Azurvig

Package leaflet: Information for the patient

AZURVIG 12.5 mg/dose, oral suspension

Sildenafil
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Azurvig is and what it is used for
2. What you need to know 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 Azurvig is and what it is used for

Azurvig contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. Azurvig will help you achieve an erection only if you are sexually stimulated.
Azurvig is a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking Azurvig

Do not take Azurvig

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines called nitrates, as this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• if you are taking nitric oxide donors, such as amyl nitrite ("poppers"), as this combination may also cause a dangerous drop in 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as Azurvig have been shown to enhance the hypotensive effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Azurvig

• if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
• if you have a penile deformity or Peyronie's disease.
• if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical exertion of sexual activity.
• if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• if you experience a sudden decrease or loss of vision, stop taking Azurvig and contact your doctor immediately. You must not use Azurvig together with other oral or topical treatments for erectile dysfunction. You must not use Azurvig together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors. You must not take Azurvig if you do not have erectile dysfunction. You must not take Azurvig if you are a woman. Special precautions for patients with kidney or liver problems If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose. Children and adolescents Azurvig oral suspension must not be administered to individuals under 18 years of age.

Other medicines and Azurvig
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are already taking riociguat.
Azurvig oral suspension may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Azurvig and when it was taken. Do not take Azurvig with other medicines unless authorized by your doctor.
Do not take Azurvig if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain").
Do not take Azurvig if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe the lowest dose of Azurvig (2 actuations equal 25 mg of sildenafil).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or confusion due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Azurvig together with alpha-blockers. This is more likely to occur within 4 hours after taking Azurvig. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Azurvig. Your doctor may start you on a lower dose of Azurvig (2 actuations equal 25 mg of sildenafil).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Azurvig oral suspension with food, drinks, and alcohol
Azurvig can be taken with or without food. However, you may notice that the onset of Azurvig's effect may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using Azurvig.

Pregnancy, breastfeeding, and fertility
Azurvig is not indicated for use in women.

Driving and using machines
Azurvig may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Azurvig.

Azurvig contains sodium benzoate
This medicine contains 0.5 mg of sodium benzoate in 0.5 ml, equivalent to 1 mg/ml.

3. How to take Azurvig

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is 4 actuations of the suspension, equivalent to 50 mg of sildenafil.
Azurvig is a prescription-only medicine; therefore, your doctor may
prescribe the most appropriate dose according to your individual characteristics.
Your doctor's aim is to find the ideal dose, sufficient to achieve the appropriate pharmacological effect
while minimizing possible adverse effects.
Each actuation contains 12.5 mg of sildenafil.

The maximum daily dose is 8 sprays, equivalent to 100 mg of sildenafil.
Do not take Azurvig oral suspension more than once a day.
Do not take Azurvig in combination with other medicinal products containing sildenafil.
Azurvig should be taken approximately one hour before planned sexual activity.
Azurvig is intended exclusively for oral administration.
Do not administer nasally or through the skin (local application).
Your doctor will prescribe the number of doses required.
For correct administration, follow the instructions for use.
Always use the pump provided with the Azurvig package.
Instructions for use

1. Before each use, shake the bottle vigorously for about 20 seconds to ensure that no drug sediment remains. See Figure 1.

2. Remove the child-resistant safety cap by pressing down firmly and turning it counterclockwise. See Figure 2.

3. Place the dosing pump on top of the bottle, carefully inserting the plastic dip tube into the bottle. Hold the dosing pump on the neck of the bottle and screw it clockwise until firmly secured. See Figure 3.

4. Rotate the dosing pump to the open position. See Figure 4.

5. Before each use (including the first time): press the pump three times to prime (load) the dosing pump. Discard any product released during this priming process onto an absorbent material. The pump is now ready for use, and each metered spray delivers an average of 12.5 mg of sildenafil. Failure to properly prime the pump may result in an underdose during administration.

Discard the product below the red line.

6. Tilt the head slightly backward. Place the pump in the mouth. Press the dosing pump as many times as necessary according to the dose prescribed by the doctor, spray the suspension onto the tongue, and immediately swallow it with saliva.

