Rabeprazole Aurobindo Italia

Patient Information Leaflet: Information for the patient

Rabeprazolo Aurobindo Italia 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Rabeprazolo Aurobindo Italia is and what it is used for
2. What you need to know before taking Rabeprazolo Aurobindo Italia
3. How to take Rabeprazolo Aurobindo Italia
4. Possible side effects
5. How to store Rabeprazolo Aurobindo Italia
6. Contents of the pack and other information

1. What Rabeprazolo Aurobindo Italia is and what it is used for

Rabeprazolo Aurobindo Italia tablets contain sodium rabeprazole as the active substance. This
active substance belongs to a group of medicines called proton pump inhibitors (PPIs). They work
by reducing the amount of acid produced by your stomach.
Rabeprazolo Aurobindo Italia tablets are used to treat the following conditions:

• Gastro-oesophageal reflux disease (GORD), which may include heartburn. Gastro-oesophageal reflux disease occurs when acid and food pass from the stomach into the oesophagus.
• Stomach or duodenal ulcer. If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), antibiotics will also be prescribed. Taking Rabeprazolo Aurobindo Italia tablets together with antibiotics helps eliminate the infection and heal the ulcer. Furthermore, the treatment prevents reinfection and helps prevent the ulcer from recurring.
• Zollinger-Ellison syndrome, a condition in which the stomach produces extremely high amounts of acid.

2. What you need to know before taking Rabeprazolo Aurobindo Italia

Do not take Rabeprazolo Aurobindo Italia

• If you are allergic (hypersensitive) to sodium rabeprazole or to any of the ingredients of this medicine (listed in section 6).
• If you are or think you may be pregnant.
• If you are breastfeeding.

Do not take Rabeprazolo Aurobindo Italia if any of the above conditions apply to you. If you have any
doubts, consult your doctor or pharmacist before taking Rabeprazolo Aurobindo Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazolo Aurobindo Italia:

• If you are allergic to other proton pump inhibitors or "imidazole-like substitutes".
• If you have liver or blood problems; such issues have occurred in some patients and resolved upon discontinuation of treatment with Rabeprazolo Aurobindo Italia.
• If you have been diagnosed with a stomach tumour.
• If you have had liver disease.
• If you are taking atazanavir for HIV infection.
• If you have low body reserves or risk factors that reduce vitamin B12 absorption and are receiving long-term treatment with sodium rabeprazole. Like all other agents that reduce acid, sodium rabeprazole may lead to reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazolo Aurobindo Italia that reduces gastric acidity.
• If you develop a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as treatment with Rabeprazolo Aurobindo Italia may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (chromogranin A).

During treatment with rabeprazole, inflammation of the kidneys may occur. Signs and symptoms may
include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever,
skin rash, and joint stiffness. You must report such signs to your doctor.
If you are unsure whether any of the conditions listed above may apply to you, consult your
doctor or pharmacist before taking Rabeprazolo Aurobindo Italia.
Children
Rabeprazolo Aurobindo Italia is not recommended for use in children.
If you have severe diarrhoea (watery or with blood) accompanied by symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazolo Aurobindo Italia and consult your doctor.
If you take a proton pump inhibitor such as Rabeprazolo Aurobindo Italia, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Other medicines and Rabeprazolo Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription or herbal products.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole or itraconazole – used to treat fungal infections. Rabeprazolo Aurobindo Italia may reduce the amount of these medicines in the blood. Your doctor may consider adjusting the dosage.
• Atazanavir – used to treat HIV infections. Rabeprazolo Aurobindo Italia may reduce the amount of this medicine in the blood and they should not be used together.
• Methotrexate (a chemotherapeutic agent used at high doses to treat tumours) – if you are taking a high dose of methotrexate, your doctor may temporarily discontinue your treatment with Rabeprazolo Aurobindo Italia.

If you are unsure whether any of the conditions listed above may apply to you, consult your
doctor or pharmacist before taking Rabeprazolo Aurobindo Italia.
Pregnancy, breastfeeding and fertility

• Do not use Rabeprazolo Aurobindo Italia if you are pregnant or think you may be pregnant.
• Do not use Rabeprazolo Aurobindo Italia if you are breastfeeding or planning to breastfeed. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and use of machines
While taking Rabeprazolo Aurobindo Italia, you may feel drowsy. If this occurs, do not drive and do not operate tools or machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Rabeprazole Aurobindo Italia

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take Rabeprazole Aurobindo Italia

• Remove the tablet from the blister pack just before taking it.
• Swallow the tablet whole with a glass of water. Do not chew or crush the tablets.
• Your doctor will inform you how many tablets to take and for how long. This will depend on your condition.
• If you are taking this medicine for a prolonged period, your doctor will monitor you regularly.

Adults and elderly patients
Gastroesophageal reflux disease (GERD)
Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 10 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• If symptoms recur after 4 weeks of treatment, your doctor may decide to continue treatment with 1 tablet of Rabeprazole Aurobindo Italia 10 mg for as long as necessary.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 20 mg once daily for 4–8 weeks.
• Take the tablet in the morning before breakfast.

