ZEDRAB Capsule 10's

Introduction About ZEDRAB CAPSULE

ZEDRAB CAPSULE is a combination of Levosulpiride and Rabeprazole which belongs
to the group of medicines called Dopamine D2 antagonists and Proton-pump
inhibitors respectively. ZEDRAB CAPSULE is indicated for the management of
Gastro-esophageal reflux disease (GERD). GERD is a chronic digestive disease in
which the stomach acid frequently flows into the esophagus leading to irritation
and inflammation of lining of food pipe. Symptoms include heartburn, chest pain,
nausea, sensation of lump in throat and stomach discomfort.

ZEDRAB CAPSULE can also be used to manage pe
gut), Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to
secrete more acid), functional dyspepsia (recurrent signs and symptoms of
indigestion without an obvious cause) and diabetic gastroparesis (delayed
gastric emptying caused due to diabetes).

Take ZEDRAB CAPSULE preferably on an empty stomach. Avoid consum
while taking ZEDRAB CAPSULE as it could potentiate the CNS depressive side
effects.

Patients receiving long-term management (>1 year) with ZEDRAB CAPSULE should be
kept on regular surveillance because it can increase the risk of bone fracture
(i.e., in the hip, wrist or spine) which is more predominant in the patients
having osteoporosis or taking corticosteroids.

Before taking ZEDRAB CAPSULE, inform your doctor if you have any heart, kidney
or liver disease as a precaution. ZEDRAB CAPSULE is not recommended for use in
pregnant or breastfeeding women, including children and adolescents (aged below
18 years).

The most common side effects of taking ZEDRAB CAPSULE are nausea, vomiting,
stomach pain, diarrhea, constipation and headache. Consult your doctor if any of
these symptoms worsen.

Uses Of ZEDRAB CAPSULE

• Manage Gastro-Esophageal Reflux Disease (GERD)
• Manage function dyspepsia
• Manage pe
• Manage Zollinger-Ellison syndrome
• Manage diabetic gastroparesis

How ZEDRAB CAPSULE Works

ZEDRAB CAPSULE reduces stomach ulcers, nausea and acid reflux, where rabeprazole
acts 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 CTZ (area in
medulla oblongata that causes vomiting when stimulated) and in the gut, thus
facilitating the movement of food from the stomach into the intestines followed
by healing of ulcers or inflammatory lesions in the stomach and in the
esophagus.

How to use ZEDRAB CAPSULE

Take ZEDRAB CAPSULE on an empty stomach or as advised by your physician. Swallow
ZEDRAB CAPSULE as a whole and do not crush or chew the medicine. Your doctor
will decide the correct dose and duration of therapy for you depending upon your
age, body weight and disease condition.

Side Effects Of ZEDRAB CAPSULE

Common

• infections, weakness or flu-like symptoms
• difficulty in sleeping
• headache or dizziness
• cough, runny nose or sore throat
• nausea, vomiting, stomach pain, diarrhea, wind (flatulence) or constipation
• aches or back pain
• benign polyps in stomach

Uncommon

• nervousness, drowsiness
• chest infection
• sinusitis (painful and blocked sinuses)
• dryness of mouth
• indigestion or belching
• skin rash or redness
• leg pain, muscle pain or joint pain
• fractures of the spine, hip and wrist
• urinary tract infection
• chest pain
• fever or chills

Rare

• loss of appetite
• depression
• visual disturbance
• sore mouth, taste disturbance
• stomach upset or pain
• sweating
• kidney problems
• weight gain

Stop taking ZEDRAB CAPSULE and contact your doctor immediately if you experience
any of the following side effects:

• skin rash on sun exposed areas with joint pain
• severe (watery or bloody) diarrhea accomp
• severe allergic reactions (such as sudden swelling of the face, leading to breathing difficulties or low blood pressure which may cause fainting or collapse)
• frequent infections such as high fever or sore throat or ulcers in the mouth or throat
• bleeding or bruising easily
• severe skin blistering with oral sores
• signs of liver disease (yellowing of the skin and eyes, dark urine and tiredness)
• signs of serious skin reactions (such as erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis causing severe skin redness with blistering or peeling, bleeding in the lips, eyes, mouth, nose and genitals with a high fever and joint pains)
• signs of decreased magnesium levels in the blood (such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia)

How To Manage Side Effects

Diarrhea:

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 lot 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.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines while you are feeling dizzy. Do not consume too much of alcohol, as it
can aggravate your dizziness. 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 and 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

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

!### Breastfeeding

ZEDRAB CAPSULE is strictly not recommended for use in breastfeeding women.
Consult your doctor before taking ZEDRAB CAPSULE.

