GASTRO SL Capsule 10's

Introduction About GASTRO SL CAPSULE

GASTRO SL CAPSULE is a combination of Esomeprazole and Levosulpiride which
belongs to the group of medicines called Proton-pump inhibitors and Dopamine D2
antagonists respectively. GASTRO SL CAPSULE is indicated for the management of
Gastro-esophageal reflux disease (GERD) among patients who do not adequately
respond to proton-pump inhibitors alone (Ex. pantoprazole, rabeprazole,
esomeprazole, omeprazole).

GERD is a chronic digestive disease in which the stomach acid frequently flows
into the esophagus leading to irritation of lining of food pipe. Symptoms
include heartburn, chest pain, nausea, sensation of lump in throat and stomach
discomfort.

GASTRO SL CAPSULE can also be used to manage pe
infection or NSAID use. Pe
linings of the stomach, esophagus or intestines. Symptoms include stomach pain,
flatulence, indigestion, vomiting and fatigue.

Along management with GASTRO SL CAPSULE eat less spicy food and drink plenty of
water or fluids as advised by your physician. Avoid consum
could aggravate your existing disease conditions.

Patients receiving long-term management with GASTRO SL CAPSULE should be kept on
regular surveillance to rule out the risk of bone fractures (hip, wrist or
spine), predominantly in patients taking corticosteroids and in patients with
other recognized risk factors like osteoporosis. Before taking GASTRO SL
CAPSULE, inform your doctor if you have any heart, kidney or liver disease as a
precaution.

GASTRO SL CAPSULE is not recommended for use in pregnant or breastfeeding women,
including children and adolescents (aged below 18 years) due to lack of safety
and effectiveness.  GASTRO SL CAPSULE should be used with caution in elderly
patients (aged 65 years or above).

The most common side effects of taking GASTRO SL CAPSULE are headache, nausea,
vomiting, stomach pain, diarrhea or constipation. Consult your doctor if any of
the side effects worsen.

Uses Of GASTRO SL CAPSULE

• Manage Gastro-esophageal reflux disease (GERD) among patients who do not respond to proton-pump inhibitors (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole) alone
• Manage pe

How GASTRO SL CAPSULE Works

GASTRO SL CAPSULE reduces pe
by inhibiting the secretions of stomach acid by blocking the proton pump (H+ K+
ATPase) at the secretory surface of gastric parietal cells and levosulpiride
acts by blocking the dopamine D2 receptors in the gut which promotes the
secretions of acetylcholine, thus facilitating gastric emptying and healing of
ulcers and/or esophageal lesions.

How to use GASTRO SL CAPSULE

Take GASTRO SL CAPSULE as advised by your physician. Swallow GASTRO SL CAPSULE
with a glass of water. Do not crush or chew the medicine. Your doctor will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Side Effects Of GASTRO SL CAPSULE

Common

• headache
• nausea or vomiting
• diarrhea, stomach pain, constipation, flatulence
• benign polyps in stomach

Uncommon

• swollen ankles and feet
• insomnia (lack of sleep)
• dizziness
• pins and needles (tingling sensation in the body)
• sleepiness
• vertigo (spinning sensation)
• dry mouth
• skin rash, lumpy rash (hives) and itching
• fracture of wrist, hip or spine

Rare

• agitation, confusion, depression, aggression
• blurred vision
• changes in taste
• bronchospasm (difficulty in breathing)
• mouth sores
• fungal infection (Ex. thrush)
• hair loss
• skin sensitivity (skin rash following sun exposure)
• joint pain or muscle pains
• tiredness or lack of energy
• increased sweating
• abnormal heart rhythm

Stop taking GASTRO SL CAPSULE and contact your doctor immediately if you
experience the following side effects:

• signs of severe allergic reactions (such as skin rash, sudden wheezing, swelling of the lips, tongue and throat or body, fainting or difficulty in swallowing)
• signs of severe allergic skin reactions (such as skin redness with severe blisters or peeling, bleeding in the eyes, lips, mouth, nose or genitals associated with a high fever and joint pains)
• signs of liver problems (such as yellowing of the skin, dark urine and tiredness)

How To Manage Side Effects

Nausea and vomiting:

Stick to simple meals. Avoid eating oil rich, fried or spicy food. Do not lie
down or sleep immediately after eating. Consult your doctor if the symptom did
not improve.

Diarrhoea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated.
Avoid taking any medicine on your own for managing diarrhea. Consult your doctor
if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a
pain-relieving balm on the forehead if required. Do not consume too much of
alcohol. Consult your doctor if the symptom did not improve.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly and exercise regularly.
Consult your doctor if the symptom did not improve.Constipation:

Eat fiber rich foods such as fresh fruits, vegetables, cereals and drink plenty
of water. Try to exercise more regularly. Consult your doctor if the symptom did
not improve on its own.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals.
Keep a heat pad on your stomach. Do not self-manage on your own and consult your
doctor if the symptom did not improve on its own.

Warning & Precautions

!### Pregnancy

GASTRO SL CAPSULE is not recommended for use in pregnant women. Consult your
doctor before taking GASTRO SL CAPSULE.

!### Breastfeeding

GASTRO SL CAPSULE is not recommended for use in breastfeeding women. Consult
your doctor before taking GASTRO SL CAPSULE.

!### Driving and Using Machines

Do not drive or operate any heavy tools or machines if you experience dizziness,
drowsiness or blurred vision after taking GASTRO SL CAPSULE.

!### Alcohol

Avoid consum
aggravate your existing disease condition.

!### Kidney

GASTRO SL CAPSULE is not recommended for use in patients with severe kidney
disease. Consult your doctor before taking GASTRO SL CAPSULE.

!### Liver

GASTRO SL CAPSULE is not recommended for use in patients with severe liver
disease. Consult your doctor before taking GASTRO SL CAPSULE.

