Sildenafil 10 mg/ml Oral suspension

Sildenafil Oral suspension is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension). What you need to know before you take Sildenafil Oral suspension 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”).

Uses of Sildenafil For Oral Suspension

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. These medicines are often given for relief of chest pain (or “angina pectoris”).

• Sildenafil can cause visual disturbances like blurred vision.
• Alcohol consumption may increase side effects when using sildenafil.
• The syrup should be stored at room temperature away from light.
• Patients should avoid heavy meals before taking sildenafil.
• Regular monitoring is recommended for long-term use.

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.

5.7 Priapism

SILDENAFIL - sildenafil citrate for suspension ANI Pharmaceuticals, Inc. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.

8.6 Patients with Hepatic Impairment

SILDENAFIL (sil DEN a fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. They need to know if you have any of these conditions: History of blood diseases, such as sickle cell anemia or leukemia Stomach ulcers, other stomach or intestine problems An unusual or allergic reaction to sildenafil, other medications, foods, dyes, or preservatives Take it as directed on the prescription label at the same time every day.

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Use a specially marked oral syringe, spoon, or dropper to measure each dose. Do not mix this medication with other medications or flavoring. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. 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).

• 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.

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).

• The shelf life of sildenafil syrup depends on formulation and storage.
• Expiry dates should always be checked before use.
• Improper storage can lead to degradation of active ingredients.
• The liquid form allows for precise dose adjustments.
• Careful titration is essential to avoid overdose risks.

if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).

• 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 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).

What are some side effects that I need to call my doctor about right away?

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine. Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

8.7 Patients with Renal Impairment

Tell your care team right away if you have any change in your eyesight or hearing. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Other Interactions

Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. Side effects that you should report to your care team as soon as possible: Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision Sudden vision loss in one or both eyes Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 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. have high blood pressure in the blood vessels in the lungs.

1 INDICATIONS AND USAGE

This includes any possible side effects not listed in this leaflet. What Sildenafil Oral suspension is and what it is used for 2. What you need to know before you take Sildenafil Oral suspension 3. Contents of the pack and other information What Sildenafil Oral suspension is and what it is used for Sildenafil Oral suspension contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Sildenafil Oral suspension brings down blood pressure in the lungs by widening 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. currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.

Further information

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

What should I do if I accidentally use too much sildenafil?

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others. If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose.

Medical Professionals

Do not take double or extra doses. Do not take this medication with any of the following: Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin This medication may also interact with the following: Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and sildenafil spray to make sure your medications work as intended. This list may not describe all possible interactions. 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.

12 CLINICAL PHARMACOLOGY

Keep out of the reach of children and pets. After this medication is mixed by your pharmacist, store it below 30 degrees C (86 degrees F) or in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Throw away any unused medication after 60 days. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Allergy warning

Sign up for our Health Essentials emails for expert guidance on nutrition, fitness, sleep, skin care and more. Note: Introduction and Additional Common Questions written and medically approved by Cleveland Clinic professionals. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Back to top Sildenafil 10 mg/ml Oral suspension Active Ingredient: ATC code: My Account Area Below is a text only representation of the Patient Information Leaflet (ePIL). The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

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Last updated on emc: 24 May 2024 The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: sildenafil 20 mg tablets PL 00427/0258. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. You may need to read it again. 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).