Rabeprazole Tarbis 10 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rabeprazol Tarbis 10 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rabeprazol Tarbis contains the active ingredient sodium rabeprazole. 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 heartburn. GERD is caused by stomach acid and food moving back 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 Pariet together with antibiotics eradicates the infection and allows the ulcer to heal. It also prevents recurrence of the infection and ulcer.
• Zollinger-Ellison syndrome, a condition characterized by the production of very high amounts of acid in the stomach.

You should speak to a doctor if your condition worsens or does not improve.

2. What you need to know before taking Rabeprazol Tarbis

Do not take Rabeprazol Tarbis:

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

Do not take sodium rabeprazole 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

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

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".

• If liver and blood problems have occurred in some patients, but often improve when treatment with Pariet is stopped.

• If you have a stomach tumor.

• If you have ever had liver problems.

• If you are taking atazanavir, a medicine used to treat HIV infection.

• If you have reduced body stores or risk factors associated with low levels of vitamin B12 and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12.

• This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy

• Tingling sensations

• Sore or red tongue, mouth ulcers

• Muscle weakness

• Changes in vision

• Memory problems, confusion, depression

• If you have ever had a skin reaction after treatment with a medicine similar to Pariet used to reduce stomach acid.

• If you develop a skin rash, especially on areas of skin exposed to sunlight, 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 (chromogranin A).

• During treatment with rabeprazole, inflammation of the kidney 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 should report these signs to your doctor.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking sodium rabeprazole.

Children

Rabeprazol Tarbis must not be given to children.

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

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

Taking Rabeprazol Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as well as herbal 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. Sodium rabeprazole may reduce blood levels of these medicines. Your doctor may need to adjust your dose.

• Atazanavir, a medicine used to treat HIV infection. Pariet may reduce blood levels of this type of medicine and therefore 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 whether any of the above apply to 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 while breastfeeding or if you plan to start breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 occurs, do not drive or operate tools or machinery.

Rabeprazol Tarbis contains sodium

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

3. How to take Rabeprazol Tarbis

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Remove a 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

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

For gastroesophageal reflux disease (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

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

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one 20 mg rabeprazole sodium 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 usual dose is one 10 mg or 20 mg rabeprazole sodium tablet once daily 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 dosage.

For stomach ulcers (peptic ulcers)

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

For intestinal ulcers (duodenal ulcers)

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

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

• The usual dose is one 20 mg rabeprazole sodium tablet twice daily for seven days.
• Your doctor will also instruct you to take 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, in which excess stomach acid is produced

• The usual starting dose is three 20 mg rabeprazole sodium 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.

Patients with liver problems: Consult your doctor, who will exercise special caution when starting and during treatment with rabeprazole sodium.

If you take more Rabeprazol Tarbis than you should:

If you take more rabeprazole sodium than you should, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 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, then continue as usual. However, if it is almost time for your next dose, simply skip the missed dose and continue with your regular schedule.

If you have forgotten to take 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 missed doses.

If you stop taking Rabeprazol Tarbis:

Symptom relief usually occurs before the ulcer has completely healed. It is important that you do not stop treatment until your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Stop taking Rabeprazol Tarbis and contact 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 your face, difficulty breathing, or low blood pressure which may cause fainting or collapse
• Frequent infections, such as sore throat or high temperature (fever), or mouth or throat ulcers
• Bruising or easy bleeding

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

Uncommon (affect fewer than 1 in 100 people):

• Feeling nervous, drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion or burping
• Skin rash or redness
• Muscle, leg or joint pain
• Fractures in the hip, wrist or spine
• Bladder 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 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
• Decreased 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
• Inflammation of the intestine (leading to diarrhoea)
• Low levels of sodium in the blood which may cause tiredness, confusion, muscle spasms, seizures and coma
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease)
• Skin rash, possibly with joint pain

If you take sodium rabeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Don't be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Tarbis

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Tarbis

The active substance is sodium rabeprazole.

Each Rabeprazol Tarbis 10 mg tablet contains 10 mg of sodium rabeprazole, equivalent to 9.42 mg.

The other components are:

Tablet core: mannitol (E421), magnesium oxide (E530), hydroxypropylcellulose (E463), magnesium stearate (E572).

Intermediate layer: ethylcellulose, magnesium oxide.

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

Appearance of the medicine and contents of the pack

Rabeprazol Tarbis 10 mg gastro-resistant tablets: coated, pink-colored, round tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 European Economic Area member states under the following names:

Date of the most recent revision of this leaflet: July 2022

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