RABEPRAZOLO 10 mg Enteric-Coated Tablets

Зміст інструкції

1. Rabeprazolo Aurobindo Italia 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is Rabeprazolo Aurobindo Italia 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

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

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Rabeprazolo Aurobindo Italia and what it is used for

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

• “Gastroesophageal Reflux Disease” (GERD), which can include heartburn. Gastroesophageal reflux disease occurs when acid and food pass from the stomach into the esophagus.
• Stomach or upper intestinal ulcer. If these ulcers are infected by a bacterium called Helicobacter pylori( H. pylori) you will also be prescribed antibiotics. The use of Rabeprazolo Aurobindo Italia tablets together with antibiotics allows the elimination of the infection and the healing of the ulcer. Furthermore, the therapy blocks the infection and ensures that the ulcer does not recur.
• Zollinger-Ellison syndrome, when the stomach produces an extremely high amount 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 rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are or think you might 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, ask 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 substitutes”.
• If you have problems with your liver or blood; these problems have occurred in some patients and resolved with discontinuation of treatment with Rabeprazolo Aurobindo Italia.
• If you have been diagnosed with a stomach tumor.
• If you have had liver disease.
• If you are taking atazanavir, for HIV infections.
• If you have reduced body stores or risk factors that reduce the absorption of vitamin B12 and are receiving long-term treatment with rabeprazole sodium. Like all other acid-reducing agents, rabeprazole sodium can 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 acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop therapy with Rabeprazolo Aurobindo Italia. Remember to also report any other side effects such as joint pain.
• If you are to undergo a specific blood test (chromogranin A).

During the intake of 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,
rash and joint stiffness. You should report these signs to your doctor.
If you are unsure whether any of the above conditions may also apply to you, ask your
doctor or pharmacist before taking Rabeprazolo Aurobindo Italia.

Children
Rabeprazolo Aurobindo Italia is not recommended in children.
If you have severe diarrhea (watery or with blood) with symptoms such as fever, pain or abdominal tenderness,
stop taking Rabeprazolo Aurobindo Italia and see a doctor.
If you are taking a proton pump inhibitor such as Rabeprazolo Aurobindo Italia, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or
spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of
osteoporosis), consult your doctor.

Other medicines and Rabeprazolo Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription or herbal products.
In particular, tell 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 decrease 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 decrease the amount of this medicine in the blood and they should not be used together.
• Methotrexate (a chemotherapeutic medicine used at high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Rabeprazolo Aurobindo Italia.

If you are unsure whether any of the above conditions may also apply to you, ask 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 might be.
• Do not use Rabeprazolo Aurobindo Italia if you are breastfeeding or planning to breastfeed. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
While taking Rabeprazolo Aurobindo Italia you may feel drowsy. If this happens, do not
drive and do not use 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 Rabeprazolo Aurobindo Italia

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

Taking Rabeprazolo Aurobindo Italia

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

Adults and the elderly
“Gastroesophageal Reflux Disease” (GERD)
Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 10 mg once a day 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 Rabeprazolo Aurobindo Italia 10 mg for as long as they deem necessary.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 20 mg once a day for 4-8 weeks.
• Take the tablet in the morning before breakfast.

Long-term treatment of symptoms (GERD maintenance therapy)

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 10 mg or 20 mg once a day for the time indicated by your doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will want to review you at regular intervals to assess symptoms and dosage.

Treatment of stomach ulcer (peptic ulcer)

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 20 mg once a day for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue treatment for another six weeks if your condition does not improve.

Treatment of duodenal ulcer

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 20 mg once a day for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue treatment for another four weeks if your condition does not improve.

Treatment and prevention of ulcers caused by H. Pylori infections

• The recommended dose is 1 tablet of Rabeprazolo Aurobindo Italia 20 mg twice a day for seven days.
• Your doctor will prescribe you to also take antibiotics called amoxicillin and clarithromycin. For further information on the other medicines used in the treatment of Helicobacter pyloriinfection, please read the relevant package leaflets.

