sildenafil) of Azurvig.

The patient should tell their doctor or pharmacist if they are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Azurvig with food, drink, and alcohol

Azurvig can be taken with or without food. Although taking Azurvig while eating a large meal may prolong the time it takes for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Azurvig, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Azurvig is not intended for use by women.

Driving and using machines

Azurvig may cause dizziness and vision disturbances. Patients should be aware of how they react to Azurvig before driving or operating machinery.

Azurvig contains sodium benzoate

This medicinal product contains 0.5 mg of sodium benzoate per 0.5 mL, which corresponds to 1 mg/mL.

3. How to take Azurvig

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

The recommended initial dose is 4 doses of the suspension, equivalent to 50 mg of sildenafil.

The possibility of adjusting the dose according to concomitant diseases, tolerance, and efficacy for each patient is an important feature of the pharmaceutical form of dosing containing sildenafil.

Azurvig is a prescription-only medicine, and the doctor may prescribe it in the most suitable dose, taking into account the specific characteristics of the patient. Azurvig allows the doctor to choose the smallest effective dose using the same medicine and facilitates dose titration and (or) its current correction if the patient's condition requires it, and this is in accordance with medical criteria. This minimizes adverse events.

The doctor's goal is to establish the ideal dose, sufficient to achieve the desired pharmacological effect, but low enough to minimize adverse events.

Each dose contains 12.5 mg of sildenafil.

The maximum daily dose of the suspension is 4 doses, equivalent to 50 mg of sildenafil.

Azurvig oral suspension should not be taken more than once a day.

Azurvig should not be taken with other medicines containing sildenafil.

Azurvig should be taken about an hour before planned sexual intercourse.

Azurvig is intended for oral use only.

It should not be administered intranasally or on the skin (topical administration).

The doctor will prescribe the appropriate number of doses needed.

Instructions for proper administration can be found in the Instructions for Use.

Always use the pump provided with the Azurvig packaging.

Instructions for Use:

• 1. Shake the bottle vigorously for 20 seconds to remove any sediment before use. See Figure 1.

• 2. Remove the child-resistant cap by pressing down and twisting to the left. See Figure 2.

• 3. Place the dosing pump on the bottle, carefully inserting the plastic tube into the bottle. Then, hold the dosing pump in place on the neck of the bottle and twist it to the right until it is securely locked. See Figure 3.

• 4. Turn the dosing pump to the open position. See Figure 4.

• 5. Before each use (including the first use): Prime the pump by pressing it three times to prepare (fill) the dosing pump. Discard the medicine released during this priming on an absorbent material. The pump is now ready for use, and each measured dose contains an average of 12.5 mg of sildenafil. Failure to prime the pump may result in a reduced dose being administered during use.

Discard the medicine when it is below the red line.

• 6. Gently tilt the head back. Place the pump in the mouth. Press the dosing pump the required number of times, according to the dose recommended by the doctor, and administer the suspension onto the tongue and swallow it immediately with saliva. Avoid direct contact between the end of the dosing pump and the inside of the mouth and tongue. See Figure 5.

• 7. Turn the dosing pump to the closed position (Figure 6) and remove the pump after wiping it on the inner wall of the bottle by unscrewing it to the left (Figure 7).

• 8. Close the bottle immediately after each use with the child-resistant cap (Figure 8).

• 9. Wash the entire dosing pump with water, making sure that no medicine or water remains in the pump by pressing it several times onto an absorbent material. Leave the pump to dry completely before reusing it. See Figures 9 and 10.

The medicine should be stored in a place that is out of sight and reach of children.

NOTE FOR PATIENTS - according to the instructions for use requiring priming of the dosing pump before each use and washing the dosing pump, the bottle will contain an average final volume for administration of 20 mL of oral suspension.

The medicine should be stored in a place that is out of sight and reach of children.

If the patient feels that the effect of Azurvig is too strong or too weak, they should consult their doctor or pharmacist.

