RABEPRAZOLO 10 mg Enteric-Coated Tablet

Зміст інструкції

1. RABEPRAZOLO ALTER 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is RABEPRAZOLO ALTER and what it is used for
   2. What you need to know before taking RABEPRAZOLO ALTER
   3. How to take RABEPRAZOLO ALTER
   4. Possible side effects
   5. How to store RABEPRAZOLO ALTER
   6. Contents of the pack and other information

RABEPRAZOLO ALTER 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Rabeprazole sodium

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RABEPRAZOLO ALTER and what it is used for

RABEPRAZOLO ALTER contains the active ingredient rabeprazole sodium. This active ingredient belongs
to a class of medicines called Proton Pump Inhibitors (PPIs). They work by decreasing the amount of
acid that your stomach produces.
RABEPRAZOLO ALTER is 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. RABEPRAZOLO ALTER can also be used as long-term (maintenance) treatment of GERD and for the symptomatic treatment of moderate to very severe GERD (symptomatic GERD);
• Stomach ulcer or ulcer of the upper part of the intestine. If these ulcers are infected by a bacterium called Helicobacter pylori(H. Pylori) you will also be prescribed antibiotics. The use of rabeprazole tablets together with antibiotics allows the elimination of the infection and the healing of the ulcer. Furthermore, the therapy helps to block 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 ALTER

Do not take RABEPRAZOLO ALTER

• if you are allergic 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 rabeprazole if any of the above conditions apply to you. If you have any doubts, ask your doctor or pharmacist before taking Rabeprazolo Alter.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you need to undergo a specific blood test (Chromogranin A);
• if you are allergic to other proton pump inhibitors or “imidazole substitutes”;
• if you have problems with your liver or blood; such problems have occurred in some patients and resolved with discontinuation of treatment;
• if you have been diagnosed with or suspect a tumor of the stomach or esophagus;
• if you have or have had liver disease, you should inform your doctor. The doctor may check your liver function more often;
• if you are taking atazanavir, a medicine used to treat HIV (see section “Other medicines and RABEPRAZOLO ALTER”);
• If you have reduced body stores or risk factors that reduce the absorption of vitamin B12 and are receiving long-term treatment with Rabeprazolo Alter. Like all other acid-reducing agents, rabeprazole sodium can lead to reduced absorption of vitamin B12.
• if you suffer from severe diarrhea as this may increase the risk of gastrointestinal infections. In this case, stop taking RABEPRAZOLO ALTER.
• if you have ever had a skin reaction after treatment with a medicine similar to RABEPRAZOLO ALTER that reduces stomach 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 ALTER. Remember to also report any other undesirable effects such as joint pain.

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 apply to you, ask your doctor or pharmacist before taking RABEPRAZOLO ALTER.
If you are undergoing long-term treatment (over one year), you should consult your doctor at regular intervals.
For intakes longer than three months, there may be a decrease in blood magnesium levels with consequent fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. The doctor should decide whether to periodically check magnesium levels in the blood.
For intakes longer than one year, this medicine may cause a slight increase in the risk of fractures of the hip, wrist and spine, especially if you are elderly or have other known risk factors.

Children
The use of RABEPRAZOLO ALTER 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 ALTER and consult your doctor.
If you are taking a proton pump inhibitor such as RABEPRAZOLO ALTER, 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 ALTER
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 ALTER may decrease the amount of these medicines in the blood. Your doctor may consider adjusting the dosage.
• Atazanavir, used to treat HIV infections. RABEPRAZOLO ALTER 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 tumors) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with RABEPRAZOLO ALTER.

If you are unsure whether any of the above conditions may apply to you, ask your doctor or pharmacist before taking RABEPRAZOLO ALTER.

Pregnancy, breastfeeding and fertility

• Do not use RABEPRAZOLO ALTER if you are pregnant or think you might be.
• Do not use RABEPRAZOLO ALTER if you are breastfeeding or planning to breastfeed.

If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
While taking RABEPRAZOLO ALTER you may feel drowsy. If this happens, do not drive vehicles and do not use tools or machinery.

RABEPRAZOLO ALTER contains mannitol
This medicine contains mannitol which can have a mild laxative effect.

3. How to take RABEPRAZOLO ALTER

Always take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
The dose and duration of therapy will be adjusted by the doctor based on your health conditions.
If you are taking the medicine for a prolonged period of time, your doctor will need to monitor you.

