Pirfenidon Zentiva (pirfenidone 267 mg)
Film-coated tablet antifibrotic medication for idiopathic pulmonary fibrosis (IPF)
Quick Facts About Pirfenidon Zentiva
Key Takeaways About Pirfenidon Zentiva
- Slows IPF progression: Pirfenidone does not cure idiopathic pulmonary fibrosis but reduces the annual decline in forced vital capacity (FVC) and may reduce mortality risk, as shown in the CAPACITY and ASCEND randomised trials.
- Dose titration is essential: Start with 801 mg/day in week 1, 1,602 mg/day in week 2, and increase to the maintenance dose of 2,403 mg/day (nine 267 mg tablets) from day 15 onwards.
- Always take with food: Food substantially reduces nausea, dizziness and peak plasma concentration, improving tolerability.
- Strict sun protection is mandatory: Pirfenidone causes severe photosensitivity. Broad-spectrum SPF 50+ sunscreen, protective clothing, and avoidance of sunbeds are required throughout treatment.
- Liver monitoring is required: Liver function tests are needed before treatment, monthly for six months, and then at least every three months. Hepatotoxicity may require dose reduction or temporary interruption.
What Is Pirfenidon Zentiva and What Is It Used For?
Pirfenidon Zentiva is a generic film-coated tablet containing 267 mg of pirfenidone, a prescription antifibrotic medicine used to treat adults with idiopathic pulmonary fibrosis (IPF). It slows the rate at which lung function declines by reducing fibroblast proliferation and the production of scar-tissue proteins and inflammatory cytokines in the lungs.
Pirfenidon Zentiva is a generic version of the originator medicine Esbriet® (originally developed by InterMune and marketed by Roche). It contains the same active ingredient, pirfenidone, at the same 267 mg strength and is bioequivalent to the reference product, meaning it achieves comparable plasma concentrations when taken according to the same schedule. Since the originator's patent expiration, several generic formulations of pirfenidone have become available across the European Union and other regions, improving access to this life-prolonging therapy for patients with idiopathic pulmonary fibrosis.
Pirfenidone belongs to the pharmacological class of antifibrotic agents classified under ATC code L04AX05 (selective immunosuppressants, other). It acts through a pleiotropic mechanism that reduces the activity of transforming growth factor beta (TGF-β) and tumour necrosis factor alpha (TNF-α), both of which are key mediators in the pathological pathway that drives progressive scarring of lung tissue. In preclinical and human studies, pirfenidone has been shown to reduce fibroblast proliferation, collagen synthesis, and the accumulation of extracellular matrix components that thicken the alveolar walls and impair gas exchange.
The primary clinical indication for Pirfenidon Zentiva is the treatment of mild to moderate idiopathic pulmonary fibrosis in adults. IPF is a chronic, progressive, and ultimately fatal interstitial lung disease of unknown cause that primarily affects older adults, typically those aged 60 years and older. The disease is characterised by progressive dyspnoea, a persistent dry cough, finger clubbing, and bibasilar inspiratory crackles (“Velcro crackles”) on auscultation. Median survival from diagnosis without antifibrotic treatment has historically been reported at approximately three to five years.
The efficacy of pirfenidone in IPF was established primarily in the CAPACITY programme (two phase III trials, studies 004 and 006) and the ASCEND trial (study 016), published in The Lancet (2011) and the New England Journal of Medicine (2014), respectively. Pooled analyses of these trials demonstrated a statistically significant reduction in the decline of forced vital capacity (FVC) and in the composite outcome of death or disease progression. Based on this evidence, pirfenidone is recommended as a first-line antifibrotic therapy in the international ATS/ERS/JRS/ALAT clinical practice guideline for the treatment of idiopathic pulmonary fibrosis.
Pirfenidone is not a cure for IPF. It is a disease-modifying therapy intended to slow progression, preserve lung function, and potentially prolong survival. Lung transplantation remains the only curative option for eligible patients with end-stage disease. Pirfenidone is typically prescribed and monitored by a pulmonologist or respiratory physician working within a specialist interstitial lung disease (ILD) centre, in line with international standards of care.
