Sildenafil 10 mg/ml Oral suspension

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 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. If you stop taking Sildenafil Oral suspension 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.

Consumer Information Use and Disclaimer

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 sildenafil citrate tablets 150 mg affect vision. You should be aware of how you react to the medicine before you drive or use machines. This medicine contains 2.0 mg sodium benzoate in each ml.

How should I store sildenafil?

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For adults, the recommended dose is 20 mg (2 ml of Oral suspension) three times a day (taken 6 to 8 hours apart) taken with or without food. 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.

Warnings for other groups

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). If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should stop taking Sildenafil Oral suspension and contact a doctor immediately (see also section 2): if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours.

Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

4. Contraindications

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). Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs. Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature. Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men. Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data). The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

8.5 Geriatric Use

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). If you take more Sildenafil Oral suspension than you should You should not take more medicine than your doctor tells you to. The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

• Sildenafil syrup may be preferred for those with swallowing issues.
• It can be mixed with water or other liquids if approved by a doctor.
• The taste of the syrup might require flavoring agents.
• There's limited data on the stability of sildenafil syrup long-term.
• Use of sildenafil in women is not approved and not well-studied.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed. Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.

Brand names

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.

Pulmonary hypertension

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

What are the most common side effects of sildenafil?

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. Medicines containing sacubitril/valsartan used to treat heart failure. Sildenafil Oral suspension with food and drink 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. If you get any side effects, talk to your doctor or nurse. You can also report side effects directly (see details below).

What happens if I overdose?

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 problem with the pumping chambers of your heart.

2.2 Recommended Dosage in Pediatric Patients

have high blood pressure in the blood vessels in the lungs. 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.

5.7 Priapism

currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds. 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). By reporting side effects you can help provide more information on the safety of this medicine. or search for MHRA Yellow Card in the Google Play or Apple App Store. Keep this medicine out of the sight and reach of children.

• Sildenafil syrup is sometimes used in pediatric cases, off-label.
• Off-label use in children requires careful dosage adjustment.
• Lack of standardization makes typical dosing guidelines difficult.
• Pharmacokinetics in syrup form are less well-studied.
• Always seek professional medical advice before use.

This medicinal product does not require any special storage conditions.