RABEX 10 мг Энтеросолирующая таблетка
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Инструкция по применению RABEX
Содержание инструкции
RABEX 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
Rabeprazole
Generic medicine
Read this leaflet carefully before taking this medicinebecause 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, because it could be dangerous.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What RABEX is and what it is used for
- 2. What you need to know before you take RABEX
- 3. How to take RABEX
- 4. Possible side effects
- 5. How to store RABEX
- 6. Contents of the pack and other information
1. WHAT IS RABEX 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 stomach ulcers.
- gastro-oesophageal reflux disease (GERD) with or without ulcers. Gastro-oesophageal reflux disease is commonly called inflammation of the oesophagus caused by acid and is associated with heartburn. Heartburn is a burning sensation that starts in the stomach or lower chest and extends up to the neck. RABEX can be used as long-term (maintenance) treatment of gastro-oesophageal reflux disease. RABEX can also be used for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GERD).
- Zollinger-Ellison syndrome which is a disease characterised by the production of an extremely high amount of acid in the stomach.
In association with two antibiotics (clarithromycin and amoxicillin) RABEX is used for the eradication of the infection
from H pyloriin patients affected by peptic ulcer. For further information on the antibiotics used in the
eradication therapy of H pylori, see their respective package leaflets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEX
Do not take RABEX
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- If you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of 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 that contain other proton pump inhibitors.
- If you have or have had 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 RABEX, which reduces stomach acid. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with RABEX. Also remember to report any other unwanted effects such as joint pain. If these conditions apply to you, talk to your doctor before using RABEX.
The doctor may have performed or is performing another examination called an endoscopy to diagnose your condition
and/or exclude a malignant disease. The possibility of stomach and esophageal tumors must be excluded
before starting treatment.
If you take RABEX for a long period of time (over 1 year), your doctor will probably subject you to a
periodic monitoring. When you see your doctor, you should report all new or different symptoms that you have noticed.
During treatment with RABEX, some abnormal blood values have been reported. Generally, the values
return to normal when treatment is stopped.
Children
RABEX is not recommended in children.
If you take a proton pump inhibitor such as RABEX, especially for a period longer than one year, you
may experience a slight increase in the risk of fractures of the hip, wrist or spine. If
you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult
your doctor.
Other medicines and RABEX
Tell 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 RABEX if you are taking atazanavir.
- ketoconazole or itraconazole (used to treat infections caused by a fungus).
Pregnancy and breastfeeding
RABEX must not be used during pregnancy or breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
It is unlikely that RABEX will have a negative effect on your ability to drive a car or operate machinery.
However, rabeprazole can occasionally cause drowsiness. Therefore, if you feel drowsy, you should
avoid driving or using complex machinery.
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3. HOW TO TAKE RABEX
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is:
Adults and the elderly
Duodenal ulcers and benign gastric ulcers:20 mg of RABEX to be taken once a day in the morning. The
majority of patients suffering from duodenal ulcer are treated for four weeks and the majority of
patients affected by benign stomach ulcer are treated for six weeks. However, some
patients may require further treatment to achieve healing.
Gastroesophageal reflux disease with ulcer:20 mg of RABEX to be taken once a day for four-
eight weeks.
Long-term treatment of gastroesophageal reflux disease (GERD): 10 mg or 20 mg of RABEX once
a day depending on the response.
Symptomatic treatment of gastroesophageal reflux disease:10 mg of RABEX once a day for
4 weeks. Once the symptoms have disappeared, your doctor may tell you to take 10 mg of RABEX once a day
as needed for subsequent symptom control.
Zollinger-Ellison syndrome:60 mg of RABEX once a day to start. The dose may be
subsequently adjusted by the doctor depending on the response to treatment. Your doctor will tell you how
many tablets to take and when.
Eradication of H. pylori:20 mg of RABEX to be taken twice a day, usually for 7 days (in
association with two antibiotics: clarithromycin and amoxicillin).
Use in children
RABEX is not recommended 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 a day, the tablets should be taken in the morning before
breakfast.
