Rabeprazole Alter

Package leaflet: Information for the patient

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

Sodium rabeprazole
Please read all of 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

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

RABEPRAZOLO ALTER contains the active substance sodium rabeprazole. 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 ALTER is used to treat the following conditions:

• Gastroesophageal reflux disease (GERD), which may include heartburn. Gastroesophageal reflux disease occurs when acid and food flow back from the stomach into the esophagus. RABEPRAZOLO ALTER can also be used for long-term treatment (maintenance) of GERD and for the symptomatic treatment of moderate to severe GERD (symptomatic GERD);
• Stomach or duodenal ulcer. If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), you will also be prescribed antibiotics. Taking rabeprazole tablets together with antibiotics helps eliminate the infection and heal the ulcer. In addition, this treatment prevents recurrence of the infection and helps prevent the ulcer from returning;
• Zollinger-Ellison syndrome, a condition in which the stomach produces extremely high amounts of acid.

2. What you should know before taking RABEPRAZOLO ALTER

Do not take RABEPRAZOLO ALTER

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

Do not take rabeprazole if any of the conditions above apply to you. If you have any doubts, consult your doctor or pharmacist before taking RABEPRAZOLO ALTER.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you are due to have a specific blood test (chromogranin A);
• 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;
• if you have been diagnosed with or suspected of having a stomach or oesophageal tumour;
• if you have or have had liver disease, you must inform your doctor. Your doctor may monitor your liver function more frequently;
• if you are taking atazanavir, a medicine used to treat HIV (see section "Other medicines and RABEPRAZOLO ALTER");
• if you have low body stores or risk factors that reduce vitamin B12 absorption and are receiving long-term treatment with RABEPRAZOLO ALTER. Like all other agents that reduce stomach acid, sodium rabeprazole may lead to reduced absorption of vitamin B12.
• if you suffer from severe diarrhoea, as this may increase the risk of gastrointestinal infections. In this case, discontinue use of RABEPRAZOLO ALTER.
• if you have ever had a skin reaction after treatment with a medicine similar to RABEPRAZOLO ALTER that reduces gastric acidity.
• if you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with RABEPRAZOLO ALTER may need to be discontinued. Remember to also report any other adverse effects such as joint pain.

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 ALTER.

If you are on long-term treatment (over one year), you should consult your doctor regularly.

For treatment lasting longer than three months, magnesium levels in the blood may decrease, leading to fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Your doctor should consider periodic monitoring of blood magnesium levels.

With treatment lasting longer than one year, this medicine may slightly increase the risk of fractures of the hip, wrist, or spine, especially in elderly patients or those with other known risk factors.

Children

The use of RABEPRAZOLO ALTER is not recommended in children.

If you develop severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking RABEPRAZOLO ALTER and consult your doctor.

If you are taking a proton pump inhibitor such as RABEPRAZOLO ALTER, 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 ALTER

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 ALTER may reduce the amount of these medicines in the blood. Your doctor may need to adjust the dosage.
• Atazanavir, used to treat HIV infections. RABEPRAZOLO ALTER 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 ALTER.

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

Pregnancy, breastfeeding and fertility

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

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

Driving and use of machines

During treatment with RABEPRAZOLO ALTER, you may feel drowsy. If this occurs, do not drive or operate tools or machinery.

RABEPRAZOLO ALTER contains mannitol

This medicine contains mannitol, which may have a mild laxative effect.

3. How to take RABEPRAZOLE ALTER

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment will be determined by your doctor according to your medical condition.
If you are taking this medicine for a prolonged period, your doctor should monitor you regularly.

Taking RABEPRAZOLE ALTER

• 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 should monitor you regularly.

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

• The recommended dose is 1 tablet of 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 ALTER 10 mg for as long as considered necessary.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is 1 tablet of 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 10 mg or 20 mg once daily, for the duration indicated by your doctor.
• Take the tablet in the morning before breakfast.
• Your doctor should review you regularly to assess your symptoms and dosage.

Treatment of stomach ulcer (peptic ulcer)

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

Treatment of intestinal ulcer (duodenal ulcer)

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

Treatment and prevention of ulcers caused by Helicobacter pylori infection

• The recommended dose is 1 tablet of 20 mg twice daily for seven days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin.
• For further information on the 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

• It is recommended to start treatment with 3 tablets of RABEPRAZOLE ALTER 20 mg once daily.
• The dose may subsequently be adjusted by your doctor according to your response to treatment.
• If you are on long-term treatment, you should see your doctor regularly to monitor symptoms and review the dose.

Use in children
This medicine must not be used in children.

Patients with liver problems
You must consult your doctor, who will exercise particular caution when starting treatment with RABEPRAZOLE ALTER and throughout the course of therapy.

If you take more RABEPRAZOLE ALTER than you should
If you take more tablets than prescribed, consult your doctor or go to the nearest hospital Emergency Department. Always bring the tablets or the pack with you.

If you forget to take RABEPRAZOLE ALTER

• Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.
• 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.

If you stop taking RABEPRAZOLE ALTER
Relief from symptoms 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 doubts about how to use this medicine, consult 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 or moderate in severity and resolve without discontinuing the medicine.
Stop treatment with RABEPRAZOLO ALTER and contact your doctor immediately if you notice any of the following side effects; you may require urgent 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 or fever, or mouth or throat ulcers; bruising or bleeding occurring easily.
  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 and 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 burping;
• 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 disorders (detected by blood tests).

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

• Loss of appetite (anorexia);
• Depression;
• Hypersensitivity (including allergic reactions);
• Vision disorders;
• Mouth inflammation (stomatitis) or taste disturbances;
• Stomach disorders or stomach pain;
• Liver problems including yellowing of the skin and whites of the eyes (jaundice);
• Itching and blister formation;
• Sweating;
• Kidney problems;
• Weight gain;
• Changes in white blood cells (detected by blood tests) which may lead to frequent infections;
• Reduced platelet count in the blood which may lead to bleeding or bruising more easily than normal.

Not known (frequency cannot be estimated from available data)

• Breast swelling in men;
• Fluid retention;
• Low sodium levels in the blood which may lead to tiredness, confusion, muscle spasms, seizures and coma;
• Erythema, possible joint pain;
• Patients with previous liver problems may very rarely develop encephalopathy (brain disease);
• Inflammation of the intestine (causing diarrhoea).

If you take RABEPRAZOLO ALTER for more than three months, your blood magnesium levels may decrease.
Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 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 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 RABEPRAZOLE ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not refrigerate.
Medicines must 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. Package contents and other information

What RABEPRAZOLO ALTER contains
RABEPRAZOLO ALTER 10 mg gastro-resistant tablets

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

RABEPRAZOLO ALTER 20 mg gastro-resistant tablets

• The active substance is sodium rabeprazole. Each tablet contains 20 mg of sodium rabeprazole.
• The other components are: mannitol, trisodium phosphate, magnesium oxide, low-substituted hydroxypropylcellulose LH-11, hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Areosil 200).
• Coating components: 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 are pink, biconvex tablets.
RABEPRAZOLO ALTER 20 mg gastro-resistant tablets are yellow, biconvex tablets.
Each pack contains a blister of 7, 14, 28, or 30 tablets.

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

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