Long-term treatment of symptoms (maintenance therapy for GERD)

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 10 mg or 20 mg once daily for the duration prescribed by your doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will want to review you regularly to assess your symptoms and dosage.

Treatment of stomach ulcer (peptic ulcer)

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 20 mg once daily for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another six weeks if your condition has not improved.

Treatment of intestinal ulcer (duodenal ulcer)

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 20 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another four weeks if your condition has not improved.

Treatment and prevention of ulcers caused by H. pylori infection

• The recommended dose is 1 tablet of Rabeprazole Aurobindo Italia 20 mg twice daily for seven days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin. For further information on other medicines used in the treatment of Helicobacter pylori infection, please refer to their respective package leaflets.

Treatment of Zollinger-Ellison syndrome (a condition in which the stomach produces very high amounts of acid)

• Treatment should be initiated with 3 tablets of Rabeprazole Aurobindo Italia 20 mg once daily.
• The dose may then be adjusted by your doctor according to your response to treatment. If you are on long-term treatment, you will need regular follow-up visits with your doctor to monitor symptoms and review dosage.

Patients with liver problems
You should consult your doctor, who will exercise particular caution when starting your treatment with Rabeprazole Aurobindo Italia and throughout the course of therapy.
If you take more Rabeprazole Aurobindo Italia than you should
If you take more Rabeprazole Aurobindo Italia than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Always bring the tablets or the packaging with you.
If you forget to take Rabeprazole Aurobindo Italia

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
• If you forget to take the medicine for more than 5 days, contact your doctor before taking it again.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Rabeprazole Aurobindo Italia
Symptom relief usually occurs before the ulcer is completely healed. It is important not to stop taking the tablets unless your doctor tells you to do so.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effects are generally mild in severity and resolve without stopping treatment.
Stop taking Rabeprazole Aurobindo Italia and contact your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden swelling of the face, shortness of breath or low blood pressure, which could lead to fainting or collapse.
• Frequent infections such as sore throat, fever, or mouth or throat ulcers.
• Easy bruising or bleeding. These side effects are rare (occur in fewer than 1 in 1,000 people).
• Severe blistering skin reactions or irritation or ulcers in the mouth or throat. These side effects are very rare (occur in fewer than 1 in 10,000 people).

Other possible side effects:
Common (occur in fewer than 1 in 10 people)

• Infections.
• Difficulty falling asleep.
• Headache or dizziness.
• Cough, cold, runny nose (rhinorrhea), sore throat (pharyngitis).
• Stomach or intestinal problems such as: abdominal pain, diarrhoea, flatulence, nausea, vomiting or constipation.
• Non-specific pain, back pain.
• Weakness, flu-like syndrome.
• Benign polyps in the stomach.

Uncommon (occur in fewer than 1 in 100 people)

• Nervousness or drowsiness.
• Lower respiratory tract infections (bronchitis).
• Blocked and painful nose (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness of the skin.
• Muscle, leg or joint pain.
• Fractures of the hip, wrist or spine.
• Bladder infections (urinary tract infections).
• Chest pain.
• Chills or fever.
• Liver problems (shown by blood tests).

Rare (occur in fewer than 1 in 1,000 people)

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Vision disorders.
• Inflammation of the mouth (stomatitis) or taste disturbances.
• Stomach disorders or stomach pain.
• Liver problems, including yellowing of the skin and whites of the eyes (jaundice).
• Itching and blistering rash.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells in the blood (shown by blood tests), which may lead to frequent infections.
• Reduced platelets in the blood, which may lead to bleeding or bruising more easily than normal.

Other possible side effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Low levels of sodium in the blood, which may cause tiredness, confusion, muscle spasms, seizures and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (a brain disorder).
• Erythema, possible joint pain.
• Inflammation of the intestine (causing diarrhoea). If you take Rabeprazole Aurobindo Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.

Do not be alarmed by this list of possible side effects. You may not experience any of them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rabeprazolo Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Blister: store below 25 °C. Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rabeprazolo Aurobindo Italia contains

• The active substance is sodium rabeprazole. Each tablet contains 10 mg (or 20 mg) of sodium rabeprazole.
• The other components are: tablet core: povidone, mannitol (E421), light magnesium oxide, low-substituted hydroxypropylcellulose, magnesium stearate; coating: ethylcellulose, light magnesium oxide; gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Description of the appearance of Rabeprazolo Aurobindo Italia and package contents

Rabeprazolo Aurobindo Italia 10 mg gastro-resistant tablets: biconvex, elliptical, pink, coated tablets.
Rabeprazolo Aurobindo Italia 20 mg gastro-resistant tablets: biconvex, elliptical, yellow, coated tablets.
10 mg pack: 14 tablets in blister packs.
20 mg packs: 14 and 28 tablets in blister packs.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
Coripharma ehf - Reykjavikurvegur 78 - Hafnarfjörður, Is-220 (Iceland)

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Rabeprazolo Aurobindo Italia