RABEPRAZOLO 10 mg Tabletki Powlekane
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Jak stosować RABEPRATSOLO DOK JENERIKI
Treść ulotki
- RABEPRAZOLO DOC Generici 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
- RABEPRAZOLO DOC Generici 10 mg: pink, film-coated, oblong, biconvex tablet, 20 mg: yellow, film-coated, oblong, biconvex tablet.
RABEPRAZOLO DOC Generici 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
Generic medicine
Read this leaflet carefully before taking this medicine as 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What RABEPRAZOLO DOC Generici is and what it is used for
- 2. What you need to know before you take RABEPRAZOLO DOC Generici
- 3. How to take RABEPRAZOLO DOC Generici
- 4. Possible side effects
- 5. How to store RABEPRAZOLO DOC Generici
- 6. Contents of the pack and other information
1. What is RABEPRAZOLO DOC Generici and what is it used for
RABEPRAZOLO DOC Generici belongs to a group of medicines called proton pump inhibitors (PPIs).
RABEPRAZOLO DOC Generici works by reducing the amount of acid produced by the stomach.
RABEPRAZOLO DOC Generici is used to treat:
- ulcer of the upper digestive tract (duodenal ulcer) and benign stomach ulcer;
- gastroesophageal reflux disease (GERD) with or without ulcer. GERD is commonly described as inflammation of the esophagus caused by acid and associated with heartburn. Heartburn is a burning sensation that goes from the stomach or chest up to the neck. RABEPRAZOLO DOC Generici can also be used for the long-term treatment of gastroesophageal reflux disease (GERD maintenance therapy). RABEPRAZOLO DOC Generici can also be used for the symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD);
- Zollinger-Ellison syndrome, a condition in which the stomach produces extremely high amounts of acid.
In association with two antibiotics (clarithromycin and amoxicillin) RABEPRAZOLO DOC Generici
is used for the eradication of H. pyloriinfection in patients with peptic ulcer. For further
information on the antibiotics used in H. pylorieradication therapy, please read their respective
package leaflets.
2. What you need to know before taking RABEPRAZOLO DOC Generici
Do not take RABEPRAZOLO DOC Generici:
- if you are allergic to rabeprazole sodium or 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 or pharmacist before taking RABEPRAZOLO DOC Generici
- if you are allergic to other proton pump inhibitors
- if you have or have had any 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 RABEPRAZOLO DOC Generici that reduces stomach acid
- if you are going to have a specific blood test (Chromogranin A).
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop therapy with
RABEPRAZOLO DOC Generici. Remember to also report any other undesirable effects such as
joint pain.
Your doctor may have requested or may request a further examination called endoscopy in order to
diagnose your condition and/or exclude a malignant condition. The possibility of a tumor
in the stomach and esophagus must be excluded before starting treatment.
If you take RABEPRAZOLO DOC Generici for a long time (more than 1 year), your doctor
will probably check you regularly. You should report any new or different symptom each
time you see your doctor.
During treatment with RABEPRAZOLO DOC Generici, abnormal blood values have been reported.
Usually the values return to normal when the treatment is stopped.
If you are taking a proton pump inhibitor such as RABEPRAZOLO DOC Generici, especially
for a period longer than one year, there may be 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.
Contact your doctor or pharmacist immediately if you experience severe (watery or with blood) or
persistent diarrhea with symptoms such as fever, abdominal pain or discomfort, as rabeprazole
has been associated with a slight increase in infectious diarrhea.
Children
RABEPRAZOLO DOC Generici is not recommended for use in children.
Other medicines and RABEPRAZOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is particularly important if you are taking any of the following medicines:
- atazanavir (used to treat HIV); the use of RABEPRAZOLO DOC Generici is not recommended if you are taking atazanavir
- ketoconazole or itraconazole (used to treat fungal infections)
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
RABEPRAZOLO DOC Generici should not be used during pregnancy and breastfeeding.
Driving and using machines
It is unlikely that RABEPRAZOLO DOC Generici will affect your ability to drive or operate
machinery.
However, rabeprazole may occasionally cause drowsiness. Therefore, in these cases
you should avoid driving and operating complex machinery.
3. How to take RABEPRAZOLO DOC Generici
Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is:
Adults and the elderly
Duodenal ulcer and benign gastric ulcer:20 mg of RABEPRAZOLO DOC Generici to be
taken once a day in the morning. Most patients with duodenal ulcer are
treated for four weeks, most of those with benign stomach ulcer for six
weeks. However, some patients may require further treatment to achieve
healing.
Gastro-oesophageal reflux disease (GERD) with ulcer:20 mg of RABEPRAZOLO DOC
Generici to be taken once a day for 4 to 8 weeks.
Long-term treatment of gastro-oesophageal reflux disease:10 or 20 mg of
RABEPRAZOLO DOC Generici once a day depending on the response.
Symptomatic treatment of gastro-oesophageal reflux disease:10 mg of RABEPRAZOLO
DOC Generici once a day for 4 weeks. Once the symptoms have disappeared, the
doctor may tell you to take 10 mg of RABEPRAZOLO DOC Generici once a day as
needed for subsequent symptom control.
