Akirab

Patient Information Leaflet: Information for the User

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

Sodium rabeprazole
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. 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, consult your doctor, pharmacist, or nurse.

Contents of this leaflet:

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

1. What Akirab is and what it is used for

Akirab contains the active substance sodium rabeprazole, which belongs to a group of medicines called proton pump inhibitors (PPIs).
Akirab works by reducing the amount of acid produced in the stomach.

Akirab 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 starting in the stomach or lower chest and rising up to the neck. Akirab can be used as long-term maintenance treatment for gastroesophageal reflux disease. Akirab can also be used for the 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 stomach acid.

In combination with two antibiotics (clarithromycin and amoxicillin), Akirab 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, see their respective package leaflets.

2. What you need to know before taking Akirab

Do not take AKIRAB

• if you are allergic (hypersensitive) 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, pharmacist, or nurse before taking AKIRAB.
During treatment with rabeprazole, inflammation of the kidneys may occur. Signs and symptoms may include
decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever,
skin rash, and joint stiffness. You must report such signs to your doctor.
Inform your doctor before taking this medicine:

• If you are allergic to medicines containing other proton pump inhibitors or "imidazole substitutes".
• If you have or have had liver or blood problems; such problems have occurred in some patients and resolved upon discontinuation of rabeprazole treatment.
• If you have been diagnosed with a stomach tumor.
• If you are taking a medicine called atazanavir (used to treat HIV).
• If you have low body stores or risk factors that reduce vitamin B12 absorption and are receiving long-term treatment with sodium rabeprazole. Like all other agents that reduce acid, sodium rabeprazole may lead to reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to AKIRAB that reduces gastric acidity. If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue AKIRAB therapy. Remember to report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (Chromogranin A).

If any of these conditions apply to you, consult your doctor before using AKIRAB.
Your doctor may perform or may have already performed another test called endoscopy to diagnose your condition
and/or exclude malignant disease. The possibility of stomach and esophageal tumors must be ruled out
before starting treatment.
If you take Akirab for a long period of time (over 1 year), your doctor will likely monitor you periodically.
When you see your doctor, report any new or different symptoms you have noticed.
Abnormal blood test results have been reported during treatment with Akirab. Usually, values
return to normal when treatment is stopped.
Children
Akirab is not recommended for use in children.
If you have severe diarrhea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness,
stop taking Akirab and contact your doctor.
If you are taking a proton pump inhibitor such as Akirab, 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 have
osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), consult
your doctor.
If you take a proton pump inhibitor such as Akirab for a long period, you may have an increased
risk of developing stomach polyps, which are abnormalities in the inner lining of the stomach.
Stomach polyps that develop an ulcer can cause bleeding in the stomach. Large stomach polyps can cause
intestinal obstruction. Your doctor may decide to reduce the duration of treatment and
adjust the dose of PARIET you are taking.
Other medicines and AKIRAB
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription. It is particularly important that your doctor knows if you are already
taking any of the following medicines:

• atazanavir (used to treat HIV); it is not recommended to take Akirab if you are taking atazanavir;
• ketoconazole or itraconazole (used to treat fungal infections);
• methotrexate (a chemotherapeutic agent used at high doses to treat tumors) and you are taking a high dose of methotrexate, your doctor may temporarily discontinue your Akirab treatment.

Pregnancy and breastfeeding
Akirab must not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Akirab will have a negative effect on your ability to drive or operate machinery.
However, rabeprazole may occasionally cause drowsiness. Therefore, if you experience drowsiness,
you should avoid driving or operating complex machinery.
AKIRAB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Akirab

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly
Gastroesophageal reflux disease (GERD)
Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of Akirab 10 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• If symptoms recur after 4 weeks of treatment, your doctor may decide to continue treatment with 1 tablet of Akirab 10 mg for as long as necessary.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is 1 tablet of Akirab 20 mg once daily for 4–8 weeks.
• Take the tablet in the morning before breakfast.

