Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
PIRFENIDONE
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AX05
FILM COATED TABLETS
PIRFENIDONE 267 MG
PER OS
Required
F. HOFFMANN-LA ROCHE AG, SWITZERLAND
PIRFENIDONE
Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
2023-10-31
IF YOU STOP TAKING THE MEDICINE In certain situations, the doctor will advise you to stop taking ESBRIET. If for any reason you have to stop taking ESBRIET for more than 14 consecutive days, the doctor will restart treatment with ESBRIET 267 MG and will instruct you to first take 1 unit 3 times a day, and will then gradually increase the dosage to 801 mg, 3 times a day. DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND THE DOSE EACH TIME YOU TAKE A MEDICINE. WEAR GLASSES IF YOU NEED THEM. IF YOU HAVE FURTHER QUESTIONS REGARDING USE OF THE MEDICINE, CONSULT THE DOCTOR OR PHARMACIST. . SIDE EFFECTS As with any medicine, use of ESBRIET may cause side effects in some users. Do not be alarmed by the list of side effects. You may not suffer from any of them. STOP TAKING ESBRIET AND INFORM THE DOCTOR IMMEDIATELY IF YOU SUFFER FROM THE FOLLOWING EFFECTS: • swelling of the face, lips and/or tongue, itching, urticaria, breathing difficulties or wheezing, or fainting sensation, which are signs of angioedema, a severe allergic reaction or anaphylaxis. • yellowing of the eyes or skin, dark urine, which may also be accompanied by itching of the skin, pain in the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily than in the past, or feeling tired. These may be signs of impaired liver function and can indicate liver injury, which is an uncommon side effect. • reddish non-elevated, or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens- Johnson syndrome or toxic epidermal necrolysis. ADDITIONAL SIDE EFFECTS: Inform the doctor if you experience any side effect. Very common side effects (may affect more than 1 in 10 patients): • infections of the throat or the airways going into the lungs and/or sinusitis • feeling sick (nausea) • stomach problems such as acid reflux, vomiting, and feeling con Izlasiet visu dokumentu
1 Esbriet Tabs PI Ver 8 ESBRIET ® TABLETS pirfenidone FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Esbriet 801 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 267 mg pirfenidone. Each film-coated tablet contains 801 mg pirfenidone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”. Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with “PFD”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. Posology _Adults_ Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/day over a 14-day period as follows: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day) ● Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day) ● Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) The recommended maintenance daily dose of Esbriet is 801 mg three times a day with food for a total of 2403 mg/day. Doses above 2403 mg/day are not recommended for any patient (see section 4.9). Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose. _ _ For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration. _Dose adjustments and other considerations for safe use _ _Gastrointestinal events:_ In patients who Izlasiet visu dokumentu