Taking RABEPRAZOLO ALTER

• 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 Elderly
“Gastroesophageal Reflux Disease” (GERD)
Treatment of moderate to very severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of 10 mg once a day for four weeks.
• Take the tablet in the morning before breakfast.
• If symptoms recur after 4 weeks of treatment, the doctor may decide to continue treatment with 1 tablet of RABEPRAZOLO ALTER 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 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 10 mg or 20 mg once a day, for the time indicated by the doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will want to review you at regular intervals to check your symptoms and dosage.

Treatment of stomach ulcer (peptic ulcer)

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

Treatment of duodenal ulcer

• The recommended dose is 1 tablet of 20 mg once a day for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuing 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 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 Helicobacterpyloriinfection, please refer to their respective 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 ALTER 20 mg once a day.
• The dose may then be adjusted by the 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 check your symptoms and review the dose.

Use in children
The medicine should not be used in children.

Patients with liver problems
You should consult your doctor who will take particular care at the beginning of treatment with
RABEPRAZOLO ALTER and throughout the therapy.

If you take more RABEPRAZOLO ALTER than you should
If you should take more tablets than you have been prescribed, 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 ALTER

• Do not take a double dose (two doses at the same time) to make up for the missed tablet.
• If you forget to take a dose, take it as soon as you remember. However, if it is already time to take the next dose, skip the missed 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.

If you stop taking RABEPRAZOLO ALTER
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 doubts 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 gets them.
Side effects are generally mild or moderate and resolve without stopping the
medicine.
Stop treatment with RABEPRAZOLO ALTER and immediately consult your doctor if you notice the
appearance of any of the side effects listed below, as you may need
urgent 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 with These side effects are rare (affecting less than 1 in 1,000 people).

Severe blistering of the skin or irritation or ulcers in the mouth and throat These side effects are
very rare (affecting less than 1 in 10,000 people).
Other possible side effects:

Common(affecting less than 1 in 10 people)

• Infections;
• Difficulty sleeping;
• Headache or dizziness;
• Cough, cold, runny nose (“nasal discharge”), 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(affecting 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;
• Muscle, leg or joint pain;
• Fractures of the hip, wrist or spine;
• Bladder infections (urinary tract infections);
• Chest pain;
• Chills or fever;
• Liver disorders (highlighted by blood tests).

Rare(affecting less than 1 in 1000 people)

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

Not known(frequency cannot be estimated from available data)

• Breast enlargement in men;
• Fluid retention;
• Low levels of sodium in the blood which can lead to fatigue, confusion, muscle spasms, convulsions and coma;
• Erythema, possible joint pain;
• Patients who have had previous liver problems may, very rarely, develop encephalopathy (brain disease);
• Inflammation of the intestine (causing diarrhea).

If you take RABEPRAZOLO ALTER 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 a decrease in blood levels of potassium or calcium. The doctor should decide whether to check
magnesium levels in the blood 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 https://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store RABEPRAZOLO ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not refrigerate.
Medicines should not be disposed of via 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 ALTER contains
RABEPRAZOLO ALTER10 mg gastro-resistant tablets

• The active ingredient is sodium rabeprazole. Each tablet contains 10 mg of sodium rabeprazole.
• The other ingredients are: mannitol, trisodium phosphate, magnesium oxide, low substituted hydroxypropylcellulose LH-11, hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Areosil 200).
• The coating components are: ethylcellulose, magnesium oxide, Eudragit L100 55, triethyl citrate, talc, titanium dioxide (E171), red iron oxide (E172). RABEPRAZOLO ALTER20 mg gastro-resistant tablets
• The active ingredient is sodium rabeprazole. Each tablet contains 20 mg of sodium rabeprazole.
• The other ingredients are mannitol, trisodium phosphate, magnesium oxide, low substituted hydroxypropylcellulose LH-11, hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Areosil 200).
• The coating components are: ethylcellulose, magnesium oxide, Eudragit L100 55, triethyl citrate, talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of RABEPRAZOLO ALTER and contents of the pack
RABEPRAZOLO ALTER 10 mg gastro-resistant tablets is a pink, biconvex tablet.
RABEPRAZOLO ALTER 20 mg gastro-resistant tablets is a yellow, biconvex tablet.
Each pack contains a blister of 7, 14, 28, 30 tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi 7,
20144, Milan

Manufacturer
Laboratorios Alter S.A.
C/Mateo Inurria, 30, 28036
Madrid (Spain)