IPF is a chronic lung disease in which the alveolar walls become progressively thickened by scar tissue (fibrosis) of unknown cause. This scarring reduces the ability of oxygen to pass from the lungs into the bloodstream, causing breathlessness on exertion and a chronic dry cough. The diagnosis is established using high-resolution CT (HRCT) demonstrating a usual interstitial pneumonia (UIP) pattern, often combined with multidisciplinary discussion and, when necessary, surgical lung biopsy.
What Should You Know Before Taking Pirfenidon Zentiva?
Before starting Pirfenidon Zentiva, your pulmonologist will review your liver and kidney function, check for interacting medicines (particularly fluvoxamine and strong CYP1A2 inhibitors), and screen for contraindications. Pre-treatment liver function tests and a review of smoking and sun-exposure habits are mandatory.
Pirfenidone is a high-exposure, long-term therapy with a well-characterised safety profile but several important precautions. Because it is metabolised predominantly by the liver enzyme CYP1A2, many clinically significant drug interactions and pharmacogenetic variations affect its plasma concentration. In addition, it produces dose-dependent gastrointestinal and dermatological side effects that require careful counselling before initiation to ensure adherence and safety over the course of what is typically lifelong or multi-year therapy.
Contraindications
Pirfenidon Zentiva must not be used in patients with any of the following conditions:
- Known hypersensitivity to pirfenidone or to any of the excipients listed in the product information
- History of angioedema with pirfenidone in a previous treatment course
- Concomitant use of fluvoxamine, a strong CYP1A2 inhibitor that can increase pirfenidone exposure several-fold and cause severe adverse reactions
- Severe hepatic impairment (Child-Pugh class C) or end-stage liver disease
- Severe renal impairment with creatinine clearance less than 30 mL/min, or end-stage renal disease requiring dialysis
Before the first prescription, your healthcare provider will check baseline alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). If any of these values exceed three times the upper limit of normal (ULN), pirfenidone should generally not be initiated. Your doctor will also estimate your glomerular filtration rate (eGFR) to assess kidney function and ensure that Pirfenidon Zentiva is appropriate for you.
Warnings and Precautions
Several clinically important warnings apply to the use of Pirfenidon Zentiva. Patients and caregivers should be familiar with each of them before starting treatment and should report any relevant symptoms promptly to their pulmonologist or general practitioner.
- Hepatotoxicity: Elevations in serum transaminases (ALT and/or AST) are among the most common abnormalities observed during pirfenidone therapy. They are usually asymptomatic, reversible, and managed by dose reduction or temporary interruption. Rarely, clinically significant liver injury may occur. Attend all scheduled blood tests and report symptoms such as yellowing of the eyes or skin (jaundice), dark urine, clay-coloured stools, unexplained nausea or vomiting, or upper-right abdominal pain immediately.
- Photosensitivity and skin reactions: Pirfenidone produces significant phototoxicity. Sunburn-like reactions, erythema, and blistering can occur even after brief exposure to sunlight or artificial UV sources. Strict sun-protection measures are required throughout treatment.
- Gastrointestinal effects: Nausea, dyspepsia, decreased appetite, abdominal discomfort, and diarrhoea are common, particularly during dose titration. Always take the medicine with food to reduce symptom intensity. Dose reduction may be necessary if symptoms persist.
- Weight loss: Clinically meaningful weight loss has been reported in patients receiving pirfenidone. Monitor weight regularly, especially in older or frail patients, and discuss nutritional support with your healthcare team if appetite is reduced.
- Smoking: Cigarette smoking induces CYP1A2 and significantly reduces plasma concentrations of pirfenidone, potentially diminishing efficacy. All patients should be offered smoking-cessation support before and during treatment.
- Hepatic or renal impairment: Patients with moderate hepatic (Child-Pugh B) or moderate renal impairment require more frequent monitoring. Dose adjustment may be necessary.
- Angioedema: Rare cases of angioedema (swelling of the face, lips, tongue, or throat) have been reported. If such symptoms occur, pirfenidone must be stopped immediately and medical attention sought urgently. Future re-exposure is contraindicated.
