PACKAGE LEAFLET: INFORMATION FOR THE USER

RABEX 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Rabeprazole
Generic 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. Do not give it to others, 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, pharmacist or nurse. See Section 4.

Contents of this leaflet:

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

1. WHAT RABEX IS AND WHAT IT IS USED FOR

RABEX belongs to a group of medicines called proton pump inhibitors (PPIs).
RABEX works by reducing the amount of acid produced by the stomach.
RABEX 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. Gastroesophageal reflux disease is commonly referred to as acid-induced inflammation of the oesophagus and is associated with heartburn. Heartburn is a burning sensation that starts in the stomach or lower chest and moves up to the neck. RABEX can be used as long-term treatment (maintenance) of gastroesophageal reflux disease. RABEX can also be used for symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD).
Zollinger-Ellison syndrome, a condition characterized by the production of extremely high amounts of acid in the stomach.

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING RABEX

Do not take RABEX

If you are allergic (hypersensitive) to sodium rabeprazole or to any of the excipients in RABEX (listed in section 6).
If you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking RABEX if:
- You are allergic to medicines containing other proton pump inhibitors.
- You have or have had liver problems.
- You are taking a medicine called atazanavir (used to treat HIV).
- You have ever had a skin reaction after treatment with a medicine similar to RABEX that reduces gastric acidity. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with RABEX may need to be discontinued. Remember to also report any other adverse effects such as joint pain. If any of these conditions apply to you, speak with your doctor before using RABEX.

Your doctor may perform or may have already performed another test called endoscopy to diagnose your condition and/or rule out malignant disease. Stomach and esophageal tumors must be excluded before starting treatment.
If you take RABEX for a long period of time (more than 1 year), your doctor will likely monitor you periodically. When you see your doctor, be sure to report any new or different symptoms you have noticed.
Abnormal blood test results have been reported during treatment with RABEX. These usually return to normal once treatment is stopped.
Children
RABEX is not recommended for use in children.
If you take a proton pump inhibitor such as RABEX, 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 have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Other medicines and RABEX
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. It is especially important that your doctor knows if you are taking any of the following medicines:

Atazanavir (used to treat HIV); taking RABEX is not recommended if you are taking atazanavir.
Ketoconazole or itraconazole (used to treat fungal infections).

Pregnancy and breastfeeding
RABEX must not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that RABEX will negatively affect your ability to drive or operate machinery.
However, rabeprazole may occasionally cause drowsiness. Therefore, if you experience drowsiness, you must avoid driving or operating complex machinery.

3. HOW TO TAKE RABEX

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure,
consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly
Duodenal ulcers and benign gastric ulcers: 20 mg of RABEX once daily in the morning.
Most patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated for six weeks. However, some
patients may require additional treatment to achieve healing.
Gastroesophageal reflux disease with esophagitis: 20 mg of RABEX once daily for four to
eight weeks.
Long-term treatment of gastroesophageal reflux disease (GERD): 10 mg or 20 mg of RABEX once
daily depending on response.
Symptomatic treatment of gastroesophageal reflux disease: 10 mg of RABEX once daily for
4 weeks. Once symptoms have resolved, your doctor may instruct you to take 10 mg of RABEX once daily as needed for ongoing symptom control.
Zollinger-Ellison syndrome: Start with 60 mg of RABEX once daily. The dose may be
subsequently adjusted by your doctor depending on response to treatment. Your doctor will tell you how many
tablets to take and when.
Eradication of H. pylori: 20 mg of RABEX twice daily, usually for 7 days (in
combination with two antibiotics: clarithromycin and amoxicillin).
Use in children
RABEX is not recommended for use in children.
Instructions for use
The tablets should be swallowed whole with half a glass of water, without breaking or chewing them.
When taking RABEX once daily, the tablets should be taken in the morning before breakfast.
If you take more RABEX than you should
If you have taken more RABEX than you should have, inform your doctor immediately.
If you forget to take RABEX
Do not take a double dose to make up for the forgotten 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.
Do not take a double dose to make up for the forgotten dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, RABEX may cause adverse reactions, although not everyone experiences them.
If you notice any of the following serious adverse reactions, stop taking RABEX and contact your doctor
immediately:

Sudden shortness of breath, swelling of lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.
Skin redness with blistering or peeling, possibly associated with high fever and joint pain. Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These could be signs of erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.

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

Cough, sore throat (pharyngitis), runny nose
Nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence (bloating)
Back pain, non-specific pain
Weakness or loss of strength, flu-like symptoms
Drowsiness
Headache, dizziness
Infection
Benign polyps in the stomach

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

Nervousness
Drowsiness
Inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)
Indigestion, dry mouth, belching
Skin rash, skin redness (erythema)
Muscle pain, joint pain, leg cramps
Urinary tract infection
Chest pain, chills, fever
Increased liver enzymes, as shown by blood tests

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

Blood disorders such as reduced white blood cells or platelets. This may cause weakness, bruising or increase the risk of infections.
Increase in white blood cell count
Allergic reactions including facial swelling, low blood pressure and breathing difficulties
Loss of appetite
Depression
Vision disturbances
Inflammation of the stomach or mouth, altered taste
Liver inflammation, jaundice (yellowing of the skin or whites of the eyes), brain disorder associated with liver failure (hepatocellular insufficiency)
Itching, sweating, skin blisters

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

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

Adverse reactions not known (frequency cannot be estimated from available data):

Low levels of sodium in the blood
Confusion
Swelling of feet and ankles
Breast enlargement in men
Erythema, possible joint pain

If you take RABEX for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, vertigo 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 should decide whether regular monitoring of blood magnesium levels is necessary.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RABEX

Keep this medicine out of the sight and reach of children.
Blister pack: store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not use RABEX after the expiry date stated on the carton, blister and label after EXP. The expiry date refers to the last day of the month.
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. OTHER INFORMATION

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

Description of the appearance of RABEX and contents of the pack
RABEX 10 mg gastro-resistant tablets: pink, biconvex, elliptical, coated tablets.
RABEX 20 mg gastro-resistant tablets: yellow, biconvex, elliptical, coated tablets.
Pack size: 14 tablets in blister packs.

Marketing Authorization Holder
S.F. GROUP Srl – Via Tiburtina 1143 – 00156 Rome, Italy

Manufacturer responsible for batch release
Actavis hf.
Reykjavikurvegur 76-78, IS-220 Hafnarfjörður – Iceland
Special Product’s Line S.r.l.
Strada Paduni, 240 – 03012 Anagni (FR) – Italy
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

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