• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”). Sildenafil Oral suspension can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.
• if you are taking riociguat. This drug 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 Sildenafil Oral suspension have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Talk to your doctor before taking Sildenafil Oral suspension if you:

• have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
• have a severe heart problem.
• have a problem with the pumping chambers of your heart.
• have high blood pressure in the blood vessels in the lungs.
• have low blood pressure at rest.
• lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
• have a rare inherited eye disease (retinitis pigmentosa).
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia),
• cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
• take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease or loss of vision, stop taking Sildenafil Oral suspension and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Sildenafil Oral suspension and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Sildenafil Oral suspension should not be given to children below 1 year of age.

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

• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of angina pectoris or “chest pain” (see section 2. Before you take Sildenafil Oral suspension).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
• Blood thinning medicines (for example warfarin) although these did not result in any side effect.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms of low blood pressure (e.g. dizziness, light headedness).

You should not drink grapefruit juice while you are being treated with Sildenafil Oral suspension.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil Oral suspension should not be used during pregnancy unless strictly necessary. Sildenafil Oral suspension should not be given to women of child bearing potential unless using appropriate contraceptive methods. Sildenafil Oral suspension passes into your breast milk at very low levels and would not be expected to harm your baby.

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

• Sodium benzoate (E 211). This medicine contains 2.0 mg sodium benzoate in each ml.
• This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of Oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of Oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food. Higher doses should not be used in children.

The oral suspension must be shaken well before use.

• Open the bottle: press the cap and turn it anticlockwise (figure 1).
• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.

• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic screw cap.
• Empty the contents of the syringe into your mouth.
• After dosing, wash the syringe with water only (figure 7).

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

If you take more medicine than you have been told to take contact your doctor immediately. Taking more Sildenafil Oral suspension than you should may increase the risk of known side effects.

If you forget to take Sildenafil Oral suspension, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

Suddenly stopping your treatment with Sildenafil Oral suspension may lead to your symptoms getting worse.

Do not stop taking Sildenafil Oral suspension unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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The active ingredient is Sildenafil (as citrate).

Each 1 ml of Sildenafil Oral suspension contains 10 mg of Sildenafil.

The other ingredients are sucralose (E 955), xanthan gum (E 415), acesulfame potassium (E 950), glycerol (E 422), sodium benzoate (E 211), citric acid monohydrate (E 330), sodium citrate (E 331), 30% simethicone emulsion (including benzoic acid (E 210)), strawberry flavour (containing natural flavouring substances, flavouring substances, glyceryl triacetate, water and triethyl citrate) and purified water.

Sildenafil Oral suspension is a white to off white suspension.

This medicine is supplied in amber glass bottle with a white child resistant tamper evident closure containing 122 ml of liquid product.

The package contains a 2 ml oral syringe with a polypropylene body, purple HDPE plunger, graduations printed at 0.5 ml 1.0 ml, 1.5 ml and 2.0 ml together with a low density polyethylene bottle adaptor.

The Marketing Authorisation Holder is:

The Manufacturer is: