ZULBEX 20 mg. 28 tablets
Zulbex tablets contain rabeprazole. It belongs to a class of drugs called proton pump inhibitors. They act by reducing the amount of acid produced in the stomach.
Zulbex tablets are used for:
• Active duodenal ulcer and active benign gastric / stomach ulcer (peptic ulcer).
Symptomatic erosive or ulcerative gastroesophageal reflux disease (GERD), which is commonly called inflammation of the esophagus caused by acid and associated with an increase heartburn, or for long-term treatment of GERD (maintenance treatment of GERD).
Symptomatic treatment of moderate to very severe gastro-oesophageal refluksivna disease (symptomatic GERD), also associated with increased heartburn.
Syndrome Zollinger-Ellison, a rare disease in patients whose stomachs produce very large amounts of acid.
In combination with two antibiotics (clarithromycin and amoxicillin) Zulbex tablets are used for the eradication of H Pylori infection in patients with peptic ulcer disease
2. BEFORE YOU TAKE ZULBEX
Do not take Zulbex:
- If you are allergic (hypersensitive) to rabeprazole or any other ingredients of Zulbex
- - If you are pregnant, think you may be pregnant or are breast-feeding (see "Pregnancy and lactation")
Take special care with Zulbex
Tell your doctor or pharmacist:
- If you are allergic to other proton pump inhibitors
- If you have a stomach tumor
- If you have a history of liver disease
- If you are taking atazanavir (a medicine used to treat AIDS)
- If you are taking this medicine for a long time, your doctor will want to monitor you.
In some patients have blood problems and liver problems, which resolved after discontinuation of rabeprazole.
Taking proton pump inhibitors as Zulbex, especially for a period longer than one year may slightly increase the risk of fractures of the hip, wrist or spine to you. Tell your doctor if you have osteoporosis or are taking corticosteroids (they may increase the risk of osteoporosis).
Zulbex should not be used in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor or pharmacist:
- If you are taking ketoconazole or igrakonazol (medicines used to treat fungal infections)
- If you are taking atazanavir (a medicine used to treat HTV)
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine. Do not take Zulbex tablets if you are pregnant or think you may be pregnant. Do not take Zulbex tablets if you are breastfeeding or plan to breastfeed.
Driving and using machines
You may feel sleepy during the intake Zulbex. If this happens, that drive or operate any tools or machines.
2. HOW TO TAKE ZULBEX?
Always take Zulbex exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
You should swallow whole tablets ZULBEX. DO NOT crush, or chew!
The dosages below are those which are generally recommended for adults and elderly. Do not change the dose or duration of treatment itself. Zulbex should not be used in children.
Active duodenal ulcer and active benign gastric ulcers: The usual dose is one tablet Zulbex 20 mg once daily. If you have an active duodenal ulcer, the treatment is expected to last for four weeks, but after that time your doctor may decide to continue your treatment for another four weeks.
If you have an active benign gastric ulcer, the treatment is expected to last six weeks, but after that time your doctor may decide to continue your treatment for a further six weeks.
Erosive or ulcerative gastroesophageal reflux disease: The usual dose is one tablet Zulbex 20 mg once daily. Your treatment is expected to last for four weeks, but after that time your doctor may decide to continue your treatment for another four weeks.
Maintenance treatment of GERD
The usual dose is one tablet Zulbex 10 mg or 20 mg once daily. Your doctor will advise you on how long to take tablets. You should regularly consult and browse your doctor,, to assess the effect of tablets and your symptoms.
The usual dose is one tablet Zulbex 10 mg once daily. Your treatment once daily is expected to last up to four weeks. If symptoms do not disappear within four weeks, consult your doctor. After these initial four weeks of treatment if your symptoms recur, your doctor may tell you to take one tablet Zulbex 10 mg, and be taken only when necessary to control symptoms.
The usual recommended dose is three tablets Zulbex 20 mg once a day in the beginning. 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. You should see your doctor at regular intervals for a review to assess the operation of your tablet and your symptoms.
