S Ppi L Cap

S-Ppi-L Capsule

S-Ppi-L Capsule is a prescription medicine manufactured by Blue Cross Laboratories Ltd. It is commonly referred to by its brand name, S-Ppi-L Capsule.

Composition Each hard gelatin capsule contains:

• Esomeprazole Magnesium Trihydrate IP equivalent to Esomeprazole 40 mg (as gastro-resistant tablet)
• Levosulpiride 75 mg (as uncoated sustained release tablet)

Uses S-Ppi-L Capsule is primarily used for the management and treatment of various gastrointestinal conditions:

• Gastroesophageal Reflux Disease (GERD): It treats GERD, also known as acid reflux, particularly in patients who do not adequately respond to proton-pump inhibitors (PPIs) alone. GERD is characterized by stomach acid flowing back into the esophagus, causing symptoms like heartburn, chest pain, and irritation.
• Peptic Ulcer Disease: It is also effective in managing peptic ulcers, which are painful sores that develop on the linings of the stomach, esophagus, or intestines.
• Irritable Bowel Syndrome (IBS): Levosulpiride, one of its active ingredients, is also used for the treatment of irritable bowel syndrome, characterized by persistent stomach pain, flatulence, diarrhea, or constipation.

Dosage and Administration The typical recommended dose is one capsule once daily, usually for a duration of 4 to 8 weeks. It should be administered on an empty stomach, preferably in the morning or at least 30-60 minutes prior to a meal. The capsules should be swallowed whole with water and should not be opened, chewed, or crushed. The exact dosage and duration of treatment will be determined by a doctor based on the patient's condition, age, gender, and overall medical history.

Side Effects Common side effects may include:

• Headache
• Nausea or vomiting
• Diarrhea or constipation
• Stomach pain, abdominal pain, or flatulence
• Drowsiness, sleepiness, or unusual tiredness and weakness
• Insomnia (lack of sleep)
• Dizziness or vertigo (spinning sensation)
• Pins and needles (tingling sensation in the body)
• Dry mouth
• Skin rash, lumpy rash (hives), and itching
• Benign polyps in the stomach (fundic gland polyps)

Less common or more serious side effects, particularly due to Levosulpiride, can include:

• Breast tenderness or gynecomastia
• Irregular menstrual periods
• Weight gain
• Increased salivation
• Decrease in libido
• Fever or excessive sweating
• Change in heart rate

Precautions

• Contraindications: S-Ppi-L Capsule is not recommended for individuals with a known allergy to esomeprazole, levosulpiride, or any other components of the formulation. It is also contraindicated in patients with epilepsy, bipolar disorder, pheochromocytoma, gastrointestinal perforations or bleeding, breast cancer, severe renal or hepatic insufficiency, porphyrias, and alcohol intoxication.
• Alcohol: Avoid or limit alcohol consumption as it can increase the risk of adverse effects, including drowsiness and increased stomach acid production.
• Pregnancy and Breastfeeding: It is not recommended for use in pregnant or breastfeeding women due to a lack of safety and effectiveness data.
• Driving and Operating Machinery: This medicine may cause drowsiness, dizziness, or affect consciousness, so avoid driving or operating heavy machinery if you experience these effects.
• Kidney and Liver Disease: Use with caution in patients with heart, kidney, or liver disease. Dose adjustments and safety monitoring may be required, especially in severe cases.
• Elderly Patients: Use with caution in elderly patients (aged 65 years or above) as they may be more susceptible to side effects like postural hypotension, sedation, and extrapyramidal effects.
• Long-term Use: Prolonged use may increase the risk of bone fractures (hip, wrist, or spine), particularly in patients taking corticosteroids or with osteoporosis.
• Children and Adolescents: Not recommended for use in children and adolescents (aged below 18 years) due to lack of safety and effectiveness.
• Drug Interactions: Inform your doctor about all other medications you are taking, including prescriptive or over-the-counter drugs, herbal medications, or dietary supplements, to avoid potential interactions (e.g., with diltiazem, levodopa or other antiparkinson drugs, and rilpivirine-containing products).

