RABEPRAZOLO 10 mg Tabletki Powlekane

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1. Rabeprazolo TecniGen 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is Rabeprazolo TecniGen and what it is used for
   2. What you need to know before taking Rabeprazolo TecniGen
   3. How to take Rabeprazolo TecniGen
   4. Possible side effects
   5. How to store Rabeprazolo TecniGen
   6. Package contents and other information

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

1. What is Rabeprazolo TecniGen and what it is used for

Rabeprazolo TecniGen contains the active ingredient rabeprazole sodium. It belongs to a group of
medicines called proton pump inhibitors (PPIs), which work by reducing the amount of acid
produced by the stomach.
Rabeprazolo TecniGen gastro-resistant tablets is used:

• to treat active duodenal ulcers (ulcers of the upper part of the intestine);
• to treat active benign gastric ulcers (ulcers of the stomach);
• to treat gastroesophageal reflux disease (GERD), generally described as inflammation of the esophagus, associated with pain, discomfort and heartburn, caused by the reflux of stomach acid and food into the esophagus, both of moderate to very severe degree, and in the erosive and ulcerative form;
• for the long-term therapy of GERD (GERD maintenance therapy);
• for patients with an extremely high level of stomach acid, a condition called Zollinger-Ellison syndrome;
• for the eradication of the bacterium Helicobacter pylori( H. pylori) in patients with peptic ulcer in association with appropriate antibacterial therapeutic regimens.

2. What you need to know before taking Rabeprazolo TecniGen

Do not take Rabeprazolo TecniGen
If you are allergic to rabeprazole sodium or to any of the other ingredients of this medicine
(listed in section 6).
If you are pregnant or think you may be pregnant.
If you are breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazolo TecniGen.
Tell your doctor before taking this medicine if:
you are allergic to other proton pump inhibitors belonging to the benzimidazole group, because
you may also be allergic to rabeprazole;
you have been diagnosed with a tumor of the stomach or esophagus;
you have problems with your liver; your doctor will take particular care at the beginning of treatment with
Rabeprazolo TecniGen and during the entire therapy;
you are taking atazanavir (used for HIV/AIDS infection) (see below “Other medicines
and Rabeprazolo TecniGen”);
you need to undergo a specific blood test (Chromogranin A).
During treatment with Rabeprazolo TecniGen, cases of alterations in blood tests (reduction in platelet count or white blood cells, alteration of liver enzymes) have been reported, which
generally return to normal levels at the end of treatment.
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
TecniGen. Remember to report any other undesirable effects such as joint pain.
If you have severe diarrhea (watery or with blood) with symptoms such as fever, pain or abdominal tenderness, stop taking Rabeprazolo TecniGen and see your doctor.
Taking a proton pump inhibitor such as Rabeprazolo TecniGen, particularly for a period longer than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which
can increase the risk of osteoporosis).
Long-term use, for at least three months, of medicines such as Rabeprazolo TecniGen may
lead to a reduction in magnesium levels in the blood: this reduction can cause serious manifestations
such as fatigue, tetany (spasms and involuntary muscle contractions), delirium, convulsions,
dizziness and ventricular arrhythmia (a type of heart rhythm disturbance) or it may begin in a
insidious way.
If you are undergoing prolonged treatment or if you take Rabeprazolo TecniGen together with digoxin (a
medicine used for heart conditions) or medicines that can cause a reduction
in magnesium levels in the blood (e.g. diuretics), your doctor may consider it appropriate to have blood tests before starting treatment and periodically during treatment.
During the intake of 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,
rash and joint stiffness. You should report these signs to your treating physician.

Other medicines and Rabeprazolo TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole or itraconazole (medicines used to treat fungal infections): Rabeprazolo TecniGen may reduce the amount of these medicines in the blood. Your doctor may consider adjusting the dose of ketoconazole or itraconazole.
• Atazanavir (used in the treatment of HIV infection): Rabeprazolo TecniGen may reduce the amount of this medicine in the blood. These medicines should not be taken together.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Rabeprazolo TecniGen if you are pregnant or think you may be.
Do not use Rabeprazolo TecniGen if you are breastfeeding.