Pirfenidone should be initiated and supervised by physicians experienced in the diagnosis and management of idiopathic pulmonary fibrosis, typically a consultant pulmonologist working within an accredited interstitial lung disease clinic. Baseline high-resolution CT imaging and pulmonary function tests (FVC and diffusing capacity for carbon monoxide, DLCO) are usually required prior to starting therapy, and periodic reassessment determines whether the treatment is providing clinical benefit.
Stop taking Pirfenidon Zentiva and seek urgent medical review if you notice yellowing of the skin or eyes, unusually dark urine, pale stools, persistent right-sided abdominal pain, unexplained nausea or loss of appetite, or easy bruising or bleeding. These may indicate drug-induced liver injury.
Pregnancy and Breastfeeding
There are no adequate and well-controlled studies of pirfenidone in pregnant women. Animal studies have not shown direct harmful effects with respect to reproductive toxicity at clinical doses, but as a precautionary measure the use of pirfenidone during pregnancy should be avoided. Women of childbearing potential should use effective contraception during treatment.
It is not known whether pirfenidone or its metabolites are excreted into human breast milk. Available pharmacokinetic data in animals have shown excretion of pirfenidone and/or its metabolites in milk, with the potential for accumulation. A risk to the breastfed newborn or infant cannot be excluded. Pirfenidon Zentiva should not be used during breastfeeding; if treatment is necessary, a decision must be made whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of the medicine for the mother.
Because idiopathic pulmonary fibrosis is a disease of later adulthood, pregnancy is relatively uncommon in this patient population. Nonetheless, the decision to initiate or continue pirfenidone in a person of childbearing potential must be made after a careful discussion of potential risks and benefits with the prescribing physician.
Effects on Driving and Using Machines
Pirfenidone may cause dizziness and fatigue, which could moderately affect the ability to drive or use machines. Patients should assess their individual response to pirfenidone before driving or operating heavy machinery, particularly during dose titration and in the first weeks of therapy. Never drive if you feel dizzy or drowsy.
How Does Pirfenidon Zentiva Interact with Other Drugs?
Pirfenidone is metabolised primarily by CYP1A2 (70–80%), with minor contributions from other enzymes. Strong CYP1A2 inhibitors (especially fluvoxamine, which is contraindicated) can dramatically raise plasma levels, while strong inducers (including cigarette smoke and rifampicin) can reduce them. Always tell your doctor and pharmacist about every medicine, supplement, and lifestyle factor, including smoking.
Drug interactions with pirfenidone are clinically meaningful and fall into three main categories: pharmacokinetic interactions through CYP1A2 metabolism, pharmacodynamic interactions with medicines that share overlapping toxicity, and lifestyle-related interactions such as smoking and heavy caffeine intake. Understanding these interactions is essential to maintain both the safety and efficacy of long-term therapy.
Pirfenidone itself is a weak inhibitor of CYP2D6 and CYP2C9 at clinical concentrations, but its impact on the metabolism of co-administered drugs is generally modest. The clinically important interactions therefore arise mainly from the effects of other medicines on pirfenidone exposure, rather than the other way around.
In addition to prescription medicines, several common over-the-counter products and lifestyle factors may affect pirfenidone levels. Cigarette smoking is one of the strongest inducers of CYP1A2 and reduces pirfenidone AUC by approximately 50%, which can significantly diminish therapeutic effect. Grapefruit juice has a modest effect and does not require avoidance, but combined use of multiple CYP1A2-modulating agents can compound exposure changes.
