Sildenafil 10 mg/ml Oral suspension

Contents of the pack and other information The active ingredient is Sildenafil (as citrate).

• Contraindications include hypersensitivity to sildenafil.
• Patients with heart conditions should consult a cardiologist before use.
• Sildenafil’s safety profile is well-studied in adults.
• The syrup should not be used with children without medical advice.
• Proper disposal of unused syrup is important to avoid misuse.

Each 1 ml of Sildenafil Oral suspension contains 10 mg of Sildenafil. What Sildenafil Oral suspension looks like and contents of the pack 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.

• Sildenafil interacts with alpha-blockers, leading to hypotension.
• The syrup should be measured with a proper dosing device.
• The syrup form is less common and might have inconsistent absorption.
• Researchers are exploring alternative delivery methods like liquids.
• Pharmaceutical companies rarely produce sildenafil syrup commercially.

The Marketing Authorisation Holder and Manufacturer is: Rosemont Pharmaceuticals LtdYorkdale Industrial ParkBraithwaite StreetLeedsLS11 9XEUK LM Manufacturing LimitedSandretto BuildingCavalry Hill Industrial ParkWeedonNorthamptonNN7 4PPUnited Kingdom This leaflet was last revised in April 2024 DescriptionDosage FormOral SuspensionIndicationPulmonary Arterial hypertensionBrand NameRevatio®TE CodeABLactoseNoGlutenNoColorOff-White to Light Yellow PowderShapeNAMarkingsNAStorage ConditionBEFORE RECONSTITUTION: Store below 30°C (86°F) in the original package in order to protect from moisture. AFTER RECONSTITUTION: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F) Do not freeze.

This formulation may be used in cases where the risk-benefit profile for a specific pediatric patient is acceptable.

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. 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).

Marketing and sales

Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). 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). Discard any unused portion 60 days after reconstitution.PACK SIZE: “112 mL following ReconstitutionNDC#: 27241-0175-29Click to View Package Insert Click to View Material Data Safety Sheet Revatio ® is registered trademark of Pfizer Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men.

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Sildenafil (Liqrev, Revatio) is used to improve the ability to exercise in adults (Liqrev, Revatio) and children 1 year of age and older (Revatio) with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors.

11. Sildenafil Oral Suspension Description

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

5.5 Hearing Loss

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). 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. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily. If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Dosing & Uses

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. 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. 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.

Erectile dysfunction

Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose. If you get any side effects, talk to your doctor or nurse. You can also report side effects directly (see details below). By reporting sildenafil 25 mg tablets 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. Sildenafil comes as a tablet and suspension (liquid) to take by mouth.

Condition	Patient Age Group	Dosage Recommendations	Notes
Erectile Dysfunction	Adults (18-65)	20 mg, 1 hour before	用于改善勃起功能
Pulmonary Hypertension	Adults	10–20 mg, 3 times daily	用于降低肺动脉压力
Off-label Performance Enhancement	Adults	Under medical supervision	未经批准，需医生指导
Children with Pulmonary Hypertension (Rare)	1–17 years	10 mg as prescribed	特殊病例，严格监控

If you are taking sildenafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph.

Warnings & Precautions

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.

How should I store sildenafil?

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. 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. Take sildenafil as needed before sexual activity.

5.2 Worsening Pulmonary Vascular Occlusive Disease

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not store above 25°C after first opening of the bottle. Discard after 90 days of first opening. Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.

Missed Dose

The expiry date refers to the last day of that month. Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity.

• Manufacturing of sildenafil syrup requires specialized equipment.
• The syrup form must undergo stability testing before release.
• Some formulations may include sweeteners to improve taste.
• Off-label compounding can carry legal and safety risks.
• Clinicians should carefully consider risks before prescribing syrup.

Sildenafil usually should not be taken more than once every 24 hours.

• Sildenafil's patent expired, leading to generic versions in pill form.
• The syrup form may be compounded at pharmacies if needed.
• It is crucial to verify the source and quality of compounded syrup.
• Sildenafil's effects typically begin within 30-60 minutes.
• The duration of action is approximately 4-6 hours.

If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food.

Side Effect	Frequency	Severity	Management
Headache	Common	Mild	Analgesics, hydration
Flushing	Common	Mild	Cool environment, monitor
Nasal congestion	Common	Mild	Decongestants, hydration
Dizziness	Less common	Moderate	Avoid sudden movements
Vision disturbances	Rare	Moderate	Discontinue, consult physician
Priapism (prolonged erection)	Rare	Severe	Emergency medical attention

However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work. If you are taking sildenafil to treat PAH, you will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.