ASSURANS TAB

INTRODUCTION ABOUT ASSURANS TABLET ASSURANS TABLET contains Sildenafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used for pulmonary arterial hypertension (PAH) in adults and children. Pulmonary arterial hypertension 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. Before taking ASSURANS TABLET 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 ASSURANS TABLET, as it may increase the risk of side effects.ASSURANS TABLET 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 ASSURANS TABLET. The most common side effects of ASSURANS TABLET are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. USES OF ASSURANS TABLET It is used for pulmonary arterial hypertension HOW ASSURANS TABLET WORKS ASSURANS TABLET 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 function. DIRECTIONS FOR USE Take ASSURANS TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush 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 ASSURANS TABLET without consulting your doctor. SIDE EFFECTS OF ASSURANS TABLET 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 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 Stop taking ASSURANS TABLET and contact your doctor immediately if you experience any of the following side effects: 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 Dizziness Or Drowsiness 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. 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. Nausea And Vomiting Take ASSURANS TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens. WARNING & PRECAUTIONS PREGNANCY Monitoring required ASSURANS TABLET 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 ASSURANS TABLET. BREASTFEEDING Use with Caution ASSURANS TABLET should be used with caution for use in breastfeeding women. Therefore, consult your doctor before taking it. DRIVING AND USING MACHINES Consult your doctor Do not drive or operate any machines if you experience dizziness or blurred vision after taking ASSURANS TABLET. ALCOHOL Consult your doctor Avoid consumption of alcohol while taking ASSURANS TABLET as it may reduce the effectiveness of ASSURANS TABLET. KIDNEY Use with Caution ASSURANS TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it. LIVER Consult your doctor ASSURANS TABLET is not recommended for use in patients with severe liver diseases. It should be used with caution in patients with other minor liver problems. Therefore, consult your doctor before taking it. ALLERGY Contraindicated Do not take ASSURANS TABLET if you are allergic to Sildenafil. LUNGS Use with Caution ASSURANS TABLET should be used with caution in patients with pulmonary hypertension caused due to narrowing or blockade of veins (instead of arteries). Consult your doctor before taking. HEART DISEASE Consult your doctor ASSURANS TABLET 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). Consult your doctor before taking it. USE IN PEDIATRICS Monitoring required ASSURANS TABLET 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 Use with Caution ASSURANS TABLET should be used with caution in elderly patients. Consult your doctor before taking. OTHERS ASSURANS TABLET is not recommended for use if you: Previously had loss of vision due to non-arteritic anterior ischaemic optic neuropathy Before taking ASSURANS TABLET inform your doctor if you have: Sickle cell anaemia   A rare inherited eye diseases Cancers of blood (leukaemia) or bone marrow (multiple myeloma) Penile deformation Peyronie’s disease Stomach ulcer or bleeding disorder such as haemophilia Nosebleed Dehydration due to diarrhoea, fever, or less intake of fluids or increased sweating INTERACTIONS A. Drug-Drug interactions: Before taking ASSURANS TABLET, inform your doctor if you are taking any of the following medicines such as: Nitrates or amyl nitrites (used for relieving chest pains) Ex. nitroglycerin and isosorbide dinitrate Other medicines used for PAH (Ex. riociguat, bosentan or iloprost) Medicines used for prostate problems or blood pressure such as alpha-blocker (Ex. silodosin, doxazosin) Ketoconazole or itraconazole (used to manage fungal infections) St. John’s wort or nefazodone (used for depression) Antibiotics (used to manage bacterial infections) Ex. erythromycin, clarithromycin and telithromycin Rifampicin (used to manage tuberculosis) Saquinavir and ritonavir (used for HIV infections) Medicines used for blood thinning (Ex. warfarin) Medicines used to manage epilepsy (Ex. carbamazepine, phenytoin, and phenobarbital) B. Drug-Food Interactions: Avoid drinking grapefruit juice while taking ASSURANS TABLET, as it may increase the risk of side effects. Overdosage: If you or anyone else accidentally took more ASSURANS TABLET, 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 Arterial Hypertension          Dosage Forms :   Tablet, Capsule, Oral Disintegrating Strips, Oral Jelly, Injection, Effervescent Tablet, Spray MORE INFORMATION Keep ASSURANS TABLET out of reach of children Store ASSURANS TABLET at room temperature FAQs ABOUT ASSURANS TABLET Q: What are the uses of ASSURANS TABLET? A: ASSURANS TABLET is used for 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. Q: What does ASSURANS TABLET do? A: ASSURANS TABLET 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. Q: How to take ASSURANS TABLET? A: ASSURANS TABLET should be taken as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Q: Can elderly men take ASSURANS TABLET? A: Yes. ASSURANS TABLET 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. Q: Can ASSURANS TABLET be used in women? A: Yes. ASSURANS TABLET can be used in women for 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 ASSURANS TABLET. Q: What are the side effects of ASSURANS TABLET? A: The most common side effects of ASSURANS TABLET are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Q: What medicines should I avoid while taking ASSURANS TABLET? A: Before taking ASSURANS TABLET inform your doctor about all the medicines that you use for current illness.  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 antiepileptic drugs (Ex. carbamazepine, phenytoin). Q: Can I consume alcohol while taking ASSURANS TABLET? A: No. Consumption of alcohol while taking ASSURANS TABLET gives less efficient results. Avoid alcohol to achieve maximum benefits of ASSURANS TABLET.