Major Drug Interactions
| Drug / Drug Class | Mechanism | Effect on Pirfenidone | Management |
|---|---|---|---|
| Fluvoxamine | Strong CYP1A2 inhibitor | Pirfenidone exposure increased up to 4-fold | Contraindicated – discontinue fluvoxamine before starting pirfenidone |
| Ciprofloxacin 750 mg twice daily | Moderate CYP1A2 inhibitor | Increases exposure by about 80% | Reduce pirfenidone to 1,602 mg/day (six tablets) |
| Other moderate CYP1A2 inhibitors (amiodarone, propafenone, mexiletine) | CYP1A2 inhibition | Variable increase in exposure | Use with caution; monitor for increased adverse effects |
| Rifampicin | Strong CYP1A2 inducer | Decreases exposure by about 50% | Concomitant use should be avoided; alternative therapy preferred |
| Omeprazole | Mild CYP1A2 inducer | Possible small decrease in pirfenidone exposure | Clinically relevant effect unlikely; no routine dose adjustment |
| Cigarette smoking / nicotine | Strong CYP1A2 induction (polycyclic hydrocarbons) | Decreases exposure by about 50% | Smoking cessation strongly recommended before and during therapy |
| Grapefruit and grapefruit juice | Weak CYP1A2 inhibition | Minor increase in exposure | No strict restriction; moderate intake is acceptable |
| Alcohol | Additive hepatotoxicity | May increase risk of liver enzyme elevations | Limit intake; avoid heavy or daily consumption |
Minor or Lower-Risk Interactions
Several other pharmacological interactions are theoretically possible but of lower clinical importance for most patients. These include mild CYP1A2 inhibition from caffeine metabolites, modest effects of St John's Wort (a pan-CYP inducer), and potential additive QT-prolongation when combined with certain antiarrhythmics. Although these interactions rarely require specific dose adjustment, they should still be disclosed to your healthcare team so that monitoring strategies can be individualised.
Ask your pulmonologist or pharmacist to carry out a formal medication review before starting Pirfenidon Zentiva and again annually. Bring a complete list of all prescription medicines, over-the-counter products, vitamins, herbal remedies, and supplements. This is the single most effective way of preventing harmful drug-drug interactions.
What Is the Correct Dosage of Pirfenidon Zentiva?
The recommended target dose in adults is 2,403 mg per day, given as three 267 mg tablets three times daily with food. Treatment must begin with a 14-day titration schedule to reduce gastrointestinal side effects. Never take the medicine on an empty stomach.
Pirfenidone has a half-life of approximately 2.4 hours, which is why it is dosed three times daily. Steady-state plasma levels are reached within one to two days of starting a given dose level. Administration with food reduces peak plasma concentration (Cmax) by about 50% and total exposure (AUC) by about 15%, which is why food intake is specifically recommended to reduce nausea and dizziness rather than achieve higher drug levels.
The standard initiation schedule is structured to allow the body to adapt gradually to the medicine. During the first two weeks, patients take increasing numbers of 267 mg tablets three times daily, reaching the maintenance dose of nine tablets per day (three tablets per dose, three doses per day) by day 15. This titration is directly associated with lower rates of nausea, dyspepsia and discontinuation compared with starting immediately at the full dose.
Two-Week Titration Schedule
Adults
Standard Adult Dosage
After completing the two-week titration, adults take three 267 mg tablets (801 mg) at the start of breakfast, three tablets at the start of lunch and three tablets at the start of dinner, for a total daily dose of 2,403 mg. Tablets should be swallowed whole with a glass of water and not crushed or divided. Taking each dose at the beginning of a meal, rather than after, is preferred as it maximises the gastric-protective effect of food.
If treatment is interrupted for more than 14 consecutive days for any reason, it should be restarted with the initial two-week titration schedule to re-establish tolerance. Shorter interruptions (fewer than 14 days) can resume at the previous maintenance dose without re-titration.
Dose Modifications for Side Effects
Dose Adjustments for Gastrointestinal or Photosensitivity Reactions
If a patient experiences persistent gastrointestinal side effects despite taking the medicine with food, the daily dose may be reduced to 1,602 mg/day (two tablets three times daily) or even 801 mg/day (one tablet three times daily) for one to two weeks, before attempting cautious re-escalation. For photosensitivity reactions or skin rash, the dose may be reduced to 801 mg/day until resolution, after which gradual escalation back to the maintenance dose can be considered.