Treatment of Zollinger-Ellison Syndrome, a condition in which the stomach produces a very high amount of acid

• It is recommended to start treatment with 3 tablets of Rabeprazolo Aurobindo Italia 20 mg once a day.
• The dose may subsequently be adjusted by your doctor based on your response to treatment. If you are undergoing long-term treatment, you will need to see your doctor at regular intervals to monitor symptoms and review the dose.

Patients with liver problems
You should consult your doctor who will pay particular attention at the beginning of your treatment with Rabeprazolo
Aurobindo Italia and throughout the therapy.

If you take more Rabeprazolo Aurobindo Italia than you should
If you should take more Rabeprazolo Aurobindo Italia than has been prescribed for you, consult your doctor or
the emergency room of the nearest hospital. Always bring the tablets or the package with you.

If you forget to take Rabeprazolo Aurobindo Italia

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

If you stop taking Rabeprazolo Aurobindo Italia
Relief of symptoms usually occurs normally before the ulcer is completely healed. It is
important not to stop taking the tablets until your doctor tells you to. 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 everyone gets them.
Side effects are generally mild and resolve without stopping treatment with the
medicine.

Stop treatment with Rabeprazolo Aurobindo Italia and immediately consult your doctor if
you notice the appearance of any of the side effects listed below – you may need
urgent medical treatment:

• Allergic reactions - signs may include: sudden swelling of the face, shortness of breath or low blood pressure, which may cause fainting or collapse.
• Frequent infections such as sore throat or fever or ulcers in the mouth or throat.
• Bruising or bleeding that occurs easily. These side effects are rare (occurring in less than 1 in 1,000 people).
• Severe blistering skin reactions or irritation or ulcers in the mouth and throat. These side effects are very rare (occurring in less than 1 in 10,000 people).

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

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, cold, runny nose (“nasal drip”), sore throat (pharyngitis).
• Effects on the stomach or intestines such as: abdominal pain, diarrhea, flatulence, nausea, vomiting or constipation.
• Non-specific pain, back pain.
• Weakness, flu-like syndrome.
• Benign polyps in the stomach.

Uncommon (occur in less than 1 in 100 people)

• Nervousness or drowsiness.
• Lower airway 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 and spine.
• Bladder infections (urinary tract infections).
• Chest pain.
• Chills or fever.
• Liver disorders (highlighted by blood tests).

Rare (occur in less 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).
• Itchy skin and blistering.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells in the blood (highlighted by blood tests) that can lead to frequent infections.
• Reduced platelets in the blood that can lead to bleeding or bruising more easily than normal.

Other possible side effects (frequency not known)

• Breast enlargement in men.
• Fluid retention.
• Low levels of sodium in the blood which can lead to fatigue, confusion, muscle spasms, convulsions and coma.
• Patients who have had previous liver problems may, very rarely, develop encephalopathy (brain disease).
• Erythema, possible joint pain.
• Inflammation of the intestine (causing diarrhea). If you take Rabeprazolo Aurobindo Italia for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to reduced levels of potassium or calcium in the blood. The doctor should decide whether to check blood magnesium levels periodically.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Blisters: store at a temperature below 25 °C. Keep in the original package to protect the
medicine 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 the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rabeprazolo Aurobindo Italia contains

• The active ingredient is rabeprazole sodium. Each tablet contains 10 mg (or 20 mg) of rabeprazole sodium.
• The other ingredients 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 contents of the pack
Rabeprazolo Aurobindo Italia 10 mg gastro-resistant tablets: biconvex, elliptical, pink, coated tablet.
Rabeprazolo Aurobindo Italia 20 mg gastro-resistant tablets: biconvex, elliptical, yellow, coated tablet.

Pack of 10 mg:14 tablets in blisters.

Packs of 20 mg:14 and 28 tablets in blisters.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
Italy Rabeprazolo Aurobindo Italia