If you take moreRABEX 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 a missed dose. If you forget to take a dose,
take it as soon as you remember. If it is almost time to take the next dose, wait until that time.
Do not take a double dose to make up for a missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, RABEX can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking RABEX and consult your doctor immediately:
- Sudden shortness of breath, swelling of lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
- Yellowing of the skin, dark urine and fatigue, which can be symptoms of liver problems.
- Redness of the skin with blisters or peeling and which may be associated with high fever and joint pain. There may also be severe blisters and bleeding of the lips,
Pag. 3to 6
of the eyes, mouth, nose and genitals. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Common side effects (may affect up to 1 in 10 people): 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
- drowsiness
- headache, dizziness
- infection
- Benign polyps in the stomach Uncommon side effects (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
- 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 side effects (may affect up to 1 in 1,000): blood problems such as a decrease in white blood cells or platelets. This can cause weakness, bruising or increase the likelihood of infections.
- increase in the number of white blood cells
- allergic reactions including swelling of the face, low blood pressure and difficulty breathing
- loss of appetite
- depression
- altered vision
- inflammation of the stomach, mouth, altered taste
- inflammation of the liver, jaundice (yellowing of the skin or corneas), brain disorder associated with liver failure (hepatocellular insufficiency)
- itching, sweating, blisters on the skin
- inflammation of the kidneys (interstitial nephritis)
- weight gain
- Very rare side effects (may affect up to 1 in 10,000): 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)) Side effects with unknown frequency (the frequency of which cannot be estimated based on available data):
- low levels of sodium in the blood
- confusion
- swelling of the feet and ankles
- enlargement of the breasts in men
- erythema, possible joint pain
If you take RABEX for more than three months, your blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation,
Pag. 4to 6
seizures, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to regularly check magnesium levels in the blood.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.qov.itfit/responsabili . By reporting side effects 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.
Blisters: store at a temperature below 25°C. Store in the original package to protect the
medicine from humidity.
Do not use RABEX after the expiry date which is stated on the carton, blister and label after EXP. The
expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. FURTHER INFORMATION
What RABEX contains
The active ingredient is rabeprazole sodium.
Each RABEX 10 mg gastroresistant tablet contains 10 mg of rabeprazole sodium.
Each RABEX 20 mg gastroresistant tablet contains 20 mg of rabeprazole sodium.
The excipients are: tablet core: povidone, mannitol(E421), light magnesium oxide,
low substituted hydroxypropylcellulose, magnesium stearate; coating: ethylcellulose, light
magnesium oxide; gastrointestinal coating: ethyl acrylate methacrylate 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 RABEX and contents of the pack
RABEX 10 mg gastroresistant tablets: biconvex, elliptical, pink, coated tablet.
RABEX 20 mg gastroresistant tablets: biconvex, elliptical, yellow, coated tablet.
Pack:14 tablets in blisters.
Marketing Authorisation Holder
S.F. GROUP Srl – Via Tiburtina 1143 – 00156 Roma
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
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3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
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- Страна регистрации
- Форма выпускаEnteric-coated tablet, 10 MG
- Код АТХA02BC04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги RABEXФорма выпуска: Enteric-coated tablet, 10 MGДействующее вещество: рабепразолаОтпускается по рецептуФорма выпуска: Enteric-coated tablet, 10 MGДействующее вещество: рабепразолаПроизводитель: JANSSEN CILAG S.P.A.Отпускается по рецептуФорма выпуска: Enteric-coated tablet, 10 MGДействующее вещество: рабепразолаПроизводитель: LABORATORI ALTER S.R.L.Отпускается по рецепту
Аналоги RABEX в других странах
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Аналог RABEX в Испания
Аналог RABEX в Польша
Аналог RABEX в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
RABEX требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество RABEX — рабепразола. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
RABEX производится компанией S.F. GROUP S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения RABEX с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить RABEX в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (рабепразола) включают AKIRAB, PARIET, RABEPRATSOLO ALTER. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