Dose Adjustments for Liver Enzyme Elevations
If ALT and/or AST rise above 3 × ULN (but below 5 × ULN) without symptoms or bilirubin elevation, the dose is typically reduced or temporarily interrupted, and liver tests are repeated weekly. If transaminases exceed 5 × ULN or are accompanied by bilirubin elevation, clinical symptoms or a rash, pirfenidone must be permanently discontinued. After resolution, the physician may consider cautious re-challenge in selected patients, starting again from the titration schedule.
Children and Adolescents
Paediatric Use
Pirfenidon Zentiva is not indicated for use in children and adolescents under 18 years of age. Idiopathic pulmonary fibrosis in this sense is a disease of older adults; paediatric interstitial lung diseases (childhood interstitial and diffuse lung disease, chILD) have different underlying causes and are managed by specialist paediatric pulmonologists using different therapeutic strategies. Safety and efficacy of pirfenidone in patients under 18 years have not been established.
Elderly Patients
Geriatric Dosage Considerations
No dose adjustment is required based on age alone. However, the majority of patients with IPF are older than 65 years, and age-related reductions in renal or hepatic function should be considered when prescribing and monitoring pirfenidone. Older adults may be more vulnerable to weight loss and dehydration during gastrointestinal adverse events, and may have a higher background rate of concomitant medications that can contribute to drug interactions. More frequent monitoring and careful dose titration are advisable.
Missed Dose
If you forget to take a dose of Pirfenidon Zentiva, take it with food as soon as you remember, provided it is within a few hours of the scheduled time. If it is nearly time for the next dose, skip the missed one and continue with your normal schedule. Do not take a double dose to compensate. Consistent dosing supports stable plasma drug levels and is particularly important given pirfenidone's relatively short half-life.
If more than 14 consecutive days are missed (for example due to illness, hospitalisation or travel), contact your pulmonologist before restarting. In this situation, treatment should be re-initiated using the full two-week titration schedule to reduce the risk of gastrointestinal adverse effects upon re-exposure.
Overdose
Clinical experience with pirfenidone overdose is limited. Multiple doses of pirfenidone up to 4,005 mg/day (15 tablets, five per dose) have been given to healthy volunteers without notable adverse effects other than mild to moderate gastrointestinal symptoms. In the event of a suspected overdose, contact your local poison control centre or go to the nearest emergency department immediately. Bring the packaging with you. Treatment is supportive and may include clinical observation, symptom control, monitoring of vital signs and liver function tests. There is no specific antidote.
| Patient Group | Recommended Dose | Notes |
|---|---|---|
| Adults (maintenance) | 2,403 mg/day (9 × 267 mg) | Three tablets three times daily with food, after 14-day titration |
| Week 1 | 801 mg/day | One 267 mg tablet three times daily |
| Week 2 | 1,602 mg/day | Two 267 mg tablets three times daily |
| Elderly (≥65 years) | As in adults | No age-based adjustment; monitor renal and hepatic function |
| Children (<18 years) | Not recommended | Safety and efficacy not established |
| Mild hepatic impairment (Child-Pugh A) | Standard dose | Monitor LFTs closely |
| Moderate hepatic impairment (Child-Pugh B) | Use with caution | More frequent LFT monitoring; consider dose reduction |
| Severe hepatic impairment (Child-Pugh C) | Contraindicated | Do not use |
| Mild to moderate renal impairment (CrCl 30–89 mL/min) | Standard dose | Use with caution |
| Severe renal impairment or dialysis (CrCl <30 mL/min) | Contraindicated | Do not use |
What Are the Side Effects of Pirfenidon Zentiva?
The most frequent side effects of pirfenidone are photosensitivity reactions, nausea, diarrhoea, fatigue, headache, dyspepsia, decreased appetite and weight loss. Most are mild to moderate and manageable with dose adjustment, taking the medicine with food, and strict sun protection. Serious side effects such as hepatotoxicity or angioedema are rare but require urgent attention.
Like all medicines, Pirfenidon Zentiva can cause side effects, although not everyone experiences them. The adverse event profile has been characterised extensively in the randomised CAPACITY and ASCEND trials, their open-label extension studies, and post-marketing pharmacovigilance databases covering more than a decade of global use. Side-effect frequencies below are categorised according to the CIOMS convention used in European Summary of Product Characteristics documents: very common (affecting more than 1 in 10 people), common (between 1 in 10 and 1 in 100), uncommon (between 1 in 100 and 1 in 1,000) and rare (fewer than 1 in 1,000).
