RABEPRAZOLO 10 mg Enteric-Coated Tablets

Зміст інструкції

1. Rabeprazolo Krka 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is Rabeprazolo Krka and what it is used for
   2. What you need to know before you take 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

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

Rabeprazole sodium

Generic medicine

Read 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 pass it on to others even if their symptoms are the same as yours because it could 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 Krka is and what it is used for
• 2. What you need to know before you take 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 is Rabeprazolo Krka and what it is used for

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

• active duodenal ulcer or active benign gastric ulcer/stomach ulcer (peptic ulcers),
• symptomatic gastro-oesophageal reflux disease (GORD) which is ulcerous or erosive, commonly defined as inflammation of the oesophagus caused by acid and associated with heartburn, or for the long-term treatment of GORD (GORD maintenance),
• symptomatic treatment of moderate to very severe gastro-oesophageal 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) Rabeprazolo Krka tablets is used to eradicate H. Pyloriinfection in patients with peptic ulcer.

2. What you need to know before you take Rabeprazolo Krka

Do not take Rabeprazolo Krka

• if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant, think you may be pregnant or if you are breast-feeding (see section Pregnancy and breast-feeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazolo Krka
Tell your doctor or pharmacist:
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• if you are allergic to other proton pump inhibitors,
• if you have been told you have a stomach tumour,
• if you have had liver disease in the past,
• if you are taking atazanavir (a medicine used to treat HIV).
• if you have low levels of vitamin B12 in your body or factors that may lead to a reduction in vitamin B12 and if you are receiving long-term treatment with rabeprazole sodium. As with all 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 Krka that reduces stomach acid.
• you are going to have a specific blood test (Chromogranin A).

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 treatment with Rabeprazolo Krka.
Also remember to report any other undesirable effects such as joint pain.
If you have been taking this medicine for a long time, your doctor will want to perform some checks.
Blood and liver problems have been observed in some patients, but these problems often
improve when treatment with rabeprazole is stopped.
If you experience severe diarrhea (watery or with blood) with symptoms such as fever, abdominal pain or
malaise, stop taking Rabeprazolo Krka and consult a doctor immediately.
Taking a proton pump inhibitor such as Rabeprazolo Krka, especially for a period
longer than one year, may slightly increase the risk of fracture of the hip, wrist and spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can
increase the risk of osteoporosis).

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

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

• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections). Rabeprazolo Krka may decrease the levels of this type of medicine in the blood. Your doctor may need to adjust the dose.
• if you are taking atazanavir (a medicine used to treat HIV). Rabeprazolo Krka may decrease the levels of this type of medicine in the blood and they should not be used at the same time.
• if you are taking methotrexate (a chemotherapeutic medicine used at high doses to treat cancer). If you are taking high doses of methotrexate, your doctor may temporarily stop treatment with Rabeprazolo Krka. If you are not sure if you are undergoing any of the treatments mentioned above, contact your doctor or pharmacist before using Rabeprazolo Krka.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may 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.
Do not take Rabeprazolo Krka tablets if you are breast-feeding or are planning to breast-feed.

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

3. How to take Rabeprazolo Krka

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
YOU MUST SWALLOW RABEPRAZOLO KRKA TABLETS WHOLE. YOU MUST NOT
BREAK OR CHEW THEM.
The following dosages are those usually recommended for adults and the elderly. Do not change the dose or the
length of treatment on your own.

Use in children
Rabeprazolo Krka must not be used in children.

Active duodenal ulcer or active benign gastric ulcer
The usual dose is one Rabeprazolo Krka 20 mg tablet once a day.
If you have an active duodenal ulcer, your treatment is expected to continue for 4 weeks; but after this
period your doctor may decide to continue the treatment for another 4 weeks.
If you have an active benign gastric ulcer, your treatment is expected to continue for 6 weeks; but after
this period your doctor may decide to continue the treatment for another 6 weeks.

Ulcerative or erosive gastro-oesophageal reflux disease
The usual dose is one Rabeprazolo Krka 20 mg tablet once a day. Your
treatment is expected to continue for 4 weeks; but after this period your doctor may decide to continue the
treatment for another 4 weeks.

Maintenance of GORD
The usual dose is one Rabeprazolo Krka 10 mg or 20 mg tablet once a day. The doctor will advise you on the duration of therapy. You should go to the doctor at regular intervals for a review of the
tablet and symptoms.

Symptomatic GORD
The usual dose is one Rabeprazolo Krka 10 mg tablet once a day. Treatment is expected to continue for 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 tell you to take
one Rabeprazolo Krka 10 mg tablet as and when necessary to control your symptoms.

