Prucasoft 1 mg 14 tablets

Prucasoft 1 mg 14 tablets

Composition:
Each film-coated tablet contains: 1.32 mg prucalopride succinate, equivalent to 1 mg prucaloprideFull excipient list:Spray-dried lactose, corn starch, microcrystalline cellulose PH 112 (Emcocel XLM), citric acid anhydrous, croscarmellose sodium, colloidal silicon dioxide (Aerosil 200), magnesium stearate, Opadry II White (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000, talc).
Description:
Prucasoft is used for the symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
It stimulates propulsive gut motility, promoting regular and more effective bowel movements.
Indications for Use:
- Prucasoft is indicated for the symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Dosage and Method of Administration:
Adults: 2 mg once daily, with or without food.
- Doses above 2 mg do not increase efficacy.
- If not effective after 4 weeks, reassess therapy.
Elderly (>65 years): Start with 1 mg once daily. Increase to 2 mg if needed.
Renal impairment: Severe impairment (GFR <30 ml/min/1.73 m²): 1 mg once daily.
Mild-moderate impairment: no adjustment needed.
Hepatic impairment: Severe impairment (Child-Pugh C): start at 1 mg; may increase to 2 mg if needed.
Paediatric population: Not recommended for patients <18 years.
Method of administration: Oral use.
Contraindications:
- Hypersensitivity to prucalopride or excipients
- Renal impairment requiring dialysis-Intestinal perforation or obstruction
- Obstructive ileus-Severe inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
- Toxic megacolon/megarectum.
Precautions:
- Use 1 mg in severe renal impairment
- Caution in severe hepatic impairment
- Limited data in severe unstable diseases (cardiac, pulmonary, neurological, psychiatric, cancer, AIDS, endocrine disorders)
- Use caution in arrhythmias and ischemic cardiac disease
- Severe diarrhoea may reduce efficacy of oral contraceptives-use additional contraception
- Contains lactose-do not use in: galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
Side Effects:
Very common (≥1/10):
- Headache
- Nausea
- Diarrhoea
- Abdominal pain.
Common (≥1/100–<1/10):
- Decreased appetite
- Dizziness
- Vomiting
- Dyspepsia
- Flatulence
- Abnormal gastrointestinal sounds
- Fatigue.
Uncommon (≥1/1000–<1/100):
- Tremor
- Migraine 
- Palpitations
- Rectal haemorrhage
- Pollakiuria
- Pyrexia
- Malaise
- Vertigo.
Pregnancy and Breastfeeding:
Pregnancy: Limited clinical data.
Spontaneous abortions reported; causal link unknown.
Not recommended during pregnancy or if contraception is not used
Breast-feeding: Prucalopride is excreted into breast milk.
Decide whether to stop breast-feeding or stop therapy
Storage Conditions:
Store below 30°C.
Keep in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 2 strips, each strip with 7 film-coated tablets (total 14 tablets) and leaflet.