In clinical practice, tolerability of pirfenidone can usually be improved by three simple strategies: (1) always take the medicine at the start of a meal; (2) use comprehensive sun protection from the first day of therapy; and (3) communicate side effects promptly to your healthcare team so that dose modifications can be made early, before they lead to discontinuation. Discontinuation rates in long-term observational cohorts have dropped substantially over time thanks to these proactive management strategies.
Very Common Side Effects
May affect more than 1 in 10 people
- Photosensitivity reaction (sunburn-like rash on UV-exposed skin)
- Nausea
- Rash (non-photosensitive)
- Fatigue and tiredness
- Diarrhoea
- Dyspepsia (indigestion, heartburn)
- Decreased appetite
- Headache
- Upper respiratory tract infection
Common Side Effects
May affect up to 1 in 10 people
- Weight loss
- Dizziness
- Insomnia or disturbed sleep
- Vomiting
- Gastro-oesophageal reflux disease
- Abdominal distension or pain
- Constipation
- Flatulence
- Elevated ALT, AST and/or gamma-GT
- Pruritus (itching)
- Dry skin or erythema
- Muscle or joint pain
- Hot flushes
- Sinusitis, pharyngitis
Uncommon Side Effects
May affect up to 1 in 100 people
- Severe hepatotoxicity with clinically significant transaminase rise
- Solar dermatitis or blistering sunburn
- Syncope or pre-syncope
- Palpitations
- Depressed mood, anxiety
- Agranulocytosis or neutropenia
Rare Side Effects
May affect up to 1 in 1,000 people
- Angioedema (facial, lip or throat swelling)
- Drug-induced liver injury requiring discontinuation
- Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare)
- Severe allergic (anaphylactic) reactions
Signs of angioedema or anaphylaxis (swelling of the face, lips, tongue or throat; difficulty breathing or swallowing; a widespread nettle-like rash); features of liver injury (jaundice, dark urine, severe right-upper abdominal pain); a severe blistering rash, peeling skin, or mucosal ulceration; or sudden unexplained breathlessness. Stop taking Pirfenidon Zentiva and call your local emergency number or go to the nearest emergency department.
Any suspected adverse reaction, regardless of severity, should be reported to your healthcare provider and, where possible, to your national pharmacovigilance authority (for example, the UK MHRA Yellow Card Scheme, the US FDA MedWatch programme, or your national regulatory body). Reporting suspected reactions allows continued monitoring of the benefit-risk balance of the medicine and helps refine safety information for future patients.
Managing Photosensitivity
Photosensitivity is the single most characteristic adverse effect of pirfenidone and is the leading cause of skin-related discontinuation in clinical practice. Reactions range from mild erythema and pruritus to severe sunburn-like blistering. The reaction can occur even on overcast days because UVA light, which is largely responsible for phototoxicity, penetrates clouds and window glass.
Effective photoprotection requires a layered approach. Apply a broad-spectrum sunscreen with SPF 50 or higher and high UVA protection (e.g. PPD 16+ or Boots 5-star) to all exposed skin daily, including on cloudy or winter days. Reapply every two hours when outdoors and after sweating, swimming or towel-drying. Wear a wide-brimmed hat and UV-protective clothing (UPF 50+) during outdoor activities. Avoid tanning beds and medical phototherapy unless specifically cleared by your healthcare team. UV-filtering window film may be useful for car windows if you drive regularly.
How Should You Store Pirfenidon Zentiva?
Store Pirfenidon Zentiva below 30°C (86°F) in the original packaging to protect from light and moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. Return any unused tablets to your pharmacy for safe disposal.
