Rabeprozole Tecnigen

Package leaflet: Information for the user

Rabeprazole TecniGen 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rabeprazolo TecniGen contains the active substance 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 are used:

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

2. What you need to know before taking Rabeprazolo TecniGen

Do not take Rabeprazolo TecniGen
If you are allergic to sodium rabeprazole 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.
Inform 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 stomach or esophageal cancer;
you have liver problems; your doctor will exercise particular caution at the beginning of treatment with
Rabeprazolo TecniGen and throughout the 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, abnormalities in blood tests (reduced platelet count or white blood cells, altered liver enzymes) have been reported, which usually return to normal after treatment ends.

If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Rabeprazolo TecniGen. Remember to report any other adverse effects such as joint pain.

If you develop severe diarrhea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazolo TecniGen and contact your doctor.

Taking a proton pump inhibitor such as Rabeprazolo TecniGen, particularly for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroid medicines (which may increase the risk of osteoporosis).

Long-term use, for at least three months, of medicines such as Rabeprazolo TecniGen may lead to reduced magnesium levels in the blood: this reduction may cause serious symptoms such as fatigue, tetany (spasms and forced, involuntary muscle contractions), delirium, seizures, dizziness, and ventricular arrhythmia (a type of irregular heartbeat), or may begin insidiously.

If you are undergoing prolonged treatment or if you are taking Rabeprazolo TecniGen together with digoxin (a medicine used for heart conditions) or other medicines that may cause reduced magnesium levels in the blood (e.g. diuretics), your doctor may consider it appropriate to perform blood tests before starting treatment and periodically during treatment.

During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report such signs to your doctor.

Other medicines and Rabeprazolo TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Rabeprazolo TecniGen if you are pregnant or think you may be pregnant.
Do not use Rabeprazolo TecniGen if you are breastfeeding.

Driving and using machines
During treatment with Rabeprazolo TecniGen, you may experience drowsiness. If this occurs, do not drive and do not operate tools or machinery.

Rabeprazolo TecniGen contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Rabeprazolo TecniGen contains mannitol: it may have a mild laxative effect.

3. How to take Rabeprazole TecniGen

Take this medicine exactly as directed by your doctor or pharmacist. If you
are unsure, consult your doctor or pharmacist.
Administration of Rabeprazole TecniGen

• Remove the tablet from the blister pack just 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 advise you on how many tablets to take and for how long. This will depend on your condition.
• If you are taking this medicine for a prolonged period, your doctor will need to monitor you regularly.

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

• The recommended dose is 1 tablet of Rabeprazole TecniGen 20 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another four weeks if your condition has not improved.

Treatment of stomach ulcer (active benign gastric ulcer)

• The recommended dose is 1 tablet of Rabeprazole TecniGen 20 mg once daily for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe continuation of treatment for another six weeks if your condition has not improved.

Gastroesophageal reflux disease (GERD)
Treatment of moderate to very severe symptoms (symptomatic GERD)

• The recommended dose is 1 tablet of Rabeprazole TecniGen 10 mg once daily for four weeks.
• Take the tablet in the morning before breakfast.
• If symptoms persist after 4 weeks of treatment, your doctor will perform further investigations. After resolution of symptoms, your doctor may decide to restart treatment with 1 tablet of Rabeprazole TecniGen 10 mg if symptoms recur, for as long as deemed necessary.

Treatment of erosive or ulcerative symptomatic GERD

• The recommended dose is 1 tablet of Rabeprazole TecniGen 20 mg once daily for 4–8 weeks.
• Take the tablet in the morning before breakfast.

Long-term treatment of GERD (maintenance therapy for GERD)

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

Treatment and prevention of ulcers caused by Helicobacter pylori infection

• The recommended dose is 1 tablet of Rabeprazole TecniGen 20 mg twice daily for seven days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin. For further information on the other medicines used in the treatment of Helicobacter pylori infection, please refer to their respective package leaflets.

Treatment of Zollinger-Ellison syndrome, a condition in which the stomach produces very high amounts of acid.

• It is recommended to start treatment with 3 tablets of Rabeprazole TecniGen 20 mg once daily.
• The dose may subsequently be adjusted by your doctor according to your response to treatment. If you are on long-term treatment, you will need to see your doctor at regular intervals to monitor symptoms and review the dose.

Use in children
This medicine must not be used in children.
Patients with renal problems
No dosage adjustments are necessary in patients with kidney problems.
Patients with hepatic problems
If you have liver problems, you must consult your doctor, who will exercise particular caution at the start of your treatment with Rabeprazole TecniGen and throughout the therapy.

If you take more Rabeprazole TecniGen than you should
Contact your doctor or pharmacist immediately if you take more Rabeprazole TecniGen than you should.

If you forget to take Rabeprazole TecniGen
If you forget to take a dose, take the tablet as soon as you remember and continue your treatment as usual. Do not take the missed tablet if it is almost time for your next dose.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rabeprazole TecniGen
Do not stop taking Rabeprazole TecniGen gastro-resistant tablets just because you feel better, before your doctor tells you to do so, as you may not yet be cured.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, stop treatment with Rabeprazole TecniGen and inform your doctor:
Allergic reactions, symptoms of which may include sudden swelling of the face, difficulty breathing, or low blood pressure that may cause fainting or collapse.
Frequent infections, such as sore throat, high temperature (fever), or mouth or throat ulcers.
Frequent bruising or bleeding.
Severe blistering reactions, redness, or mouth and throat ulcers.

The following side effects have been observed with Rabeprazole TecniGen:

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.
Infection of the upper respiratory tract (bronchitis).
Inflammation of the sinuses (sinusitis).
Dry mouth.
Stomach discomfort due to digestive problems (dyspepsia), belching.
Skin rash or redness.
Muscle pain, leg cramps, joint pain.
Fracture of the hip, wrist, or spine (see Warnings and precautions).
Bladder and urinary tract infection.
Chest pain.
Chills or fever.
Abnormal liver function test results.

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).
Reduced platelet count (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 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 the 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 pains (subacute cutaneous lupus erythematosus).
Inflammation of the intestine (causing diarrhoea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Rabeprazole TecniGen

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 substance is sodium rabeprazole.
Each Rabeprazolo TecniGen 10 mg tablet contains 10 mg of sodium rabeprazole as the active substance.
Other excipients are:
mannitol, trisodium phosphate, magnesium oxide, low-substituted hydroxypropylcellulose H-11, hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Aerosil 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 sodium rabeprazole as the active substance.
The excipients are:
mannitol, trisodium phosphate, magnesium oxide, low-substituted hydroxypropylcellulose H-11, hypromellose, magnesium stearate, crospovidone, colloidal silicon dioxide (Aerosil 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 contents of the pack.
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 blisters made of polyamide/aluminum/PVC/AL, containing 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

This Patient Information Leaflet was last revised on