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

• The recommended dose is 1 tablet of Akirab 10 mg or 20 mg once daily for the duration indicated by your doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will review your condition and dosage at regular intervals.

Duodenal and gastric ulcers
Treatment of stomach ulcer (peptic ulcer)

• The recommended dose is 1 tablet of Akirab 20 mg once daily for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another six weeks if your condition does not improve.

Treatment of intestinal ulcer (duodenal ulcer)

• The recommended dose is 1 tablet of Akirab 20 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another four weeks if your condition does not improve.

Treatment and prevention of ulcers caused by H. pylori infection

• The recommended dose is 1 tablet of Akirab 20 mg twice daily for seven days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin. For further information on other medicines used in the treatment of Helicobacter pylori infection, consult the respective package leaflets.

Zollinger-Ellison Syndrome
Treatment of Zollinger-Ellison Syndrome, a condition in which the stomach produces a very high amount of acid

• It is recommended to start treatment with 3 tablets of Akirab 20 mg once daily.
• The dose may subsequently be adjusted by your doctor based on your response to treatment. If you are on long-term treatment, you will need regular check-ups with your doctor to monitor symptoms and review the dose.

Patients with liver problems
You should consult your doctor, who will exercise particular caution at the start of your treatment with Akirab and
throughout the therapy.
Use in children
Akirab is not recommended for use in children.

Instructions for use
Swallow the tablets whole with half a glass of water, without breaking or chewing them.
When taking Akirab once daily, the tablets should be taken in the morning before breakfast.

If you take more Akirab than you should
If you have taken more Akirab than you should have, contact your doctor immediately.

If you forget to take AKIRAB
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. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Akirab can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Akirab 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 blisters or peeling, possibly associated with high fever and joint pain. Severe blistering and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. This could be erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis.

The frequency of the possible side effects listed below is defined according to the following convention:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 in 100 people
• Uncommon: affects 1 to 10 in 1,000 people
• Rare: affects 1 to 10 in 10,000 people
• Very rare: affects less than 1 in 10,000 people
• Not known: frequency cannot be estimated from available data

Common:

• cough, sore throat (pharyngitis), runny nose;
• nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence;
• back pain, non-specific pain;
• weakness or loss of strength, flu-like symptoms;
• difficulty falling asleep;
• headache, dizziness;
• infections;
• benign stomach polyps.

Uncommon:

• nervousness;
• drowsiness;
• bronchitis (inflammation of the bronchial tubes), sinusitis (inflammation of the sinuses);
• 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;
• fractures of the hip, wrist, or spine.

Rare:

• blood disorders such as reduced white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections;
• 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 or mouth, altered taste;
• liver inflammation, jaundice (yellowing of the skin or eyes), brain disorder associated with liver failure (hepatocellular insufficiency);
• itching, sweating, skin blisters;
• kidney inflammation (interstitial nephritis);
• weight gain.

Very rare:

• sudden onset of severe skin 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:

• low sodium levels in the blood;
• confusion;
• swelling of feet and ankles;
• breast enlargement in men;
• erythema, possible joint pain;
• intestinal inflammation (causing diarrhea);
• patients with previous liver problems may very rarely develop encephalopathy (brain disease).

If you take AKIRAB 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, consult
your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium.
Your doctor should decide whether to monitor your blood magnesium levels regularly.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor
or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps
provide more information on the safety of this medicine.

5. How to store Akirab

Keep this medicine out of the sight and reach of children.
Blister pack: store below 25°C. Keep in the original packaging to protect from moisture.
Do not use Akirab 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. Contents of the pack and other information

What AKIRAB contains

• The active substance is sodium rabeprazole. Each AKIRAB 10 mg gastro-resistant tablet contains 10 mg of sodium rabeprazole. Each AKIRAB 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, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

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

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Responsible manufacturer for batch release
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

Revision of the package leaflet: