Patient leaflet - Sildenafil 12.5 mg/actuation, Oromucosal spray, suspension

1. What Sildenafil is and what is it used for

Sildenafil contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil will only help you to get an erection if you are sexually stimulated.

Sildenafil is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2. What you need to know before you take Sildenafil

Do not take Hezkue Go:

If you are allergic 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 may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
If you have a severe heart or liver problem.
If you have recently had a stroke or a heart attack, or if you have low blood pressure.
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
If you have ever had loss of vision due to non-arteritic anterior ischaemic 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 secondary to blood clots). PDE5 inhibitors, such as Sildeanfil has been shown to increase the hypotensive effects of this medicine. If you are taking Riociguat or are unsure tell your doctor.

Warnings and precautions

Check with your doctor before taking Sildenafil:

If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
If you have a deformity of your penis or Peyronie’s Disease.
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.
If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
If you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

You should not use Sildenafil with any other oral or local treatments for erectile dysfunction.

You should not use Sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take Sildenafil if you do not have erectile dysfunction.

You should not take Sildenafil if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Sildenafil

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

Sildenafil may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.

You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take Sildenafil if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking Riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (1 mL is equivalent to 25 mg of sildenafil) of Hezkue Go.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (1 mL is equivalent to 25 mg of sildenafil) of Sildenafil.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure

Sildenafil with food and drink and alcohol

Sildenafil can be taken with or without food. However, you may find that Sildenafil takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking this medicine.

Pregnancy and breast-feeding

Sildenafil is not indicated for use in women.

Driving and using machines

Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to medicine before you drive or use machinery.

Sildenafil contains sodium benzoate

This medicinal product contains less than 1 mmol (23 mg) of sodium benzoate per ml of suspension. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.

3. How to take Sildenafil

Always take Sildenafil exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 2 mL equivalent to 50 mg sildenafil (4 pumps). Each press of the dosing pump releases 0.5 mL of suspension containing 12.5 mg of sildenafil.

If this medicine does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

Your doctor may then recommend a decrease or increase of the dose to 1mL of the suspension equivalent to 25 mg (2 pumps), or 4 mL of suspension equivalent to 100 mg (8 pumps).

You should take Sildenafil about an hour before you plan to have sex. Sildenafil should not be taken more than once a day.

Do not take Sildenafil together with other medications that contain sildenafil.

Method of administration

This medication is to be administered orally. Do not administer this medicine via the nose and do not apply this medicine on the skin. Your doctor will prescribe you the correct number of doses you need. For a correct administration, please follow the Instructions for Use. Always use the pump supplied with the pack.

Instructions for use

Shake the bottle vigorously for approximately 20 seconds to ensure that the

medicine is mixed in the bottle before each use (Fig 1).

Remove the child-resistant screw cap by pushing it down firmly and turning it anticlockwise. (Fig 2)

Place the dosage pump on top of the bottle, sliding the plastic tube carefully into the liquid in the bottle. Hold the dosing pump onto the neck of the bottle and screw clockwise until it is firmly attached to the bottle. (Fig 3)

Turn the nozzle on the dosing pump to the open position. (Fig 4)

Before every use (including first-time use):

Activate the pump three times to prepare (prime) the dosage pump, discard any product released during this activation into an absorbent material.

The pump is now ready to be used and each metered spray delivers an average of 12.5 mg of sildenafil.

A failure in this priming process may lead to a lower dose when used.

Tilt your head back a little. Open your mouth and put

the bottle next to your chin (see picture). Press the dosage pump as many times as required, according to the dose prescribed by your doctor. Apply the suspension onto the tongue and swallow the suspension immediately with saliva. Avoid direct contact between the end of the dosage pump and the inside of the mouth and tongue. (Fig 5)

Turn the nozzle on the dosage pump to the closed position. (Fig 6)

Remove the pump from the bottle unscrewing anticlockwise. Tap the plastic

tube against the internal wall of the bottle to remove any excess liquid. (Fig 7)

Put the child resistant screw cap back on the bottle and turn clockwise to close it immediately after each use. (Fig 8)

Wash the dosage pump thoroughly with water. Ensure no product or water remains in the pump by activating the pump several times into an absorbent material. Allow the pump to dry thoroughly before the next use. (Fig 9 & 10)

NOTE FOR PATIENTS – Sildenafil requires priming before each dose and washing of the dosing pump after each use. Therefore, a small amount of product is discarded with each use. The approximate volume of Sildenafil that is used is 20 ml in each 30 ml bottle.

