Rabeprazole Tecnigen 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazol TecniGen 20 mg gastro-resistant tablets EFG

Sodium rabeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

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

Rabeprazol TecniGen contains the active ingredient sodium rabeprazole. Rabeprazole belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazol is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include heartburn. GERD is caused by the backflow of acid and food from the stomach into the esophagus.

• Stomach ulcers or ulcers in the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), antibiotic treatment will be required. Taking Rabeprazol TecniGen together with antibiotics will eliminate the infection and allow the ulcer to heal. It will also prevent recurrence of the infection and ulcer.

• Zollinger-Ellison syndrome, a condition characterized by the production of very high levels of acid in the stomach.

2. What you need to know before starting to take Rabeprazol TecniGen

Do not take Rabeprazol TecniGen

• If you are allergic to sodium rabeprazole or to any of the other components of Rabeprazol TecniGen (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

Do not take Rabeprazol TecniGen if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Rabeprazol TecniGen.

See also the section on Pregnancy and breastfeeding.

Children

Should not be administered to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol TecniGen:

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".
• If liver or blood problems have occurred in some patients, although these often improve when treatment with Rabeprazol TecniGen is discontinued.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medication for HIV/AIDS.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol TecniGen used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol TecniGen. Remember to mention any other symptoms you may experience, such as joint pain.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before taking Rabeprazol.

If you experience severe diarrhea (watery or bloody) accompanied by symptoms such as fever or abdominal pain or tenderness, stop taking Rabeprazol TecniGen and see your doctor immediately.

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

Use of Rabeprazol TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole or itraconazole, medications used to treat fungal infections. Rabeprazol may reduce the blood levels of these medications. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV/AIDS. Rabeprazol may reduce blood levels of this type of medication and therefore they should not be used together.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before taking Rabeprazol.

Pregnancy, breastfeeding, and fertility

• Do not take Rabeprazol if you are pregnant or think you may be pregnant.
• Do not take Rabeprazol while breastfeeding or if you plan to start breastfeeding.

Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.

Driving and using machines

You may feel drowsy while taking Rabeprazol. If this occurs, do not drive or operate tools or machinery.

Warnings about excipients:

May have a mild laxative effect because it contains mannitol.

3. How to take Rabeprazole TecniGen

Follow exactly the instructions for the use of Rabeprazole TecniGen provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Remove one tablet from the blister pack only when it is time to take your medicine.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets you should take and how long your treatment should last, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you.

Adults and elderly patients

For gastroesophageal reflux disease (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is one Rabeprazole TecniGen 10 mg tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms return after 4 weeks of treatment, your doctor may instruct you to take one Rabeprazole TecniGen 10 mg tablet as needed ("on-demand").

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is one Rabeprazole TecniGen 20 mg tablet once daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The recommended dose is one Rabeprazole TecniGen 10 mg or 20 mg tablet once daily for as long as your doctor has instructed.
• Take the tablet in the morning before eating.
• Your doctor will want to see you at regular intervals to monitor your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The recommended dose is one Rabeprazole TecniGen 20 mg tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Rabeprazole TecniGen for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The recommended dose is one Rabeprazole TecniGen 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Rabeprazole TecniGen for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. pylori infection and to prevent relapses

• The recommended dose is one Rabeprazole TecniGen 20 mg tablet twice daily for 7 days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin.

For more information about the other medicines used to treat H. pylori, please read the package leaflets for each of them.

Zollinger-Ellison syndrome, a condition in which the stomach produces excess acid

• The recommended starting dose is three Rabeprazole TecniGen 20 mg tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment.

If you are on long-term treatment, you will need to see your doctor at regular intervals to review your dose and symptoms.

Use in children. This medicine should not be given to children.

Patients with liver problems. Consult your doctor, who will exercise special caution when starting and during treatment with Rabeprazole TecniGen.

If you take more Rabeprazole TecniGen than you should

If you take more Rabeprazole TecniGen than prescribed, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Telephone: 91 5620420).

If you forget to take Rabeprazole TecniGen

• If you forget to take a tablet, take one as soon as you remember, and then continue as usual. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.
• If you have missed taking your medicine for more than 5 days, consult your doctor before taking any more medicine.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Rabeprazole TecniGen

Symptom relief usually occurs before the ulcer has completely healed.

It is important not to stop treatment until your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rabeprazol TecniGen can cause adverse effects, although not everyone experiences them.

Adverse effects are usually mild and improve without you needing to stop treatment.

Stop taking Rabeprazol TecniGen and see your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reactions – signs 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 or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or bleeding easily.

These adverse effects are rare (affect fewer than 1 in 1,000 people).

• Severe blistering of the skin, or sores or ulcers in your mouth and throat.

These adverse effects are very rare (affect fewer than 1 in 10,000 people).

Other possible adverse effects:

Frequent (affect fewer than 1 in 10 people)

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, runny nose, or sore throat (pharyngitis).
• Effects on your stomach or intestine such as stomach pain, diarrhea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation.
• Aches or back pain.
• Weakness or flu-like symptoms (flu-like symptoms).
• Benign polyps in the stomach.

Uncommon (affect fewer than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or burping.
• Skin rash or redness.
• Muscle, leg, or joint pain.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).
• If you are taking proton pump inhibitors such as Rabeprazol TecniGen, especially for more than one year, there may be a slight increase in the risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Rare (affect fewer than 1 in 1,000 people)

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach disorder or stomach pain.
• Liver problems, including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections.
• Decrease in blood platelets which may cause bleeding or bruising more easily than normal.

Other possible adverse effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures, and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).
• If you are taking Rabeprazol TecniGen for more than three months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea).

Do not be alarmed by this list of adverse effects. You may not experience any of them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Rabeprazol TecniGen

Keep out of the sight and reach of children.

Do not store above 30 °C.

Do not refrigerate.

Do not use Rabeprazol TecniGen after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Rabeprazol TecniGen

• The active substance is sodium rabeprazole. Each tablet of Rabeprazol TecniGen contains 10 milligrams of sodium rabeprazole as the active substance.

• The other components (excipients) are:
  Core: mannitol, trisodium phosphate, magnesium oxide, hydroxypropylmethylcellulose, low-substituted hydroxypropylcellulose, crospovidone, colloidal silicon dioxide, magnesium stearate.
  Coating: ethylcellulose, magnesium oxide, Eudragit L100 55, triethyl citrate, talc, titanium dioxide (E171), iron oxide red (E172).

Appearance of the medicinal product and contents of the container

Rabeprazol TecniGen 10 mg gastro-resistant tablets are presented as pink, round, biconvex tablets, not scored, in packs of 28 tablets.

Other pack sizes:

Rabeprazol TecniGen 20 mg gastro-resistant tablets: packs of 14, 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, nº 13. 3ºD
28108 - Alcobendas (Madrid)

Manufacturer:

Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid

This leaflet was approved in September 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/