PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

RABEPRAZOLE DOC Generici 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Generic medicine
Please read all of this leaflet carefully before you start taking 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RABEPRAZOLE DOC Generici is and what it is used for
What you need to know before taking RABEPRAZOLE DOC Generici
How to take RABEPRAZOLE DOC Generici
Possible side effects
How to store RABEPRAZOLE DOC Generici
Contents of the pack and other information

1. What RABEPRAZOLO DOC Generici is and what it is used for

RABEPRAZOLO DOC Generici belongs to a group of medicines called proton pump inhibitors (PPIs).
RABEPRAZOLO DOC Generici works by reducing the amount of acid produced by the stomach.
RABEPRAZOLO DOC Generici is used to treat:

ulcers in the upper part of the intestine (duodenal ulcer) and benign gastric ulcers;
gastroesophageal reflux disease (GERD), with or without ulceration. GERD is commonly described as inflammation of the esophagus caused by acid, associated with heartburn. Heartburn is a burning sensation that travels from the stomach or chest up to the neck. RABEPRAZOLO DOC Generici can also be used for long-term treatment of gastroesophageal reflux disease (maintenance therapy for GERD). RABEPRAZOLO DOC Generici can also be used for short-term symptomatic treatment of moderate to severe gastroesophageal reflux disease (symptomatic GERD);
Zollinger-Ellison syndrome, a condition in which the stomach produces extremely high amounts of acid.

In combination with two antibiotics (clarithromycin and amoxicillin), RABEPRAZOLO DOC Generici is used for the eradication of H. pylori infection in patients with peptic ulcer. For further information on the antibiotics used in H. pylori eradication therapy, please read their respective package leaflets.

2. What you need to know before taking RABEPRAZOLE DOC Generics

Do not take RABEPRAZOLE DOC Generics:

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 breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking RABEPRAZOLE DOC Generics

if you are allergic to other proton pump inhibitors
if you have or have had any liver problems
if you are taking a medicine called atazanavir (used to treat HIV)
if you have ever had a skin reaction after treatment with a medicine similar to RABEPRAZOLE DOC Generics that reduces stomach acid
if you need to undergo a specific blood test (Chromogranin A).

If you develop 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 RABEPRAZOLE DOC Generics. Remember to also report any other adverse effects such as joint pain.
Your doctor may request or may have already requested an additional examination called endoscopy in order to diagnose your condition and/or exclude malignancy. The possibility of stomach or esophageal cancer must be ruled out before starting treatment.
If you take RABEPRAZOLE DOC Generics for a long time (more than 1 year), your doctor will likely monitor you regularly. You must report any new or different symptoms whenever you see your doctor.
Abnormal blood test results have been reported during treatment with RABEPRAZOLE DOC Generics. Usually, values return to normal after stopping treatment.
If you take a proton pump inhibitor such as RABEPRAZOLE DOC Generics, especially for 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 may increase the risk of osteoporosis), consult your doctor.
Contact your doctor or pharmacist immediately if you experience severe (watery or bloody) or persistent diarrhoea with symptoms such as fever, abdominal pain or tenderness, since rabeprazole has been associated with a slight increase in infectious diarrhoea.
Children
RABEPRAZOLE DOC Generics is not recommended for use in children.
Other medicines and RABEPRAZOLE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking any of the following medicines:

atazanavir (used to treat HIV); the use of RABEPRAZOLE DOC Generics is not recommended if you are taking atazanavir
ketoconazole or itraconazole (used to treat fungal infections)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
RABEPRAZOLE DOC Generics must not be used during pregnancy or breastfeeding.
Driving and using machines
It is unlikely that RABEPRAZOLE DOC Generics will affect your ability to drive or operate machinery.
However, rabeprazole may occasionally cause drowsiness. In such cases, you should avoid driving and using complex machinery.