Once the volume of the product in the bottle goes below the red line (marked on the bottom of the bottle), stop using Sildenafil and discard.

If you take more Sildenafil than you should

You may experience an increase in side effects and their severity.

You should not take more doses than your doctor tells you to.

Contact your doctor if you take more doses than you should.

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

4. Possible side effects

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

Side effects with Sildenafil may include:

Allergic reaction - this occurs infrequently (may affect up to 1 in 100 people). Symptoms include sudden wheezing, shortness of breath or dizziness, swelling of the eyelids, face, lips, or throat. Get medical help immediately if you get any of these symptoms.
Chest pains - this occurs infrequently (may affect up to 1 in 100 people). If they appear during or after sexual intercourse:
- Get into a semi-sitting position and try to relax.
- Do not use nitrates to treat chest pain.
- Contact your doctor immediately.
Prolonged and sometimes painful erections - this occurs 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.
A sudden decrease or loss of vision - this occurs rarely (may affect up to 1 in 1,000 people). If this happens contact your doctor immediately
Serious skin reactions - this occurs rarely (may affect up to 1 in 1,000 people).
If you experience symptoms which can include severe peeling and swelling of the skin, buccal blisters, bumps on the genitals and around the eyes, and fever. contact your doctor immediately.
Seizures or fits - this occurs rarely (may affect up to 1 in 1,000 people). If this happens contact your doctor immediately.

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
flushing (symptoms include a feeling of sudden warmth in the upper body)
indigestion
abnormal colour perception
blurred vision
visual impairment
nasal congestion
dizziness

Infrequent (may affect up to 1 in 100 people):

vomiting
skin rash
eye irritation, eye discharge / red eyes, eye pain
vision of flashing lights, visual clarity, sensitivity to light, watery eyes
palpitations
fast heart rate
high blood pressure
low blood pressure
muscle pain
feeling drowsy
reduced touch sensation
vertigo
ringing in the ears
dry mouth
blocked or congested sinuses, inflammation of the lining of the nose (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
nosebleed
feeling of heat
feeling of tiredness

Rare (may affect up to 1 in 1,000 people):

fainting
stroke
heart attack
irregular heartbeat
temporary decrease in blood flow to some parts of the brain
feeling of tightness in the throat
numbness in the mouth
bleeding in the back of the eye
double vision, decreased visual acuity
abnormal sensation in the eye, swelling of the eye or eyelid
small particles or spots in the vision, vision of halos around lights
dilation of the eye pupil, change colour of the whites of the eye
bleeding from the penis
presence of blood in the semen
dry nose, swelling inside the nose
feeling of irritability
sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card scheme on the MHRA website (www.yellowcard.mhra.gov.uk) or with the MHRA Yellow Card app in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil

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

Do not use Sildenafil after the expiry date which is stated on the carton and bottle as “EXP”. The expiry date refers to the last day of that month.

The expiry date after first opening of the bottle is 10 months. Fill in the date of first opening in the space on the box to know when this expiry date has been reached.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Sildenafil contains

The active substance is sildenafil.

Each 1 mL (corresponds to TWO pumps) of suspension contains 25 mg of sildenafil.

The other ingredients are:

sodium benzoate, anhydrous citric acid, sucralose, acesulfame potassium, hypromellose, xanthan gum, peppermint flavour, masking flavour, purified water

What Sildenafil looks like and contents of the pack

Sildenafil is a white to off- white oromucosal spray suspension with a mint aroma flavour

The primary packaging material of the product Sildenafil consists of high-density polyethylene (HDPE) translucent bottles that contains 16 mL of drug product, closed with a high-density polyethylene (HDPE) child-resistant cap. The box contains a metering pump of 0.5 mL per pump as the administration device.

Manufacturer

Farmalider, SA

C/ Aragoneses, 2

28108 Alcobendas - Madrid

Spain

Edefarm, SL

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191 Valencia