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INTRODUCTION
ESYLNAFIL contains Sildenafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used in adults and in children to treat pulmonary arterial hypertension (PAH). PAH can be defined as an increased blood pressure in the blood vessels that supplies the lungs. It can be caused due to narrowing of blood vessels (arteries) supplying the heart and the lungs. Symptoms of PAH might include shortness of breath, tiredness, weakness, and feeling faint.
Sildenafil reduces blood pressure within the lungs by relaxing the blood vessels supplying the lungs. This enhances blood flow and oxygen supply to the lungs which ultimately reduces pressure within the lungs and improves its functions.
Before taking ESYLNAFIL inform your doctor if you have any liver, kidney, or heart problems. It should be used with caution in patients with eye problems, stomach problems, anemia, or penile deformity. Avoid consuming grapefruit juice while taking ESYLNAFIL, as it may increase the risk of side effects.
ESYLNAFIL should be used in pregnant or breastfeeding women only if it is considered necessary by the physician. Women of childbearing potential should use suitable contraceptive method to avoid pregnancy while undergoing therapy with ESYLNAFIL. It is also not suitable for use in infants aged below 1 year.
The most common side effects of ESYLNAFIL are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Also inform your doctor if you experience any painful or prolonged erections after taking ESYLNAFIL.
USES OF ESYLNAFIL
- Treats pulmonary arterial hypertension in adults and in children
HOW ESYLNAFIL WORKS
ESYLNAFIL reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions.
DIRECTIONS FOR USE
Take ESYLNAFIL as advised by your physician. Swallow the medicine with a glass of water. Do not cursh or chew. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking ESYLNAFIL without consulting your doctor.
SIDE EFFECTS OF ESYLNAFIL
COMMON
- headache
- flushing
- indigestion, diarrhoea
- pain in the arms or legs
- infection under the skin
- flu-like symptoms, throat infection, fever
- inflammation of the sinuses
- decreased number of red blood cells (anaemia)
- fluid retention
- difficulty in sleeping, anxiety, shaking
- sensation of pins and needles
- reduced sensation to touch
- eye problems (eye redness, blurred vision, light sensitivity, effects on colour vision, eye irritation)
- vertigo (spinning sensation)
- nosebleed, runny nose, cough, stuffy nose
- nausea, vomiting, stomach inflammation, heartburn, piles, abdominal distension, dry mouth, diarrhea
- hair loss
- skin redness, night sweats
- muscle pain, back pain
- increased erections
UNCOMMON
- eye problems (reduced sharpness of vision, double vision, abnormal sensation in the eye)
- penile bleeding
- presence of blood in semen and/or urine
- breast enlargement in men
RARE
Stop taking ESYLNAFIL and contact your doctor immediately if you experience any of the following side effects:
- prolonged or painful erection
- sudden, partial, temporary, or permanent decrease or loss of vision in one or both eyes
- allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing)
- pneumonia (infection of lungs) and other respiratory infection or inflammation (bronchitis)
- abnormal heartbeat, chest pain, fainting
- infections (viral infection of the gut, urinary tract infections and tooth cavities)
- fits
- hearing impairment
- difficulty in breathing
- inflammation of digestive tract
HOW TO MANAGE SIDE EFFECTS
Nausea and Vomiting:
Take ESYLNAFIL with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
WARNING & PRECAUTIONS
PREGNANCY
ESYLNAFIL is generally not recommended for use in pregnant unless considered necessary by the physician. Therefore, consult your doctor before taking it. Women of child-bearing potential should use proper contraceptive method to avoid pregnancy while undergoing therapy with ESYLNAFIL.
BREASTFEEDING
ESYLNAFIL should be used with caution for use in breastfeeding women. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or blurred vision after taking ESYLNAFIL.
ALCOHOL
Avoid consumption of alcohol while taking ESYLNAFIL as it may reduce the effectiveness of ESYLNAFIL.
KIDNEY
ESYLNAFIL should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
ESYLNAFIL is not recommended for use in patients having severe liver diseases. It should be used with caution in patients with other minor liver problems. Therefore, consult your doctor before taking.
ALLERGY
Do not take ESYLNAFIL if you are allergic to Sildenafil.
LUNGS
ESYLNAFIL should be used with caution in patients with pulmonary hypertension caused due to narrowing or blockade of veins (instead of arteries). Kindly consult your doctor before taking.
HEART DISEASE
ESYLNAFIL is not recommended for use in patients with severe heart diseases (such as any recent heart attack or stroke, or severe low blood pressure). It should be used with caution in patients with other heart problems (such as problems in heart chambers or valves, low blood pressure at rest). Therefore, consult your doctor before taking it.
OTHERS
ESYLNAFIL is not recommended for use if you:
- previously had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION; a type of nerve damage caused due to lack of blood and oxygen supply to the eye)
Before taking ESYLNAFIL inform your doctor if you:
- have sickle cell anaemia (an inherited blood disorder characterized by low RBC count)
- have any type of rare inherited eye diseases (such as retinitis pigmentosa)
- have cancers of blood (leukaemia) or bone marrow (multiple myeloma)
- have penile deformation
- have Peyronie’s disease (development of fibrous scar tissue that results in painful erection)
- have stomach ulcer or bleeding disorder such as haemophilia
- have nosebleeds
- have dehydration due to diarrhoea, fever, or less intake of fluids or increased sweating
Use in pediatrics:
ESYLNAFIL should be used in children and adolescents (aged between 1-18 years) only if prescribed by the physician. It is not recommended for use in infants aged below 1 year. Therefore, consult your doctor before taking.