Avoid direct contact between the tip of the dosing pump and the inside of the mouth or tongue.
See Figure 5.

7. Rotate the dosing pump to the closed position (Figure 6). Remove the pump by unscrewing it counterclockwise, after allowing it to drain against the inner walls of the bottle (Figure 7).

8. After each use, immediately close the bottle with the child-resistant safety cap (Figure 8).

9. Wash the dosing pump thoroughly with water, press the pump several times onto an absorbent material, ensuring that no product or water remains inside the pump. Allow it to dry completely before the next use. See Figure 9 and Figure 10.

PATIENT NOTE – With these instructions for use, which require priming before each
administration and subsequent washing of the dosing pump, the bottle will contain an average effective
deliverable volume of 20 ml of oral suspension.
Keep the medicine out of the sight and reach of children.
If you feel that the effect of Azurvig is too strong or too weak, consult your doctor or pharmacist.
Azurvig will help you achieve an erection only if you are sexually stimulated. The time required for Azurvig
to take effect varies from person to person, but generally ranges from half an hour to one hour.
The effect of Azurvig may take longer if you have just consumed a heavy meal.
If Azurvig does not help you achieve an erection, or if the erection does not last long enough to complete
sexual intercourse, inform your doctor.
If you take more Azurvig than you should:
You may notice an increase in the frequency and severity of adverse effects.
Do not take more doses than prescribed by your doctor.
Contact your doctor if you have taken more doses than recommended.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects reported in association with the use of Azurvig are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking Azurvig and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (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 – occurs uncommonly: If it occurs during or after sexual intercourse:
  • Sit semi-upright and try to relax.
  • Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, blisters in the mouth, genital area, or around the eyes, fever.
• Seizures or convulsions – occur 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 (symptoms include a sudden feeling of warmth in the upper body), indigestion, enhanced colour vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensitivity, vertigo, tinnitus, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, epistaxis, sensation of warmth, and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numb mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, eye or eyelid swelling, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, changes in the colour of the white part of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, and sudden decrease or loss of hearing.
During the post-marketing phase of sildenafil, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, of the men who experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of sildenafil.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azurvig

Keep this medicine out of the sight and reach of children.
For unopened bottles:
Store below 30°C. Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.
After first opening:
Do not use more than 10 months after first opening. Store the medicine below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azurvig contains

• The active substance is sildenafil. Each ml of suspension contains sildenafil citrate equivalent to 25 mg of sildenafil (35.1 mg as citrate salt). Each spray (0.5 ml of suspension) contains 12.5 mg of sildenafil (as citrate salt).
• The other ingredients are: Sodium benzoate, anhydrous citric acid, sucralose (E-955), acesulfame potassium (E-950), hypromellose (15 cP), xanthan gum, mint flavour 501500 TP0504 (containing: maize maltodextrin), flavouring components (menthofuran 0.6%, pulegone 0.2%, estragole 0.09%), modified maize starch E-1450 (7.9%), flavour-masking agent (SC241160 containing: natural flavouring substances, sucralose E-955 (94.5%), potato maltodextrin and monoammonium glycyrrhizinate (0.4%)), purified water.

Description of the appearance of Azurvig and contents of the pack
Azurvig is a white to off-white suspension, free from extraneous particles, with a characteristic
mint odour.
The primary packaging material consists of a 30 ml high-density polyethylene (HDPE) bottle, equipped with a child-resistant closure made of a high-density polyethylene (HDPE) cap. The pack also includes a 0.5 ml dosing pump made of polypropylene for each spray.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Italy

Manufacturer
Zinereo Pharma, S.L.U.
A Relva, s/n
36400 O Porriño - Pontevedra
Spain
Or
Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117.
46191 Villamarchante – Valencia
Spain
Or
Farmalider, S.A.
C/ Aragoneses, 2
28108 Alcobendas - Madrid
Spain

More detailed information on this medicinal product is available on the AIFA website:
https://aifa.gov.it/bancadatifarmaci/home