!### Driving and Using Machines

Do not drive or operate any heavy tools or machines if you experience dizziness,
drowsiness or sleepiness after taking ZEDRAB CAPSULE.

!### Alcohol

Avoid consum
depression (characterized by confusion, attention impairment and anxiety),
dizziness and/or drowsiness. Consult your doctor before taking ZEDRAB CAPSULE.

!### Kidney

ZEDRAB CAPSULE should be taken with caution in patients with kidney disease.
Consult your doctor before taking ZEDRAB CAPSULE.

!### Liver

ZEDRAB CAPSULE should be taken with caution in patients with a previous history
of liver problems. Consult your doctor before taking ZEDRAB CAPSULE.

!### Allergy

Do not take ZEDRAB CAPSULE if you are allergic to Levosulpiride, Rabeprazole or
other proton-pump inhibitors (Ex. pantoprazole, omeprazole, lansoprazole).

!### Lungs

ZEDRAB CAPSULE should be taken with caution in patients with asthma or other
respiratory diseases. Consult your doctor before taking ZEDRAB CAPSULE.

!### Heart Disease

ZEDRAB CAPSULE should be taken with caution in patients with heart disease.
Consult your doctor before taking ZEDRAB CAPSULE.

Others

ZEDRAB CAPSULE is not recommended for use if you have:

• parkinson’s disease
• history of epilepsy
• neurole
• breast cancer (with high levels of prolactin in the body)

Before taking ZEDRAB CAPSULE, inform your physician if you:

• have a tumor in the stomach or breast
• have bleeding or perforation of the gastrointestinal tract
• have or at risk of developing vitamin-B12 deficiency
• had developed any skin reaction following management with similar medicines that can reduce stomach acid
• are due to have a specific blood test (Chromogr
• have osteoporosis
• are a smoker
• have porphyria (a rare blood disorder)
• have alcohol intoxication (drinking large amount of alcohol in short period)
• have or had phaeochromocytoma (tumors of adrenal gland) in the past
• have or had prolactinoma (a noncancerous tumor of pituitary gland) in the past
• have hypokalemia (decreased potassium levels in blood)
• have neuroendocrine tumor (tumors in neuroendocrine cells)
• have m
• have painful breasts

Use in pediatrics:

ZEDRAB CAPSULE is not recommended for use in children and adolescents (aged
below 18 years). Consult your doctor before taking ZEDRAB CAPSULE.

Use in geriatrics:

ZEDRAB CAPSULE should be used with caution in elderly patients (aged 65 years or
above). Consult your doctor before taking ZEDRAB CAPSULE. Proper dose
adjustments and careful monitoring are required in such patients.

