Rabeprazole EC and Levosulprideare SR Capsules 20mg+75mg
What Rabeprazole and Levosulprideare and what they are used for
Rabeprazole and Levosulpiride is a medicine which contains Rabeprazole and Levosulpiride
Rabeprazole
Rabeprazole belongs to a group of medicines called Proton Pump Inhibitors (PPIs). Rabeprazole act by reducing the amount of acid made by the stomach. Rabeprazole is used to treat:
? ulcer in the upper part of the intestine (duodenal ulcer)
? gastro-oesophagal reflux disease (GERD) with or without ulcer.
GERD is commonly referred to as inflammation of the gullet caused by acid and associated with heartburn. Heartburn is a burning feeling rising from the stomach or lower chest up towards the neck. Rabeprazole may be used as a long term treatment of GERD (GORD maintenance). Rabeprazole may also be used for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GERD).
? Zollinger-Ellison Syndrome, which is a condition when the stomach makes extremely high amounts of acid.
Levosulpiride
Levosulpiride belongs to the class of antipsychotic medicines. However, it is primarily used for its gut motility properties i.e to improve food movement and treats disorders of the stomach and intestines. This medicine works by inhibiting the action of certain specific neurotransmitters in the brain and specific regions of the stomach and the intestine.
Do not take if you have an allergy to the drug
Do not take this medicine if you
? are allergic to rabeprazole sodium, Levosulpiride or any of the other ingredients of this medicine
Before you take this drug, tell your healthcare practitioner about other medications you may be taking
Rabeprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important in case you are taking any of the following medicines:
? atazanavir (used to treat HIV); it is not recommended to take Rabeprazole if you are taking atazanavir.
? ketoconazole or itraconazole (used to treat infections caused by a fungus).
Levosulpiride
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol: Consumption of alcohol while taking this medicine can cause CNS depression characterized by confusion, lack of focus, anxiety, drowsiness etc.
Avoid or limit the uptake of alcohol while taking this medicine as the risk of adverse effects are increasingly high. Contact your doctor if an excess of drowsiness is experienced.
Interaction with Medicine
?Diltiazem
?Pregabalin
?Sucralfate
?Tramadol
?Aluminium Hydroxide/Magnesium Hydroxide
?Ipratropium
Disease interactions
?Heart Disease: This medicine should be used with caution in patients suffering from a disease of the heart and blood vessels. You may require an adjusted dose and safety monitoring to safely use this medicine.
?Gastro-intestinal bleeding: This medicine should be used with extreme caution in patients suffering from perforation and bleeding of the stomach and the intestine. Report any instance of fever with chills, nausea, vomiting, presence of blood in the stool to the doctor.
?Prolactin imbalance: This medicine should not be used in patients having an abnormal level of the hormone prolactin. Breast cancer due to a high level of prolactin should be ruled out before treatment with this medicine is initiated.
?Neuroleptic Malignant Syndrome (NMS): Use of this medicine is not recommended if the patient suffers from Neuroleptic malignant syndrome. Introduction or reintroduction of this medicine should be done with caution in patients having a known history of this syndrome.
?Asthma: This medicine should be used with caution if you have asthma. Report any instances of difficulty in breathing, wheezing, chest pain etc to the doctor immediately.
Lab interactions
Prolactin test: Report the use of this medicine before undergoing a laboratory test to determine the levels of the hormone prolactin in the body. This medicine can interfere with the test and yield false-positive results.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you?re taking.
How should you take this medicine?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is: Once capsule once daily
If you take more this medicine than you should:
If you have taken more this medicine than prescribed by your doctor, seek medical advice.
If you forget to take this medicine
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then.
What are the possible side effects?
Rabeprazole
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop taking Rabeprazole and contact a doctor immediately:
? sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction).
? yellow skin, dark urine and tiredness which can be symptoms of liver problems.
? reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
Common side effects (may affect up to 1 in 10 people):
? cough, sore throat (inflammation of the pharynx), runny nose.
? nausea, vomiting, abdominal pain, diarrhoea, constipation, wind (flatulence).
? back pain, non-specific pain. ? weakness or loss of strength, flu-like symptoms.
? sleeplessness.
? headache, dizziness.
? infection.
? benign polyps in the stomach.
Uncommon side effects (may affect up to 1 in 100 people):
? nervousness.
? sleepiness. ? inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis).
? indigestion, dry mouth, belching.
? rash, skin redness (erythema).
? muscle pains, joint pains, leg cramps.
? urinary tract infection.
? chest pain, chills, fever.
? increased liver enzymes, which is measured by blood tests.
? fracture of the hip, wrist or spine.
Rare side effects (may affect up to 1 in 1,000 people):
? blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
? increased number of white blood cells.
? allergic reactions including facial swelling, low blood pressure and breathing difficulties.
? loss of appetite.
? depression.
? visual disturbance.
? inflammation of the stomach, inflammation of the mouth, taste disturbance.
? inflammation of the liver, jaundice (yellowing of the skin or eyes), brain disturbance associated with liver failure (hepatic encephalopathy).