Azurvig oral suspension allows for an erection only if there is prior sexual stimulation. The time it takes for Azurvig to work varies from person to person, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a large meal. The patient should contact their doctor if, after taking Azurvig, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Azurvig than recommended

The patient may experience more frequent and more severe side effects.

Do not take more doses than recommended by the doctor.

The patient should contact their doctor in case of taking more doses than recommended.

If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Azurvig can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Azurvig are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking Azurvig and seek medical help immediately:

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 patients) Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual intercourse:
• the patient should sit up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1000 patients) If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or sudden loss of vision - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs rarely

Other side effects:

Very common(may occur in more than 1 in 10 patients): headache.

Common(may occur in 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing with a colored glow, blurred vision, disturbances in vision, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing in the ears, dry mouth, stuffy or congested sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, arm or leg pain, nosebleeds, feeling hot, and feeling tired.

Rare(may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or dots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or loss of hearing.

Rarely, after the medicine was placed on the market, cases of unstable angina (heart disease) and sudden death have been reported. It is important that in most, but not all, men who experienced these side effects, heart function disorders existed before taking Azurvig. It is not possible to determine whether these side effects were related to the use of sildenafil.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Azurvig

The medicine should be stored in a place that is out of sight and reach of children.

In the case of an unopened bottle:

Store in a temperature below 30°C. Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month stated.

After first opening:

Do not use after 10 months after first opening the bottle. Store in a temperature below 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Azurvig contains

• The active substance of Azurvig is sildenafil. 1 ml of the suspension contains sildenafil citrate equivalent to 25 mg of sildenafil (35.1 mg as citrate). Each pump dose (0.5 ml suspension) contains 12.5 mg of sildenafil (as citrate).
• Other ingredients: sodium benzoate, anhydrous citric acid, sucralose (E-955), acesulfame potassium (E-950), hypromellose (15 cP), xanthan gum, peppermint flavor 501500 TP0504 containing: corn maltodextrin, flavoring agents (menthofuran 0.6%, pulegone 0.2%, estragol 0.09%) and modified corn starch E-1450 (7.9%)), masking flavor SC241160 containing: natural flavoring substances, sucralose E-955 (94.5%), potato maltodextrin, and glycyrrhizic acid ammonium salt (0.4%)), purified water.

What Azurvig looks like and contents of the pack

Azurvig is a white or off-white suspension, free from foreign substances, with a characteristic peppermint smell.

The primary packaging material consists of high-density polyethylene (HDPE) bottles with a capacity of 30 ml, equipped with a child-resistant closure, consisting of an HDPE cap and containing a 0.5 ml dosing pump.

Marketing authorization holder and manufacturer

Marketing authorization holder

Alpen Pharma GmbH

Steinenfeld, 3

77736 Zell am Harmersbach

Germany

Phone: +49 7243 2004910

Fax: +49 7835 634685

Manufacturer

Zinereo Pharma, S.L.U.

A Relva, s/n

36400 O Porriño, Pontevedra

Spain

Phone: +34 986 345 200

Fax: +34 986 345 201

Farmalider, S.A.

C/ Aragoneses, 2

Alcobendas, Madrid

28108 Spain

Or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117.

46191 Villamarchante – Valencia

Spain

Phone: +34 962 79 37 17

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria

Azurvig 12.5 mg/pump actuation, oral suspension

Czech Republic

Azurvig

Greece

Azurvig 12.5 mg/πάτημα δοσομετρικής αντλίας, πόσιμο εναιώρημα

Hungary

Azurvig 12.5 mg/pumpálásonként belsőleges szuszpenzió

Italy

Azurvig

Poland

Azurvig

Portugal

Erepry 12.5 mg/aplicação da bomba doseadora suspensão oral

Romania

Azurvig 12.5 mg/acționare a pompei, suspensie orală

Slovakia

Azurvig 12.5 mg/dávka pumpy, perorálna suspenzia

France

AZULVIG 12.5 mg/pression, suspension buvable

Croatia

Azurvig 12.5 mg/po potisku, oralna suspenzija

Date of last revision of the leaflet 12/2024

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: http://www.urpl.gov.pl