Use in geriatrics:
ESYLNAFIL should be used with caution in elderly patients. Therefore, consult your doctor before taking.
INTERACTIONS
A. Drug-Drug Interaction:
Before taking ESYLNAFIL, inform your doctor if you are taking any of the following:
- nitrates or amyl nitrites (used for reliving chest pains) Ex. nitroglycerin and isosorbide dinitrite
- other medicines used to treat PAH (Ex. riociguat, bosentan or iloprost)
- medicines used to treat prostate problems or blood pressure such as alpha-blocker (Ex. silodosin, doxazosin)
- ketoconazole or itraconazole (used to treat fungal infections)
- St. John’s wort or nefazodone (used to treat depression)
- antibiotics (used to treat bacterial infections) Ex. erythromycin, clarithromycin and telithromycin
- rifampicin (used in treatment of tuberculosis)
- saquinavir and ritonavir (used to treat HIV infections)
- medicines used for blood thinning (Ex. warfarin)
- medicines used to treat epilepsy (Ex. carbamazepine, phenytoin, and phenobarbital)
B. Drug-Food Interaction:
Avoid drinking grapefruit juice while taking ESYLNAFIL as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more ESYLNAFIL, consult your doctor immediately as there can be chances of increased side effects.
SYNOPSIS
| Drug | : | Sildenafil |
| Pharmacological Category | : | Phosphodiesterase type 5 inhibitors |
| Therapeutic Indication | : | Pulmonary Aterial Hypertension |
| Dosage Forms | : | Tablet, Capsule, Oral Disintegrating Strips, Oral Jelly, Injection, Effervescent Tablet, Spray |
MORE INFORMATION
- Keep ESYLNAFIL out of reach of children
- Store ESYLNAFIL at room temperature
FAQs ABOUT ESYLNAFIL
What are the uses of ESYLNAFIL?
ESYLNAFIL is used to treat pulmonary arterial hypertension (PAH) in both adults and in children. It reduces blood pressure within the lungs by relaxing the blood vessels supplying the lungs.
What does ESYLNAFIL do?
ESYLNAFIL reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions.
How to take ESYLNAFIL?
ESYLNAFIL should be taken as advised by your physician. Swallow the medicine with a glass of water. Do not cursh or chew. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking ESYLNAFIL without consulting your doctor.
Can elderly men take ESYLNAFIL ?
Yes. ESYLNAFIL should be used with caution in elderly patients, especially if they have any pre-existing heart conditions and taking medicines for it. Consult your doctor before taking.
Can ESYLNAFIL be used in women?
Yes. ESYLNAFIL can be used in women for treating pulmonary arterial hypertension. However, it should be used in pregnant or breastfeeding women only if considered necessary by the physician. Therefore, consult your doctor before taking it. Women of child-bearing potential should use proper contraceptive method to avoid pregnancy while undergoing therapy with ESYLNAFIL.
Can ESYLNAFIL treat erectile dysfunction?
No. ESYLNAFIL is not meant for treating erecrtile dysfunction. It is used for treating pulmonary arterial hypertension in adults and children and adolescents (1-18 years). If you wish to treat erectile dysfunction, consult your doctor for advice. Your doctor would either prescribe a higher dose of sildenafil or suggest an alternative therapy based on your medical condition.
What are the side effects of ESYLNAFIL?
The most common side effects of ESYLNAFIL are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Also inform your doctor if you experience any painful or prolonged erections after taking ESYLNAFIL.
Can ESYLNAFIL affect sexual performance?
No. ESYLNAFIL is used to reduce increased blood pressure in the lungs. It may have influence on erection but cannot improve sexual performance.
Can ESYLNAFIL cause painful erections?
Yes. ESYLNAFIL may cause painful and prolonged erectiuons. Inform your doctor if you experience any such effects.
What medicines should I avoid while taking ESYLNAFIL?
Before taking ESYLNAFIL, inform your doctor about all the medicines that you use to treat your current illnesses. Avoid concomittant use of similar medicines which can relaxes your blood pressure such as nitrates (Ex. nitroglycerin). It is also important to inform your doctor about the use of antibiotics (Ex. erythromycin, clarithromycin, telithromycin, rifampicin), antivirals (Ex. saquinavir and ritonavir) and antiepiletic drugs (Ex. carbamazepine, phenytoin) before undergoing treatment with ESYLNAFIL.
Can I consume alcohol while taking ESYLNAFIL?
No. Consumption of alcohol while taking ESYLNAFIL gives less efficient results. Avoid alcohol to achieve maximum benefits of ESYLNAFIL.
REFERENCES
1. K.D. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 303-304.
2. Sukhdeep Bhogal, Ola Khraisha, Mohammad Al Madani, Jennifer Treece, Steven Baumrucker and Timir K Paul. Sildenafil for Pulmonary Arterial Hypertension. NIH National Library of Medicine, National center for biotechnology information. July/Aug 2019. [Accessed on 6th May 2022] https://pubmed.ncbi.nlm.nih.gov/30946047/
3. Gautam V Ramani and Myung H Park. Update on the clinical utility of sildenafil in the treatment of pulmonary arterial hypertension. NIH. National Library of Medicine. National Centre of Biotechnology Information. PMC. PubMed Central. May 2010. [Accessed on 11th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880338/
4. Pfizer Ltd. Electronic Medicines Compendium (EMC). [Revised 1/2021] [Accessed on 2nd May 2022] https://www.medicines.org.uk/emc/files/pil.181.pdf
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