Zollinger-Ellison syndrome:60 mg of RABEPRAZOLO DOC Generici once a day to
start. The dose may be adjusted based on how you respond to treatment. Your doctor will tell you
how many tablets you should take and when.
Eradication of H. pylori infection:20 mg of RABEPRAZOLO DOC Generici twice a day
and normally for 7 days (in combination with two antibiotics – clarithromycin and
amoxicillin).
Use in children
The use of RABEPRAZOLO DOC Generici is not recommended in children.
Instructions for use
The tablets must be swallowed whole with half a glass of water and must not be
chewed or crushed.
When RABEPRAZOLO DOC Generici is taken once a day, the tablets must be
taken in the morning before breakfast.
If you take more RABEPRAZOLO DOC Generici than you should
If you take more RABEPRAZOLO DOC Generici than prescribed by your doctor, ask
for advice from your doctor.
If you forget to take RABEPRAZOLO DOC Generici
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 to take the next dose, wait until
then.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
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
RABEPRAZOLO DOC Generici and contact your doctor immediately:
- sudden wheezing, 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
- reddening of the skin with blisters or scales which may be associated with high fever and joint pain. Severe blister formation and bleeding may also occur on the lips, eyes, mouth, nose and genitals. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis
Common (may affect up to 1 in 10 people):
- cough, sore throat (pharyngitis), runny nose
- nausea, vomiting, abdominal pain, diarrhoea, constipation, wind (flatulence)
- back pain, non-specific pain
- weakness or loss of strength, flu-like symptoms
- drowsiness
- headache, dizziness
- infection
- benign polyps in the stomach
Uncommon (may affect up to 1 in 100 people):
- nervousness
- drowsiness
- inflammation of the airways (bronchitis), inflammation of the sinuses (sinusitis)
- indigestion, dry mouth, belching
- rash, redness of the skin (erythema)
- muscle pain, joint pain, leg cramps
- urinary tract infection
- chest pain, chills, fever
- increased liver enzymes, measured through blood tests
Rare (may affect up to 1 in 1,000 people):
- blood problems such as a reduction in the number of white blood cells or platelets. This can cause weakness, bruising or make infections more likely
- 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
- visual disturbances
- 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, sweating, blisters on the skin
- inflammation of the kidneys (interstitial nephritis)
- weight gain
Very rare (may affect up to 1 in 10,000 people):
- sudden onset of severe rash or blister formation 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 (frequency cannot be estimated from the 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 pains
- inflammation of the intestine (causing diarrhoea)
If you take RABEPRAZOLO DOC Generici for more than three months, it is possible that blood levels of
magnesium may decrease. Low levels of magnesium can manifest with fatigue,
involuntary muscle contractions, disorientation, convulsions, dizziness, 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 periodically 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.gov.it/it/responsabili”.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store RABEPRAZOLO DOC Generici
Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C. Store in the original package to protect
from humidity.
Do not use this medicine after the expiry date which is reported on the box and on the blister after
“EXP”. The expiry date refers to the last day of that 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. Contents of the pack and other information
What RABEPRAZOLO DOC Generici contains
- The active ingredient is rabeprazole sodium. Each tablet contains 10 or 20 mg of rabeprazole sodium.
- The other ingredients are: core: povidone, mannitol (E421), light magnesium oxide, low substituted hydroxypropylcellulose, magnesium stearate; coating: hydroxypropyl methylcellulose, light magnesium oxide; gastro-resistant 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 RABEPRAZOLO DOC Generici and contents of the pack
RABEPRAZOLO DOC Generici 10 mg: pink, film-coated, oblong, biconvex tablet, 20 mg: yellow, film-coated, oblong, biconvex tablet.
Package containing 14 tablets in blisters.
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy
Manufacturers
Actavis hf
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This medicinal product has been authorised in the Member States of the European Economic Area
with the following denominations:
Estonia: RABEPRAZOLE DOC Generici
Italy: RABEPRAZOLO DOC Generici gastro-resistant tablets
This leaflet was last updated in
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- Kraj rejestracji
- Postać farmaceutycznaEnteric-coated tablet, 10 MG
- Kod ATCA02BC04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki RABEPRATSOLO DOK JENERIKIPostać farmaceutyczna: Enteric-coated tablet, 10 MGSubstancja czynna: rabeprazoleWymaga receptyPostać farmaceutyczna: Enteric-coated tablet, 10 MGSubstancja czynna: rabeprazoleProducent: JANSSEN CILAG S.P.A.Wymaga receptyPostać farmaceutyczna: Enteric-coated tablet, 10 MGSubstancja czynna: rabeprazoleProducent: LABORATORI ALTER S.R.L.Wymaga recepty
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Substancją czynną w RABEPRATSOLO DOK JENERIKI jest rabeprazole. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
RABEPRATSOLO DOK JENERIKI jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie RABEPRATSOLO DOK JENERIKI jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Możesz kupić RABEPRATSOLO DOK JENERIKI w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (rabeprazole) to m.in. AKIRAB, PARIET, RABEPRATSOLO ALTER. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