Interactions

A. Drug-Drug interactions:

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

• medicines used to manage HIV infection (Ex. atazanavir, nelfinavir, saquinavir, rilpivirine)
• antacids (used to neutralize stomach acid secretions) Ex. aluminium hydroxide, magnesium hydroxide
• sucralfate (used to manage duodenal ulcer)
• cisapride (used to manage heart burn in patients with gastroesophageal reflux disease)
• anticholinergics (medicines that causes smooth muscle relaxation and decreases body secretions) Ex. atropine, scopolamine, homatropine
• levodopa (used for parkinson’s disease)
• medicines causing low levels of potassium in blood such as furosemide (used to manage edema), corticosteroids (used to manage inflammation) Ex. cortisol, laxatives such as bisacodyl (used to manage constipation)
• iron salts (used to manage iron deficiency) Ex. ferrous sulphate, ferric ammonium citrate
• medicines used to manage high blood pressure and other heart problems (Ex. captopril, enalapril, losartan, valsartan, diltiazem, digoxin, quinidine)
• atomoxetine (used to manage attention-deficit hyperactivity disorder)
• terfenadine (used to manage allergic conditions)
• chloroquine (used to manage or manage malaria)
• clarithromycin or amoxicillin (used to manage bacterial infections)
• medicines used to manage cancer (Ex. erlotinib, dasatinib, nilotinib)
• methotrexate (used to manage cancer and auto-immune disease)
• tacrolimus or mycophenolate mofetil (used to manage organ rejection after transplant)
• ketoconazole, itraconazole (used to manage fungal infection)
• warfarin (used for blood thinning and management of heart problems)
• pregabalin (used to manage neuropathic pain)
• tramadol (used to manage pain)
• ipratropium (used to manage symptoms of COPD/asthma)

Overdosage:

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

Synopsis

Drug	:	Levosulpiride, Rabeprazole
Pharmacological Category	:	Dopamine D2 antagonists, Proton-pump inhibitors
Therapeutic Indication	:	Pe
Dosage Forms	:	Tablet, Capsule

More Information

• Keep ZEDRAB CAPSULE out of reach of children
• Store ZEDRAB CAPSULE at room temperature

FAQs About ZEDRAB CAPSULE

When and how should I take ZEDRAB CAPSULE?

Take ZEDRAB CAPSULE on an empty stomach or as advised by your physician. Swallow
the medicine as a whole and do not crush or chew the medicine. Your doctor will
decide the correct dose of ZEDRAB CAPSULE and duration of therapy for you
depending upon your age, body weight and health condition.

Can ZEDRAB CAPSULE be used in children?

ZEDRAB CAPSULE is not recommended for use in children and adolescents (aged
below 18 years). Kindly consult child’s doctor if your child experiences any
symptoms of gastro-esophageal reflux disease (such as nausea, discomfort in
upper stomach, heartburn, burping, etc.)

Can I consume alcohol while taking ZEDRAB CAPSULE?

No, avoid consum
CNS depression (characterized by confusion, attention impairment and anxiety),
dizziness and/or drowsiness. Also, if you are a chronic alcoholic or suffering
from acute alcohol intoxication, please inform your doctor as a precaution
before taking ZEDRAB CAPSULE.

Can I drive or operate machinery after taking ZEDRAB CAPSULE?

ZEDRAB CAPSULE may cause dizziness in some individuals and so avoid driving or
operating any tools or machines while you are feeling dizzy. Try to rest and
relax. Get enough sleep. Do not consume too much of alcohol, as it can aggravate
your dizziness. Consult your doctor before taking ZEDRAB CAPSULE.

Does prolong use of ZEDRAB CAPSULE cause bone fractures?

Yes, prolonged use of ZEDRAB CAPSULE can increase the risk of bone fracture
(particularly in the hips, wrist or spine), particularly in the elderly patients
and in patients with other risk factors such as having osteoporosis or taking
corticosteroids. Consult your doctor before taking ZEDRAB CAPSULE. During
management with ZEDRAB CAPSULE your doctor may monitor to rule out the risk of
fractures. Do not take ZEDRAB CAPSULE for a prolonged period without consulting
your doctor.

What to do If I forget to take ZEDRAB CAPSULE?

You should take ZEDRAB CAPSULE immediately when you remember. If it is time for
your next dose of ZEDRAB CAPSULE skip the missed dose and follow your regular
dose schedule. Do not double the dose to match up your missed dose.

What are the common side effects of ZEDRAB CAPSULE?

The most common side effects of taking ZEDRAB CAPSULE are nausea, vomiting,
headache, stomach pain, diarrhea, constipation, infections, cough or sore
throat. Consult your doctor if any of the side effects worsen.

Useful Diagnostic Tests

• Anti-Saccharomyces Cerevisiae (ASCA), IgA
• Anti-Saccharomyces Cerevisiae (ASCA), IgG
• Complete Blood Count
• Helicobacter Pylori IgA
• Helicobacter Pylori IgG