RABEPRAZOLO 10 mg Enteric-Coated Tablet

Зміст інструкції

1. Rabeprazolo Zentiva 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is Rabeprazolo Zentiva and what is it used for
   2. What you need to know before taking Rabeprazolo Zentiva
   3. How to take Rabeprazolo Zentiva
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RABEPRAZOLO ZENTIVA
   6. Package contents and other information

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

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

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

Rabeprazolo Zentiva contains the active ingredient rabeprazole sodium. This belongs to a group
of medicines called “proton pump inhibitors (PPIs)”. They work by decreasing the amount of
acid produced by your stomach.
Rabeprazolo Zentiva is used to treat the following conditions:
“Gastroesophageal reflux disease” (GERD), which may be accompanied by heartburn. GERD occurs when acid and food pass from the stomach into the esophagus.
Ulcer of the stomach or the upper part of the intestine. If these ulcers are infected by
bacteria called “Elicobacter pylori” ( H. pylori), you will also need to take antibiotics. Using
Rabeprazolo Zentiva tablets and antibiotics together will reduce the infection and
the ulcer will heal. In addition, the therapy helps to block the infection and ensures that the ulcer
does not recur.
Zollinger-Ellison syndrome, when your stomach produces an excessive amount of
acid.

2. What you need to know before taking Rabeprazolo Zentiva

Do not take Rabeprazolo Zentiva

• If you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

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

• If you are allergic to other proton pump inhibitors or “benzimidazole substitutes”;
• Some patients have had problems with blood and liver, but often they have improved with discontinuation of treatment with Rabeprazolo Zentiva;
• If you have a stomach tumor;
• If you have ever had previous liver problems;
• If you are taking atazanavir for HIV infections;
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with rabeprazole sodium. Like all drugs that reduce acid secretion, rabeprazole sodium can lead to reduced absorption of vitamin B12;
• If you have ever previously had a skin reaction after treatment with a medicine similar to Rabeprazolo Zentiva that reduces gastric acidity;
• If you are going to undergo 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 it may be necessary to stop therapy with Rabeprazolo
Zentiva. Remember to also report any other undesirable effects such as joint pain.
If you experience severe diarrhea (watery or with blood) with symptoms such as fever, pain or abdominal tenderness, stop taking Rabeprazolo Zentiva and go to your doctor immediately.
If you are taking a proton pump inhibitor such as Rabeprazolo Zentiva, 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.

Children
Rabeprazolo Zentiva should not be given to children as there is no experience with Rabeprazolo
Zentiva in children.

Other medicines and Rabeprazolo Zentiva:
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor or pharmacist especially if you are taking any of the following medicines:

• Medicines to treat fungal infections (such as ketoconazole or itraconazole). Rabeprazolo Zentiva may reduce the amount of these medicines in the blood. Your doctor may consider it appropriate to adjust the dose.
• Atazanavir for the treatment of HIV infections. Rabeprazolo Zentiva may reduce the amount of this medicine in the blood. They should not be used together.
• Methotrexate (a chemotherapeutic medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt treatment with Rabeprazolo Zentiva. If you are unsure if any of the above conditions apply to you, talk to your doctor or pharmacist before taking Rabeprazolo Zentiva.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby
consult your doctor or pharmacist before taking this medicine.
There are no adequate data on the use of rabeprazole in pregnant women. Therefore, you should not take
Rabeprazolo Zentiva if you are pregnant or think you may be pregnant.
It is not known whether the active ingredient passes into breast milk. Therefore, you should not take Rabeprazolo
Zentiva if you are breastfeeding.

Driving and operating machinery
It is unlikely that Rabeprazolo Zentiva will impair your ability to drive or operate machinery.
However, occasionally, Rabeprazolo Zentiva may cause drowsiness. Therefore, you should not drive or
operate machinery if you feel drowsy.

3. How to take Rabeprazolo Zentiva

Always take Rabeprazolo Zentiva exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
Taking this medicine
Only remove the tablet from the blister when it is time to take the medicine.
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 have been taking this medicine for a long time, your doctor will want to check you.

Adults and the elderly
For “Gastroesophageal Reflux Disease” (GERD)
Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one 10 mgtablet once a dayfor 4 weeks.
• Take the tablet in the morning before eating.
• If your condition returns after 4 weeks of treatment, your doctor may tell you to take one Rabeprazolo Zentiva 10 mg tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one 20 mgtablet once a dayfor 4 or 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (GERD maintenance therapy)

• The usual dose is one 10 mg or 20 mg tablet oncea dayfor the time your doctor has told you.
• Take the tablet in the morning before eating.
• Your doctor will want to see you regularly to check your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg tablet once a dayfor 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazolo Zentiva for another 6 weeks if your condition does not improve.

For duodenal ulcers

• The usual dose is one 20 mg tablet once a dayfor 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazolo Zentiva for another 4 weeks if your condition does not improve.

For ulcers caused byH. pyloriinfection and to prevent them from recurring

• The usual dose is one 20 mg tablet twice a dayfor seven days.
• Your doctor may also tell you to take antibiotics called amoxicillin and clarithromycin.
• The following combination is recommended

For further information on other medicines used for the treatment of H. pylori,consult the
package leaflet of the individual medicines.