Pirfenidon Zentiva 267 mg film-coated tablets are usually supplied in blister packs within an outer carton. Store the medicine at room temperature, not exceeding 30°C, in the original blister and carton to protect the tablets from moisture and light. Keep the carton closed and avoid transferring tablets into a different container such as a generic weekly pill organiser unless specifically advised that this is acceptable by your pharmacist, because exposure to light and humidity can reduce the stability of pirfenidone.
Keep all medicines out of the reach and sight of children. Blister packs look colourful and may attract curious children; storing Pirfenidon Zentiva in a high, lockable cupboard is strongly recommended. If a child accidentally ingests pirfenidone tablets, contact your local poison control centre or emergency department immediately.
Check the expiry date (EXP) printed on the carton and on each blister strip before using. The expiry date refers to the last day of the specified month. Do not use Pirfenidon Zentiva after the expiry date, as the potency of the active ingredient may be reduced and degradation products could theoretically increase the risk of adverse effects. Also inspect the tablets before use: do not take tablets that are cracked, discoloured, or visibly damaged.
Do not dispose of medicines via wastewater or household waste. Return unused Pirfenidon Zentiva tablets to your pharmacy. Many countries operate pharmaceutical take-back schemes specifically designed to prevent the entry of medicines into the water supply and the environment. Responsible disposal reduces accidental exposure and supports environmental sustainability.
When travelling, keep Pirfenidon Zentiva in your hand luggage (never checked luggage) in the original packaging, together with a copy of the prescription and a letter from your pulmonologist if travelling internationally. Avoid exposing the blisters to high heat, such as in a parked car or near a radiator. Bring enough supply for the entire trip plus a buffer of one to two weeks in case of travel disruption.
What Does Pirfenidon Zentiva Contain?
Each film-coated tablet contains 267 mg of the active substance pirfenidone, together with pharmaceutical excipients that provide tablet structure, stability and the film coating. Patients with known excipient intolerances should confirm the specific formulation with their pharmacist before starting treatment.
Active ingredient: Each film-coated tablet contains 267 mg of pirfenidone. The chemical name is 5-methyl-1-phenyl-2(1H)-pyridinone. The molecular formula is C12H11NO and the molecular weight is 185.22 g/mol. Pirfenidone is a small-molecule synthetic pyridinone derivative that is orally bioavailable and is absorbed rapidly from the gastrointestinal tract.
Inactive ingredients (typical for film-coated pirfenidone tablets): The tablet core usually contains microcrystalline cellulose, croscarmellose sodium, povidone (K-30), colloidal anhydrous silica, and magnesium stearate. The film coating typically contains hypromellose (HPMC), titanium dioxide (E171), polyethylene glycol (macrogol), and iron oxide or other pharmaceutical-grade colourants to provide the characteristic appearance of the tablet.
If you have a known allergy or intolerance to any pharmaceutical excipient, discuss this with your pharmacist before starting Pirfenidon Zentiva. Although pirfenidone tablets do not generally contain lactose, gluten or animal-derived products, the exact composition may vary slightly between generic formulations and batches. The patient information leaflet included in the pack provides a definitive list of all excipients.
Pirfenidon Zentiva is a generic medicine, which means that although the brand name and excipients may differ from the originator Esbriet®, the active ingredient, strength, dosage form and clinical efficacy are bioequivalent within regulatory standards. Generic medicines are subject to the same quality, safety and manufacturing standards as originator products and are approved only after rigorous regulatory review by the European Medicines Agency or national medicines agencies.
Clinical Evidence Base
The pivotal trials supporting the efficacy of pirfenidone in IPF include:
- CAPACITY (Studies 004 and 006): Two multinational phase III randomised controlled trials of 779 IPF patients, published in The Lancet in 2011. Pirfenidone at 2,403 mg/day significantly reduced the absolute decline in percent predicted FVC compared with placebo over 72 weeks in Study 004.
- ASCEND (Study 016): A confirmatory phase III trial in 555 IPF patients, published in the New England Journal of Medicine in 2014. At 52 weeks, pirfenidone reduced the proportion of patients with a 10% or greater decline in FVC or death by 47.9%. A pooled analysis combining CAPACITY and ASCEND at one year demonstrated a 48% reduction in the risk of all-cause mortality.