3. How to take RABEPRAZOLE DOC Generics

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly
Duodenal ulcer and benign gastric ulcer: 20 mg of RABEPRAZOLE DOC Generics once daily in the morning. Most patients with duodenal ulcer are treated for four weeks, and most patients with benign gastric ulcer for six weeks. However, some patients may require additional treatment to achieve healing.
Gastro-oesophageal reflux disease (GORD) with oesophagitis: 20 mg of RABEPRAZOLE DOC Generics once daily for 4 to 8 weeks.
Long-term treatment of gastro-oesophageal reflux disease: 10 or 20 mg of RABEPRAZOLE DOC Generics once daily, depending on response.
Symptomatic treatment of gastro-oesophageal reflux disease: 10 mg of RABEPRAZOLE DOC Generics once daily for 4 weeks. Once symptoms have resolved, your doctor may instruct you to take 10 mg of RABEPRAZOLE DOC Generics once daily as needed for ongoing symptom control.
Zollinger-Ellison syndrome: 60 mg of RABEPRAZOLE DOC Generics once daily initially. The dose may be adjusted according to your response to treatment. Your doctor will tell you how many tablets to take and when.
Eradication of H. pylori infection: 20 mg of RABEPRAZOLE DOC Generics twice daily, usually for 7 days (in combination with two antibiotics – clarithromycin and amoxicillin).
Use in children
The use of RABEPRAZOLE DOC Generics is not recommended in children.
Instructions for use
The tablets should be swallowed whole with half a glass of water and must not be chewed or crushed.
When RABEPRAZOLE DOC Generics is taken once daily, the tablets should be taken in the morning before breakfast.
If you take more RABEPRAZOLE DOC Generics than you should
If you take more RABEPRAZOLE DOC Generics than prescribed by your doctor, consult your doctor for advice.
If you forget to take RABEPRAZOLE DOC Generics
Do not take a double dose to make up for the missed dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then and take the next dose at the usual time.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking
RABEPRAZOLE DOC Generics and contact your doctor immediately:

sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction)
yellowing of the skin, dark urine and tiredness, which may be symptoms of liver problems
skin redness with blisters or peeling, which may be associated with high fever and joint pain. Severe blistering and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis

Common (may affect up to 1 in 10 people):

cough, sore throat (pharyngitis), runny nose
nausea, vomiting, abdominal pain, diarrhoea, constipation, gas (flatulence)
back pain, non-specific pain
weakness or loss of strength, flu-like symptoms
drowsiness
headache, dizziness
infection
benign polyps in the stomach

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

nervousness
drowsiness
inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)
indigestion, dry mouth, burping
rash, skin redness (erythema)
muscle pain, joint pain, leg cramps
urinary tract infection
chest pain, chills, fever
increased liver enzymes, measured by blood tests

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

blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising or make infections more likely
increased number of white blood cells
allergic reactions including facial swelling, low blood pressure and breathing difficulties
loss of appetite
depression
visual disturbances
inflammation of the stomach, inflammation of the mouth, taste disturbances
inflammation of the liver, jaundice (yellowing of the skin or eyes), brain disorders associated with liver failure (hepatic encephalopathy)
itching, sweating, blisters on the skin
inflammation of the kidneys (interstitial nephritis)
weight gain

Very rare (may affect up to 1 in 10,000 people):

sudden onset of severe rash or blistering or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN))

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

low levels of sodium in the blood
confusion
swelling of the feet and ankles
breast enlargement in men
erythema, possible joint pain
inflammation of the intestine (causing diarrhoea)

If you take RABEPRAZOLE DOC Generics for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
Reporting of side effects
If you experience any side effect, 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 the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RABEPRAZOLE DOC Generics

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What RABEPRAZOLO DOC Generici contains

The active substance is sodium rabeprazole. Each tablet contains 10 or 20 mg of sodium rabeprazole.
The other components are: core: povidone, mannitol (E421), light magnesium oxide, low-substituted hydroxypropylcellulose, magnesium stearate; coating: ethylcellulose, light magnesium oxide; gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Description of the appearance of RABEPRAZOLO DOC Generici and package contents
RABEPRAZOLO DOC Generici 10 mg: pink, film-coated, oblong, biconvex tablet.
RABEPRAZOLO DOC Generici 20 mg: yellow, film-coated, oblong, biconvex tablet.
Pack size: 14 tablets in blister packs.
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy
Manufacturers
Actavis hf
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This medicinal product has been authorized in the Member States of the European Economic Area
under the following names:
Estonia: RABEPRAZOLE DOC Generici
Italy: RABEPRAZOLO DOC Generici gastro-resistant tablets
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