PATIENT INFORMATION LEAFLET

Rabeprazol TecniGen 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

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

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

2.What you need to know before you start taking Rabeprazol TecniGen

3.How to take Rabeprazol TecniGen

4.Possible side effects

5.Storage of Rabeprazol TecniGen

6.Contents of the pack and additional information

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

Rabeprazol is used to treat:

• “Gastroesophageal reflux disease” (GERD), which may include the appearance of

acid reflux. The cause of GERDis the passage of acid and food from the stomach into the

esophagus.

• Stomach ulcers or ulcers in the upper part of the small intestine (duodenal ulcers). If these

ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori),

you will need to take antibiotics. Taking Rabeprazol TecniGen and the antibiotics

together will eliminate the infection and the ulcer will heal. It will also prevent the infection and the reoccurrence of the ulcer.

• Zollinger-Ellison syndrome, a disease characterized by the production of

very high amounts of acid in the stomach.

Do not take Rabeprazol TecniGen

•If you are allergic to rabeprazol sodium, 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 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 Pregnancy and breastfeeding section.

Children

It 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 benzimidazoles".

Inform your doctor or pharmacist if you have experienced liver and blood problems in some patients but often improve when treatment with Rabeprazol TecniGen is interrupted.

• 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 similar medication to Omeprazol TecniGen for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina A)

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

If you are unsure whether the above affects you, consult your doctor or pharmacist before taking Rabeprazol.

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

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

Use of Rabeprazol TecniGen with other medications

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole or itraconazole, medications for fungal infections. Rabeprazol may decrease the amount of these medications in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used for HIV/AIDS treatment. Rabeprazol may decrease the amount of this type of medication in the blood, so they should not be used together.

If you are unsure whether the above affects 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 during breastfeeding or if you plan to start breastfeeding.

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

Driving and operating machinery

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

Warnings about excipients:

It may cause a mild laxative effect because it contains mannitol.

Follow exactly the administration instructions of Rabeprazol TecniGen indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Medication intake

• Only remove one tablet from the blister when it is time to take your medication.
• Swallow the tablet whole with a little water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and the duration of your treatment, which will depend on your indication.
• If you are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly patients

Gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• The recommended dose is one Rabeprazol TecniGen 10 mg tablet once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms recur after 4 weeks of treatment, your doctor will tell you to take one Rabeprazol TecniGen 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

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

Maintenance treatment of symptoms (GERD maintenance)

• The recommended dose is one Rabeprazol TecniGen 10 mg or 20 mg tablet once a day for as long as your doctor has indicated.
• Take the tablet in the morning before eating.
• Your doctor will want to see you at regular intervals to check your symptoms and dose.

For stomach ulcers (peptic ulcers)

• The recommended dose is one Rabeprazol TecniGen 20 mg tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol TecniGen for another 6 weeks if your symptoms do not improve.

For duodenal ulcers

• The recommended dose is one Rabeprazol TecniGen 20 mg tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol TecniGen for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. Pylori infection and to prevent recurrences

• The recommended dose is one Rabeprazol TecniGen 20 mg tablet twice a day for 7 days.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

For more information on other medications used to treat H. pylori, read the prospectus for each one.

Zollinger-Ellison syndrome, where excess acid is produced in the stomach

• The recommended dose is three Rabeprazol TecniGen 20 mg tablets once a day initially.
• The dose may be adjusted by your doctor depending on how you respond to treatment.

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

Use in children.This medication should not be administered to children.

Patients with liver problems.Consult your doctor, who will have special care in the initiation and during treatment with Rabeprazol TecniGen.

If you take more Rabeprazol TecniGen than you should

If you take more Rabeprazol TecniGen than you should, talk to your doctor or go to the hospital immediately. Bring the medication with you.

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

If you forget to take Rabeprazol TecniGen

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

If you interrupt treatment with Rabeprazol TecniGen

Relief of symptoms usually occurs before the ulcer is completely healed.

It is essential not to interrupt treatment until your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Rabeprazol TecniGen can cause side effects, although not everyone will experience them.

Side effects are usually mild and improve without you stopping treatment.

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

• Allergic reactions - symptoms may include: sudden swelling of your face, difficulty breathing or low blood pressure that can cause dizziness or fainting.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Cardenials or easy bleeding.

These side effects are rare (affect less than 1 in 1,000 people).

• Severe blisters on your skin, or sores or ulcers in your mouth and throat.

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

Other possible side effects:

Frequent (affect less than 1 in 10 people)

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

Rarely (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Blocked and painful sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Rash on the skin or redness.
• Muscle pain, leg pain or joint pain.
• 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 a year, you may slightly increase the risk of hip, wrist and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

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

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disorders.
• Stomach upset or stomach pain.
• Liver problems that include yellowing of the skin and white of the eyes (jaundice).
• Itching or blistering rash.
• Sweating.
• Renal problems.
• Weight gain.
• Changes in white blood cells in the blood (shown in blood tests) that can cause frequent infections.
• Decreased platelets in the blood that can cause bleeding or the appearance of bruises with increased ease.

Other possible side effects (frequency unknown)

• Swelling of the breasts in men.
• Fluid retention.
• Low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions and coma.
• Patients who have previously had liver problems, may develop a very rare encephalopathy (brain disease).
• If you are taking Rabeprazol TecniGen for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels 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 worry about the list of side effects. You may not experience any of them.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Keep out of the sight and reach of children.

Do not store at a temperature above 30 °C.

Do not refrigerate.

Do not use Rabeprazol TecniGen after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rabeprazol TecniGen

- The active ingredient is rabeprazol sodium. Each Rabeprazol TecniGen tablet contains 10 milligrams of rabeprazol sodium as the active ingredient

- 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 (E 172).

Appearance of the product and content of the packaging

Rabeprazol TecniGen 10 mg gastro-resistant tablets are presented as round, biconvex, pink tablets, without scoring in packs of 28 tablets.

Other presentations:

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

Holder of the marketing authorization and Responsible for manufacturing:

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Responsible for manufacturing:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

This prospectus was approved in September 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/