Zollinger-Ellison syndrome
The usual recommended dose is 3 Rabeprazolo Krka 20 mg tablets once a day for
begin with. The dose may then be adjusted according to your response to treatment. The doctor will tell you
how many tablets to take and when you should take them. You should go to the doctor at regular intervals for a
review of the tablets and symptoms.

Eradication of H. pylori
The usual recommended dose is 20 mg of Rabeprazolo Krka to be taken (in association with two
antibiotics: 500 mg of clarithromycin and 1 g of amoxicillin) twice a day, generally for 7 days. Symptoms usually subside before the ulcer is completely healed. It is therefore important not
to stop taking the tablets until your doctor tells you to. For further information
on the other medicines used for H. pylorieradication therapy, please refer to their respective package
leaflets.
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If you take more Rabeprazolo Krka than you should
Do not take more tablets a day than you have been prescribed. If you accidentally take more
tablets than the prescribed dose, consult your doctor or go to hospital immediately. Always take the tablets and the box with you to
hospital so that the doctor knows what you have taken.

If you forget to take Rabeprazolo Krka
If you forget to take a dose, take it as soon as you remember, and then continue the therapy as
usual. If you forget to take the medicine for more than 5 days, call your doctor before taking another
medicine.
Do not take a double dose to make up for a missed dose.

If you stop taking Rabeprazolo Krka
Do not change the dose and do not stop the treatment without discussing it first with your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this can cause side effects, although not everybody gets them.
Side effects are usually mild and disappear after stopping treatment with
this medicine.
Stop treatment with Rabeprazolo Krka and contact your doctor immediately if you notice any of the
following side effects. You may need urgent medical attention:

• allergic reactions. Signs may include: sudden swelling of the face, difficulty breathing or low blood pressure which can cause fainting or collapse;
• frequent infections, such as sore throat or high temperature (fever), or ulcers in the mouth or throat
• bruising or easy bleeding. These side effects are rare (may affect up to 1 in 1,000 people)
• severe blistering of 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 (wind), benign polyps in the stomach
• pain of unknown cause, back pain
• asthenia (weakness), flu-like syndrome

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

• nervousness or drowsiness
• bronchitis, sinusitis
• dyspepsia (indigestion), dry mouth, eructation (burping)
• skin rash, skin redness
• muscle or joint pain, leg cramps, hip, wrist or spine fracture
• urinary tract infection
• chest pain
• chills, fever
• changes in liver function values

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Rare(may affect up to 1 in 1000 people) :

• anorexia (loss of appetite)
• depression
• hypersensitivity (including allergic reactions)
• vision disturbances
• gastritis (stomach upset 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)
• itching, sweating, blisters on the skin (these reactions usually resolved after stopping therapy)
• sweating
• kidney problems such as interstitial nephritis (disorders of the connective tissue within the kidneys)
• weight gain
• changes in white blood cells (verified by blood tests) which can 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 the feet and ankles
• breast enlargement in men
• hyponatremia (low levels of sodium in the blood) - symptoms are feeling sick and unwell with weak muscles or feeling confused.
• erythema, possible joint pains.
• inflammation of the intestine (causing diarrhoea)

If you have been taking rabeprazole for more than 3 months, it is possible that the levels of magnesium in your blood may
decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you develop any of these
symptoms, inform your doctor immediately. Low levels of magnesium can also lead to a
reduction in potassium and calcium levels in the blood. Your doctor may decide to perform regular
blood tests to monitor your magnesium levels.

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.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 Krka

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. 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 at a temperature above 30°C.
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..
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6. Contents of the pack and other information

What Rabeprazolo Krka contains

• The active ingredient is rabeprazole sodium. Rabeprazolo Krka 10 mg gastro-resistant tablets Each gastro-resistant tablet contains 10 mg of rabeprazole sodium, equivalent to 9.42 mg of rabeprazole. Rabeprazolo Krka 20 mg gastro-resistant tablets Each gastro-resistant tablet contains 20 mg of rabeprazole sodium, equivalent to 18.85 mg of rabeprazole.
• The other ingredients are: mannitol (E421), magnesium oxide, light (E530), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463), magnesium stearate (E470b) for the tablet core and ethylcellulose (E462), magnesium oxide light (E530), hydroxypropylmethylcellulose phthalate, acetylated 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 rounded edges, with a diameter of approximately 5.7 millimeters.
The 20 mg gastro-resistant tablets are yellow-brown, biconvex, round tablets with a diameter of approximately 7.2 millimeters.
For both dosages, blisters are available in packs 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 for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:

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