Driving and operating machinery
During the intake of Rabeprazolo TecniGen you may feel drowsy. If this happens, do not
drive and do not use tools or machinery.

Rabeprazolo TecniGencontains small amounts of ethanol (alcohol) less than 100 mg per dose.

Rabeprazolo TecniGencontains mannitol: it may have a mild laxative effect.

3. How to take Rabeprazolo TecniGen

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts consult your doctor or pharmacist.
Taking of Rabeprazolo TecniGen

• Remove the tablet from the blister immediately before taking it.
• Swallow the tablet whole with a glass of water, preferably before breakfast. Do not chew or crush the tablets.
• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.
• If you take the medicine for a prolonged period of time, your doctor will need to keep you under control.

Adults and Elderly
Treatment of duodenal ulcer (active duodenal ulcer)

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 20 mg once a day for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue the treatment for another four weeks if your condition does not improve.

Treatment of gastric ulcer (active benign gastric ulcer)

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 20 mg once a day for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue the treatment for another six weeks if your condition does not improve.

“Gastroesophageal Reflux Disease” (GERD)
Treatment of moderate to very severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 10 mg once a day for four weeks.
• Take the tablet in the morning before breakfast.
• If the symptoms continue after 4 weeks of treatment, your doctor will subject you to further investigations. After resolving the symptoms, the doctor may decide to resume treatment with 1 tablet of Rabeprazolo TecniGen 10 mg if the symptoms reappear, for the time he deems necessary.

Treatment of symptomatic erosive or ulcerative GERD

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 20 mg once a day for 4-8 weeks.
• Take the tablet in the morning before breakfast.

Long-term treatment of GERD (GERD maintenance therapy)

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 10 mg or 20 mg once a day for the time indicated by the doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will want to review you at regular intervals to assess symptoms and dosage.

Treatment and prevention of ulcers caused by Helicobacter Pylori infections

• The recommended dose is 1 tablet of Rabeprazolo TecniGen 20 mg twice a day for seven days.
• Your doctor will prescribe you to also take antibiotics called amoxicillin and clarithromycin. For further information on the other medicines used in the treatment of Helicobacter pyloriinfection, please consult the relevant package leaflets.

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 Rabeprazolo TecniGen 20 mg once a day.
• The dose may subsequently be adjusted by the doctor based on your response to treatment. If you are on long-term treatment, you will need to see your doctor at regular intervals to check symptoms and review the dose.

Use in children
The medicine should not be used in children.

Patients with kidney problems
No dosage adjustments are necessary in patients with kidney problems.

Patients with liver problems.
If you have liver problems, you should consult your doctor who will pay particular attention at the beginning of
your treatment with Rabeprazolo TecniGen and throughout the therapy.

If you take more Rabeprazolo TecniGen than you should
Seek immediate medical or pharmacist advice if you take more Rabeprazolo TecniGen than
you should.

If you forget to take Rabeprazolo TecniGen
If you forget to take a dose, take the tablet immediately when you remember and continue
therapy as usual. Do not take the forgotten tablet if it is almost time to take the next dose.
Do not take a double dose to make up for the missed tablet.

If you stop taking Rabeprazolo TecniGen
Do not stop taking Rabeprazolo TecniGen gastro-resistant tablets just because you feel
better, before your doctor tells you to do so, because you may not be cured.
If you have any doubts about the use of 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.
manifest.

If you experience any of the following side effects, stop taking Rabeprazolo
TecniGen and tell your doctor:
Allergic reactions, symptoms may include sudden swelling of the face, difficulty
breathing or low blood pressure which can cause fainting or collapse.
Frequent infections, such as sore throat, high temperature (fever) or mouth or throat ulcers.
Bruising or bleeding easily.
Severe blistering, redness or ulcers of the mouth and throat.
With Rabeprazolo TecniGenthe following side effects have been observed:

Common side effects(may affect up to 1 in 10 people) :
Infections.
Difficulty sleeping (insomnia).
Headache or dizziness.
Cough, runny nose (rhinitis) or sore throat (pharyngitis).
Abdominal pain, diarrhoea, flatulence, feeling unwell (nausea), vomiting or constipation.
Non-specific pain, back pain.
Weakness (asthenia) or flu-like symptoms.
Benign polyps in the stomach.

