ACILESOL gastro - resistant table. 20 mg.

What Acilesol and what it is used
Acilesol belongs to a group of medicines called proton pump inhibitors . Atsilesol works by reducing the amount of acid produced by the stomach

Acilesol used for treatment of :
ulcers in the upper intestine ( duodenal ulcers ) and benign gastric ulcer ;
gastro-oesophageal reflux disease (GERD ) with or without ulceration. GERD is often characterized by inflammation of the esophagus caused by acids and associated with heartburn . Heartburn is a burning sensation in the stomach rising or lower chest up to the neck . Atsilesol can be used as long-term treatment of GERD (GERD maintenance therapy ) ;
Syndrome called Zollinger - Ellison (Zollinger-Ellison), a condition where the stomach acid levels produced by oversize .
In combination with two antibiotics (clarithromycin and amoxicillin ) Atsilesol used for the eradication of Helicobacter pylori infection in patients with peptic ulcer disease . For more information about the antibiotics used in eradication therapy Helicobacter pylori, see leaflet with information about the patient .

2 . Before you take Atsilesol
Do not take Atsilesol
if you are allergic (hypersensitive) to rabeprazole sodium or any 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 Atsilesol :
if you are allergic to other proton pump inhibitors ;
if you have or have had liver problems;
if you take a medicine called atazanavir (atazanavir) ( used to treat HIV- infection).
If any of the above applies to you , talk to your doctor before using Atsilesol .
Your doctor may perform or have performed an additional study, called endoscopy to diagnose your condition and / or exclude malignancy. The possibility of the presence of tumors in the stomach or the esophagus should be turned off before the start of treatment.
If you take Atsilesol term (more than 1 year) Your doctor will likely monitor you regularly. Should report any new or different symptoms when your doctor.
Taking proton pump inhibitors as Atsilesol , especially for a period longer than one year can increase the risk of fracture of the hip , wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) .
There have been some anomalies in blood values during treatment with Atsilesol . Usually normalized when treatment is discontinued.

children
Atsilesol use in children is not recommended.

Other medicines and Acilesol
Please tell your doctor or pharmacist if you are taking , have recently taken or may take any other medicines .
This is especially important if you are taking any of the following :
atazanavir (used to treat AIDS ) ; not recommended to take Atsilesol if you are taking atazanavir ;
ketoconazole or itraconazole (used for the treatment of infections caused by fungi) .
Pregnancy and lactation
Atsilesol should not be used in pregnancy and lactation .
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Atsilesol is unlikely to affect your ability to drive or operate machinery.
However, rabeprazole may sometimes cause drowsiness. Therefore, if you are affected , you should avoid driving or operating complex machinery .

3 . How to take Atsilesol
Always take this medicine exactly as recommended by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and elderly
Duodenal ulcer and benign gastric ulcer : one 20 mg tablet Atsilesol should be taken once daily in the morning . In most patients with duodenal ulcer healing was achieved within four weeks, and most patients with benign gastric ulcers fail to heal within six weeks. A small number of patients may require additional treatment to achieve cure.

Gastro- oesophageal reflux disease (GERD ) with ulcer : one 20 mg tablet Atsilesol should be taken once daily for four to six weeks.

Long-term treatment of GERD : one 20 mg tablet once a day Atsilesol depending on the therapeutic response .

Syndrome Zollinger-Ellison: to start with a 60 mg tablet once a day Atsilesol . The dose may be adjusted by your doctor depending on how you respond to treatment. Your doctor will tell you how many tablets to take and when to take them .

Eradication of Helicobacter pylori: a 20 mg tablet Atsilesol must be taken twice daily and generally for 7 days ( in combination with two antibiotics - clarithromycin, and amoxicillin ) .

Use in children
Acilesol not recommended for use in children .

Instructions for use
The tablets should be swallowed whole with half a glass of water , they can not be chewed or crushed.
When Atsilesol taken once daily tablets should be taken in the morning before breakfast.