Zollinger – Ellison syndrome, when an excessive amount of acid is produced by the
stomach

• The usual recommended starting dose is 60 mg(three 20 mg tablets) once aday.
• The dose may then be adjusted by your doctor depending on your response to treatment. If you are undergoing long-term treatment, you will need to see your doctor regularly to reassess the therapy and symptoms.

Use in patients with liver problems
You should consult your doctor who will pay particular attention when you start treatment with
Rabeprazolo Zentiva and throughout the treatment.

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

If you take more Rabeprazolo Zentiva than you should
If you have taken more Rabeprazolo Zentiva than you should, contact your doctor or go to the nearest
hospital. Bring the packaging with you.

If you forget to take Rabeprazolo Zentiva

• If you forget to take a dose, take it as soon as you remember. However, if it is almost 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, talk to your doctor before taking the medicine again.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Rabeprazolo Zentiva
Improvement of symptoms normally occurs before the ulcer is completely healed . It is
important that you do not stop taking the tablets before your doctor has told you
to do so.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazolo Zentiva can cause side effects, although not everybody gets them.

Side effects are usually mild and improve without having to stop taking this medicine.

Stop taking Rabeprazolo Zentiva and see your doctor immediately if you notice any of the
following side effects – you may need urgent medical treatment:

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): signs can include: sudden swelling of the face, difficulty breathing or low blood pressure which can cause fainting or collapse.
• Other serious conditions (rare:may affect up to 1 in 1,000 people): frequent infections, such as sore throat or fever, or ulcers in the mouth or throat, bruising or bleeding that happens easily.
• Serious skin conditions (very rare:may affect up to 1 in 10,000 people): severe blistering of the skin or ulcers in the mouth or throat (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome).

• Other serious skin conditions (frequency not known:frequency cannot be estimated from the available data): redness, possible joint pain (Cutaneous lupus erythematosus).

• Other serious skin conditions (frequency not known:the frequency cannot be defined based on available data): erythema, possible joint pain (Subacute cutaneous lupus erythematosus).

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

• infections
• difficulty sleeping
• headache or feeling dizzy
• cough, runny nose or sore throat (pharyngitis)
• effects on the stomach or intestines such as stomach pain, diarrhoea, feeling unwell (nausea), discomfort (vomiting) constipation or wind (flatulence), benign polyps in the stomach
• pain or back pain
• weakness or flu-like symptoms

Uncommon(may affect up to 1 in 100 people)

• feeling nervous or sleepy
• chest infections (bronchitis)
• pain and sinusitis
• dry mouth
• indigestion or belching
• skin redness or flushed skin
• muscle, leg or joint pain
• fractures of the hip, wrist and spine
• bladder infections (urinary tract infections)
• chest pain
• chills or fever
• liver problems (seen with blood tests)

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

• loss of appetite (anorexia)
• depression
• hypersensitivity (including allergic reactions)
• vision disturbances
• inflammation of the mouth (stomatitis) or altered taste
• stomach or abdominal discomfort
• liver problems including yellowing of the skin and whites of the eyes (jaundice)
• itching, rash or blistering of the skin
• sweating
• kidney problems
• weight gain
• changes in white blood cells (seen with blood tests) which can lead to frequent infections
• reduced platelets in the blood which can lead to bleeding or bruising more easily than normal

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

• swelling of the breasts in men
• fluid retention
• low levels of sodium in the blood which can cause tiredness and confusion, muscle spasms, convulsions and coma
• patients who have previously had liver problems may very rarely develop encephalopathy (a brain disease)
• inflammation of the bowel (leading to diarrhoea)

If you take Rabeprazolo Zentiva for more than three months, your blood magnesium levels may
decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience
any of these symptoms, consult your doctor immediately. Low magnesium levels can also
lead to decreased blood levels of potassium or calcium. Your doctor may decide to
regularly check your magnesium levels in the blood.

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 ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or the carton after “exp”.
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
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 Zentiva contains
The active ingredient is: rabeprazole sodium.
Each Rabeprazolo Zentiva 10 mg gastro-resistant tablet contains 10 mg of rabeprazole sodium
equivalent to 9.42 mg of rabeprazole.
Each Rabeprazolo Zentiva 20 mg gastro-resistant tablet contains 20 mg of rabeprazole sodium
equivalent to 18.85 mg of rabeprazole.
The other ingredients are:
Tablet core:
Mannitol, magnesium oxide, sodium edetate, crospovidone type A, calcium stearate, povidone.
Tablet coating:
Triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1), ethylcellulose, hypromellose, sodium
anhydrous carbonate, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172).
Rabeprazolo Zentiva 10 mg gastro-resistant tablets also contain iron oxide red
(E172).

Description of the appearance of Rabeprazolo Zentiva and package contents:
Rabeprazolo Zentiva 10 mg gastro-resistant tablets are round, pink in color.
Rabeprazolo Zentiva 20 mg gastro-resistant tablets are round, yellow in color.
Rabeprazolo Zentiva is available in blister packs of 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98,
120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale Bodio 37/b – 20158 Milan
Italy

Manufacturer
Sofarimex – Ind. Quimica e Farmaceutica, S.A.
Av. das Indústrias – Alto do Colaride
2735-213 Cacém - Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: