Rabeprazole Sandoz

Rabeprazole Sandoz

rabeprazole

Manufacturer:

Sandoz

Distributor:

Zuellig
Full Prescribing Info
Contents
Rabeprazole.
Description
Rabeprazole Sandoz also contains the following excipients: Tablet Core: Calcium hydroxide, mannitol, low-substituted hydroxypropyl cellulose and sodium stearyl fumarate. Coating 1: Hypromellose, talc. Gastro-Resistant Coating 2: Hypromellose phthalate, dibutyl sebacate, yellow ferric oxide (E172), red ferric oxide (E172) (in 10 mg only) and titanium dioxide (E171).
Action
Rabeprazole belongs to a group of medicines called "proton-pumped inhibitors".
These medicines reduce the production of acid in the stomach.
Indications/Uses
Treatment of ulcers in the gut (duodenal ulcer) and in the stomach (benign gastric ulcer); relieving the symptoms of the heartburn caused by errosive or ulcerative gastro-esophageal reflux disease (GORD) which is also called reflux oesophagitis; long-term treatment of GORD to prevent reoccurence; relieving the symptoms of moderate to very severe GORD (symptomatic GORD) like heartburn and acid regurgitation; severely increased acid secretion in the stomach (Zollinger-Ellison syndrome); treatment of infections caused by bacteria called Helicobacter pylori when given in combination with antibiotic therapy.
Dosage/Direction for Use
Duodenal Ulcer: Usual Dose: 20 mg once daily in the morning for 4 weeks. May prolong treatment for another 4 weeks.
Stomach Ulcer: Ususal Dose: 20 mg once daily in the morning for 6 weeks. May prolong treatment for another 6 weeks.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GORD):
Usual Dose: 20 mg once daily for 4-8 weeks.
Long-Term Treatment of GORD:
Usual Maintenance Dose: 10 mg or 20 mg once daily. If the patient is on long-term treatment, consult the physician at regular intervals for review of tablets and symptoms.
Relieving the Symptoms of Moderate to Very Severe Gastro-Esophageal Reflux Disease (GORD): Usual Dose: 10 mg once daily for 4 weeks. If symptoms don not resolve within 4 weeks, consult the physician. Following this initial 4-week treatment, if symptoms return, the patient may take one 10-mg tablet when needed in order to control symptoms.
Severely Increased Acid Secretion in the Stomach (Zollinger-Ellison Syndrome): Usual Starting Dose: 60 mg once daily. The dose may then be adjusted depending on how the patient responds to treatment. Doses up to 60 mg twice daily may be given. The physician will inform the patient on how many tablets to take, when to take them and for how long it should be taken.
Treatment of Infections Caused by H. pylori when Given in Combination with Antibiotic Therapy: Usual Dose: 20 mg twice daily in combination with 2 antibiotics. Recommended Combination: Rabeprazole Sandoz 20 mg + clarithromycin 500 mg + amoxicillin 1 g, taken together twice daily for 7 days.
Impaired Liver and Kidney Function:Dose adjustment is not necessary.
Missed Dose: It is important to take the medicine every day as a regular treatment to be more effective. However, if the patient forgets to take ≥1 doses, take another as soon as the patient remembers and then go on as prescribed. Do not take a double dose to make up for the forgotten dose.
Administration: If Rabeprazole Sandoz is taken once daily, take the tablet before eating in the morning. Swallow the tablets whole. Do not crush or chew the tablets.
Contraindications
Hypersensitivity to rabeprazole or to any of the excipients of Rabeprazole Sandoz.
Use in pregnancy & lactation: Ask the physician or pharmacist before taking any medicine. Do not take Rabeprazole Sandoz if the patient is pregnant or breastfeeding.
Warnings
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton-pump inhibitors for at least 3 months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the proton-pump inhibitors. For patients expected to be on prolonged treatment or who take proton-pump inhibitors with medications eg, digoxin or drugs that may cause hypomagnesemia (eg, diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Special Precautions
Before starting treatment with Rabeprazole Sandoz, the possibility of tumours in the gullet or stomach must be excluded. Patients on long-term treatment (>1 year) should be kept under regular surveillance.
Patient with allergy (hypersensitive) to other proton-pump inhibitors.
Exercise caution when treatment is to be given in patient with liver problems.
Taking atazanavir (a drug used to treat HIV) with Rabeprazole Sandoz is not recommended (See Interactions).
Effects on the Ability to Drive or Operate Machinery: Usually, Rabeprazole Sandoz does not affect the ability to drive and use machines. However, patients may become sleepy. Driving or operating machinery should be avoided if this side effect occurs.
Use in children: Rabeprazole Sandoz is not recommended for use in children.
Use In Pregnancy & Lactation
Ask the physician or pharmacist before taking any medicine. Do not take Rabeprazole Sandoz if the patient is pregnant or breastfeeding.
Adverse Reactions
Like all medicines, Rabeprazole Sandoz can cause adverse reactions although not everybody gets them.
Serious Adverse Reactions: Contact the physician immediately if any serious adverse reaction (it may be an allergic reaction) occurs.
Rare Serious Adverse Reactions (Affects 1-10 Users in 10,000): Swelling of the face, lips, tongue and throat which may cause difficulty in breathing, speaking or swallowing; a sharp drop in blood pressure; pallor, fainting, collapse.
Other Possible Adverse Reactions: Common (Affects 1-10 Users in 1000): Nervousness, drowsiness; cough with phlegm, chest pain, fever, chills; feeling of pressure or pain in the cheeks and forehead; indigestion; dry mouth, belching; rash, skin reddening; muscle pain, leg cramps, joint pain; urinary tract infection; increased liver enzymes.
Rare (Affects 1-10 Users in 10,000): Blood disorders which may lead to frequent infections, bleeding or bruising more easily than normal or tiredness; loss of appetite (anorexia); vision disturbance; gastritis which might cause stomach pain and nausea; sore mouth; taste disturbances; liver disorder (hepatitis) leading to brain damage in patients who have previously has liver disease; itching and skin blisters which usually disappear on stopping treatment; sweating kidney problems which might cause high or low urine output; weight gain; depression.
Not Known (Frequency Cannot be Estimated from Available Data): Low sodium levels in the blood; confusion; breast enlargement in men; swelling of the ankles, feet or fingers; decreased gastric acidity due to any means, including proton-pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract.
Treatment with proton-pump inhibitors may lead to slightly increase risk of gastrointestinal infections eg, Salmonella and Campylobacter and possibly Clostridium difficile.
Consult the physician or pharmacist if any of the adverse reactions gets serious.
Drug Interactions
Some medicines may cause problems if taken with Rabeprazole Sandoz. Inform the physician before taking Rabeprazole Sandoz if the patient is currently taking ketoconazole or itraconazole (drugs used to treat fungal infections) as the dose may need to be adjusted; atazanavir (a drug used to treat HIV).
Storage
Store below 25°C.
ATC Classification
A02BC04 - rabeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Gastro-resistant tab 10 mg (pink, round, biconvex) x 98's. 20 mg (yellow, round, biconvex) x 98's.
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