Prucalopride 2 mg Film-coated Tablets (Prucalopride Succinate)

Adult dose

Administered orally and can be taken at any time of day, regardless of meals. Adults should take 2 mg once daily. For those over 65 years of age, the initial dose is 1 mg once daily, which can be increased to 2 mg once daily if needed. In patients with severe renal impairment and severe hepatic impairment, 1 mg should be administered once daily. Doses exceeding 2 mg per day are not expected to result in increased efficacy and should be administered once daily for up to 4 weeks.

This medication should not be used by individuals who have allergic reactions to the active ingredient or excipients. It should not be administered to individuals with severely impaired kidney function, especially those requiring dialysis. This medication is also not suitable for individuals with bowel perforation or obstruction, or those with severe inflammatory bowel diseases such as Crohn's disease or ulcerative colitis. This medication contains lactose, so individuals with a genetic condition that prevents lactose digestion should avoid it. Since the kidneys are the main route of drug elimination, caution should be exercised when using this medication in patients with significantly reduced kidney function, and the dose should be adjusted accordingly. Safety has not been adequately studied in patients with serious conditions affecting the heart, liver, lungs, or nervous system, so caution is necessary. Individuals with a history of arrhythmias or cardiovascular disease should be especially cautious when using this medication. In cases of liver dysfunction, especially in severe liver impairment, the dose should be reduced. Care is required when taking this medication along with drugs that can alter the electrical stability of heartbeats. Common side effects during use include headache and gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. These side effects usually occur early in treatment and often resolve naturally over time. Rarely, symptoms like palpitations or dizziness may occur, and if such symptoms arise, consultation with a physician is advised. In cases of severe diarrhea, the effectiveness of oral contraceptives may be reduced, so it is advisable to use additional contraception methods. There is a low potential for drug interactions with this medication; however, caution is required when used with certain antifungal agents or heart-related medications. Experience with this medication during pregnancy is limited, and its use during pregnancy is not recommended. Women of childbearing age should employ effective contraception while taking this medication. Its use is also not recommended for breastfeeding women, as it may affect the baby. It is advisable not to use this medication in children or adolescents under 18 years of age. In cases of overdose, symptoms such as headache, nausea, or diarrhea may occur, and appropriate treatment may be necessary depending on the symptoms. This medication may cause dizziness or fatigue when first taken, so caution is advised when driving or operating machinery. Store the medicine out of the reach of children, avoiding moisture, and keep it in its original container for safety.

Serious side effects

Chest discomfort

Mild side effects

• Headache
• dizziness
• tremors
• palpitations
• nausea
• diarrhea
• abdominal pain
• vomiting
• dyspepsia
• rectal bleeding

This medication should be stored in a container that protects it from light and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage can help maintain the efficacy and safety of the medication.

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/Alu-Alu * 2)