Eradication of H. pylori
The usual recommended dose is 20 mg Zulbex which must be taken (in combination two antibiotics - clarithromycin 500 mg and amoxicillin 1 g) twice daily, usually 7 days. Relief of symptoms will normally occur before the ulcer has healed completely. Therefore, it is important not to stop taking the tablets until your doctor tells you. For more detailed information on other drugs for eradication of H. pylori see their leaflets with information about products.
If you take more tablets Zulbex than you should
Do not take more tablets than prescribed. If you take more tablets than the prescribed dose please consult your doctor or hospital immediately. Always take the tablets and the container with you to the hospital so that the doctor knows what has been accepted!
If you forget to take Zulbex
If you forget to take a dose, just take it as soon as you remember and then continue as usual. If you forget to take your medicine for more than 5 days, call your doctor before taking a higher dose of the drug.
Do not take a double dose to make up. If you stop taking Zulbex
Do not change the dose or stop treatment without discussing it with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zulbex can cause side effects, although not everybody gets them.
Very common: may affect 1 in 10 people
Common: may affect 1 to 10 users in 100
Nechesgi: may occur in 1 to 10 of 1000 users
Rare: may occur in 1 to 10 10 000 users
Very rare, can occur in less than 1 in 10 000 users
Not known: frequency can not be made from the available data.
Stop taking Zulbex and see a doctor immediately if you notice redness of the skin with blisters or peeling. Can be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be a syndrome "Stevens-Johnson" or toxic epidermal necrolysis.
Other possible side effects:
- Insomnia (difficulty sleeping), headache, dizziness
- Cough, pharyngitis (sore throat), rhinitis (runny nose)
- Diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence (gas)
- Pain without a cause, back pain
- Asthenia (weakness), flu syndrome
- Nervousness or drowsiness Bronchitis, sinusitis
- Dyspepsia (indigestion), dry mouth, belching
- Skin rash, redness of the skin
- Muscle or joint pain, leg cramps, fractures of the hip, wrist or spine
- Urinary tract infection Chest Pain
- Chills, fever
- Changes in values in liver function tests
- Anorexia (loss of appetite) Depression
- Hypersensitivity - severe and sudden allergic reaction such as facial swelling, low blood pressure and shortness of breath, which disappears after discontinuation.
- Visual disturbances
- Gastritis (stomach upset or pain in the stomach), stomatitis (sore mouth), taste disturbances
- Liver problems such as hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and whites of the eyes), hepatic encephalopathy (brain damage due to disease of the liver)
- Itching, sweating, skin blisters (these effects usually disappear after cessation of treatment)
- Kidney problems, such as interstitial nephritis (connective tissue disease in the kidneys)
- Weight gain Changes in white blood cells:
- Neutropenia (decrease of neutrophils, a type of white blood cells) or leukopenia (decreased white blood cell count) - the reduction of the white blood cells, leading to frequent infections, such as sore throat or high temperature (fever), or mouth ulcers or throat. Leukocytosis (increased white blood cell count), thrombocytopenia (reduction of blood platelets) - decreased blood platelets leads to bleeding or bruising more easily than usual.
Severe skin reactions:
Erythema multiforme (skin with blisters) Toxic epidermal necrolysis (severe skin damage with damage to the top layer of skin from the lower layers of the skin on the body) Syndrome Stevens-Johnson (large blisters, peeling and bleeding under the skin and also in the lips, eyes, mouth and nose)
- Not known:
- Swelling of the legs or ankles
- Swelling of the male breast
- Hyponatremia (low sodium levels in the blood) - the symptoms are feeling sick and unwell with muscle weakness or confusion. If you are taking rabeprazole more than three months is possible levels of magnesium in your blood to fall. Low magnesium levels can occur with nausea, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor immediately. Low levels of magnesium can also lead to a reduction in the potassium or calcium level in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZULBEX?
Keep out of the reach of children.
Zulbex not use after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Store in the original package in order to protect from moisture and light. Do not store above 30 ° C.