RABEPRAZOLO 10 mg Enteric-Coated Tablet

Содержание инструкции

1. Rabeprazolo Sandoz 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is Rabeprazolo Sandoz and what it is used for
   2. What you need to know before taking Rabeprazolo Sandoz
   3. How to take Rabeprazolo Sandoz
   4. Possible side effects
   5. How to store Rabeprazolo Sandoz
   6. Package Contents and Other Information

Rabeprazolo Sandoz 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start using 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 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 Sandoz is and what it is used for
• 2. What you need to know before you take Rabeprazolo Sandoz
• 3. How to take Rabeprazolo Sandoz
• 4. Possible side effects
• 5. How to store Rabeprazolo Sandoz
• 6. Contents of the pack and other information

1. What is Rabeprazolo Sandoz and what it is used for

Rabeprazolo belongs to a group of medicines called “proton pump inhibitors”.
These medicines reduce the production of acid in the stomach.
Rabeprazolo Sandoz is used in adults for:

• the treatment of ulcers in the intestine (a condition also called duodenal ulcer)
• the treatment of ulcers in the stomach (a condition also called benign gastric ulcer)
• relieving the symptoms of heartburn caused by erosive or ulcerative gastroesophageal reflux disease (GERD), also called reflux esophagitis
• the long-term treatment of GERD, to prevent recurrence
• relieving the symptoms of moderate to very severe GERD (symptomatic GERD), such as heartburn and acid regurgitation
• the treatment of a marked increase in acid secretion in the stomach (Zollinger-Ellison syndrome)
• the treatment of infections caused by bacteria called Helicobacter pylori( H. pylori), when administered in combination with antibiotic therapy.

2. What you need to know before taking Rabeprazolo Sandoz

Do not take Rabeprazolo Sandoz if

• you are allergic to rabeprazole or any of the other ingredients of this medicine (listed in section 6)
• you are pregnant or think you might be

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• you are breastfeeding. Do not take Rabeprazolo Sandoz if any of the above conditions apply to you. If you have any doubts, ask your doctor or pharmacist before taking Rabeprazolo Sandoz.

Warnings and precautions
Tell your doctor or pharmacist before taking Rabeprazolo Sandoz:

• if you are allergic to other proton pump inhibitors or “imidazole substitutes”
• if you have a stomach tumor
• if you are undergoing long-term treatment (over one year), you should consult your doctor at regular intervals
• if you suffer from or have suffered from liver disorders in the past, you must inform your doctor. The doctor may check your liver function more often
• taking these tablets is not recommended if you are taking atazanavir (a medicine used to treat HIV) at the same time (see section 2).
• if you have reduced body reserves 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 are going to undergo a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazolo Sandoz that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop therapy with Rabeprazolo Sandoz. Remember to also report any other undesirable effects such as joint pain. If you have severe diarrhea (watery or with blood) with symptoms such as fever, pain or abdominal tenderness, stop taking Rabeprazolo Sandoz and contact your doctor.

If you are taking a proton pump inhibitor such as Rabeprazolo Sandoz, especially for a
period longer than one year, there may be a slight increase in the risk of fracture
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.

Children
Rabeprazolo Sandoz should not be used in children.

Other medicines and Rabeprazolo Sandoz
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
Consult your doctor before taking these tablets if you are already taking:

• ketoconazole or itraconazole (medicines used to treat fungal infections): a dose adjustment may be necessary
• atazanavir (a medicine used to treat HIV). Rabeprazolo Sandoz may decrease the amount of this type of medicine in the blood and they should not be used together.
• methotrexate (a chemotherapeutic medicine used at high doses for cancer treatment)
• if you are taking high doses of methotrexate, your doctor may temporarily suspend your treatment with Rabeprazolo Sandoz

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take these tablets if you are pregnant or breastfeeding.

Driving and using machines
Generally Rabeprazolo Sandoz does not impair the ability to drive vehicles and use machines.
However, this medicine may cause drowsiness in some patients. If you experience this
side effect, you should not drive or operate machinery.

Rabeprazolo Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet,
i.e. essentially ‘sodium-free’.

3. How to take Rabeprazolo Sandoz

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
If you are taking Rabeprazolo Sandoz once a day, take the tablet before
breakfast, in the morning.
Swallow the tablets whole. Do not crush or chew the tablets.

Ulcers in the intestine (duodenal ulcer)
The usual dose is 20 mg once a day, in the morning, for 4 weeks. The doctor may
decide to extend the treatment for another 4 weeks.

Ulcers in the stomach
The usual dose is 20 mg once a day, in the morning, for 6 weeks. The doctor may
decide to extend the treatment for another 6 weeks.

Erosive or ulcerative gastroesophageal reflux disease (GERD)
The usual dose is 20 mg once a day for 4-8 weeks.

Long-term treatment of gastroesophageal reflux disease (GERD)
The usual maintenance dose is 10 mg or 20 mg once a day. If you are undergoing
long-term treatment, you should consult your doctor at regular intervals for review of dosage and
symptoms.

Relief of symptoms of gastroesophageal reflux disease (GERD) from moderate to very
severe
The usual dose is 10 mg once a day for 4 weeks.
If symptoms do not resolve within 4 weeks, consult your doctor. After these first four
weeks of treatment, if symptoms recur, your doctor may prescribe you a
10 mg tablet as needed, to control these symptoms.
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Severe increase in stomach acid secretion (Zollinger-Ellison syndrome)
The usual initial dose is 60 mg once a day. The dose may then be adjusted by
the doctor depending on your response to treatment. Doses up to 60 mg
twice a day may be prescribed to you. Your doctor will tell you how many tablets to take, when to take them, and for how
long to take them.

Treatment of infections caused byH. pyloriwhen administered in combination with
antibiotic therapy
The usual dose is 20 mg twice a day, in combination with two antibiotics. The
recommended combination is:
Rabeprazolo Sandoz 20 mg + clarithromycin 500 mg + amoxicillin 1 g, taken together twice a
day for 7 days.

Hepatic and renal impairment
No dose adjustment is necessary.

Use in children
These tablets should not be given to children.

If you take more Rabeprazolo Sandoz than you should
If you accidentally take a quantity of medicine greater than that prescribed to you,
contact your doctor or go to the nearest hospital emergency room. Bring this leaflet
with you, the remaining tablets and the outer packaging, so that the doctor or healthcare
staff know which medicine you have taken.

If you forget to take Rabeprazolo Sandoz
It is important to take the medicine every day, as regular treatment is more effective. If
however you forget to take one or more doses, take another as soon as you remember and then
continue according to the prescription. Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

If you stop taking Rabeprazolo Sandoz
Symptom relief usually occurs before the ulcer is completely healed. It
is important not to stop taking the tablets until your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
If you notice any of the following serious side effects, you should contact your doctor immediately
(this could be an allergic reaction).

Rare serious side effects(may affect up to 1 in 1,000 people)

• swelling of the face, lips, tongue and throat, which can cause difficulty breathing, speaking or swallowing, sudden drop in blood pressure, paleness, fainting or collapse.

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Very rare serious side effects(may affect up to 1 in 10,000 people)

• blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal cavities or genitals (Stevens-Johnson syndrome) or peeling of the skin (toxic epidermal necrolysis).

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

• headache, dizziness
• inability to sleep
• cough, sore throat, runny nose and nasal congestion
• diarrhea, vomiting, nausea, stomach pain, constipation, flatulence
• non-specific pain, back pain
• infection
• weakness, flu-like illness
• benign polyps in the stomach

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

• nervousness, drowsiness
• cough with phlegm, chest pain and fever
• feeling of pressure or pain in the cheeks and forehead
• indigestion, dry mouth, belching
• skin rash, skin redness
• muscle pain, leg cramps, joint pain
• urinary tract infection
• chest pain, chills, fever
• increased liver enzymes
• fracture of the hip, wrist or spine

Rare side effects(may affect up to 1 in 1,000 people) are:

• blood disorders, which can cause frequent infections or a greater tendency to bleeding and bruising or fatigue
• loss of appetite (anorexia)
• vision disorders
• gastritis, which may cause stomach pain and nausea
• pain in the oral cavity
• altered taste
• liver disease (hepatitis), which can cause yellowing of the skin or whites of the eyes (jaundice)
• liver failure, which causes brain damage in patients who have previously suffered from liver disorders
• itching and blistering of the skin: these usually disappear when treatment is stopped
• sweating
• kidney problems, which may cause an increase or decrease in urination
• weight gain
• depression
• Hypersensitivity (including allergic reactions)

Frequency not known(frequency cannot be estimated from the available data)
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• low levels of sodium in the blood
• low levels of magnesium in the blood
• confusion
• enlargement of the breasts in men
• swelling of ankles, feet or fingers
• erythema, possible joint pain
• Inflammation of the intestine (causing diarrhea) If you take Rabeprazolo Sandoz for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to reduced blood levels of potassium or calcium. The doctor should decide whether to periodically check magnesium levels in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://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 Sandoz

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 blister pack and
on the outer packaging, after the wording Exp. The expiry date refers to the last day
of that month.
Do not store at a temperature above 25°C. Store in the original packaging to
protect the medicine from moisture.
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. Package Contents and Other Information

What Rabeprazolo Sandoz contains
The active ingredient is rabeprazole sodium.
Each 10 mg gastro-resistant tablet contains 10 mg of rabeprazole sodium.
Each 20 mg gastro-resistant tablet contains 20 mg of rabeprazole sodium.
The other ingredients are:
Core: calcium hydroxide, mannitol, low substituted hydroxypropylcellulose and sodium stearyl
fumarate.
Coating 1: hypromellose, talc.
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Gastro-resistant coating 2 (10 mg): hypromellose phthalate, dibutyl sebacate, iron oxide
yellow (E172), iron oxide red (E172) and titanium dioxide (E171).
Gastro-resistant coating 2 (20 mg): hypromellose phthalate, dibutyl sebacate, iron oxide
yellow (E172) and titanium dioxide (E171).

Description of the appearance of Rabeprazolo Sandoz and package contents
Rabeprazolo Sandoz 10 mg is presented as pink, round,
biconvex gastro-resistant tablets, film-coated.
Rabeprazolo Sandoz 20 mg is presented as yellow, round,
biconvex gastro-resistant tablets, film-coated.
Al/Al blisters with desiccant: 7, 10, 14, 20, 28, 30, 56, 60 and 98 gastro-resistant tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A.,Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals d.d., Verovskova 57, SI-1526, Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Rabeprazol Hexal 10 mg - magensaftresistente Tabletten
Rabeprazol Hexal 20 mg - magensaftresistente Tabletten
Ireland Rabeprazole 10 mg gastro-resistant tablets
Rabeprazole 20 mg gastro-resistant tablets
Italy RABEPRAZOLO Sandoz 10 mg gastro-resistant tablets
RABEPRAZOLO Sandoz 20 mg gastro-resistant tablets
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