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FIBORESP FORTE 801 Tablet 10's
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INTRODUCTION
FIBORESP FORTE 801 contains Pirfenidone which belongs to the group of medicines called Anti-fibrotics or Anti-inflammatory agents. It is used in the treatment of mild to moderate Idiopathic pulmonary fibrosis in adults. Idiopathic pulmonary fibrosis is a condition in which the tissues in the lungs (alveoli) become swollen and scarred over time and making it difficult to breathe. This makes it hard for the lungs to work properly.
FIBORESP FORTE 801 is not recommended for use in patients with severe or end-stage liver or kidney disease. Before taking FIBORESP FORTE 801 inform your doctor if you have mild to moderate liver disease, kidney problems or photosensitivity reactions. FIBORESP FORTE 801 is not recommended for use in pregnant women unless advised by your doctor. It is not known whether FIBORESP FORTE 801 passes into breast milk, hence consult your doctor before taking this medicine.
FIBORESP FORTE 801 is not recommended for use in children and adolescents below 18 years of age. FIBORESP FORTE 801 should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking this medicine. Avoid smoking while using FIBORESP FORTE 801 as it reduces the effect of this medicine. Also, avoid drinking grapefruit juice as it may lead to unwanted effects.
The most common side effects of taking FIBORESP FORTE 801 are nausea, stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset, weight loss, decreased appetite, tiredness, dizziness, headache. Consult your doctor if any of the above side effects worsen.
USES OF FIBORESP FORTE 801
- Treats idiopathic pulmonary fibrosis
HOW FIBORESP FORTE 801 WORKS
FIBORESP FORTE 801 works by exhibiting anti-inflammatory, antioxidant and antifibrotic properties that suppress the factors (transforming growth factor -β (TGF-β)) causing scarring and swelling of the tissues. As a result, it treats and controls the fibrosis of the tissues resulting in improving lung function.
DIRECTIONS FOR USE
Take FIBORESP FORTE 801 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF FIBORESP FORTE 801
COMMON
- infections of the throat or the airways and sinusitis, influenza and/or common cold
- nausea
- stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset
- weight loss
- decreased appetite
- difficulty sleeping
- tiredness, dizziness, headache
- shortness of breath
- joint pain
- bladder infections
- feeling sleepy
- change in taste sensation
- hot flushes
- bloating, abdominal pain and discomfort, heartburn, and flatulence
- elevated liver enzymes
- sunburn or skin reactions due to exposure in the sun or to sun lamps
- skin problems such as rashes, itchy skin, redness, dry skin
- muscle pain
- weakness or feeling low in energy
- chest pain
UNCOMMON
- headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting (due to low levels of sodium in the blood)
Stop taking FIBORESP FORTE 801 and contact your doctor immediately if you experience any of the following side effects:
- signs of angioedema or serious allergic reactions or anaphylaxis such as urticaria, itching, swelling of the face, lips, tongue or throat causing difficulty in breathing or feeling faint
- signs of abnormal liver function such as yellowish discolouration of skin and white of the eye, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness
- signs and symptoms of stevens-johnson syndrome or toxic epidermal necrolysis such as fever and flu-like symptoms followed by reddish or circular patches on the trunk, often with central blisters, peeling of the skin, ulcers on mouth, throat, eyes, nose and genitals
HOW TO MANAGE SIDE EFFECTS
Headache:
Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Apply a pain-relieving balm on the forehead if necessary. Contact your doctor if the symptom does not improve.
Nausea and Vomiting:
Take the FIBORESP FORTE 801, with or just after a meal. Stick to simple meals. Avoid eating oily, fried or spicy foods. Contact your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if the symptom does not improve.
Constipation:
Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Contact your doctor if the symptom does not improve.
Decreased appetite:
Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Contact your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
FIBORESP FORTE 801 is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking FIBORESP FORTE 801.
BREASTFEEDING
It is not known whether FIBORESP FORTE 801 pass through the breast milk, hence, consult your doctor before taking FIBORESP FORTE 801.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or tired after taking FIBORESP FORTE 801.
KIDNEY
FIBORESP FORTE 801 is not recommended for use in patients with severe or end-stage kidney disease (requiring dialysis). It should be used with caution in patients with mild to moderate kidney problems. Consult your doctor before taking FIBORESP FORTE 801.
LIVER
FIBORESP FORTE 801 is not recommended for use in patients with severe or end-stage liver disease. It should be used with caution in patients with mild to moderate liver disease. Consult your doctor before taking FIBORESP FORTE 801.
ALLERGY
Do not take FIBORESP FORTE 801 if you are allergic to Pirfenidone.
OTHERS
Before taking FIBORESP FORTE 801, inform your doctor if you:
- have photosensitive reactions (more sensitive) to sunlight
- are a smoker
Use in pediatrics:
FIBORESP FORTE 801 is not recommended for use in children and adolescents under 18 years of age. Contact child’s doctor for advice.