- Real-world data (e.g., INSIGHTS-IPF, EMPIRE, PASSPORT): European observational registries and post-marketing surveillance have confirmed effectiveness and tolerability in routine clinical practice.
Frequently Asked Questions About Pirfenidon Zentiva
Pirfenidone is intended as a long-term, disease-modifying therapy for idiopathic pulmonary fibrosis. Because IPF is a chronic, progressive disease, treatment is typically continued indefinitely for as long as you tolerate it and derive benefit. Your pulmonologist will review your progress at regular intervals (usually every three to six months) using pulmonary function tests, imaging and a symptom assessment. Treatment may be discontinued if side effects become unacceptable, if the disease progresses despite therapy (for example, a substantial ongoing decline in FVC or frequent acute exacerbations), or if you proceed to lung transplantation.
Pirfenidone and nintedanib are the two approved antifibrotic therapies for IPF, but they work by different mechanisms (nintedanib is a tyrosine kinase inhibitor). Routine combination therapy is not recommended outside of specialist centres or clinical trials because of overlapping gastrointestinal and hepatic toxicities. Switching from one antifibrotic to the other because of intolerance or disease progression is a common clinical strategy, and your pulmonologist will make this decision based on international consensus guidelines and your individual circumstances.
Gastrointestinal side effects occur because pirfenidone is a gastric irritant and can be absorbed rapidly, which may trigger nausea and dyspepsia. Practical strategies include: (1) always take each dose at the beginning of a meal, not after; (2) spread meals evenly through the day; (3) avoid spicy, very fatty or acidic foods on the same day if they worsen symptoms; (4) consider adding an acid-suppressing medicine such as a proton pump inhibitor under medical advice; and (5) ask your doctor about a temporary dose reduction if symptoms persist. Gastrointestinal tolerability usually improves after the first few weeks.
Moderate occasional alcohol consumption is usually not strictly forbidden, but because both alcohol and pirfenidone can raise liver enzymes, the combination may increase the risk of hepatotoxicity. Most pulmonologists advise limiting alcohol to no more than a few drinks per week at most, avoiding binge drinking, and abstaining entirely if liver enzyme elevations have occurred. Discuss your individual situation with your healthcare provider.
Yes – routine vaccination is strongly encouraged in patients with idiopathic pulmonary fibrosis because respiratory infections can precipitate acute exacerbations. Annual influenza vaccination, pneumococcal vaccination (both PCV13/PCV20 and PPSV23 as per national guidance), and updated COVID-19 vaccines are recommended. Pirfenidone is not a classical immunosuppressant and does not generally require special spacing from vaccines. However, confirm the appropriate vaccination schedule with your healthcare provider.
Stop exposing the affected skin to sunlight and contact your healthcare provider for assessment. Mild photosensitive rashes are often managed by temporary dose reduction and strict sun protection. For more severe reactions, pirfenidone may need to be interrupted. Seek urgent medical attention for blistering, widespread skin peeling, mucosal involvement (mouth, eyes or genitals), fever, or breathing difficulty, as these may indicate a severe cutaneous adverse reaction such as Stevens-Johnson syndrome.
Many herbal remedies and supplements can affect liver enzymes (CYP1A2 in particular) or add to hepatotoxicity. Common examples to discuss with your healthcare provider include St John's Wort (CYP inducer), green-tea extracts in high doses, kava, and high-dose niacin. Paracetamol (acetaminophen) is generally safe at standard doses but should not exceed 3 g per 24 hours in patients taking pirfenidone who have any liver risk factors. Always tell your pharmacist that you take pirfenidone before buying any over-the-counter product.
References and Sources
This article is based on internationally recognised medical and pharmaceutical guidelines, peer-reviewed pivotal clinical trials, and regulatory product information. All information has been reviewed by qualified healthcare professionals and follows evidence-based principles.
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- King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis (ASCEND). New England Journal of Medicine. 2014;370(22):2083-2092. doi:10.1056/NEJMoa1402582
- Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. The Lancet. 2011;377(9779):1760-1769. doi:10.1016/S0140-6736(11)60405-4
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