Package Insert: Information for the Patient

Rabeprazol Tarbis 20 mg Gastrorresistant Tablets EFG

Rabeprazol sodium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Rabeprazol Tarbis and how is it used

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

3. How to take Rabeprazol Tarbis

4. Possible adverse effects

5. Storage of Rabeprazol Tarbis

6. Contents of the package and additional information

Rabeprazol Tarbis contains the active ingredient rabeprazol sodium. It 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 Tarbis tablets are used for the treatment of:

• “Gastroesophageal Reflux Disease” (GERD), which may include the appearance of acid reflux. The cause of GERD is the passage of acid and food from the stomach into the esophagus.
• Stomach ulcers or ulcers of 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 Pariet and antibiotics together will eliminate the infection and the ulcer will heal. It will also prevent the infection and the recurrence of the ulcer.
• Zollinger-Ellison syndrome, a disease characterized by the production of very high amounts of acid in the stomach.

You should speak with a doctor if you worsen or do not improve.

Do not take Rabeprazol Tarbis:

• if you are allergic (hypersensitive) to rabeprazol sodium, or to any of the excipients of this medication (listed in section 6).
• if you are pregnant, or think you may be pregnant.
• if you are breastfeeding.

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

Warnings and precautions

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

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".
• If you have seen liver and blood problems in some patients, but often improve when treatment with Pariet is stopped.
• If you have a stomach tumor.
• If you have had any liver problems.
• If you are taking atazanavir, a medication for HIV infection.
• If you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced B12 absorption.
• This medication may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Inform your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy
• Tickling
• Painful or red tongue, mouth ulcers
• Weak muscles
• Altered vision
• Memory problems, confusion, depression

• If you have ever had a skin reaction after treatment with a similar medication to Pariet for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with Pariet. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).
• 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 your doctor of these signs.

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

Children

Rabeprazol Tarbis should not be administered to children.

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

Taking a proton pump inhibitor like rabeprazol sodium, especially for more than a year, may slightly increase the risk of fractures in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Use of Rabeprazol Tarbis with other medications

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

In particular, inform your doctor or pharmacistif you are taking any of the following medications:

Ketoconazole or itraconazole, medications for fungal infections.Rabeprazol sodium may decrease the amount of these medications in the blood. Your doctor may need to adjust your dose.

-Atazanavir, a medication used to treat HIV infection. Pariet may decrease the amount of this type of medication in the blood, so they should not be used together.

Methotrexate (a chemotherapy medication used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Rabeprazol Tarbis.

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

Pregnancy, breastfeeding, and fertility

- Do not take Rabeprazol Tarbis if you are pregnant or think you may be pregnant.

- Do not take Rabeprazol Tarbis during breastfeeding or if you plan to start breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Rabeprazol Tarbis contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

• Only remove one tablet from the blister pack 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

The following doses are generally recommended for adults and elderly patients. Do not change the dose or duration of treatment yourself.

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• The usual dose is one 10 mg rabeprazole sodium 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 10 mg rabeprazole sodium tablet when needed ("on demand")

Treatment of more severe symptoms (GERD erosive or ulcerative)

• The usual dose is one 20 mg rabeprazole sodium tablet once a day for 4 to 8 weeks
• Take the tablet in the morning before eating

Maintenance treatment of symptoms (GERD maintenance)

• The usual dose is one 10 mg or 20 mg rabeprazole sodium 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 usual dose is one 20 mg rabeprazole sodium tablet once a day for 6 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take rabeprazole sodium for another 6 weeks if your symptoms do not improve

For duodenal ulcers

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

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

• The usual dose is one 20 mg rabeprazole sodium 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 package inserts for each one

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

• The usual dose is three 20 mg rabeprazole sodium 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.

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

If you take more Rabeprazol Tarbis than you should:

If you take more rabeprazole sodium 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rabeprazol Tarbis:

If you forget to take a tablet, take it as soon as you remember and then continue with your usual schedule.

However, if it is almost time to take the next tablet, simply skip the missed tablet and continue with your usual schedule

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 doses.

If you interrupt treatment with Rabeprazol Tarbis:

The relief of symptoms usually occurs before the ulcer has completely healed. It is essential not to interrupt treatment until your doctor tells you to

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Stop taking Rabeprazol Tarbis and see your doctor immediately if you noticeany 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
• Cardenals 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, dizziness.

• Cough, runny nose, sore throat (pharyngitis).

•Effects on your stomach or intestine such as stomach pain, diarrhea, gas (flatulence), feeling sick (nauseas), being sick (vomiting) or constipation.• Back pain or back pain.

•Weakness or flu-like symptoms (pseudogripal).

• Benign polyps in the stomach.

Occasional(affect less than 1 in 100 people):

• Feeling nervous, drowsy.

• Chest infection (bronchitis)

• Sinus pain and blocked (sinusitis)

• Dry mouth

• Indigestion or belching

• Skin rash or redness

• Muscle pain, leg pain or joint pain

• Fractures in the hip, wrist and spine

• Urinary tract infection (urinary tract infection)

• Chest pain

• Chills or fever

• Changes in liver function (shown in blood tests)

Rare(may affect up to 1 in 1,000 people):

• Loss of appetite (anorexia).

• Depression.

• Hypersensitivity (including allergic reactions)

• Visual disturbances.

• Inflamed mouth (stomatitis) or taste disorders

• Stomach problems or stomach pain

• Liver problems that include yellowing of the skin and white of the eyes (jaundice)

• Itching or blistering rash

• Sweating

• Kidney problems

• Weight gain

• Changes in white blood cells in the blood (shown in blood tests) that may cause frequent infections

• Decreased platelets in the blood that may cause bleeding or the appearance of bruises with increased ease

Other possible side effects (unknown frequency)

• Swelling of the breasts in men

• Fluid retention

• Inflammation of the intestine (which leads to diarrhea)

• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, • convulsions and coma

• Patients who have previously had liver problems, may develop very rarely a • encephalopathy (brain disease)

• Skin rash, possibly with joint painIf you take rabeprazol sodium for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Do not worry about the list of side effects. You may not experience any of them.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above30 °C. Store in the original packaging to protect from light and moisture.

Do not use this medication if you observe the packaging with signs of manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rabeprazol Tarbis

The active ingredient is rabeprazol sodium.

Each Rabeprazol Tarbis 20 mg tablet contains 20 mg of rabeprazol sodium, equivalent to 18.85 mg

The other components are:

Tablet core: mannitol (E421), magnesium oxide (E530), hydroxypropylcellulose (E463), magnesium stearate (E462).

Intermediate layer: ethylcellulose, magnesium oxide.

Tablet coating: hypromellose phthalate, dibutyl sebacate, iron oxide red (E172), titanium dioxide (E171), talc.

Appearance of the product and contents of the packaging

Rabeprazol Tarbis 20mg gastro-resistant tablets: coated, pink, round.

The packaging contains blisters of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, and 120 tablets.

It is possible that not all presentations are marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: July 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/