Pulmiprove 125 mg 30 tablets

Pulmiprove 125 mg 30 tablets

Composition:
Each film-coated tablet contains:
Bosentan monohydrate 129.082 mg (equivalent to 125 mg bosentan anhydrous).
Excipients:
Maize starch, microcrystalline cellulose (Avicel PH 101), croscarmellose sodium, crospovidone, poloxamer, glyceryl behenate, magnesium stearate, colloidal silicon dioxide (Aerosil 200), Opadry AMP Yellow.
Description:
Pulmiprove is an endothelin receptor antagonist that reduces pulmonary vascular resistance and arterial pressure, improving exercise capacity and symptoms in patients with pulmonary arterial hypertension (PAH).
It is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Indications for Use:
- Pulmonary arterial hypertension (idiopathic, heritable, secondary to scleroderma, or associated with congenital systemic-to-pulmonary shunts).
- Systemic sclerosis with ongoing digital ulcer disease.
Dosage and Method of Administration:
- Adults: 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily.
- Tablets are taken orally, morning and evening, with or without food, swallowed with water.
- Treatment should be initiated and monitored by a physician experienced in PAH management.
Contraindications:
- Hypersensitivity to bosentan or any excipients.
- Moderate to severe hepatic impairment (Child-Pugh class B or C).
- Baseline ALT/AST >3× upper limit of normal.
- Concomitant use with cyclosporine A.
- Pregnancy or women of childbearing potential not using reliable contraception.
Precautions:
- Monitor liver aminotransferases and haemoglobin monthly. 
Discontinue or reduce dose if ALT/AST >3× ULN.
- May cause anaemia, hypotension, or peripheral oedema.
- Contraindicated during pregnancy; breastfeeding is not recommended.
Side Effects:
- Very common - headache, oedema, elevated liver enzymes.
- Common - anaemia, syncope, flushing, hypotension, pruritus, rash, GERD, diarrhoea.
- Uncommon - thrombocytopenia, leukopenia, hepatitis, jaundice.
- Rare - anaphylaxis, angioedema, liver cirrhosis, hepatic failure.
Pregnancy and Lactation:
Contraindicated during pregnancy (teratogenic).
Breastfeeding should be avoided during treatment.
Storage Conditions:
Store below 30 °C, in a dry place.
Packaging:
Carton box containing 3 blisters, each with 10 tablets, and a package leaflet.