Staxar

Italy
Brand name Staxar
Form film, orodispersible
Active substance / Dosage
SILDENAFIL CITRATE
Prescription type Prescription only
ATC code
G04BE03
Registration number 050386
Manufacturer FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L.

Table of Contents

Package leaflet: Information for the patient

Staxar 50 mg orodispersible film-coated tablet

Sildenafil
Generic medicine
Please read all of this leaflet carefully before you take 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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Staxar is and what it is used for

Staxar 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 flow into the penis during sexual stimulation. Staxar will help you achieve an erection only
if you are sexually stimulated.
Staxar is a treatment for adult men with 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 Staxar

Do not take Staxar

  • 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 pectoris attacks (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
  • if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as this combination may also cause a dangerous drop in blood pressure.
  • 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 sildenafil have been shown to increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, inform your doctor.
  • 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 ever experienced sudden vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

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

  • if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a cancer of blood cells), or multiple myeloma (a cancer of the bone marrow).
  • if you have a deformity of the penis or Peyronie's disease.
  • if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
  • if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
  • if you experience sudden decrease or loss of vision, stop taking Staxar and contact your doctor immediately. You must not use Staxar together with other oral or topical treatments for erectile dysfunction.

You must not use Staxar together with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or with any other PDE5 inhibitor.
You must not take Staxar if you do not have erectile dysfunction.
You must not take Staxar if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor. Your doctor may decide to
administer a lower dose.
Children and adolescents
Staxar must not be given to individuals under 18 years of age.
Other medicines and Staxar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Staxar may interact with certain medicines, particularly those used to treat chest pain.
If a medical emergency occurs, you must inform the doctor, pharmacist, or nurse that you have taken Staxar and when you took it. Do not take Staxar with other medicines unless your doctor has authorized it.
Do not take Staxar if you are taking medicines called nitrates, because 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 pectoris attacks (or "chest pain").
Do not take Staxar if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of sildenafil, 25 mg.
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be due to low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking sildenafil together with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil.
To reduce the possibility of these symptoms occurring, you should already be on a regular daily dose of an alpha-blocker before starting treatment with sildenafil.
Your doctor may start you on a lower dose of sildenafil (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used
for the treatment of heart failure.
Staxar with food, drinks and alcohol
Sildenafil can be taken with or without food. However, you may notice that the onset of sildenafil'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 excessive alcohol consumption before using sildenafil.
Pregnancy, breastfeeding and fertility
Staxar is not indicated for use in women.
Driving and using machines
Staxar may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to Staxar.
Staxar contains sodium and propylene glycol
Staxar contains less than 1 mmol (23 mg) of sodium per film. This means it is essentially "sodium-free".
Staxar also contains 18 mg of propylene glycol (E 1520) per film.

3. How to take Staxar

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 50 mg.
Staxar must not be taken more than once a day.
Do not take Staxar orodispersible film in combination with sildenafil tablets.
You should take Staxar approximately one hour before anticipated sexual activity. The time it takes for Staxar to work varies from person to person, but normally takes between half an hour and one hour.
Place the orodispersible film on your tongue, where it will dissolve within seconds; then swallow it with saliva or water.
The orodispersible film must be taken on an empty stomach, as it may take longer to start working if taken with a heavy meal.
If a second 50 mg orodispersible film is needed to achieve a 100 mg dose, you must wait until the first film has completely disintegrated and has been swallowed before taking the second orodispersible film.
If you feel that the effect of Staxar is too strong or too weak, consult your doctor or pharmacist.
Staxar will help you achieve an erection only if you are sexually stimulated.
If Staxar 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 Staxar than you should:
You may notice an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase efficacy.
Do not take more Staxar than prescribed by your doctor.
Contact your doctor if you take more films than directed.
If you have further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
How to take Staxar orodispersible film

  • Sildenafil (sildenafil citrate) is available as a 50 mg orodispersible film that dissolves in the mouth.
  • Open the Staxar orodispersible film sachet with dry hands.
  • The orodispersible film should be placed on the tongue, where it dissolves and can be swallowed with saliva.
  • The orodispersible film can be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany ingestion of tablets with liquids.

Instructions for use
Important: do not handle the orodispersible film with wet hands!

Six numbered panels showing how to open a sachet, fold it into a triangle, and pour the contents into the mouth for

Instructions for use:
Step 1. Hold the sachet with the back facing towards you. Locate the arrow on the side, situated in the top left corner of the sachet, and hold it with that side facing upwards. The sachet is partially sealed on this side, with two visible flaps.
Step 2. Hold the two visible flaps of the sachet at the position of the arrow symbol. Gently begin pulling both flaps in opposite directions, thus separating the two sides of the sachet.
Step 3. Continue pulling until the two sides of the sachet are almost separated. The orodispersible film is now visible inside the sachet. It is not necessary to completely separate both sides of the sachet to remove the orodispersible film.
Steps 4, 5 and 6. Carefully remove the orodispersible film from the sachet and place it on your tongue. It will dissolve rapidly, making it easy to swallow.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them. The side effects reported in association with sildenafil use are usually mild to moderate in intensity and short-lived.

If you experience any of the following serious side effects, stop taking Staxar and contact your doctor immediately:

  • Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden breathlessness, 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 in a semi-upright position 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 you have an erection lasting more than 4 hours, you must seek immediate medical attention.
  • Sudden decrease or loss of vision – occurs rarely.
  • Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, 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, increased brightness of colours in 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, light flashes, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, 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 (including heartburn), blood in urine, pain in arms or legs, epistaxis (nosebleed), feeling 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, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, 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 eye, penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.

Following marketing experience, 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, pharmacist or nurse. You can also report side effects directly via 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 Staxar

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton/pouch after "EXP".
The expiry date refers to the last day of that month.
Do not remove the orodispersible film from the outer aluminium pouch until ready to take the medicine.
Do not use the medicine if you notice that the aluminium pouch is damaged.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
These measures will help protect the environment.

6. Package contents and other information

What Staxar contains

  • The active substance is sildenafil. Each orodispersible film contains 50 mg of sildenafil (as citrate salt).
  • The other ingredients are:

Hypromellose 50 cps (E 464)
Propylene glycol (E 1520)
Povidone (E 1201)
Anhydrous sodium carbonate (E 500)
Polysorbate 80
Poly(vinyl alcohol) (E 1203)
Sucralose
Hypromellose 15 cps (E 464)
Sodium lauryl sulfate
Neotame
Bitterness masking agent (B.T.M.) NG-410-146-4
Raspberry flavour
Partially demethylated peppermint oil
FD & C Blue 1 (E 133)

Description of the appearance of Staxar and the contents of the pack
Staxar 50 mg is a blue, rectangular, non-sticky, opaque orodispersible film. Staxar 50 mg orodispersible film is available in sachets containing a single orodispersible film.
Packs of 4 and 8 orodispersible films in cardboard.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta

This medicinal product is authorised in EEA Member States under the following names:
Netherlands: Staxar 50 mg orodispergeerbare film
Italy: Staxar