!### Allergy

Do not take GASTRO SL CAPSULE if you are allergic to Levosulpiride, Esomeprazole
or other proton pump inhibitors (Ex. pantoprazole, rabeprazole, omeprazole).

!### Heart Disease

GASTRO SL CAPSULE should be used with caution in patients with prolongation of
QTc interval (irregular electrical activity of the heart), stroke and cardiac
insufficiency. Consult your doctor before taking GASTRO SL CAPSULE.

Others

GASTRO SL CAPSULE is not recommended for use if you:

• have parkinson’s disease
• have history of epilepsy
• have porphyria (a rare blood disorder)
• have breast cancer or non-cancerous tumor in breast
• have alcohol intoxication (drinking too much alcohol in short period)
• have certain tumors like phaeochromocytoma (tumor in adrenal glands) or pituitary prolactinoma (tumors of pituitary gland)
• have hypokalemia (low blood potassium levels)
• have bleeding or perforation in the stomach or intestines
• have m

Before taking GASTRO SL CAPSULE, inform your physician if you:

• are due to have a specific blood test (Chromogr
• reduced vitamin B12 levels in body
• osteoporosis

Use in pediatrics:

GASTRO SL CAPSULE is not recommended for use in children and adolescents (aged
below 18 years) due to lack of safety and effectiveness. Consult your child’s
doctor for advice.

Use in geriatrics:

GASTRO SL CAPSULE should be used with caution in elderly patients (aged 65 years
or above). Consult your doctor before taking GASTRO SL CAPSULE.

Interactions

A. Drug-Drug interactions:

Before taking GASTRO SL CAPSULE inform to your doctor, if you are taking any of
these medicines:

• medicines used to manage HIV infection (Ex. nelfinavir, atazanavir)
• medicines used to manage fungal infections (Ex. ketoconazole, itraconazole or voriconazole)
• medicines used to manage depression (Ex. citalopram, imipramine, clomipramine, rasagiline, selegiline, phenelzine, or St. John’s wort)
• anticholinergics (used to reduce gastrointestinal movements) such as atropine, biperiden or hyoscine butylbromide
• narcotic analgesics (used to provide pain relief) Ex. morphine, pethidine, fentanyl
• medicines that can make you feel sleepy or drowsy such as sedatives or hypnotics (Ex. phenobarbital) or tranquilizers (Ex. diazepam, clonazepam, lorazepam)
• clopidogrel (an antiplatelet medicine used to manage blood clots)
• erlotinib (used to manage cancer)
• phenytoin (used to manage epilepsy)
• medicines used for blood thinning (Ex. warfarin)
• cilostazol (a medicine used to manage intermittent claudication (pain in legs))
• cisapride (used to manage heartburn or indigestion)
• digoxin (used to manage abnormal heart rhythm)
• methotrexate (a medicine used to manage cancer or other auto-immune disease)
• tacrolimus (used to suppress immune function and manage graft rejection)
• rifampicin (used to manage tuberculosis)
• diuretics (used to reduce blood pressure by increasing urine output) Ex. furosemide, hydrochlorothiazide

B. Drug-Food interaction:

GASTRO SL CAPSULE can be taken with food or on an empty stomach. Try to take
this medicine at least one hour before meals to maximize the efficacy. However,
consult your doctor before taking GASTRO SL CAPSULE.

Overdosage:

If you or anyone else accidentally take too much of GASTRO SL CAPSULE, contact
your doctor immediately or go to a hospital straight away.

Synopsis

Drug	:	Esomeprazole, Levosulpiride
Pharmacological Category	:	Proton pump inhibitors, Dopamine D2 antagonists
Therapeutic Indication	:	Gastro-esophageal reflux disease (GERD), Pe
Dosage Forms	:	Tablet, Capsule

More Information

• Keep GASTRO SL CAPSULE out of reach of children
• Store at room temperature

FAQs About GASTRO SL CAPSULE

Can GASTRO SL CAPSULE be used in children?

GASTRO SL CAPSULE is generally not recommended for use in children and
adolescents (aged below 18 years) due to lack of safety and effectiveness.
Kindly consult your child’s doctor for advice.

Can GASTRO SL CAPSULE be used during pregnancy?

No, GASTRO SL CAPSULE is generally not recommended for use in pregnant women. If
you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking GASTRO SL CAPSULE.

Can GASTRO SL CAPSULE cause depression?

Yes, GASTRO SL CAPSULE can rarely cause depression in some individuals. If you
experience any signs of depression such as feeling extremely sad, solitary
attitude, lack of social connectivity, please contact your doctor immediately.

Can GASTRO SL CAPSULE be taken for long term?

GASTRO SL CAPSULE can be taken as a long-term therapy for gastrointestinal
disorders. However, consult your doctor before taking GASTRO SL CAPSULE. Your
doctor will decide the correct dose and duration for you depending upon your
age, body weight and health condition. Do not stop taking GASTRO SL CAPSULE
abruptly or take for a longer period than prescribed without consulting your
doctor.

Can GASTRO SL CAPSULE cause black stools?

Yes, GASTRO SL CAPSULE can rarely cause black stools or blood-stained stools in
some individuals. If you experience black stools or blood-stained stools with or
without stomach pain or indigestion, stop taking GASTRO SL CAPSULE and consult
your doctor immediately.

Is GASTRO SL CAPSULE safe to use in patients with heart problems?

GASTRO SL CAPSULE should be used with caution in patients with prolongation of
QTc interval (irregular electrical activity of the heart), stroke and cardiac
insufficiency. Consult your doctor before taking GASTRO SL CAPSULE.

Useful Diagnostic Tests

• Helicobacter Pylori IgA
• Helicobacter Pylori IgG