? itching, sweating, skin blisters.
? kidney inflammation (interstitial nephritis).
? increased weight.
Very rare side effects (may affect up to 1 in 10,000 people):
? sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)). Not known (frequency cannot be estimated from the available data):
? low levels of sodium in the blood.
? confusion.
? swelling of the feet and ankles.
? enlarged breasts in men.
? If you are on Rabeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
? rash, possibly with pain in the joints.
? inflammation of the gut (leading to diarrhoea).
Levosulpiride
Major & minor side effects for Levosulpiride
Drowsiness
Breast tenderness
Irregular menstrual periods
Gynecomastia
Constipation
Abdominal pain and cramps
Weight gain
Sleeplessness
Unusual tiredness and weakness
Increased salivation
Decrease in libido
Fever
Excessive sweating
Change in heart rate
How should I store this medicine?
Keep this medicine out of the sight and reach of children.
Store protected from light & moisture, at a temperature not exceeding 30? C
Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
General information about the safe and effective use of this medicine.
Rabeprazole
Do not take Rabeprazole if you
? are pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rabeprazole if you
? are allergic to other proton pump inhibitors.
? have or have had any liver problems.
? are taking a medicine called atazanavir (used to treat HIV).
? have reduced body stores or risk factors for reduced vitamin B12 and receive long term treatment with rabeprazole sodium. As with all acid-reducing agents, rabeprazole sodium may lead to reduced absorption of vitamin B12.
? if you are due to have a specific blood test (Chromogranin A).
? if you have ever had a skin reaction after treatment with a medicine similar to
Rabeprazole that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with Rabeprazole. Remember to also mention any other ill-effects like pain in your joints.
If the above applies to you, consult your doctor before taking Rabeprazole. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
The possibility of the stomach and oesophageal tumours should be excluded before the treatment is started. If you take Rabeprazole on a long-term basis (longer than one year) your doctor will probably monitor, you regularly. You should report any new or different symptoms whenever you see your doctor. Taking a proton pump inhibitor like Rabeprazole, especially over a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Talk to your doctor straight away if you experience severe (watery or bloody) or persistent diarrhoea with symptoms such as fever, abdominal pain or tenderness, as rabeprazole has been associated with a small increase in infectious diarrhoea
Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values become normal when the treatment is discontinued. Children Rabeprazole is not recommended for use in children.
Pregnancy and breast-feeding
Rabeprazole must not be used during pregnancy and breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Rabeprazole would affect your ability to drive or operate machinery. However, occasionally rabeprazole can cause sleepiness. Therefore, driving and operating complex machinery should be avoided if you are affected
Levosulpiride
Warnings for special population
Pregnancy
Use of this medicine during pregnancy is not recommended unless absolutely necessary. It is advised to use this medicine only when the benefits outweigh the risks involved.
Breast-feeding
Use of this medicine by breastfeeding women is not recommended. However, if it is absolutely necessary to use this medicine, then breastfeeding should be discontinued. Consult your doctor before using this medicine.
General warnings
?Heart disease: This medicine should be used with caution in patients having a history of stroke, blood clotting disorders or other ailments of the heart and blood vessels.
?Diabetes: This medicine should be used with caution in patients who are suffering from diabetes or are exposed to the risk factors.
?Hypokalemia: This medicine should be used with caution in patients having low potassium levels in the body. It is recommended to initiate treatment with Levosulpiride only after the potassium deficit is corrected.
?Breast cancer: This medicine is not recommended for use if the patient is suspected to have breast cancer associated with abnormally high levels of prolactin in the body.
?Drowsiness: This medicine is known to cause moderate to severe drowsiness and may the ability to perform tasks that require a high level of mental alertness. It is advised to refrain from driving or operating any heavy machinery after consuming this medicine.
?Leukopenia: This medicine is not recommended for use in patients who have a decreased white blood cell count characterized by frequent infections, fever with chills, sore throat, and mouth ulcers.
?Use in elderly: This medicine should be used with caution in the elderly as the risk of side effects are increasingly high. Appropriate dose adjustments should be made based on the response of the patients.
?Menstrual abnormalities: Use of this medicine has been associated with abnormalities in menstrual period. Contact your doctor if the regular periods are excessively delayed.
Miscellaneous
?To be taken before food
?To be taken as instructed by the doctor
?May cause sleepiness
?Avoid or limit the uptake of alcohol while taking this medicine as the risk of adverse effects are increasingly high. Contact your doctor if an excess of drowsiness is experienced.
?No habit forming tendencies were reported.
What are the ingredients in this medicine?
Each hard gelatin capsule contains:
Rabeprazole Sodium 20mg
(as enteric-coated pellets)
Levosulpiride 75mg
(as sustained-release pellets)
Colour: Titanium Dioxide IP, Ferric Oxide (Red) USP-NF & Ferric Oxide (Black) USP-NF
Approved colours used in capsule shell: Titanium Dioxide, Brilliant Blue, Carmoisine, Sunset Supra Yellow & Ponceau 4R.
Any other information
None.
Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)