Use in geriatrics:
FIBORESP FORTE 801 should be taken with caution in elderly patients (above 65 years of age) Your doctor will decide the dose, duration of the treatment and its frequency for you depending on the severity of your existing condition and other comorbid diseases.
INTERACTIONS
A. Drug-Drug Interaction:
Before taking FIBORESP FORTE 801, inform your doctor if you are taking any of the following medicines:
- fluvoxamine (used to treat depression and obsessive-compulsive disorder)
- chloramphenicol, enoxacin, ciprofloxacin, doxycycline (used to treat bacterial infections)
- amiodarone, propafenone, mexiletine, quinidine (used to treat heart rhythm disorders)
- omeprazole, esomeprazole (used to treat indigestion or acid reflux)
- rifampicin, rifampin (used to treat tuberculosis).
- methoxsalen (used to treat skin diseases like psoriasis and vitiligo)
- oral contraceptives such as ethinyl estradiol or norethindrone (used to prevent pregnancy)
- miconazole, fluconazole, voriconazole, terbinafine (used to treat fungal infections)
- moclobemide, fluoxetine, duloxetine, paroxetine (used to treat depression)
- bupropion (helps to stop smoking)
- cinacalcet (used to treat hyperparathyroidism)
- phenytoin, carbamazepine (used to treat fits)
B. Drug - Food interaction:
Avoid drinking grapefruit juice while taking FIBORESP FORTE 801 as it may lead to unwanted effects. Consult your doctor before taking FIBORESP FORTE 801.
Overdosage:
If you or anyone else accidentally take too much of FIBORESP FORTE 801, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Pirfenidone |
| Pharmacological Category | : | Anti-fibrotics or Anti-inflammatory agents |
| Therapeutic Indication | : | Mild to moderate Idiopathic Pulmonary Fibrosis |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep FIBORESP FORTE 801 out of reach of children
- Store at room temperature
FAQs ABOUT FIBORESP FORTE 801
Can FIBORESP FORTE 801 be used for treating lung disease?
Yes, FIBORESP FORTE 801 is used to treat mild to moderate idiopathic pulmonary fibrosis (condition in which the lungs become scarred and breathing becomes increasingly difficult) in adults above 18 years of age. Consult your doctor before taking FIBORESP FORTE 801.
Does FIBORESP FORTE 801 cause liver damage?
Yes, FIBORESP FORTE 801 may cause liver damage. Stop taking FIBORESP FORTE 801 and contact your doctor if you experience any unusual symptoms like yellowish discolouration of skin and white of the eyes, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness. Consult your doctor before taking FIBORESP FORTE 801.
Does FIBORESP FORTE 801 cause dizziness?
Yes, FIBORESP FORTE 801 may cause dizziness. To manage this effect, try to rest and relax and get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom does not improve.
Is FIBORESP FORTE 801 a steroid medicine?
No, FIBORESP FORTE 801 is not a steroid medication. It is used to treat mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. It causes scarring and swelling of the lung tissue resulting in breathing difficulties. This medicine helps to reduce the symptoms of the disease and make you breathe better.
Is FIBORESP FORTE 801 safe to use during pregnancy?
FIBORESP FORTE 801 is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking FIBORESP FORTE 801.
REFERENCES
1. Laurance Brunton. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. Chemotherapy of neoplastic diseases 12th Edition, 2011. Page - 1718.
2. Genentech, Inc. Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) (ASCEND). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2017] [Accessed on 18th June 2022] https://clinicaltrials.gov/ct2/show/NCT01366209
3. Paul W. Noble, Carlo Albera, Williamson Z. Bradford, Ulrich Costabel, Roland M. du Bois, Elizabeth A. Fagan, Robert S. Fishman, Ian Glaspole, Marilyn K. Glassberg, Lisa Lancaster, David J. Lederer, Jonathan A. Leff, Steven D. Nathan, Carlos A. Pereira, Jeffrey J. Swigris, Dominique Valeyre, and Talmadge E. King, Jr. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. NIH. National Library of Medicine, National center for biotechnology information. January 2016. [Accessed on 18th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697914/
4. Roche Products Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 18th June 2022] https://www.medicines.org.uk/emc/files/pil.2731.pdf
5. InterMune, Inc. U.S. Food & Drug Administration. [Revised in October 2014] [Accessed on 18th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf
6. Roche Pharma AG. European Medical Agency (EMA). [Revised in September 2015] [Accessed on 18th June 2022] https://www.ema.europa.eu/en/documents/product-information/esbriet-epar-product-information_en.pdf
7. Hoffmann-La Roche Limited. Pirfenidone. [Revised in August 2021] [Accessed on 18th June 2022] https://www.rochecanada.com/PMs/Esbriet/Esbriet_PM_E.pdf
USEFUL DIAGNOSTIC TESTS
- Liver function tests
VIDEOS
Pirfenidone Tablet - Drug Information
Pirfenidone Tablet : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage
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