If you take more than you need Atsilesol
If you take more than Atsilesol your doctor or seek medical attention.

If you forget to take Acilesol
Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as you remember. If it is almost time to take your next dose, wait until then.

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 Atsilesol and call your doctor immediately:
Sudden wheezing, swelling of the lips, face and body , rashes , seizures , or difficulty swallowing ( severe allergic reaction) ;
Yellowing of the skin , dark urine, and fatigue , which can be signs of liver problems ;
Skin redness blistering or peeling which can be coupled with a high temperature and joint pain . There may also be severe blisters and bleeding in the lips , eyes, mouth , nose and genitals. This could be erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis .
The frequency of possible side effects listed below are certain circumstances:
Very common: affects more than 1 in 10;
Common: affects 1 to 10 of 100 ;
Uncommon: affects 1 to 10 of 1000 ;
Rare: affects 1 to 10 10 000 ;
Very rare: affects less than 1 in 10,000 ;
Not known: frequency can not be estimated from available data.
Common:
Cough , sore throat (inflammation of the pharynx ) , runny nose ;
Nausea, vomiting, abdominal pain , diarrhea , constipation, gas ( flatulence ) ;
Back pain, nonspecific pain - Weakness or loss of strength, symptoms similar to influenza ;
insomnia ;
Headache , dizziness ;
Infection.
Uncommon:
nervousness ;
drowsiness;
Inflammation of the bronchial tubes ( bronchitis ) , inflammation of the sinuses ( sinusitis ) ;
Indigestion , dry mouth , belching ;
Rash , skin redness (erythema ) ;
Muscle pain , joint pain, leg cramps ;
Urinary tract infection ;
Chest pain, chills , fever ;
Elevations of liver enzymes that are measured by blood tests ;
Fracture of the hip , wrist or spine.
rare:
Blood troubles such as decrease in the number of white blood cells or platelets. This can lead to weakness , bruising or make infections more likely ;
Increased number of white blood cells;
Allergic reactions including swelling of the face , low blood pressure and difficulty breathing ;
Loss of appetite ;
depression ;
Visual impairment ;
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 , swelling , blistering ;
Kidney inflammation ( nephritis ) ;
Weight gain.
Very rare:
Sudden onset of severe rash or blistering or peeling of the skin. This may be associated with a high temperature and joint pain ( erythema multiforme , Stevens -Johnson syndrome , toxic epidermal necrolysis) .
Not known:
Low sodium levels in the blood ;
confusion ;
Swelling of feet and ankles ;
Breast enlargement in men ;
If you take Atsilesol for more than three months , it is possible magnesium levels in your blood decrease. Low levels of magnesium may occur with fatigue, involuntary muscle twitching, disorientation, convulsions, dizziness , increased heart rate . If you experience any of these symptoms , please contact your doctor immediately . Low levels of magnesium is also possible to bring about a decrease in the levels of potassium and calcium levels . Your doctor may decide to hold regular blood tests to monitor your levels of magnesium.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .

5 . How to store Acilesol
Keep out of reach of children.
Blisters: Do not store above 25 ° C. Store in the original package to protect from moisture.
Tablet : Store below 25 ° C. Keep container tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the carton, blister pack and label after 'EXP' . The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Contents of the pack and other information
What does Atsilesol
The active substance is sodium rabeprazole . Each tablet contains 20 mg of rabeprazole sodium.
Other ingredients are:
Core: povidone , mannitol ( E421), light magnesium oxide, low substituted hydroxypropyl cellulose, magnesium stearate;
inner shell : ethyl cellulose, light magnesium oxide; gastro-resistant coating: methacrylic acid - ethylacrylate , polysorbate 80 , sodium lauryl sulfate , propylene glycol, talc , yellow iron oxide (E172 ), titanium dioxide ( E171 ) .
Looks like and contents of the pack Atsilesol
Atsilesol 20 mg gastro-resistant tablets: yellow, film-coated , oval , biconvex tablets.