RABEPRAZOL TARBIS 20 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information Leaflet

Rabeprazol Tarbis 20 mg Gastro-Resistant Tablets EFG

rabeprazol sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

• “Gastroesophageal Reflux Disease” (GERD), which may include the occurrence of acidity. The cause of GERD is the passage of acid and food from the stomach into the esophagus.
• Stomach ulcers or ulcers in the upper part of the intestine (duodenal). If these ulcers are infected with a bacterium 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 stop 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 talk to a doctor if your symptoms worsen or do not improve.

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

Do not take Rabeprazol Tarbis:

• if you are allergic (hypersensitive) to rabeprazol sodium or any of the excipients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breast-feeding.

Do not take rabeprazol sodium if you are in any of the above situations. If you are not sure, 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 benzimidazoles”
• If liver and blood problems have been seen in some patients but often improve when treatment with Pariet is interrupted.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have reduced body stores or have risk factors associated with reduced vitamin B12 and receive long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced absorption of vitamin B12.
• This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Let your doctor know if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

• If you have ever had a skin reaction after treatment with a medicine similar to Pariet to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt 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 (Chromogranin A).
• During treatment with rabeprazol, kidney inflammation may occur. The 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 should report these signs to your doctor.

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

Children

Rabeprazol Tarbis should not be given 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 fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Using Rabeprazol Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, including herbal medicines.

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

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

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

Methotrexate (a chemotherapy medicine 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 any of the above, consult your doctor or pharmacist before taking Rabeprazol Tarbis.

Pregnancy, breast-feeding, and fertility

• Do not take Rabeprazol Tarbis if you are pregnant or think you may be pregnant.
• Do not take Rabeprazol Tarbis during breast-feeding or if you plan to start breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy while taking Rabeprazol Tarbis. If this happens, do not drive or use tools or machines.

Rabeprazol Tarbis contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Rabeprazol Tarbis

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Taking this medicine

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

Treatment of moderate to severe symptoms (Symptomatic GERD)

• The usual dose is one tablet of rabeprazol sodium 10 mg once a day for up to 4 weeks
• Take the tablet in the morning before eating
• If your symptoms return after 4 weeks of treatment, your doctor will tell you to take one tablet of rabeprazol sodium 10 mg when needed (“on demand”)

Treatment of more severe symptoms (Erosive or Ulcerative GERD)

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

Long-term treatment of symptoms (Maintenance GERD)

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

For ulcers in the intestine (duodenal ulcers)

• The usual dose is one tablet of rabeprazol sodium 20 mg once a day for 4 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take rabeprazol 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 tablet of rabeprazol sodium 20 mg twice a day for 7 days
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin

For more information about the other medicines used to treat H. pylori, read the leaflets for each of them Zollinger-Ellison Syndrome where there is an excess of acid in the stomach

• The usual dose is three tablets of rabeprazol sodium 20 mg 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 and symptom review.

Patients with liver problems.Consult your doctor, who will take special care when starting and during treatment with rabeprazol sodium.

If you take more Rabeprazol Tarbis than you should:

If you take more rabeprazol sodium than you should, talk to your doctor or go to a hospital immediately. Bring the medicine 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 medicine 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 as usual.

However, if it is almost time for your next dose, simply skip the missed dose and continue as usual.

If you forget to take your medicine for more than 5 days, consult your doctor before taking more medicine.

Do not take a double dose (two doses at the same time) to make up for missed doses.

If you stop taking Rabeprazol Tarbis:

Relief of symptoms usually occurs before the ulcer is completely healed. It is important that you do not stop treatment until your doctor tells you to

If you have any other questions 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.

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

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

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

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

• Severe skin blisters, 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:

Common(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 (nausea), being sick (vomiting), or constipation. Back pain or pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Uncommon(affect less than 1 in 100 people):

• Feeling nervous, drowsy.
• Chest infection (bronchitis)
• 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):

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

Other possible side effects (frequency not known)

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhea)
• Low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma
• Patient who have previously had liver problems, may very rarely develop encephalopathy (brain disease)
• Skin rash, possibly with joint pain If you take rabeprazol sodium for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, please inform your doctor immediately. Low magnesium levels can also lead to reduced 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Rabeprazol Tarbis

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

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

Do not store above 30 ºC. Store in the original packaging to protect from light and moisture.

Do not use this medicine if you notice signs of tampering with the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Rabeprazol Tarbis

The active ingredient is rabeprazol sodium.

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

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, red iron oxide (E172), titanium dioxide (E171), talc.

Appearance of the product and packaging content

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

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

Not all presentations may be marketed.

Marketing authorization holder and manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: July 2023

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