Rabeprazole Zentiva

Package leaflet: Information for the patient

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

Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it may 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 Rabeprazole Zentiva is and what it is used for
2. What you need to know before taking Rabeprazole Zentiva
3. How to take Rabeprazole Zentiva
4. Possible side effects
5. How to store Rabeprazole Zentiva
6. Contents of the pack and other information

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

Rabeprazolo Zentiva contains the active substance rabeprazolo sodico. It belongs to a group of medicines called "proton pump inhibitors (PPIs)". These work by reducing 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 oesophagus.
Stomach ulcer or duodenal ulcer (in the upper part of the intestine). If these ulcers are infected with bacteria called "Helicobacter pylori" (H. pylori), you will also need to take antibiotics. By taking Rabeprazolo Zentiva tablets together with antibiotics, the infection will be reduced and the ulcer will heal. In addition, this treatment helps prevent recurrence of the infection and prevents the ulcer from reappearing.
Zollinger-Ellison syndrome, a condition in which your stomach produces excessive amounts of acid.

2. What you need to know before taking Rabeprazolo Zentiva

Do not take Rabeprazolo Zentiva

• If you are allergic to sodium rabeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you might 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 to "benzimidazole derivatives";
• Some patients have experienced blood and liver problems, although these often improved after stopping treatment with Rabeprazolo Zentiva;
• If you have a stomach tumour;
• If you have previously had liver problems;
• If you are taking atazanavir for HIV infections;
• If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with sodium rabeprazole. Like all medicines that reduce gastric acid secretion, sodium rabeprazole may lead to reduced absorption of vitamin B12;
• If you have previously experienced a skin reaction after treatment with a medicine similar to Rabeprazolo Zentiva that reduces gastric acidity;
• If you need to undergo a specific blood test (chromogranin A).

If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Rabeprazolo Zentiva may need to be stopped. Remember to also report any other side effects such as joint pain.
If you experience severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazolo Zentiva and contact your doctor immediately.
If you take a proton pump inhibitor such as Rabeprazolo Zentiva, 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 suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Children
Rabeprazolo Zentiva must not be given to children, as there is no experience with Rabeprazolo Zentiva in paediatric patients.
Other medicines and Rabeprazolo Zentiva:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
There are insufficient data on the use of rabeprazole in pregnant women. Therefore, you must not take Rabeprazolo Zentiva if you are pregnant or think you might be pregnant.
It is not known whether the active substance passes into breast milk. Therefore, you must not take Rabeprazolo Zentiva if you are breastfeeding.
Driving and using machines
It is unlikely that Rabeprazolo Zentiva will affect your ability to drive or use machinery.
However, Rabeprazolo Zentiva may occasionally cause drowsiness. Therefore, do not drive or operate machinery if you feel drowsy.

3. How to take Rabeprazole Zentiva

Always take Rabeprazole Zentiva exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Taking this medicine
Remove the tablet from the blister pack only 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 monitor you.
Adults and elderly patients
For gastro-oesophageal reflux disease (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)

• The usual dose is one 10 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• If your condition recurs after 4 weeks of treatment, your doctor may advise you to take one Rabeprazole Zentiva 10 mg tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GORD)

• The usual dose is one 20 mg tablet once daily for 4 or 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance therapy for GORD)

• The usual dose is one 10 mg or 20 mg tablet once daily for the duration prescribed by your doctor.
• Take the tablet in the morning before eating.
• Your doctor will want to see you regularly to monitor your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may advise you to continue taking Rabeprazole Zentiva for another 6 weeks if your condition does not improve.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may advise you to continue taking Rabeprazole Zentiva for another 4 weeks if your condition does not improve.

For ulcers caused by H. pylori infection and to prevent their recurrence

• The usual dose is one 20 mg tablet twice daily for seven days.
• Your doctor may also prescribe antibiotics called amoxicillin and clarithromycin.
• The following combination is recommended:

For further information on other medicines used to treat H. pylori, please refer to 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 daily.
• Your doctor may subsequently adjust the dose according to your response to treatment. If you are undergoing long-term treatment, you must see your doctor regularly to reassess the therapy and your symptoms.

Use in patients with liver problems
You must consult your doctor, who will exercise particular caution when starting treatment with Rabeprazolo Zentiva and throughout the treatment period.
Use in children
This medicine must 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 immediately. Take 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 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, speak with your doctor before taking it again.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop treatment with Rabeprazolo Zentiva
Symptom improvement usually occurs before the ulcer is completely healed. It is important that you do not stop taking the tablets before your doctor tells you to do so.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Rabeprazolo Zentiva can cause adverse effects, although not everyone experiences them.
Adverse effects are usually mild and improve without the need to stop taking this medicine.
Stop taking Rabeprazolo Zentiva and contact your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): signs may include sudden swelling of the face, difficulty breathing, or low blood pressure that may cause fainting or collapse.
• Other serious conditions (rare frequency: may affect up to 1 in 1,000 people): frequent infections such as sore throat or fever, or mouth or throat ulcers, easy bruising or bleeding.
• Severe skin conditions (very rare frequency: may affect up to 1 in 10,000 people): severe blistering skin reactions or mouth or throat ulcers (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome).
• Other serious skin conditions (frequency not known: frequency cannot be estimated from available data): rash, possible joint pain (subacute cutaneous lupus erythematosus).

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

• infections
• difficulty sleeping
• headache or dizziness
• cough, runny nose or sore throat (pharyngitis)
• stomach or intestinal problems such as stomach pain, diarrhoea, feeling unwell (nausea), sickness (vomiting), constipation or gas in the intestine (flatulence), benign stomach polyps
• back pain or discomfort
• weakness or flu-like symptoms

Uncommon (may affect up to 1 in 100 people)

• feeling nervous or drowsy
• chest infections (bronchitis)
• pain and sinusitis
• dry mouth
• indigestion or burping
• skin redness or erythema
• 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 (may affect up to 1 in 1,000 people)

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

Not known (frequency cannot be estimated from available data)

• breast enlargement in men
• fluid retention
• low sodium levels in the blood which may cause tiredness and confusion, muscle spasms, seizures and coma
• patients who have previously had liver problems may very rarely develop encephalopathy (a brain disorder)
• inflammation of the intestine (leading to diarrhoea)

If you take Rabeprazolo Zentiva for more than three months, your blood magnesium levels may decrease.
Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor may decide to monitor your blood magnesium levels regularly.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RABEPRAZOLE 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 carton after “exp”.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Zentiva contains
The active substance is: sodium rabeprazole.
Each gastro-resistant tablet of Rabeprazolo Zentiva 10 mg contains 10 mg of sodium rabeprazole,
equivalent to 9.42 mg of rabeprazole.
Each gastro-resistant tablet of Rabeprazolo Zentiva 20 mg contains 20 mg of sodium rabeprazole,
equivalent to 18.85 mg of rabeprazole.
The other components are:
Tablet core:
Mannitol, magnesium oxide, edetate sodium, crospovidone type A, calcium stearate, povidone.
Tablet coating:
Triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), ethylcellulose, hypromellose, anhydrous sodium carbonate, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172).
Rabeprazolo Zentiva 10 mg gastro-resistant tablets additionally contain red iron oxide (E172).

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

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

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

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