Rabeprazole Krka

Package leaflet: Information for the user

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

Sodium rabeprazole
Equivalent medicine
Read this entire 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. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rabeprazole Krka is and what it is used for

Rabeprazole Krka tablets contain rabeprazole, which belongs to a class of medicines called proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.
Rabeprazole Krka tablets are used for:

• active duodenal ulcer or active benign gastric ulcer/stomach ulcer (peptic ulcers),
• erosive or ulcerative gastro-esophageal reflux disease (GORD), commonly known as acid-induced inflammation of the oesophagus associated with heartburn, or for long-term treatment of GORD (maintenance of GORD),
• symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GORD), also associated with heartburn,
• Zollinger-Ellison syndrome, a rare condition in patients whose stomach produces extremely high amounts of acid.
• in combination with two antibiotics (clarithromycin and amoxicillin), Rabeprazole Krka tablets are used to eradicate H. pylori infection in patients with peptic ulcer.

2. What you need to know before taking Rabeprazolo Krka

Do not take Rabeprazolo Krka

• if you are allergic (hypersensitive) to sodium rabeprazole or to any of the excipients of this medicine (listed in section 6),
• if you are pregnant, think you might be pregnant, or are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazolo Krka
Inform your doctor or pharmacist:

• if you are allergic to other proton pump inhibitors,
• if you have been told you have a stomach tumour,
• if you have previously had liver disease,
• if you are taking atazanavir (a medicine used to treat HIV),
• if you have low body reserves or risk factors for vitamin B12 deficiency and are receiving long-term treatment with sodium rabeprazole. As with all anti-acid agents, 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 Krka that reduces stomach acidity,
• if you need to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Rabeprazolo Krka.
Remember to also report any other adverse effects such as joint pain.
If you have been taking this medicine for a long time, your doctor may want to carry out regular check-ups.
In some patients, blood and liver problems have been observed, although these usually improve when treatment with rabeprazole is stopped.
If you develop severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazolo Krka and contact your doctor immediately.
Taking a proton pump inhibitor such as Rabeprazolo Krka, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

Children and adolescents
Rabeprazolo Krka must not be used in children.

Other medicines and Rabeprazolo Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist:

• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections). Rabeprazolo Krka may reduce blood levels of these medicines. Your doctor may need to adjust the dose.
• if you are taking atazanavir (a medicine used to treat HIV). Rabeprazolo Krka may reduce blood levels of this medicine and they should not be used together.
• if you are taking methotrexate (a chemotherapeutic agent used in high doses to treat cancer). If you are receiving high doses of methotrexate, your doctor may temporarily discontinue treatment with Rabeprazolo Krka. If you are unsure whether you are undergoing any of the above treatments, contact your doctor or pharmacist before using Rabeprazolo Krka.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rabeprazolo Krka tablets if you are pregnant or think you might be pregnant.
Do not take Rabeprazolo Krka tablets if you are breastfeeding or planning to breastfeed.

Driving and using machines
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While taking Rabeprazolo Krka, you may feel drowsy. If this occurs, do not drive or operate tools or machinery.

3. How to take Rabeprazole Krka

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
YOU MUST SWALLOW RABEPRAZOLE KRKA TABLETS WHOLE. DO NOT
CRUSH OR CHEW THEM.
The following doses are those usually recommended for adults and elderly patients. Do not change the dose or
duration of treatment on your own.
Use in children
Rabeprazole Krka must not be used in children.
Active duodenal ulcer or active benign gastric ulcer
The usual dose is one 20 mg Rabeprazole Krka tablet once daily.
If you have an active duodenal ulcer, your treatment is expected to last for 4 weeks; however, after this
period your doctor may decide to continue treatment for another 4 weeks.
If you have an active benign gastric ulcer, your treatment is expected to last for 6 weeks; however, after
this period your doctor may decide to continue treatment for another 6 weeks.
Ulcerative or erosive gastro-oesophageal reflux disease (GORD)
The usual dose is one 20 mg Rabeprazole Krka tablet once daily. Your treatment is expected to last for 4 weeks;
however, after this period your doctor may decide to continue treatment for another 4 weeks.
Maintenance of GORD
The usual dose is one 10 mg or 20 mg Rabeprazole Krka tablet once daily. Your doctor will advise you on the
duration of therapy. You must visit your doctor regularly for review of symptoms and tablet dosage.
Symptomatic GORD
The usual dose is one 10 mg Rabeprazole Krka tablet once daily. Treatment is expected to last up to 4 weeks.
If symptoms do not resolve within 4 weeks, consult your doctor.
After this initial 4-week treatment, if your symptoms return, your doctor may instruct you to take one 10 mg
Rabeprazole Krka tablet as needed, when required, to control symptoms.
Zollinger-Ellison syndrome
The recommended usual starting dose is three 20 mg Rabeprazole Krka tablets once daily. The dose may then
be adjusted according to your response to treatment. Your doctor will tell you how many tablets to take and
when to take them. You must visit your doctor regularly for review of symptoms and tablet dosage.
Eradication of H. pylori
The recommended usual dose is 20 mg of Rabeprazole Krka taken (in combination with two antibiotics:
500 mg clarithromycin and 1 g amoxicillin) twice daily, usually for 7 days. Symptoms usually improve before
the ulcer is completely healed. It is therefore important not to stop taking the tablets unless instructed by your
doctor. For further information on the other medicines used in H. pylori eradication therapy, please refer to
their respective package leaflets.
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If you take more Rabeprazole Krka than you should
Do not take more tablets per day than prescribed. If you accidentally take more tablets than prescribed,
consult your doctor or go to hospital immediately. Always take the tablets and the pack with you to hospital so
that the doctor knows what you have taken.
If you forget to take Rabeprazole Krka
If you forget to take a dose, take it as soon as you remember, and then continue your treatment as usual. If you
forget to take the medicine for more than 5 days, call your doctor before taking any further medicine.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Rabeprazole Krka
Do not change the dose or stop treatment without first discussing it with your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everybody gets them.
Side effects are usually mild and disappear after stopping treatment with
this medicine.
Stop taking Rabeprazole Krka 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, difficulty breathing or low blood pressure which may cause fainting or collapse;
• frequent infections, such as sore throat or high temperature (fever), or mouth or throat ulcers;
• bruising or easy bleeding. These side effects are rare (may affect up to 1 in 1,000 people);
• severe blisters on the skin, irritation or ulcers in the mouth or throat. These side effects are very rare (may affect up to 1 in 10,000 people).

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

• infections;
• insomnia (difficulty sleeping);
• headache, dizziness;
• cough, pharyngitis (sore throat), rhinitis (runny nose);
• diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence (gas), benign polyps in the stomach;
• pain without known cause, back pain;
• asthenia (weakness), influenza-like syndrome.

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

• nervousness or drowsiness;
• bronchitis, sinusitis;
• dyspepsia (indigestion), dry mouth, eructation (belching);
• skin erythema, skin redness;
• muscle or joint pain, leg cramps, hip, wrist or spine fractures;
• urinary tract infection;
• chest pain;
• chills, fever;
• changes in liver function test values.

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

• anorexia (loss of appetite);
• depression;
• hypersensitivity (including allergic reactions);
• vision disturbances;
• gastritis (stomach discomfort or pain), stomatitis (mouth infection), taste disturbances;
• liver problems such as hepatitis (liver inflammation) and jaundice (yellowing of the skin and whites of the eyes), hepatic encephalopathy (brain damage due to liver disease);
• pruritus (itching), sweating, skin blisters (these reactions usually resolved after discontinuation of therapy);
• sweating;
• kidney problems such as interstitial nephritis (disorders of connective tissue within the kidneys);
• weight gain;
• changes in white blood cells (detected by blood tests) which may lead to frequent infections, thrombocytopenia (reduced platelets in the blood) – reduced platelets in the blood cause bleeding or bruising more easily than usual.

Frequency not known (frequency cannot be estimated from the available data):

• confusion;
• swelling of feet and ankles;
• breast swelling in men;
• hyponatremia (low sodium levels in the blood) – symptoms include feeling nauseous and unwell, with weak muscles or feeling confused;
• erythema, possible joint pain;
• inflammation of the intestine (causing diarrhoea).

If you have been taking rabeprazole for more than 3 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 develop any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels.
Reporting of side effects
If you experience any side effects, 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.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 Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture and light.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Package contents and other information

What Rabeprazolo Krka contains

• The active substance is sodium rabeprazole. Rabeprazolo Krka 10 mg gastro-resistant tablets: Each gastro-resistant tablet contains 10 mg of sodium rabeprazole, equivalent to 9.42 mg of rabeprazole. Rabeprazolo Krka 20 mg gastro-resistant tablets: Each gastro-resistant tablet contains 20 mg of sodium rabeprazole, equivalent to 18.85 mg of rabeprazole.
• The other components are: mannitol (E421), magnesium oxide, light (E530), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463), magnesium stearate (E470b) for the tablet core; and ethylcellulose (E462), light magnesium oxide (E530), hypromellose phthalate, diacetylated monoglycerides (E472a), talc (E553b), titanium dioxide (E171), red iron oxide (E172) (only 10 mg), yellow iron oxide (E172) (only 20 mg) in the coating.

Description of the appearance of Rabeprazolo Krka and contents of the pack
The 10 mg gastro-resistant tablets are pink-orange, biconvex, round tablets with bevelled edges, approximately 5.7 millimetres in diameter.
The 20 mg gastro-resistant tablets are yellow-brown, biconvex, round tablets, approximately 7.2 millimetres in diameter.
For both strengths, blister packs are available in pack sizes of 7, 10, 14, 15, 28, 30, 56, 60, 90, 98 and 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the European Economic Area countries under the following names:

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