Storage Store in a cool and dry place, away from direct sunlight, and below 30°C. Keep out of the sight and reach of children.

Here are frequently asked questions and answers about S PPI L CAP by BLUE CROSS LABORATORIES LTD.

What is S PPI L CAP used for?

S PPI L CAP is primarily used to treat gastroesophageal reflux disease (GERD), which involves symptoms like heartburn, acid reflux, and stomach irritation due to stomach acid flowing back into the food pipe. It also helps in managing acidity and healing peptic ulcers by reducing acid production and protecting the stomach lining.

How does S PPI L CAP work?

This medicine contains two active ingredients: Esomeprazole and Levosulpiride. Esomeprazole, a proton pump inhibitor (PPI), works by irreversibly blocking an enzyme system in the stomach's parietal cells (the proton pump), which is responsible for producing stomach acid. This significantly reduces both basal and stimulated gastric acid secretion. Levosulpiride is a prokinetic agent that increases the release of acetylcholine, which in turn stimulates stomach and intestinal movement. It also helps to strengthen the lower esophageal sphincter, preventing the backflow of stomach contents and acid into the esophagus.

What is the usual dosage of S PPI L CAP?

The recommended dose is typically one capsule once daily. It should be taken on an empty stomach, preferably in the morning, at least one hour before a meal. The exact duration of treatment, usually between 4 to 8 weeks, will be determined by your doctor based on your health condition and response to the medicine. Do not alter the prescribed dosage without consulting your doctor.

What are the possible side effects of S PPI L CAP?

Common side effects may include headache, diarrhea, nausea, vomiting, abdominal pain, flatulence (gas), constipation, dry mouth, dizziness, and sleepiness. More serious but less common side effects can include irregular menstrual periods, breast tenderness, or gynecomastia. Long-term use of the esomeprazole component may also be associated with an increased risk of bone fractures (hip, wrist, or spine). If you experience any persistent or concerning side effects, consult your doctor.

Is S PPI L CAP safe during pregnancy or breastfeeding?

S PPI L CAP is generally not recommended for use during pregnancy as there is limited data on human exposure, and animal studies have shown potential harmful effects on the developing baby. Similarly, it is not recommended for use during breastfeeding because levosulpiride is known to be secreted in breast milk, and there is insufficient information regarding the effects of esomeprazole on newborns or infants. Always consult your doctor for advice if you are pregnant, planning pregnancy, or breastfeeding.

Can S PPI L CAP be taken with other medications?

S PPI L CAP can interact with several other medications. It may increase blood levels of certain drugs like cardiac glycosides (e.g., digoxin), immunosuppressants (e.g., tacrolimus), and some cancer medications (e.g., methotrexate). The effectiveness of antiplatelet agents like clopidogrel may be reduced. It is also contraindicated if you are taking nelfinavir (an anti-HIV medication) or drugs for Parkinson's disease, such as levodopa. If you are taking antacids or sucralfate, ensure at least a 2-hour gap between doses. Always inform your doctor about all other medicines, supplements, or herbal preparations you are currently taking to avoid potential drug interactions.

What precautions should be taken while taking S PPI L CAP?

Caution is advised if you have severe liver or kidney impairment, heart disease, Parkinson's disease, pheochromocytoma (a type of adrenal gland tumor), pituitary tumors, or a history of epilepsy, gastrointestinal bleeding, obstruction, or perforation. Avoid consuming alcohol while on this medication, as it can intensify some side effects like drowsiness and potentially increase stomach acid production. Due to potential dizziness or drowsiness, avoid driving or operating heavy machinery until you know how the medicine affects you. Long-term treatment with S PPI L CAP may increase the risk of bone fractures, especially if you have osteoporosis or are taking corticosteroids; your doctor may recommend calcium and vitamin D supplements. This medicine is not recommended for children and adolescents under 18 years of age due to lack of established safety and effectiveness.

What happens if a dose is missed?

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

How should it be stored?

Store S PPI L CAP in a cool, dry place at a temperature not exceeding 30°C. Keep it protected from moisture and light, and always keep it out of the reach of children.