Uncommon side effects(may affect up to 1 in 100 people) :
Nervousness.
Drowsiness.
Upper respiratory tract infection (bronchitis).
Inflammation of the sinuses (sinusitis).
Dry mouth.
Stomach discomfort caused by digestive problems (dyspepsia), belching.
Skin rash or redness.
Muscle pain, leg cramps, joint pain.
Hip, wrist or spine fracture (see Warnings and precautions).
Bladder and urinary tract infection.
Chest pain.
Chills or fever.
Changes in the results of liver function tests.

Rare side effects(may affect up to 1 in 1,000 people) :
Changes in the number of certain blood cells such as white blood cells (neutropenia,
leucopenia, leucocytosis) (evident from blood tests).
Reduction in the number of platelets (thrombocytopenia), evident from blood tests.
Hypersensitivity (including allergic reactions).
Loss of appetite (anorexia).
Depression.
Vision disorders.
Inflammation of the stomach (gastritis) or mouth (stomatitis).
Altered taste.
Liver problems, such as inflammation of the liver (hepatitis), brain damage due to liver
disease (hepatic encephalopathy) and yellowing of the skin and whites of the eyes (jaundice).
Itching, blistering reaction.
Sweating.
Kidney problems (interstitial nephritis).
Weight gain.

Very rare side effects(may affect up to 1 in 10,000 people) :
Acute allergic reaction with circular skin lesions (erythema multiforme).
Severe reactions with the formation of skin blisters (toxic epidermal necrolysis).
Severe skin reactions, formation of blisters on skin, mouth, eyes and genitals (Stevens-Johnson
syndrome).

Not known(frequency cannot be estimated from available data) :
Low levels of sodium in the blood.
Low levels of magnesium in the blood.
Confusion.
Swelling of the limbs (peripheral oedema).
Breast enlargement in men (gynaecomastia).
Erythema, possible joint pain (subacute cutaneous lupus erythematosus).
Inflammation of the intestine (causing diarrhoea)

Reporting of side effects
If you get any side effects, talk to 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 TecniGen

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not refrigerate.
Do not use this medicine after the expiry date which is stated on the packaging 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. Package contents and other information

What Rabeprazolo TecniGen contains:
The active ingredient is sodium rabeprazole.
Each Rabeprazolo TecniGen 10 mg tablet contains 10 mg of rabeprazole as the active ingredient.
sodium
The other excipients are:
mannitol, Trisodium phosphate, magnesium oxide, low substituted hydroxypropylcellulose H-11,
hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Aereosil 200). Coating:
ethylcellulose, magnesium oxide, ethanol, Eudragit L100 55, triethyl citrate, talc, titanium dioxide (E171),
red iron oxide (E172).
Each Rabeprazolo TecniGen 20 mg tablet contains 20 mg of rabeprazole as the active ingredient.
sodium
The excipients are:
mannitol, Trisodium phosphate, magnesium oxide, low substituted hydroxypropylcellulose H-11,
hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Aereosil 200).

Coating:ethylcellulose, magnesium oxide, ethanol, Eudragit L100 55, triethyl citrate, talc, titanium
dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Rabeprazolo TecniGen and package contents.
Rabeprazolo TecniGen 10 mg gastro-resistant tablets are pink, biconvex tablets.
Rabeprazolo TecniGen 20 mg gastro-resistant tablets are yellow, biconvex tablets.
The tablets are packaged in polyamide/aluminum/PVC/AL blisters of 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei 40,
20092 Cinisello Balsamo (MI) – Italy

Manufacturer
Laboratorios Alter S.A.
C/Mateo Inurria, 30, 28036
Madrid Spain