Roles™ tablets belong to a group of medicines called Proton Pump Inhibitors (PPIs). It contains the active ingredient rabeprazole sodium. Roles™ tablets act by reducing the amount of acid made by the stomach. Roles™ tablets are used to treat:

• Reflux Oesophagitis or GERD disease: This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Roles™ is used to treat Reflux Oesophagitis, and also used to help stop reflux oesophagitis from coming back or relapsing.
• Peptic Ulcers: Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These ulcers can be caused by too much acid being made in the stomach. Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (Clarithromycin and Amoxycillin) for you. When Roles™ is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal. Roles™ is used to treat peptic ulcers.
• Chronic Gastritis: The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting. When Roles™ tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.

How to take Roles™ tablets

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Only remove a tablet from the blister strip when it is time to take your medicine.
• Swallow your tablets whole with a drink of water.
• Do not chew or crush the tablets.
• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition. When Roles™ tablets are taken once daily, the tablets should be taken in the morning before breakfast.
• If you are taking this medicine for a long time, your doctor will want to monitor you.
• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
• If you forget to take your medicine for more than 5 days, talk to your doctor before taking any more medicine.
• The usual dose is one tablet at the same time each day. For treating Helicobacter pylori infections in combination with antibiotics (clarithromycin and amoxycillin), the dose is one tablet twice each day, morning and evening.
• The dose of Roles™ tablets is usually 20 mg, but may vary from 10 mg to 40 mg per day depending on what condition you are being treated for and how severe it is.

The recommended Adults and elderly dose is:

• Duodenal ulcer and benign gastric ulcer: 20mg Rabeprazole to be taken once daily in the morning. Most patients with duodenal ulcer are treated for four weeks and most patients with benign stomach ulcer are treated for six weeks. However a few patients may require additional treatment to achieve healing.
• Gastro-Oesophageal Reflux Disease (GORD) with ulcer: 20mg Rabeprazole to be taken once daily for four to eight weeks.
• Long term treatment of GORD: 10mg or 20mg Rabeprazole once daily depending upon response.
• Symptomatic treatment of GORD: 10mg Rabeprazole once daily for 4 weeks. Once symptoms have cleared your doctor may tell you to take 10mg Rabeprazole once daily when needed for subsequent symptom control.
• Zollinger-Ellison Syndrome: 60mg Rabeprazole once a day to start with. The dose may then be adjusted by your doctor depending on how you respond to the treatment. Your doctor
  will tell you how many tablets to take and when to take them.
• Eradication of H. pylori: 20mg Rabeprazole to be taken twice each day and normally for 7 days (in combination with two antibiotics – Clarithromycin and Amoxicillin).

Use in children

Roles™ tablets are not recommended for use in children.

What you should know about Roles™

• This medicine is well tolerated by the body, and most people do not feel or experience any serious side effects. The most common side effects are headache and digestive disturbances, and these symptoms often disappear and go away with continued treatment.
• The usual dose, once daily (however the doctor can increase the dose to twice daily), the dose is taken either 30 minutes before breakfast or 30 minutes before dinner, and the duration of treatment in most cases is between 2 to 4 weeks (your doctor may order You should continue to take this medicine for longer periods, always follow your doctor’s instructions).
• Regular use of Roles™ for long periods (once daily for more than 6 to 12 months) may cause the following problems: ① Increased risk of bone fractures, especially in elderly patients with osteoporosis, ② Decreased levels of magnesium in the blood, and this can lead to Heart rhythm disturbances,③ Decrease in vitamin B levels in the body, which may cause anemia.

Warnings and precautions

• Treatment with (Roles™) may mask stomach cancer (a disease in which malignant (cancerous) cells form in the stomach lining). Stomach cancer should be excluded, and it should be noted that improvement of symptoms does not prevent the presence of a malignant tumor in the stomach.
• Long-term treatment with rabeprazole has been associated with atrophic gastritis (changes in the type of cells lining the stomach wall, which are characterized by chronic inflammation of the gastric mucosa).
• treatment with Roles™, especially for a long period of time, may be associated with an increased risk of diarrhea caused by Clostridium difficile, a bacteria that causes severe diarrhea and colitis, a condition called pseudomembranous colitis.
• Bone fracture: Long-term therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.
• High doses of rabeprazole reduces the anti-platelet activity of clopidogrel.
• Hypomagnesemia has been reported rarely with prolonged treatment with proton pump inhibitors.
• Avoid concomitant use of Roles™ with St. John’s wort or rifampin because of a possible decrease in rabeprazole effect may happen.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and improve without you having to stop taking this medicine. If you notice any of the following serious side effects, stop taking Roles™ tablets and contact a doctor immediately, you may need urgent medical treatment(These serious side effects are very rare -affect fewer than 1 in 10,000 people):

• Allergic reactions- the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse.
• Frequent infections, such as a sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or bleeding easily.
• Sudden onset of 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)).

Do not be concerned by the following list of side effects. You may not get any of them.

Common side effects (may affect up to 1 in 10 people):

• cough, sore throat (inflammation of the pharynx), runny nose.
• effects on your stomach or gut such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation.
• aches, back pain, non-specific pain.
• weakness or loss of strength, flu like symptoms.
• difficulty sleeping.
• headache, dizziness.
• infection.
• benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people):

• feeling nervous or drowsy.
• sleepiness.
• chest infection (bronchitis).
• painful and blocked sinuses (sinusitis).
• indigestion, dry mouth, belching.
• rash, skin redness (erythema).
• muscle pains, joint pains, leg cramps.
• bladder infection (urinary tract infection).
• chest pain, chills, fever.
• muscle, leg or joint pain.
• change in how your liver is working (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 reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• changes in white blood cells (show in blood tests) which may result in frequent infection.
• allergic reactions including facial swelling, low blood pressure and breathing difficulties.
• loss of appetite (anorexia).
• depression.
• visual disturbance.
• upset stomach or stomach pain, sore mouth, taste disturbance.
• inflammation of the liver, jaundice (yellowing of the skin or eyes).
• itchy rash, sweating, skin blisters.
• kidney inflammation (interstitial nephritis).
• increased weight.

Not known (frequency cannot be estimated from the available data):

• low levels of sodium in the blood which can cause tiredness and confusion, muscle twitching, fits and coma.
• confusion.
• swelling of the feet and ankles.
• enlarged breasts in men.
• Patients who have previously had liver problems may very rarely get encephalopathy (a brain disease).
• rash, possibly with pain in the joints.
• inflammation of the gut (leading to diarrhoea). Ref#A02BC04.